Interventional Cardiology & Surgery

As the rigor of COVID-19 research comes under increasing scrutiny, a deep dive into contemporary trials of invasive cardiovascular interventions finds intricate ties with industry and the art of spin on full display.

After examining 216 randomized, controlled trials published in the past decade, researchers found that more than half (53.2%) were commercially funded. In 18.3% of these trials, the sponsor was involved with the trial conduct and reporting.

Commercially sponsored trials were significantly more likely to report results that favored the experimental therapy than trials without commercial sponsorship (64.3% vs. 48.5%; P = .02).

The association remained statistically significant after adjustment for differences in trial characteristics (exponent of regression coefficient beta, 2.80; 95% confidence interval, 1.09-7.18; P = .03), the authors reported in JAMA Internal Medicine.

“To make this clear, this is not an attack on industry-sponsored trials,” study author and cardiac surgeon Mario Gaudino, MD, of New York–Presbyterian and Weill Cornell Medical Center, New York, said in an interview. “Because industry has more money, they have the best trialists, the best research organization. So they generally do a pretty good trial; they’re larger, they have a higher Fragility Index, which means they’re more solid.

“And, most importantly, more than half of the trials were sponsored by industry,” he said. “So without industry, there wouldn’t be half the research in that 10-year period we explored.”

Previous research in cardiology and in other fields has shown that trials supported by for-profit organizations are more likely to report positive findings. The explanations often focus on bias and differential quality in how the trials were designed and reported.

In the present analysis, however, the authors found no difference between trials with and without industry funding in terms of estimated treatment effect, length of follow-up, use of composite or clinically significant outcomes, or outcome modification, compared with the published protocol.

Part of the explanation may be that industry-sponsored trials more often used a noninferiority design (26.1% vs. 14.9%) and had a higher loss of patients to follow-up (median of sample, 1.0% vs. 0.1%), Dr. Gaudino said. “But I think more, in general, it’s not so much a difference in the measurable characteristics of the trial. It’s the selection of the sites that participate, the patient population that is targeted that makes the trial very likely to get the result that industry would like to see.”

“Just think of the differences in the transcatheter MitraClip results between MITRA-FR and COAPT – basically they were related to the fact they enrolled different patients,” he said.
 

Significant spin

The analysis included 216 coronary, vascular, and structural interventional cardiology and vascular and cardiac surgical randomized, controlled trials published from January 2008 to May 31, 2019. Most were multicenter trials (78.7%); 58% originated from Europe, 12% from North America, and 10.6% from Asia.

One in six trials (16.2%) were not prospectively registered before the start of enrollment, and at least one major discrepancy existed between the registered and published primary outcome in 38% of registered trials.

“If you don’t register the trial then you can make all the changes you want to the protocol up until the moment you publish,” Dr. Gaudino observed. “There really is no rational justification for not registering a trial.”

Overall, the trials were not particularly robust, he noted. In 62 trials in which the Fragility Index was measured, only a median of five patients experiencing a different outcome in a commercially sponsored trial would change statistically significant results to nonsignificant. For noncommercially sponsored trials, that number was 4.5 and in four trials; the change in condition of only one patient was needed to switch the statistical significance.

“This finding is concerning given the substantial role that [randomized, controlled trials] results play in federal device approvals, payer criteria, and clinical consensus guidelines,” the authors wrote.

The authors also looked for interpretation bias in the trials. In the 84 trials with nonsignificant differences in the primary outcomes, 65.5% contained spin, such as focusing on statistically significant secondary outcomes or interpreting nonsignificant primary outcomes as showing treatment equivalence or comparable effectiveness. Spin was present in 80.6% of the trials with commercial sponsorship and in 54.2% without (P = .02) – a finding that remained significant after trial differences were controlled for (beta, 4.64; 95% CI, 1.05-20.54; P = .04).
 

A pivot point

“It’s just another paper showing there are issues with conflicts of interest in industry trials. I’m not particularly surprised,” said David Moher, PhD, MSc, director of the Centre for Journalology, based at the Ottawa Hospital Research Institute.

“It’s sort of high time people from all sides sat down together and tried to resolve how to actually move forward with industry wanting to do trials,” he said. “They are hugely important in drug development. How can these trials be done where the impact of industry and, for that matter, academia is minimized?”

Dr. Gaudino suggested the “ideal situation” would be to have industry put its funding into an existing funding organization, such as the National Institutes of Health or a newly created independent organization – a concept that has been floated before without much forward movement.

“We may be at a pivot point,” Dr. Moher said. “It’s quite clear that COVID has indicated some serious problems with how trials are done, how they’re disseminated, the notion of open science. I think this could be an opportunity. Whether there is so much noise, whether anybody will be able to take any of these initiative forward, I don’t know.”

No matter how trial funding is revised, patients must be brought to the table, he said.

“What frustrates me quite a bit is this almost parental view of all of this – the scientists know best, industry knows best,” Dr. Moher said. “We actually need the most important groups: patients and the public. They need to have an enormous amount of say in how this actually is formed.”

Commenting further, Dr. Moher said that “industry and academia can only do trials when they have patients willing to participate, and yet in the discussions you and I are having, what do patients think about spin in trials? I would imagine they would be horrified that they are going into studies – in a sense in many cases risking their lives – and yet people are spinning the results.”

Dr. Gaudino and Dr. Moher reported having no relevant conflicts of interest.

A version of this story originally appeared on Medscape.com.

As the rigor of COVID-19 research comes under increasing scrutiny, a deep dive into contemporary trials of invasive cardiovascular interventions finds intricate ties with industry and the art of spin on full display.

After examining 216 randomized, controlled trials published in the past decade, researchers found that more than half (53.2%) were commercially funded. In 18.3% of these trials, the sponsor was involved with the trial conduct and reporting.

Commercially sponsored trials were significantly more likely to report results that favored the experimental therapy than trials without commercial sponsorship (64.3% vs. 48.5%; P = .02).

The association remained statistically significant after adjustment for differences in trial characteristics (exponent of regression coefficient beta, 2.80; 95% confidence interval, 1.09-7.18; P = .03), the authors reported in JAMA Internal Medicine.

“To make this clear, this is not an attack on industry-sponsored trials,” study author and cardiac surgeon Mario Gaudino, MD, of New York–Presbyterian and Weill Cornell Medical Center, New York, said in an interview. “Because industry has more money, they have the best trialists, the best research organization. So they generally do a pretty good trial; they’re larger, they have a higher Fragility Index, which means they’re more solid.

“And, most importantly, more than half of the trials were sponsored by industry,” he said. “So without industry, there wouldn’t be half the research in that 10-year period we explored.”

Previous research in cardiology and in other fields has shown that trials supported by for-profit organizations are more likely to report positive findings. The explanations often focus on bias and differential quality in how the trials were designed and reported.

In the present analysis, however, the authors found no difference between trials with and without industry funding in terms of estimated treatment effect, length of follow-up, use of composite or clinically significant outcomes, or outcome modification, compared with the published protocol.

Part of the explanation may be that industry-sponsored trials more often used a noninferiority design (26.1% vs. 14.9%) and had a higher loss of patients to follow-up (median of sample, 1.0% vs. 0.1%), Dr. Gaudino said. “But I think more, in general, it’s not so much a difference in the measurable characteristics of the trial. It’s the selection of the sites that participate, the patient population that is targeted that makes the trial very likely to get the result that industry would like to see.”

“Just think of the differences in the transcatheter MitraClip results between MITRA-FR and COAPT – basically they were related to the fact they enrolled different patients,” he said.
 

Significant spin

The analysis included 216 coronary, vascular, and structural interventional cardiology and vascular and cardiac surgical randomized, controlled trials published from January 2008 to May 31, 2019. Most were multicenter trials (78.7%); 58% originated from Europe, 12% from North America, and 10.6% from Asia.

One in six trials (16.2%) were not prospectively registered before the start of enrollment, and at least one major discrepancy existed between the registered and published primary outcome in 38% of registered trials.

“If you don’t register the trial then you can make all the changes you want to the protocol up until the moment you publish,” Dr. Gaudino observed. “There really is no rational justification for not registering a trial.”

Overall, the trials were not particularly robust, he noted. In 62 trials in which the Fragility Index was measured, only a median of five patients experiencing a different outcome in a commercially sponsored trial would change statistically significant results to nonsignificant. For noncommercially sponsored trials, that number was 4.5 and in four trials; the change in condition of only one patient was needed to switch the statistical significance.

“This finding is concerning given the substantial role that [randomized, controlled trials] results play in federal device approvals, payer criteria, and clinical consensus guidelines,” the authors wrote.

The authors also looked for interpretation bias in the trials. In the 84 trials with nonsignificant differences in the primary outcomes, 65.5% contained spin, such as focusing on statistically significant secondary outcomes or interpreting nonsignificant primary outcomes as showing treatment equivalence or comparable effectiveness. Spin was present in 80.6% of the trials with commercial sponsorship and in 54.2% without (P = .02) – a finding that remained significant after trial differences were controlled for (beta, 4.64; 95% CI, 1.05-20.54; P = .04).
 

A pivot point

“It’s just another paper showing there are issues with conflicts of interest in industry trials. I’m not particularly surprised,” said David Moher, PhD, MSc, director of the Centre for Journalology, based at the Ottawa Hospital Research Institute.

“It’s sort of high time people from all sides sat down together and tried to resolve how to actually move forward with industry wanting to do trials,” he said. “They are hugely important in drug development. How can these trials be done where the impact of industry and, for that matter, academia is minimized?”

Dr. Gaudino suggested the “ideal situation” would be to have industry put its funding into an existing funding organization, such as the National Institutes of Health or a newly created independent organization – a concept that has been floated before without much forward movement.

“We may be at a pivot point,” Dr. Moher said. “It’s quite clear that COVID has indicated some serious problems with how trials are done, how they’re disseminated, the notion of open science. I think this could be an opportunity. Whether there is so much noise, whether anybody will be able to take any of these initiative forward, I don’t know.”

No matter how trial funding is revised, patients must be brought to the table, he said.

“What frustrates me quite a bit is this almost parental view of all of this – the scientists know best, industry knows best,” Dr. Moher said. “We actually need the most important groups: patients and the public. They need to have an enormous amount of say in how this actually is formed.”

Commenting further, Dr. Moher said that “industry and academia can only do trials when they have patients willing to participate, and yet in the discussions you and I are having, what do patients think about spin in trials? I would imagine they would be horrified that they are going into studies – in a sense in many cases risking their lives – and yet people are spinning the results.”

Dr. Gaudino and Dr. Moher reported having no relevant conflicts of interest.

A version of this story originally appeared on Medscape.com.

As the rigor of COVID-19 research comes under increasing scrutiny, a deep dive into contemporary trials of invasive cardiovascular interventions finds intricate ties with industry and the art of spin on full display.

After examining 216 randomized, controlled trials published in the past decade, researchers found that more than half (53.2%) were commercially funded. In 18.3% of these trials, the sponsor was involved with the trial conduct and reporting.

Commercially sponsored trials were significantly more likely to report results that favored the experimental therapy than trials without commercial sponsorship (64.3% vs. 48.5%; P = .02).

The association remained statistically significant after adjustment for differences in trial characteristics (exponent of regression coefficient beta, 2.80; 95% confidence interval, 1.09-7.18; P = .03), the authors reported in JAMA Internal Medicine.

“To make this clear, this is not an attack on industry-sponsored trials,” study author and cardiac surgeon Mario Gaudino, MD, of New York–Presbyterian and Weill Cornell Medical Center, New York, said in an interview. “Because industry has more money, they have the best trialists, the best research organization. So they generally do a pretty good trial; they’re larger, they have a higher Fragility Index, which means they’re more solid.

“And, most importantly, more than half of the trials were sponsored by industry,” he said. “So without industry, there wouldn’t be half the research in that 10-year period we explored.”

Previous research in cardiology and in other fields has shown that trials supported by for-profit organizations are more likely to report positive findings. The explanations often focus on bias and differential quality in how the trials were designed and reported.

In the present analysis, however, the authors found no difference between trials with and without industry funding in terms of estimated treatment effect, length of follow-up, use of composite or clinically significant outcomes, or outcome modification, compared with the published protocol.

Part of the explanation may be that industry-sponsored trials more often used a noninferiority design (26.1% vs. 14.9%) and had a higher loss of patients to follow-up (median of sample, 1.0% vs. 0.1%), Dr. Gaudino said. “But I think more, in general, it’s not so much a difference in the measurable characteristics of the trial. It’s the selection of the sites that participate, the patient population that is targeted that makes the trial very likely to get the result that industry would like to see.”

“Just think of the differences in the transcatheter MitraClip results between MITRA-FR and COAPT – basically they were related to the fact they enrolled different patients,” he said.
 

Significant spin

The analysis included 216 coronary, vascular, and structural interventional cardiology and vascular and cardiac surgical randomized, controlled trials published from January 2008 to May 31, 2019. Most were multicenter trials (78.7%); 58% originated from Europe, 12% from North America, and 10.6% from Asia.

One in six trials (16.2%) were not prospectively registered before the start of enrollment, and at least one major discrepancy existed between the registered and published primary outcome in 38% of registered trials.

“If you don’t register the trial then you can make all the changes you want to the protocol up until the moment you publish,” Dr. Gaudino observed. “There really is no rational justification for not registering a trial.”

Overall, the trials were not particularly robust, he noted. In 62 trials in which the Fragility Index was measured, only a median of five patients experiencing a different outcome in a commercially sponsored trial would change statistically significant results to nonsignificant. For noncommercially sponsored trials, that number was 4.5 and in four trials; the change in condition of only one patient was needed to switch the statistical significance.

“This finding is concerning given the substantial role that [randomized, controlled trials] results play in federal device approvals, payer criteria, and clinical consensus guidelines,” the authors wrote.

The authors also looked for interpretation bias in the trials. In the 84 trials with nonsignificant differences in the primary outcomes, 65.5% contained spin, such as focusing on statistically significant secondary outcomes or interpreting nonsignificant primary outcomes as showing treatment equivalence or comparable effectiveness. Spin was present in 80.6% of the trials with commercial sponsorship and in 54.2% without (P = .02) – a finding that remained significant after trial differences were controlled for (beta, 4.64; 95% CI, 1.05-20.54; P = .04).
 

A pivot point

“It’s just another paper showing there are issues with conflicts of interest in industry trials. I’m not particularly surprised,” said David Moher, PhD, MSc, director of the Centre for Journalology, based at the Ottawa Hospital Research Institute.

“It’s sort of high time people from all sides sat down together and tried to resolve how to actually move forward with industry wanting to do trials,” he said. “They are hugely important in drug development. How can these trials be done where the impact of industry and, for that matter, academia is minimized?”

Dr. Gaudino suggested the “ideal situation” would be to have industry put its funding into an existing funding organization, such as the National Institutes of Health or a newly created independent organization – a concept that has been floated before without much forward movement.

“We may be at a pivot point,” Dr. Moher said. “It’s quite clear that COVID has indicated some serious problems with how trials are done, how they’re disseminated, the notion of open science. I think this could be an opportunity. Whether there is so much noise, whether anybody will be able to take any of these initiative forward, I don’t know.”

No matter how trial funding is revised, patients must be brought to the table, he said.

“What frustrates me quite a bit is this almost parental view of all of this – the scientists know best, industry knows best,” Dr. Moher said. “We actually need the most important groups: patients and the public. They need to have an enormous amount of say in how this actually is formed.”

Commenting further, Dr. Moher said that “industry and academia can only do trials when they have patients willing to participate, and yet in the discussions you and I are having, what do patients think about spin in trials? I would imagine they would be horrified that they are going into studies – in a sense in many cases risking their lives – and yet people are spinning the results.”

Dr. Gaudino and Dr. Moher reported having no relevant conflicts of interest.

A version of this story originally appeared on Medscape.com.

COVID-19 infection is associated with a high risk for mortality in heart transplant (HT) recipients, a new case series suggests.

Investigators looked at data on 28 patients with a confirmed diagnosis of COVID-19 who received a HT between March 1, 2020, and April 24, 2020 and found a case-fatality rate of 25%.

“The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, MSc, professor of medicine at Columbia University, New York, said in an interview.

“These patients require extra precautions to prevent the development of infection,” said Dr. Uriel, who is also a cardiologist at New York Presbyterian/Columbia University Irving Medical Center.

The study was published online May 13 in JAMA Cardiology.
 

Similar presentation

HT recipients can have several comorbidities after the procedure, including hypertension, diabetes, cardiac allograft vasculopathy, and ongoing immunosuppression, all of which can place them at risk for infection and adverse outcomes with COVID-19 infection, the authors wrote.

The researchers therefore embarked on a case series looking at 28 HT recipients with COVID-19 infection (median age, 64.0 years; interquartile range, 53.5-70.5; 79% male) to “describe the outcomes of recipients of HT who are chronically immunosuppressed and develop COVID-19 and raise important questions about the role of the immune system in the process.”

The median time from HT to study period was 8.6 (IQR, 4.2-14.5) years. Most patients had numerous comorbidities.

Medscape.com

No protective effect

Twenty-two patients (79%) required admission to the hospital, seven of whom (25%) required admission to the ICU and mechanical ventilation.

Despite the presence of immunosuppressive therapy, all patients had significant elevation of inflammatory biomarkers (median peak high-sensitivity C-reactive protein [hs-CRP], 11.83 mg/dL; IQR, 7.44-19.26; median peak interleukin [IL]-6, 105 pg/mL; IQR, 38-296).

Three-quarters had myocardial injury, with a median high-sensitivity troponin T of 0.055 (0.0205 - 0.1345) ng/mL.

Treatments of COVID-19 included hydroxychloroquine (18 patients; 78%), high-dose corticosteroids (eight patients; 47%), and IL-6 receptor antagonists (six patients; 26%).

Moreover, during hospitalization, mycophenolate mofetil was discontinued in most (70%) patients, and one-quarter had a reduction in their calcineurin inhibitor dose.

“Heart transplant recipients generally require more intense immunosuppressive therapy than most other solid organ transplant recipients, and this high baseline immunosuppression increases their propensity to develop infections and their likelihood of experiencing severe manifestations of infections,” Dr. Uriel commented.

“With COVID-19, in which the body’s inflammatory reaction appears to play a role in disease severity, there has been a question of whether immunosuppression may offer a protective effect,” he continued.

“This case series suggests that this is not the case, although this would need to be confirmed in larger studies,” he said.
 

Low threshold

Among the 22 patients who were admitted to the hospital, half were discharged home and four (18%) were still hospitalized at the end of the study.

Of the seven patients who died, two died at the study center, and five died in an outside institution.

“In the HT population, social distancing (or isolation), strict use of masks when in public, proper handwashing, and sanitization of surfaces are of paramount importance in the prevention of COVID-19 infection,” Dr. Uriel stated.

“In addition, we have restricted these patients’ contact with the hospital as much as possible during the pandemic,” he said.

However, “there should be a low threshold to hospitalize heart transplant patients who develop infection with COVID-19. Furthermore, in our series, outcomes were better for patients hospitalized at the transplant center; therefore, strong consideration should be given to transferring HT patients when hospitalized at another hospital,” he added.

The authors emphasized that COVID-19 patients “will require ongoing monitoring in the recovery phase, as an immunosuppression regimen is reintroduced and the consequences to the allograft itself become apparent.”
 

Vulnerable population

Commenting on the study, Mandeep R. Mehra, MD, MSc, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, suggested that “in epidemiological terms, [the findings] might not look as bad as the way they are reflected in the paper.”

Given that Columbia is “one of the larger heart transplant centers in the U.S., following probably 1,000 patients, having only 22 out of perhaps thousands whom they transplanted or are actively following would actually represent a low serious infection rate,” said Dr. Mehra, who is also the executive director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, also in Boston.

“We must not forget to emphasize that, when assessing these case fatality rates, we must look at the entire population at risk, not only the handful that we were able to observe,” explained Dr. Mehra, who was not involved with the study.

Moreover, the patients were “older and had comorbidities, with poor underlying kidney function and other complications, and underlying coronary artery disease in the transplanted heart,” so “it would not surprise me that they had such a high fatality rate, since they had a high degree of vulnerability,” he said.

Dr. Mehra, who is also the editor-in-chief of the Journal of Heart and Lung Transplantation, said that the journal has received manuscripts still in the review process that suggest different fatality rates than those found in the current case series.

However, he acknowledged that, because these are patients with serious vulnerability due to underlying heart disease, “you can’t be lackadaisical and need to do everything to decrease this vulnerability.”

The authors noted that, although their study did not show a protective effect from immunosuppression against COVID-19, further studies are needed to assess each individual immunosuppressive agent and provide a definitive answer.

The study was supported by a grant to one of the investigators from the National Heart, Lung, and Blood Institute. Dr. Uriel reports no relevant financial relationships. The other authors’ disclosures are listed in the publication. Dr. Mehra reports no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

COVID-19 infection is associated with a high risk for mortality in heart transplant (HT) recipients, a new case series suggests.

Investigators looked at data on 28 patients with a confirmed diagnosis of COVID-19 who received a HT between March 1, 2020, and April 24, 2020 and found a case-fatality rate of 25%.

“The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, MSc, professor of medicine at Columbia University, New York, said in an interview.

“These patients require extra precautions to prevent the development of infection,” said Dr. Uriel, who is also a cardiologist at New York Presbyterian/Columbia University Irving Medical Center.

The study was published online May 13 in JAMA Cardiology.
 

Similar presentation

HT recipients can have several comorbidities after the procedure, including hypertension, diabetes, cardiac allograft vasculopathy, and ongoing immunosuppression, all of which can place them at risk for infection and adverse outcomes with COVID-19 infection, the authors wrote.

The researchers therefore embarked on a case series looking at 28 HT recipients with COVID-19 infection (median age, 64.0 years; interquartile range, 53.5-70.5; 79% male) to “describe the outcomes of recipients of HT who are chronically immunosuppressed and develop COVID-19 and raise important questions about the role of the immune system in the process.”

The median time from HT to study period was 8.6 (IQR, 4.2-14.5) years. Most patients had numerous comorbidities.

Medscape.com

No protective effect

Twenty-two patients (79%) required admission to the hospital, seven of whom (25%) required admission to the ICU and mechanical ventilation.

Despite the presence of immunosuppressive therapy, all patients had significant elevation of inflammatory biomarkers (median peak high-sensitivity C-reactive protein [hs-CRP], 11.83 mg/dL; IQR, 7.44-19.26; median peak interleukin [IL]-6, 105 pg/mL; IQR, 38-296).

Three-quarters had myocardial injury, with a median high-sensitivity troponin T of 0.055 (0.0205 - 0.1345) ng/mL.

Treatments of COVID-19 included hydroxychloroquine (18 patients; 78%), high-dose corticosteroids (eight patients; 47%), and IL-6 receptor antagonists (six patients; 26%).

Moreover, during hospitalization, mycophenolate mofetil was discontinued in most (70%) patients, and one-quarter had a reduction in their calcineurin inhibitor dose.

“Heart transplant recipients generally require more intense immunosuppressive therapy than most other solid organ transplant recipients, and this high baseline immunosuppression increases their propensity to develop infections and their likelihood of experiencing severe manifestations of infections,” Dr. Uriel commented.

“With COVID-19, in which the body’s inflammatory reaction appears to play a role in disease severity, there has been a question of whether immunosuppression may offer a protective effect,” he continued.

“This case series suggests that this is not the case, although this would need to be confirmed in larger studies,” he said.
 

Low threshold

Among the 22 patients who were admitted to the hospital, half were discharged home and four (18%) were still hospitalized at the end of the study.

Of the seven patients who died, two died at the study center, and five died in an outside institution.

“In the HT population, social distancing (or isolation), strict use of masks when in public, proper handwashing, and sanitization of surfaces are of paramount importance in the prevention of COVID-19 infection,” Dr. Uriel stated.

“In addition, we have restricted these patients’ contact with the hospital as much as possible during the pandemic,” he said.

However, “there should be a low threshold to hospitalize heart transplant patients who develop infection with COVID-19. Furthermore, in our series, outcomes were better for patients hospitalized at the transplant center; therefore, strong consideration should be given to transferring HT patients when hospitalized at another hospital,” he added.

The authors emphasized that COVID-19 patients “will require ongoing monitoring in the recovery phase, as an immunosuppression regimen is reintroduced and the consequences to the allograft itself become apparent.”
 

Vulnerable population

Commenting on the study, Mandeep R. Mehra, MD, MSc, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, suggested that “in epidemiological terms, [the findings] might not look as bad as the way they are reflected in the paper.”

Given that Columbia is “one of the larger heart transplant centers in the U.S., following probably 1,000 patients, having only 22 out of perhaps thousands whom they transplanted or are actively following would actually represent a low serious infection rate,” said Dr. Mehra, who is also the executive director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, also in Boston.

“We must not forget to emphasize that, when assessing these case fatality rates, we must look at the entire population at risk, not only the handful that we were able to observe,” explained Dr. Mehra, who was not involved with the study.

Moreover, the patients were “older and had comorbidities, with poor underlying kidney function and other complications, and underlying coronary artery disease in the transplanted heart,” so “it would not surprise me that they had such a high fatality rate, since they had a high degree of vulnerability,” he said.

Dr. Mehra, who is also the editor-in-chief of the Journal of Heart and Lung Transplantation, said that the journal has received manuscripts still in the review process that suggest different fatality rates than those found in the current case series.

However, he acknowledged that, because these are patients with serious vulnerability due to underlying heart disease, “you can’t be lackadaisical and need to do everything to decrease this vulnerability.”

The authors noted that, although their study did not show a protective effect from immunosuppression against COVID-19, further studies are needed to assess each individual immunosuppressive agent and provide a definitive answer.

The study was supported by a grant to one of the investigators from the National Heart, Lung, and Blood Institute. Dr. Uriel reports no relevant financial relationships. The other authors’ disclosures are listed in the publication. Dr. Mehra reports no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

COVID-19 infection is associated with a high risk for mortality in heart transplant (HT) recipients, a new case series suggests.

Investigators looked at data on 28 patients with a confirmed diagnosis of COVID-19 who received a HT between March 1, 2020, and April 24, 2020 and found a case-fatality rate of 25%.

“The high case fatality in our case series should alert physicians to the vulnerability of heart transplant recipients during the COVID-19 pandemic,” senior author Nir Uriel, MD, MSc, professor of medicine at Columbia University, New York, said in an interview.

“These patients require extra precautions to prevent the development of infection,” said Dr. Uriel, who is also a cardiologist at New York Presbyterian/Columbia University Irving Medical Center.

The study was published online May 13 in JAMA Cardiology.
 

Similar presentation

HT recipients can have several comorbidities after the procedure, including hypertension, diabetes, cardiac allograft vasculopathy, and ongoing immunosuppression, all of which can place them at risk for infection and adverse outcomes with COVID-19 infection, the authors wrote.

The researchers therefore embarked on a case series looking at 28 HT recipients with COVID-19 infection (median age, 64.0 years; interquartile range, 53.5-70.5; 79% male) to “describe the outcomes of recipients of HT who are chronically immunosuppressed and develop COVID-19 and raise important questions about the role of the immune system in the process.”

The median time from HT to study period was 8.6 (IQR, 4.2-14.5) years. Most patients had numerous comorbidities.

Medscape.com

No protective effect

Twenty-two patients (79%) required admission to the hospital, seven of whom (25%) required admission to the ICU and mechanical ventilation.

Despite the presence of immunosuppressive therapy, all patients had significant elevation of inflammatory biomarkers (median peak high-sensitivity C-reactive protein [hs-CRP], 11.83 mg/dL; IQR, 7.44-19.26; median peak interleukin [IL]-6, 105 pg/mL; IQR, 38-296).

Three-quarters had myocardial injury, with a median high-sensitivity troponin T of 0.055 (0.0205 - 0.1345) ng/mL.

Treatments of COVID-19 included hydroxychloroquine (18 patients; 78%), high-dose corticosteroids (eight patients; 47%), and IL-6 receptor antagonists (six patients; 26%).

Moreover, during hospitalization, mycophenolate mofetil was discontinued in most (70%) patients, and one-quarter had a reduction in their calcineurin inhibitor dose.

“Heart transplant recipients generally require more intense immunosuppressive therapy than most other solid organ transplant recipients, and this high baseline immunosuppression increases their propensity to develop infections and their likelihood of experiencing severe manifestations of infections,” Dr. Uriel commented.

“With COVID-19, in which the body’s inflammatory reaction appears to play a role in disease severity, there has been a question of whether immunosuppression may offer a protective effect,” he continued.

“This case series suggests that this is not the case, although this would need to be confirmed in larger studies,” he said.
 

Low threshold

Among the 22 patients who were admitted to the hospital, half were discharged home and four (18%) were still hospitalized at the end of the study.

Of the seven patients who died, two died at the study center, and five died in an outside institution.

“In the HT population, social distancing (or isolation), strict use of masks when in public, proper handwashing, and sanitization of surfaces are of paramount importance in the prevention of COVID-19 infection,” Dr. Uriel stated.

“In addition, we have restricted these patients’ contact with the hospital as much as possible during the pandemic,” he said.

However, “there should be a low threshold to hospitalize heart transplant patients who develop infection with COVID-19. Furthermore, in our series, outcomes were better for patients hospitalized at the transplant center; therefore, strong consideration should be given to transferring HT patients when hospitalized at another hospital,” he added.

The authors emphasized that COVID-19 patients “will require ongoing monitoring in the recovery phase, as an immunosuppression regimen is reintroduced and the consequences to the allograft itself become apparent.”
 

Vulnerable population

Commenting on the study, Mandeep R. Mehra, MD, MSc, William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, suggested that “in epidemiological terms, [the findings] might not look as bad as the way they are reflected in the paper.”

Given that Columbia is “one of the larger heart transplant centers in the U.S., following probably 1,000 patients, having only 22 out of perhaps thousands whom they transplanted or are actively following would actually represent a low serious infection rate,” said Dr. Mehra, who is also the executive director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, also in Boston.

“We must not forget to emphasize that, when assessing these case fatality rates, we must look at the entire population at risk, not only the handful that we were able to observe,” explained Dr. Mehra, who was not involved with the study.

Moreover, the patients were “older and had comorbidities, with poor underlying kidney function and other complications, and underlying coronary artery disease in the transplanted heart,” so “it would not surprise me that they had such a high fatality rate, since they had a high degree of vulnerability,” he said.

Dr. Mehra, who is also the editor-in-chief of the Journal of Heart and Lung Transplantation, said that the journal has received manuscripts still in the review process that suggest different fatality rates than those found in the current case series.

However, he acknowledged that, because these are patients with serious vulnerability due to underlying heart disease, “you can’t be lackadaisical and need to do everything to decrease this vulnerability.”

The authors noted that, although their study did not show a protective effect from immunosuppression against COVID-19, further studies are needed to assess each individual immunosuppressive agent and provide a definitive answer.

The study was supported by a grant to one of the investigators from the National Heart, Lung, and Blood Institute. Dr. Uriel reports no relevant financial relationships. The other authors’ disclosures are listed in the publication. Dr. Mehra reports no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Patients in the landmark ISCHEMIA trial with intermediate left main disease had a greater extent of coronary artery disease on invasive angiography, indicating greater atherosclerotic burden. They also had worse prognosis with a higher risk of cardiovascular events.

“Many times, we are looking at results as to whether patients have left main disease or not,” Sripal Bangalore, MD, said during the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “Here, we are showing that it’s not black and white; there are shades of gray. If a patient has intermediate left main disease, the prognosis is worse. That’s very important information we need to convey to our referrals also, because many times they may just look at the bottom line and say, ‘there is no left main disease.’ But here, we’re seeing that even having intermediate left main disease has significantly worse prognosis. We need to take that seriously.”

Prior studies show that patients with significant left main disease (LMD; defined as 50% or greater stenosis on coronary CT angiography [CCTA]) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival, said Dr. Bangalore, an interventional cardiologist at New York University Langone Health. However, the impact of intermediate LMD (defined as 25%-49% stenosis on CCTA) on outcomes is unclear.

Members of the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) research group randomized 5,179 participants to an initial invasive or conservative strategy. The main results showed that immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
 

‘Discordance’ revealed in imaging modalities

For the current analysis, named the ISCHEMIA Intermediate LM Substudy, those who underwent coronary CCTA comprise the LMD substudy cohort. The objective was to evaluate clinical and quality of life outcomes in patients with and without intermediate left main disease on coronary CT and to evaluate the impact of treatment strategy on those outcomes across subgroups.

At baseline, these patients were categorized into those with and without intermediate LMD as determined by a core lab. Patients with LMD of 50% or greater, those with prior coronary artery bypass graft surgery, and those with nonevaluable or missing data on LM stenosis were excluded.

Among the 3,913 ISCHEMIA participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these patients, 962 (26%) had intermediate LMD and 2,737 (74%) did not.

The researchers observed no significant differences in baseline characteristics between patients with and without LMD. However, patients with intermediate LMD tended to be older, and a greater proportion had hypertension and diabetes. Stress test characteristics were also similar between patients with and without LMD. However, patients with intermediate LMD tended toward a greater severity of severe ischemia.

This was also true for anatomic disease on CCTA. A higher proportion of patients with intermediate LMD had triple-vessel disease (61%-62%, compared with 36%-40% along those without intermediate LMD). In addition, a higher proportion of patients with intermediate LMD had stenosis in the proximal left anterior artery descending (LAD) artery (65% vs. 39% among those without intermediate LMD).

On analysis limited to 1,846 patients who underwent invasive angiography treatment in the main ISCHEMIA trial, 7% of those who were categorized into the intermediate LMD group were found to have LMD disease of 50% or greater, compared with 1.4% of patients who were categorized as not having intermediate LMD. “This goes to show this discordance between the two modalities [CCTA and coronary angiography], and I think we have to be careful,” said Dr. Bangalore, who also directs NYU Langone’s Cardiac Catheterization Laboratory. “There may be patients with left main disease, even if the CCTA says it’s not at 25%-29% [stenosis].”

The researchers found that, among patients who underwent invasive angiography, a greater proportion of those who were categorized into the LMD group had proximal LAD disease (43% vs. 33% among those who were categorized into the nonintermediate LMD group), triple-vessel disease (47% vs. 35%), a greater extent of coronary artery disease as denoted by a higher SYNTAX score (21 vs. 15), and a higher proportion underwent coronary artery bypass graft surgery (32% vs. 18%).
 

Intermediate LMD linked to worse outcomes

After the researchers adjusted for baseline differences between the two groups in overall substudy cohort, they found that intermediate LMD severity was an independent predictor of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, and resuscitated cardiac arrest (hazard ratio, 1.31; P = .0123); cardiovascular death/MI/stroke (HR, 1.30; P = .0143); procedural primary MI (HR, 1.64; P = .0487); heart failure (HR, 2.06; P = .0239); and stroke (HR, 1.82, P = .0362).

“We then looked to see if there is a treatment difference, a treatment effect based on whether patients had intermediate LMD,” Dr. Bangalore said. “Most of the P values were not significant. The results are very consistent with what we saw in the main analysis: not a significant difference between invasive and conservative strategy. We do see some differences, though. An invasive strategy was associated with a significantly higher risk of procedural MI [2.9% vs. 1.5%], but a significantly lower risk of nonprocedural MI [–6.4% vs. –2%].”

Dr. Bangalore added that there was significant benefit of the invasive strategy in reducing angina and improving quality of life based on the Seattle Angina Questionnaire-7. “This result was durable up to 48 months of follow-up, whether the patient had intermediate left main disease or not. These results were dependent on baseline angina status. The benefit of invasive strategy was mainly in patients who had daily, weekly, and monthly angina, and no benefit in patients with no angina; there was no interaction based on intermediate left main status.”

Dr. Bangalore emphasized that the original ISCHEMIA trial excluded patients with severe left main disease by design. “But patients with intermediate left main disease in ISCHEMIA tended to have a greater extent of coronary artery disease, indicating greater atherosclerotic burden. I don’t think that’s any surprise. They had a worse prognosis with higher risk of cardiovascular events but similar quality of life, including angina-specific quality of life.”

The key clinical message, he said, is that patients with intermediate LMD face an increased risk of cardiovascular events. “I think we have to be aggressive in trying to reduce their risk with medical therapy, etc.,” he said. “If they are symptomatic, ISCHEMIA tells us that patients have two options. They can choose an invasive strategy, because clearly there is a benefit. You have a significant benefit at making you feel better and potentially reducing the risk of spontaneous MI over a period of time. Or, you can try medical therapy first. If you do see some left main disease, it’s showing the general burden of atherosclerosis disease in those patients. I think that’s the critical message, that we have to be very aggressive with these patients.”
 

A call for more imaging studies

An invited panelist, Timothy D. Henry, MD, said that the results of the ISCHEMIA substudy should stimulate further research. “With an intermediate lesion, clearly the interventional group did better, and it wasn’t symptom related,” said Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital in Cincinnati. “So even if you do medical therapy, you’re not going to really find it out. In my mind, this should stimulate us to do more imaging of the left main that are moderate lesions, and follow this up as an independent study. I think this is a really important finding.”

ISCHEMIA was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Bangalore disclosed that he is a member of the advisory board and/or a board member for Meril, SMT, Pfizer, Amgen, Biotronik, and Abbott. He also is a consultant for Reata Pharmaceuticals.

[email protected]

SOURCE: Bangalore S et al. SCAI 2020, Abstract 11656.

Patients in the landmark ISCHEMIA trial with intermediate left main disease had a greater extent of coronary artery disease on invasive angiography, indicating greater atherosclerotic burden. They also had worse prognosis with a higher risk of cardiovascular events.

“Many times, we are looking at results as to whether patients have left main disease or not,” Sripal Bangalore, MD, said during the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “Here, we are showing that it’s not black and white; there are shades of gray. If a patient has intermediate left main disease, the prognosis is worse. That’s very important information we need to convey to our referrals also, because many times they may just look at the bottom line and say, ‘there is no left main disease.’ But here, we’re seeing that even having intermediate left main disease has significantly worse prognosis. We need to take that seriously.”

Prior studies show that patients with significant left main disease (LMD; defined as 50% or greater stenosis on coronary CT angiography [CCTA]) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival, said Dr. Bangalore, an interventional cardiologist at New York University Langone Health. However, the impact of intermediate LMD (defined as 25%-49% stenosis on CCTA) on outcomes is unclear.

Members of the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) research group randomized 5,179 participants to an initial invasive or conservative strategy. The main results showed that immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
 

‘Discordance’ revealed in imaging modalities

For the current analysis, named the ISCHEMIA Intermediate LM Substudy, those who underwent coronary CCTA comprise the LMD substudy cohort. The objective was to evaluate clinical and quality of life outcomes in patients with and without intermediate left main disease on coronary CT and to evaluate the impact of treatment strategy on those outcomes across subgroups.

At baseline, these patients were categorized into those with and without intermediate LMD as determined by a core lab. Patients with LMD of 50% or greater, those with prior coronary artery bypass graft surgery, and those with nonevaluable or missing data on LM stenosis were excluded.

Among the 3,913 ISCHEMIA participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these patients, 962 (26%) had intermediate LMD and 2,737 (74%) did not.

The researchers observed no significant differences in baseline characteristics between patients with and without LMD. However, patients with intermediate LMD tended to be older, and a greater proportion had hypertension and diabetes. Stress test characteristics were also similar between patients with and without LMD. However, patients with intermediate LMD tended toward a greater severity of severe ischemia.

This was also true for anatomic disease on CCTA. A higher proportion of patients with intermediate LMD had triple-vessel disease (61%-62%, compared with 36%-40% along those without intermediate LMD). In addition, a higher proportion of patients with intermediate LMD had stenosis in the proximal left anterior artery descending (LAD) artery (65% vs. 39% among those without intermediate LMD).

On analysis limited to 1,846 patients who underwent invasive angiography treatment in the main ISCHEMIA trial, 7% of those who were categorized into the intermediate LMD group were found to have LMD disease of 50% or greater, compared with 1.4% of patients who were categorized as not having intermediate LMD. “This goes to show this discordance between the two modalities [CCTA and coronary angiography], and I think we have to be careful,” said Dr. Bangalore, who also directs NYU Langone’s Cardiac Catheterization Laboratory. “There may be patients with left main disease, even if the CCTA says it’s not at 25%-29% [stenosis].”

The researchers found that, among patients who underwent invasive angiography, a greater proportion of those who were categorized into the LMD group had proximal LAD disease (43% vs. 33% among those who were categorized into the nonintermediate LMD group), triple-vessel disease (47% vs. 35%), a greater extent of coronary artery disease as denoted by a higher SYNTAX score (21 vs. 15), and a higher proportion underwent coronary artery bypass graft surgery (32% vs. 18%).
 

Intermediate LMD linked to worse outcomes

After the researchers adjusted for baseline differences between the two groups in overall substudy cohort, they found that intermediate LMD severity was an independent predictor of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, and resuscitated cardiac arrest (hazard ratio, 1.31; P = .0123); cardiovascular death/MI/stroke (HR, 1.30; P = .0143); procedural primary MI (HR, 1.64; P = .0487); heart failure (HR, 2.06; P = .0239); and stroke (HR, 1.82, P = .0362).

“We then looked to see if there is a treatment difference, a treatment effect based on whether patients had intermediate LMD,” Dr. Bangalore said. “Most of the P values were not significant. The results are very consistent with what we saw in the main analysis: not a significant difference between invasive and conservative strategy. We do see some differences, though. An invasive strategy was associated with a significantly higher risk of procedural MI [2.9% vs. 1.5%], but a significantly lower risk of nonprocedural MI [–6.4% vs. –2%].”

Dr. Bangalore added that there was significant benefit of the invasive strategy in reducing angina and improving quality of life based on the Seattle Angina Questionnaire-7. “This result was durable up to 48 months of follow-up, whether the patient had intermediate left main disease or not. These results were dependent on baseline angina status. The benefit of invasive strategy was mainly in patients who had daily, weekly, and monthly angina, and no benefit in patients with no angina; there was no interaction based on intermediate left main status.”

Dr. Bangalore emphasized that the original ISCHEMIA trial excluded patients with severe left main disease by design. “But patients with intermediate left main disease in ISCHEMIA tended to have a greater extent of coronary artery disease, indicating greater atherosclerotic burden. I don’t think that’s any surprise. They had a worse prognosis with higher risk of cardiovascular events but similar quality of life, including angina-specific quality of life.”

The key clinical message, he said, is that patients with intermediate LMD face an increased risk of cardiovascular events. “I think we have to be aggressive in trying to reduce their risk with medical therapy, etc.,” he said. “If they are symptomatic, ISCHEMIA tells us that patients have two options. They can choose an invasive strategy, because clearly there is a benefit. You have a significant benefit at making you feel better and potentially reducing the risk of spontaneous MI over a period of time. Or, you can try medical therapy first. If you do see some left main disease, it’s showing the general burden of atherosclerosis disease in those patients. I think that’s the critical message, that we have to be very aggressive with these patients.”
 

A call for more imaging studies

An invited panelist, Timothy D. Henry, MD, said that the results of the ISCHEMIA substudy should stimulate further research. “With an intermediate lesion, clearly the interventional group did better, and it wasn’t symptom related,” said Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital in Cincinnati. “So even if you do medical therapy, you’re not going to really find it out. In my mind, this should stimulate us to do more imaging of the left main that are moderate lesions, and follow this up as an independent study. I think this is a really important finding.”

ISCHEMIA was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Bangalore disclosed that he is a member of the advisory board and/or a board member for Meril, SMT, Pfizer, Amgen, Biotronik, and Abbott. He also is a consultant for Reata Pharmaceuticals.

[email protected]

SOURCE: Bangalore S et al. SCAI 2020, Abstract 11656.

Patients in the landmark ISCHEMIA trial with intermediate left main disease had a greater extent of coronary artery disease on invasive angiography, indicating greater atherosclerotic burden. They also had worse prognosis with a higher risk of cardiovascular events.

“Many times, we are looking at results as to whether patients have left main disease or not,” Sripal Bangalore, MD, said during the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “Here, we are showing that it’s not black and white; there are shades of gray. If a patient has intermediate left main disease, the prognosis is worse. That’s very important information we need to convey to our referrals also, because many times they may just look at the bottom line and say, ‘there is no left main disease.’ But here, we’re seeing that even having intermediate left main disease has significantly worse prognosis. We need to take that seriously.”

Prior studies show that patients with significant left main disease (LMD; defined as 50% or greater stenosis on coronary CT angiography [CCTA]) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival, said Dr. Bangalore, an interventional cardiologist at New York University Langone Health. However, the impact of intermediate LMD (defined as 25%-49% stenosis on CCTA) on outcomes is unclear.

Members of the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) research group randomized 5,179 participants to an initial invasive or conservative strategy. The main results showed that immediate revascularization in patients with stable ischemic heart disease provided no reduction in cardiovascular endpoints through 4 years of follow-up, compared with initial optimal medical therapy alone.
 

‘Discordance’ revealed in imaging modalities

For the current analysis, named the ISCHEMIA Intermediate LM Substudy, those who underwent coronary CCTA comprise the LMD substudy cohort. The objective was to evaluate clinical and quality of life outcomes in patients with and without intermediate left main disease on coronary CT and to evaluate the impact of treatment strategy on those outcomes across subgroups.

At baseline, these patients were categorized into those with and without intermediate LMD as determined by a core lab. Patients with LMD of 50% or greater, those with prior coronary artery bypass graft surgery, and those with nonevaluable or missing data on LM stenosis were excluded.

Among the 3,913 ISCHEMIA participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these patients, 962 (26%) had intermediate LMD and 2,737 (74%) did not.

The researchers observed no significant differences in baseline characteristics between patients with and without LMD. However, patients with intermediate LMD tended to be older, and a greater proportion had hypertension and diabetes. Stress test characteristics were also similar between patients with and without LMD. However, patients with intermediate LMD tended toward a greater severity of severe ischemia.

This was also true for anatomic disease on CCTA. A higher proportion of patients with intermediate LMD had triple-vessel disease (61%-62%, compared with 36%-40% along those without intermediate LMD). In addition, a higher proportion of patients with intermediate LMD had stenosis in the proximal left anterior artery descending (LAD) artery (65% vs. 39% among those without intermediate LMD).

On analysis limited to 1,846 patients who underwent invasive angiography treatment in the main ISCHEMIA trial, 7% of those who were categorized into the intermediate LMD group were found to have LMD disease of 50% or greater, compared with 1.4% of patients who were categorized as not having intermediate LMD. “This goes to show this discordance between the two modalities [CCTA and coronary angiography], and I think we have to be careful,” said Dr. Bangalore, who also directs NYU Langone’s Cardiac Catheterization Laboratory. “There may be patients with left main disease, even if the CCTA says it’s not at 25%-29% [stenosis].”

The researchers found that, among patients who underwent invasive angiography, a greater proportion of those who were categorized into the LMD group had proximal LAD disease (43% vs. 33% among those who were categorized into the nonintermediate LMD group), triple-vessel disease (47% vs. 35%), a greater extent of coronary artery disease as denoted by a higher SYNTAX score (21 vs. 15), and a higher proportion underwent coronary artery bypass graft surgery (32% vs. 18%).
 

Intermediate LMD linked to worse outcomes

After the researchers adjusted for baseline differences between the two groups in overall substudy cohort, they found that intermediate LMD severity was an independent predictor of the primary composite endpoint of cardiovascular death, MI, hospitalization for unstable angina, heart failure, and resuscitated cardiac arrest (hazard ratio, 1.31; P = .0123); cardiovascular death/MI/stroke (HR, 1.30; P = .0143); procedural primary MI (HR, 1.64; P = .0487); heart failure (HR, 2.06; P = .0239); and stroke (HR, 1.82, P = .0362).

“We then looked to see if there is a treatment difference, a treatment effect based on whether patients had intermediate LMD,” Dr. Bangalore said. “Most of the P values were not significant. The results are very consistent with what we saw in the main analysis: not a significant difference between invasive and conservative strategy. We do see some differences, though. An invasive strategy was associated with a significantly higher risk of procedural MI [2.9% vs. 1.5%], but a significantly lower risk of nonprocedural MI [–6.4% vs. –2%].”

Dr. Bangalore added that there was significant benefit of the invasive strategy in reducing angina and improving quality of life based on the Seattle Angina Questionnaire-7. “This result was durable up to 48 months of follow-up, whether the patient had intermediate left main disease or not. These results were dependent on baseline angina status. The benefit of invasive strategy was mainly in patients who had daily, weekly, and monthly angina, and no benefit in patients with no angina; there was no interaction based on intermediate left main status.”

Dr. Bangalore emphasized that the original ISCHEMIA trial excluded patients with severe left main disease by design. “But patients with intermediate left main disease in ISCHEMIA tended to have a greater extent of coronary artery disease, indicating greater atherosclerotic burden. I don’t think that’s any surprise. They had a worse prognosis with higher risk of cardiovascular events but similar quality of life, including angina-specific quality of life.”

The key clinical message, he said, is that patients with intermediate LMD face an increased risk of cardiovascular events. “I think we have to be aggressive in trying to reduce their risk with medical therapy, etc.,” he said. “If they are symptomatic, ISCHEMIA tells us that patients have two options. They can choose an invasive strategy, because clearly there is a benefit. You have a significant benefit at making you feel better and potentially reducing the risk of spontaneous MI over a period of time. Or, you can try medical therapy first. If you do see some left main disease, it’s showing the general burden of atherosclerosis disease in those patients. I think that’s the critical message, that we have to be very aggressive with these patients.”
 

A call for more imaging studies

An invited panelist, Timothy D. Henry, MD, said that the results of the ISCHEMIA substudy should stimulate further research. “With an intermediate lesion, clearly the interventional group did better, and it wasn’t symptom related,” said Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital in Cincinnati. “So even if you do medical therapy, you’re not going to really find it out. In my mind, this should stimulate us to do more imaging of the left main that are moderate lesions, and follow this up as an independent study. I think this is a really important finding.”

ISCHEMIA was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Bangalore disclosed that he is a member of the advisory board and/or a board member for Meril, SMT, Pfizer, Amgen, Biotronik, and Abbott. He also is a consultant for Reata Pharmaceuticals.

[email protected]

SOURCE: Bangalore S et al. SCAI 2020, Abstract 11656.

A new analysis from the REDUCE-IT trial has shown that the high-strength eicosapentaenoic acid product icosapent ethyl (Vascepa; Amarin) reduced the number of revascularization procedures by more than one-third in statin-treated patients whose triglyceride levels were elevated and who were at increased cardiovascular risk.

The new data were presented at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions.

REDUCE-IT, a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients whose triglyceride levels were elevated (135-499 mg/dL), whose LDL cholesterol levels were controlled (41-100 mg/dL), and who had established cardiovascular disease or diabetes plus risk factors to receive either icosapent ethyl 4 g daily or placebo.

The primary composite and other cardiovascular endpoints were substantially reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes.

“Compared with placebo, icosapent ethyl 4 g/day significantly reduced first and total revascularization events by 34% and 36%, respectively,” REDUCE-IT investigator Benjamin Peterson, MD, of Brigham and Women’s Hospital, Boston, concluded during his presentation.

This reduction was consistent with respect to urgent, emergent, and elective revascularization procedures overall, as well as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) individually, he reported.

“Prior therapies aimed at patients with elevated triglycerides have not demonstrated a consistent benefit in reducing coronary revascularization, and to the best of our knowledge, this is the first non–LDL cholesterol intervention in a major randomized trial in which statin-treated patients underwent fewer CABG surgeries,” Dr. Peterson stated.

“These data highlight the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in the at-risk REDUCE-IT population,” he added.

Detailed results showed that the percentage of patients who underwent first revascularizations was 9.2% with icosapent ethyl versus 13.3% with placebo (hazard ratio, 0.66; P < .0001; number needed to treat, 25).

Similar reductions were observed in total (first and subsequent) revascularizations (risk ratio, 0.64; P < .0001) and across urgent, emergent, and elective revascularizations. Icosapent ethyl significantly reduced the need for PCI (HR, 0.68; P < .0001) and CABG (HR, 0.61; P = .0005).

The moderator of a SCAI press conference, Kirk Garratt, MD, of the Center for Heart and Vascular Health at Christiana Care Health System in Wilmington, Del., said that “this is an impressive impact. I couldn’t count the number of zeros in the P value.”

Timothy Henry, MD, of Christ Hospital in Cincinnati, said that REDUCE-IT was an important trial. “It showed a very impressive effect on revascularizations along with all the other benefits.” But he suggested that the uptake in usage of icosapent ethyl in the United States has been slow, and he asked what could be done to enhance this.

REDUCE-IT senior investigator Deepak Bhatt, MD, replied that the product was only approved for the REDUCE-IT indication in December 2019, and he suggested that initial uptake may have been affected by the current COVID-19 pandemic.

“This new REDUCE-IT indication ― patients with established cardiovascular disease or diabetes plus risk factors who have moderately elevated triglycerides and controlled LDL ― includes a lot of patients, between 15% and 50% of all cardiovascular patients,” he said.

“We wanted to present this revascularization data at the SCAI meeting, as it is superimportant that interventional cardiologists know about this. Interventionalists have now taken ownership of LDL and make sure patients are on statins, and we hope they will now do the same thing for triglycerides,” Dr. Bhatt commented.

Dr. Henry agreed. “It should be a simple thing to take all secondary prevention patients with eligible triglycerides and be aggressive with this new therapy.”

Dr. Bhatt noted that a cost-effectiveness analysis of the REDUCE-IT trial that was presented at last year’s American Heart Association meeting “has shown the drug to be highly cost effective and actually cost saving at the current list price.”

Asked what the mechanism of benefit is, Dr. Bhatt said that “there has been good basic science showing that EPA [eicosapentaenoic acid] stabilizes cell membranes and reduces plaque vulnerability and progression.”

REDUCE-IT was sponsored by Amarin. Brigham and Women’s Hospital receives research funding from Amarin for Dr. Bhatt’s role as chair of the trial.

A version of this article originally appeared on Medscape.com.

A new analysis from the REDUCE-IT trial has shown that the high-strength eicosapentaenoic acid product icosapent ethyl (Vascepa; Amarin) reduced the number of revascularization procedures by more than one-third in statin-treated patients whose triglyceride levels were elevated and who were at increased cardiovascular risk.

The new data were presented at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions.

REDUCE-IT, a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients whose triglyceride levels were elevated (135-499 mg/dL), whose LDL cholesterol levels were controlled (41-100 mg/dL), and who had established cardiovascular disease or diabetes plus risk factors to receive either icosapent ethyl 4 g daily or placebo.

The primary composite and other cardiovascular endpoints were substantially reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes.

“Compared with placebo, icosapent ethyl 4 g/day significantly reduced first and total revascularization events by 34% and 36%, respectively,” REDUCE-IT investigator Benjamin Peterson, MD, of Brigham and Women’s Hospital, Boston, concluded during his presentation.

This reduction was consistent with respect to urgent, emergent, and elective revascularization procedures overall, as well as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) individually, he reported.

“Prior therapies aimed at patients with elevated triglycerides have not demonstrated a consistent benefit in reducing coronary revascularization, and to the best of our knowledge, this is the first non–LDL cholesterol intervention in a major randomized trial in which statin-treated patients underwent fewer CABG surgeries,” Dr. Peterson stated.

“These data highlight the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in the at-risk REDUCE-IT population,” he added.

Detailed results showed that the percentage of patients who underwent first revascularizations was 9.2% with icosapent ethyl versus 13.3% with placebo (hazard ratio, 0.66; P < .0001; number needed to treat, 25).

Similar reductions were observed in total (first and subsequent) revascularizations (risk ratio, 0.64; P < .0001) and across urgent, emergent, and elective revascularizations. Icosapent ethyl significantly reduced the need for PCI (HR, 0.68; P < .0001) and CABG (HR, 0.61; P = .0005).

The moderator of a SCAI press conference, Kirk Garratt, MD, of the Center for Heart and Vascular Health at Christiana Care Health System in Wilmington, Del., said that “this is an impressive impact. I couldn’t count the number of zeros in the P value.”

Timothy Henry, MD, of Christ Hospital in Cincinnati, said that REDUCE-IT was an important trial. “It showed a very impressive effect on revascularizations along with all the other benefits.” But he suggested that the uptake in usage of icosapent ethyl in the United States has been slow, and he asked what could be done to enhance this.

REDUCE-IT senior investigator Deepak Bhatt, MD, replied that the product was only approved for the REDUCE-IT indication in December 2019, and he suggested that initial uptake may have been affected by the current COVID-19 pandemic.

“This new REDUCE-IT indication ― patients with established cardiovascular disease or diabetes plus risk factors who have moderately elevated triglycerides and controlled LDL ― includes a lot of patients, between 15% and 50% of all cardiovascular patients,” he said.

“We wanted to present this revascularization data at the SCAI meeting, as it is superimportant that interventional cardiologists know about this. Interventionalists have now taken ownership of LDL and make sure patients are on statins, and we hope they will now do the same thing for triglycerides,” Dr. Bhatt commented.

Dr. Henry agreed. “It should be a simple thing to take all secondary prevention patients with eligible triglycerides and be aggressive with this new therapy.”

Dr. Bhatt noted that a cost-effectiveness analysis of the REDUCE-IT trial that was presented at last year’s American Heart Association meeting “has shown the drug to be highly cost effective and actually cost saving at the current list price.”

Asked what the mechanism of benefit is, Dr. Bhatt said that “there has been good basic science showing that EPA [eicosapentaenoic acid] stabilizes cell membranes and reduces plaque vulnerability and progression.”

REDUCE-IT was sponsored by Amarin. Brigham and Women’s Hospital receives research funding from Amarin for Dr. Bhatt’s role as chair of the trial.

A version of this article originally appeared on Medscape.com.

A new analysis from the REDUCE-IT trial has shown that the high-strength eicosapentaenoic acid product icosapent ethyl (Vascepa; Amarin) reduced the number of revascularization procedures by more than one-third in statin-treated patients whose triglyceride levels were elevated and who were at increased cardiovascular risk.

The new data were presented at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions.

REDUCE-IT, a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients whose triglyceride levels were elevated (135-499 mg/dL), whose LDL cholesterol levels were controlled (41-100 mg/dL), and who had established cardiovascular disease or diabetes plus risk factors to receive either icosapent ethyl 4 g daily or placebo.

The primary composite and other cardiovascular endpoints were substantially reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes.

“Compared with placebo, icosapent ethyl 4 g/day significantly reduced first and total revascularization events by 34% and 36%, respectively,” REDUCE-IT investigator Benjamin Peterson, MD, of Brigham and Women’s Hospital, Boston, concluded during his presentation.

This reduction was consistent with respect to urgent, emergent, and elective revascularization procedures overall, as well as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) individually, he reported.

“Prior therapies aimed at patients with elevated triglycerides have not demonstrated a consistent benefit in reducing coronary revascularization, and to the best of our knowledge, this is the first non–LDL cholesterol intervention in a major randomized trial in which statin-treated patients underwent fewer CABG surgeries,” Dr. Peterson stated.

“These data highlight the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in the at-risk REDUCE-IT population,” he added.

Detailed results showed that the percentage of patients who underwent first revascularizations was 9.2% with icosapent ethyl versus 13.3% with placebo (hazard ratio, 0.66; P < .0001; number needed to treat, 25).

Similar reductions were observed in total (first and subsequent) revascularizations (risk ratio, 0.64; P < .0001) and across urgent, emergent, and elective revascularizations. Icosapent ethyl significantly reduced the need for PCI (HR, 0.68; P < .0001) and CABG (HR, 0.61; P = .0005).

The moderator of a SCAI press conference, Kirk Garratt, MD, of the Center for Heart and Vascular Health at Christiana Care Health System in Wilmington, Del., said that “this is an impressive impact. I couldn’t count the number of zeros in the P value.”

Timothy Henry, MD, of Christ Hospital in Cincinnati, said that REDUCE-IT was an important trial. “It showed a very impressive effect on revascularizations along with all the other benefits.” But he suggested that the uptake in usage of icosapent ethyl in the United States has been slow, and he asked what could be done to enhance this.

REDUCE-IT senior investigator Deepak Bhatt, MD, replied that the product was only approved for the REDUCE-IT indication in December 2019, and he suggested that initial uptake may have been affected by the current COVID-19 pandemic.

“This new REDUCE-IT indication ― patients with established cardiovascular disease or diabetes plus risk factors who have moderately elevated triglycerides and controlled LDL ― includes a lot of patients, between 15% and 50% of all cardiovascular patients,” he said.

“We wanted to present this revascularization data at the SCAI meeting, as it is superimportant that interventional cardiologists know about this. Interventionalists have now taken ownership of LDL and make sure patients are on statins, and we hope they will now do the same thing for triglycerides,” Dr. Bhatt commented.

Dr. Henry agreed. “It should be a simple thing to take all secondary prevention patients with eligible triglycerides and be aggressive with this new therapy.”

Dr. Bhatt noted that a cost-effectiveness analysis of the REDUCE-IT trial that was presented at last year’s American Heart Association meeting “has shown the drug to be highly cost effective and actually cost saving at the current list price.”

Asked what the mechanism of benefit is, Dr. Bhatt said that “there has been good basic science showing that EPA [eicosapentaenoic acid] stabilizes cell membranes and reduces plaque vulnerability and progression.”

REDUCE-IT was sponsored by Amarin. Brigham and Women’s Hospital receives research funding from Amarin for Dr. Bhatt’s role as chair of the trial.

A version of this article originally appeared on Medscape.com.

The drastic drop in admissions for acute myocardial infarctions (AMI) during the COVID-19 pandemic in Italy has seen a parallel rise in MI fatality rates in those who do present to hospitals, according to a new report. This gives credence to suggestions that people have avoided hospitals during the pandemic despite life-threatening emergencies.

Salvatore De Rosa, MD, PhD, and colleagues reported their results in the European Heart Journal.

“These data return a frightening picture of about half of AMI patients not reaching out to the hospital at all, which will probably significantly increase mortality for AMI and bring with it a number of patients with post-MI heart failure, despite the fact that acute coronary syndrome management protocols were promptly implemented,” Dr. De Rosa, of Magna Graecia University in Catanzaro, Italy, and associates wrote.
 

Hospitalizations down

The study counted AMIs at 54 hospital coronary care units nationwide for the week of March 12-19, 2020, at the height of the coronavirus outbreak in northern Italy, and compared that with an equivalent week in 2019. The researchers reported 319 AMIs during the week in 2020, compared with 618 in the equivalent 2019 week, a 48% reduction (P < .001). Although the outbreak was worst in northern Italy, the decline in admissions occurred throughout the country.

An analysis of subtype determined the decline in the incidence of ST-segment elevation MI lagged significantly behind that of non-STEMI. STEMI declined from 268 in 2019 to 197 in 2020, a 27% reduction, while hospitalizations for non-STEMI went from 350 to 122, a 65% reduction.

The researchers also found substantial reductions in hospitalizations for heart failure, by 47%, and atrial fibrillation, by 53%. Incidentally, the mean age of atrial fibrillation patients was considerably younger in 2020: 64.6 vs. 70 years.
 

Death, complications up

AMI patients who managed to get to the hospital during the pandemic also had worse outcomes. Mortality for STEMI cases more than tripled, to 14% during the outbreak, compared with 4% in 2019 (P < .001) and complication rates increased by 80% to 19% (P = .025). Twenty-one STEMI patients were positive for COVID-19 and more than a quarter (29%) died, which was more than two and a half times the 12% death rate in non–COVID-19 STEMI patients.

Analysis of the STEMI group also found that the care gap for women with heart disease worsened significantly during the pandemic, as they comprised 20.3% of cases this year, compared with 25.4% before the pandemic. Also, the reduction in admissions for STEMI during the pandemic was statistically significant at 41% for women, but not for men at 18%.

Non-STEMI patients fared better overall than STEMI patients, but their outcomes also worsened during the pandemic. Non-STEMI patients were significantly less likely to have percutaneous coronary intervention during the pandemic than previously; the rate declined by 13%, from 77% to 66%. The non-STEMI mortality rate nearly doubled, although not statistically significantly, from 1.7% to 3.3%, whereas complication rates actually more than doubled, from 5.1% to 10.7%, a significant difference. Twelve (9.8%) of the non-STEMI patients were COVID-19 positive, but none died.
 

Trend extends beyond borders

Dr. De Rosa and colleagues noted that their findings are in line with studies that reported similar declines for STEMI interventions in the United States and Spain during the pandemic (J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.011; REC Interv Cardiol. 2020. doi: 10.24875/RECIC.M20000120).

Additionally, a group at Kaiser Permanente in Northern California also reported a 50% decline in the incidence of AMI hospitalizations during the pandemic (N Engl J Med. 2020 May 19. doi: 10.1056/NEJMc2015630). Likewise, a study of aortic dissections in New York reported a sharp decline in procedures during the pandemic in the city, from 13 to 3 a month (J Am Coll Cardiol. 2020 May 15. doi: 10.1016/j.jacc.2020.05.022)

The researchers in Italy didn’t aim to determine the reasons for the decline in AMI hospitalizations, but Dr. De Rosa and colleagues speculated on the following explanations: Fear of contagion in response to media reports, concentration of resources to address COVID-19 may have engendered a sense to defer less urgent care among patients and health care systems, and a true reduction in acute cardiovascular disease because people under stay-at-home orders had low physical stress.

“The concern is fewer MIs most likely means people are dying at home or presenting later as this study suggests,” said Martha Gulati, MD, chief of cardiology at the University of Arizona, Phoenix, in interpreting the results of the Italian study.

That could be a result of a mixed message from the media about accessing health care during the pandemic. “What it suggests to a lot of us is that the media has transmitted this notion that hospitals are busy taking care of COVID-19 patients, but we never said don’t come to hospital if you’re having a heart attack,” Dr. Gulati said. “I think we created some sort of fear that patients if they didn’t have COVID-19 they didn’t want to bother physicians.”

Dr. Gulati, whose practice focuses on women with CVD, said the study’s findings that interventions in women dropped more precipitously than men were concerning. “We know already that women don’t do as well after a heart attack, compared to men, and now we see it worsen it even further when women aren’t presenting,” she said. “We’re worried that this is going to increase the gap.”

Dr. DeRosa and colleagues have no relevant financial relationships to disclose.

SOURCE: De Rosa S et al. Euro Heart J. 2020 May 15. doi: 10.1093/eurheartj/ehaa409.

The drastic drop in admissions for acute myocardial infarctions (AMI) during the COVID-19 pandemic in Italy has seen a parallel rise in MI fatality rates in those who do present to hospitals, according to a new report. This gives credence to suggestions that people have avoided hospitals during the pandemic despite life-threatening emergencies.

Salvatore De Rosa, MD, PhD, and colleagues reported their results in the European Heart Journal.

“These data return a frightening picture of about half of AMI patients not reaching out to the hospital at all, which will probably significantly increase mortality for AMI and bring with it a number of patients with post-MI heart failure, despite the fact that acute coronary syndrome management protocols were promptly implemented,” Dr. De Rosa, of Magna Graecia University in Catanzaro, Italy, and associates wrote.
 

Hospitalizations down

The study counted AMIs at 54 hospital coronary care units nationwide for the week of March 12-19, 2020, at the height of the coronavirus outbreak in northern Italy, and compared that with an equivalent week in 2019. The researchers reported 319 AMIs during the week in 2020, compared with 618 in the equivalent 2019 week, a 48% reduction (P < .001). Although the outbreak was worst in northern Italy, the decline in admissions occurred throughout the country.

An analysis of subtype determined the decline in the incidence of ST-segment elevation MI lagged significantly behind that of non-STEMI. STEMI declined from 268 in 2019 to 197 in 2020, a 27% reduction, while hospitalizations for non-STEMI went from 350 to 122, a 65% reduction.

The researchers also found substantial reductions in hospitalizations for heart failure, by 47%, and atrial fibrillation, by 53%. Incidentally, the mean age of atrial fibrillation patients was considerably younger in 2020: 64.6 vs. 70 years.
 

Death, complications up

AMI patients who managed to get to the hospital during the pandemic also had worse outcomes. Mortality for STEMI cases more than tripled, to 14% during the outbreak, compared with 4% in 2019 (P < .001) and complication rates increased by 80% to 19% (P = .025). Twenty-one STEMI patients were positive for COVID-19 and more than a quarter (29%) died, which was more than two and a half times the 12% death rate in non–COVID-19 STEMI patients.

Analysis of the STEMI group also found that the care gap for women with heart disease worsened significantly during the pandemic, as they comprised 20.3% of cases this year, compared with 25.4% before the pandemic. Also, the reduction in admissions for STEMI during the pandemic was statistically significant at 41% for women, but not for men at 18%.

Non-STEMI patients fared better overall than STEMI patients, but their outcomes also worsened during the pandemic. Non-STEMI patients were significantly less likely to have percutaneous coronary intervention during the pandemic than previously; the rate declined by 13%, from 77% to 66%. The non-STEMI mortality rate nearly doubled, although not statistically significantly, from 1.7% to 3.3%, whereas complication rates actually more than doubled, from 5.1% to 10.7%, a significant difference. Twelve (9.8%) of the non-STEMI patients were COVID-19 positive, but none died.
 

Trend extends beyond borders

Dr. De Rosa and colleagues noted that their findings are in line with studies that reported similar declines for STEMI interventions in the United States and Spain during the pandemic (J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.011; REC Interv Cardiol. 2020. doi: 10.24875/RECIC.M20000120).

Additionally, a group at Kaiser Permanente in Northern California also reported a 50% decline in the incidence of AMI hospitalizations during the pandemic (N Engl J Med. 2020 May 19. doi: 10.1056/NEJMc2015630). Likewise, a study of aortic dissections in New York reported a sharp decline in procedures during the pandemic in the city, from 13 to 3 a month (J Am Coll Cardiol. 2020 May 15. doi: 10.1016/j.jacc.2020.05.022)

The researchers in Italy didn’t aim to determine the reasons for the decline in AMI hospitalizations, but Dr. De Rosa and colleagues speculated on the following explanations: Fear of contagion in response to media reports, concentration of resources to address COVID-19 may have engendered a sense to defer less urgent care among patients and health care systems, and a true reduction in acute cardiovascular disease because people under stay-at-home orders had low physical stress.

“The concern is fewer MIs most likely means people are dying at home or presenting later as this study suggests,” said Martha Gulati, MD, chief of cardiology at the University of Arizona, Phoenix, in interpreting the results of the Italian study.

That could be a result of a mixed message from the media about accessing health care during the pandemic. “What it suggests to a lot of us is that the media has transmitted this notion that hospitals are busy taking care of COVID-19 patients, but we never said don’t come to hospital if you’re having a heart attack,” Dr. Gulati said. “I think we created some sort of fear that patients if they didn’t have COVID-19 they didn’t want to bother physicians.”

Dr. Gulati, whose practice focuses on women with CVD, said the study’s findings that interventions in women dropped more precipitously than men were concerning. “We know already that women don’t do as well after a heart attack, compared to men, and now we see it worsen it even further when women aren’t presenting,” she said. “We’re worried that this is going to increase the gap.”

Dr. DeRosa and colleagues have no relevant financial relationships to disclose.

SOURCE: De Rosa S et al. Euro Heart J. 2020 May 15. doi: 10.1093/eurheartj/ehaa409.

The drastic drop in admissions for acute myocardial infarctions (AMI) during the COVID-19 pandemic in Italy has seen a parallel rise in MI fatality rates in those who do present to hospitals, according to a new report. This gives credence to suggestions that people have avoided hospitals during the pandemic despite life-threatening emergencies.

Salvatore De Rosa, MD, PhD, and colleagues reported their results in the European Heart Journal.

“These data return a frightening picture of about half of AMI patients not reaching out to the hospital at all, which will probably significantly increase mortality for AMI and bring with it a number of patients with post-MI heart failure, despite the fact that acute coronary syndrome management protocols were promptly implemented,” Dr. De Rosa, of Magna Graecia University in Catanzaro, Italy, and associates wrote.
 

Hospitalizations down

The study counted AMIs at 54 hospital coronary care units nationwide for the week of March 12-19, 2020, at the height of the coronavirus outbreak in northern Italy, and compared that with an equivalent week in 2019. The researchers reported 319 AMIs during the week in 2020, compared with 618 in the equivalent 2019 week, a 48% reduction (P < .001). Although the outbreak was worst in northern Italy, the decline in admissions occurred throughout the country.

An analysis of subtype determined the decline in the incidence of ST-segment elevation MI lagged significantly behind that of non-STEMI. STEMI declined from 268 in 2019 to 197 in 2020, a 27% reduction, while hospitalizations for non-STEMI went from 350 to 122, a 65% reduction.

The researchers also found substantial reductions in hospitalizations for heart failure, by 47%, and atrial fibrillation, by 53%. Incidentally, the mean age of atrial fibrillation patients was considerably younger in 2020: 64.6 vs. 70 years.
 

Death, complications up

AMI patients who managed to get to the hospital during the pandemic also had worse outcomes. Mortality for STEMI cases more than tripled, to 14% during the outbreak, compared with 4% in 2019 (P < .001) and complication rates increased by 80% to 19% (P = .025). Twenty-one STEMI patients were positive for COVID-19 and more than a quarter (29%) died, which was more than two and a half times the 12% death rate in non–COVID-19 STEMI patients.

Analysis of the STEMI group also found that the care gap for women with heart disease worsened significantly during the pandemic, as they comprised 20.3% of cases this year, compared with 25.4% before the pandemic. Also, the reduction in admissions for STEMI during the pandemic was statistically significant at 41% for women, but not for men at 18%.

Non-STEMI patients fared better overall than STEMI patients, but their outcomes also worsened during the pandemic. Non-STEMI patients were significantly less likely to have percutaneous coronary intervention during the pandemic than previously; the rate declined by 13%, from 77% to 66%. The non-STEMI mortality rate nearly doubled, although not statistically significantly, from 1.7% to 3.3%, whereas complication rates actually more than doubled, from 5.1% to 10.7%, a significant difference. Twelve (9.8%) of the non-STEMI patients were COVID-19 positive, but none died.
 

Trend extends beyond borders

Dr. De Rosa and colleagues noted that their findings are in line with studies that reported similar declines for STEMI interventions in the United States and Spain during the pandemic (J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.011; REC Interv Cardiol. 2020. doi: 10.24875/RECIC.M20000120).

Additionally, a group at Kaiser Permanente in Northern California also reported a 50% decline in the incidence of AMI hospitalizations during the pandemic (N Engl J Med. 2020 May 19. doi: 10.1056/NEJMc2015630). Likewise, a study of aortic dissections in New York reported a sharp decline in procedures during the pandemic in the city, from 13 to 3 a month (J Am Coll Cardiol. 2020 May 15. doi: 10.1016/j.jacc.2020.05.022)

The researchers in Italy didn’t aim to determine the reasons for the decline in AMI hospitalizations, but Dr. De Rosa and colleagues speculated on the following explanations: Fear of contagion in response to media reports, concentration of resources to address COVID-19 may have engendered a sense to defer less urgent care among patients and health care systems, and a true reduction in acute cardiovascular disease because people under stay-at-home orders had low physical stress.

“The concern is fewer MIs most likely means people are dying at home or presenting later as this study suggests,” said Martha Gulati, MD, chief of cardiology at the University of Arizona, Phoenix, in interpreting the results of the Italian study.

That could be a result of a mixed message from the media about accessing health care during the pandemic. “What it suggests to a lot of us is that the media has transmitted this notion that hospitals are busy taking care of COVID-19 patients, but we never said don’t come to hospital if you’re having a heart attack,” Dr. Gulati said. “I think we created some sort of fear that patients if they didn’t have COVID-19 they didn’t want to bother physicians.”

Dr. Gulati, whose practice focuses on women with CVD, said the study’s findings that interventions in women dropped more precipitously than men were concerning. “We know already that women don’t do as well after a heart attack, compared to men, and now we see it worsen it even further when women aren’t presenting,” she said. “We’re worried that this is going to increase the gap.”

Dr. DeRosa and colleagues have no relevant financial relationships to disclose.

SOURCE: De Rosa S et al. Euro Heart J. 2020 May 15. doi: 10.1093/eurheartj/ehaa409.

No restriction of oral food intake prior to nonemergent cardiac catheterization is as safe as the current traditional NPO [nothing by mouth] strategy, results from a large, single-center, randomized controlled trial showed.

According to lead investigator Abhishek Mishra, MD, NPO after midnight has been a standard practice before major surgery requiring general anesthesia since Mendelson Syndrome was first described in 1946. “The rational for keeping NPO after midnight has been to keep the stomach empty, to reduce gastric contents and acidity – which would reduce emesis – and eventually reduce the risk of aspiration,” Dr. Mishra, a cardiologist at the Heart and Vascular Institute at Vidant Health in Greenville, N.C., said at the at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “The rationale of NPO in the setting of cardiac catheterization is to reduce the risk of aspiration, and more so, of a patient needing emergent cardiac surgery.” The clinical question was, do we really need to keep our patients NPO prior to elective cardiac catheterization? So far, no large randomized study has been done to answer this question.”

To find out, Dr. Mishra and colleagues carried out CHOW NOW (Can We Safely Have Our Patients Eat With Cardiac Catheterization – Nix or Allow), a single-center, prospective, randomized, single-blinded study that compared the safety of a nonfasting strategy with the current fasting protocol strategies in 599 patients who underwent nonemergent cardiac catheterization at The Guthrie Clinic/Robert Packer Hospital in Sayre, Pa.

Patients in the fasting group were instructed to be NPO after midnight, but could have clear liquids up to 2 hours prior to the procedure, while those in the nonfasting group had no restriction of oral intake, irrespective of time of cardiac catheterization. The primary outcome was a composite of aspiration pneumonia, preprocedural hypertension, preprocedural hypoglycemia or hyperglycemia, incidence of nausea/vomiting, and contrast-induced neuropathy. Secondary outcomes included total cost of the index hospitalization, patient satisfaction via a questionnaire containing seven questions, and in-hospital mortality.

Of the 599 patients, 306 were assigned to the standard fasting group and the remaining 293 to the nonfasting group. Their mean age was 67 years, 45% were on a proton pump inhibitor or H2 blockers, and 33% had diabetes. In addition, 40% had acute coronary syndrome, and 23% underwent percutaneous intervention.

The researchers observed no statistically significant difference in the primary or secondary outcomes between the study groups. In the nonfasting group, 11.3% of patients met the primary endpoint, compared with 9.8% of the patients in the standard fasting group (P = .65). In addition, the nonfasting strategy was found to be noninferior to the standard fasting strategy for the primary outcome at a noninferiority margin threshold of 0.059.

Dr. Mishra and colleagues observed no differences between the standard fasting and nonfasting groups with respect to in-hospital mortality (0.3% vs. 0.7%, respectively; P = .616), patient satisfaction score (a mean of 4.4 vs. a mean of 4.5; P = .257), and mean total cost of hospitalization ($8,446 vs. $6,960; P = .654).

“In this randomized, controlled trial, we found that there was no significant difference in the rate of overall adverse events with an approach of unrestricted oral intake prior to cardiac catheterization compared to strict fasting, and it was associated with better patient satisfaction and lower cost of care, especially for hospitalized patients,” concluded Dr. Mishra, who conducted the research during his fellowship at The Guthrie Clinic.

He acknowledged certain limitations of the trial, including the fact that results are applicable only to cardiac catheterization procedures, including coronary angiographies, percutaneous coronary interventions, and left heart catheterizations. “These results are not applicable to certain high-risk coronary procedures that required the use of a large-bore access or any valve procedures,” he said.

One of the session’s invited panelists, Cindy L. Grines, MD,, said that she and other interventional cardiologists have “gone around and around” on the issue of NPO prior to nonemergent cardiac catheterization. “I actually let my patients get fluids up until the time they’re put on the cath lab table,” said Dr. Grines, chief scientific officer of the Northside Cardiovascular Institute in Atlanta. “I haven’t been giving them solid food like this, though.”

Another panelist, Timothy D. Henry, MD, said that in his clinical experience, “patients don’t like being NPO, and I think we’ve all seen cases where patients are actually volume-depleted in the morning.” Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, pointed out that most NPO policy “is not dictated by us as interventional cardiologists; it’s dictated by hospital policies or by anesthesiologists. Will [the results of this study] change what we do?”

The Donald Guthrie Research Foundation funded the study. Daniel P. Sporn, MD, FACC, was the study’s principal investigator. Dr. Mishra reported having no financial disclosures.

[email protected]

SOURCE: Mishra A et al., SCAI 2020, abstract 11758.

No restriction of oral food intake prior to nonemergent cardiac catheterization is as safe as the current traditional NPO [nothing by mouth] strategy, results from a large, single-center, randomized controlled trial showed.

According to lead investigator Abhishek Mishra, MD, NPO after midnight has been a standard practice before major surgery requiring general anesthesia since Mendelson Syndrome was first described in 1946. “The rational for keeping NPO after midnight has been to keep the stomach empty, to reduce gastric contents and acidity – which would reduce emesis – and eventually reduce the risk of aspiration,” Dr. Mishra, a cardiologist at the Heart and Vascular Institute at Vidant Health in Greenville, N.C., said at the at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “The rationale of NPO in the setting of cardiac catheterization is to reduce the risk of aspiration, and more so, of a patient needing emergent cardiac surgery.” The clinical question was, do we really need to keep our patients NPO prior to elective cardiac catheterization? So far, no large randomized study has been done to answer this question.”

To find out, Dr. Mishra and colleagues carried out CHOW NOW (Can We Safely Have Our Patients Eat With Cardiac Catheterization – Nix or Allow), a single-center, prospective, randomized, single-blinded study that compared the safety of a nonfasting strategy with the current fasting protocol strategies in 599 patients who underwent nonemergent cardiac catheterization at The Guthrie Clinic/Robert Packer Hospital in Sayre, Pa.

Patients in the fasting group were instructed to be NPO after midnight, but could have clear liquids up to 2 hours prior to the procedure, while those in the nonfasting group had no restriction of oral intake, irrespective of time of cardiac catheterization. The primary outcome was a composite of aspiration pneumonia, preprocedural hypertension, preprocedural hypoglycemia or hyperglycemia, incidence of nausea/vomiting, and contrast-induced neuropathy. Secondary outcomes included total cost of the index hospitalization, patient satisfaction via a questionnaire containing seven questions, and in-hospital mortality.

Of the 599 patients, 306 were assigned to the standard fasting group and the remaining 293 to the nonfasting group. Their mean age was 67 years, 45% were on a proton pump inhibitor or H2 blockers, and 33% had diabetes. In addition, 40% had acute coronary syndrome, and 23% underwent percutaneous intervention.

The researchers observed no statistically significant difference in the primary or secondary outcomes between the study groups. In the nonfasting group, 11.3% of patients met the primary endpoint, compared with 9.8% of the patients in the standard fasting group (P = .65). In addition, the nonfasting strategy was found to be noninferior to the standard fasting strategy for the primary outcome at a noninferiority margin threshold of 0.059.

Dr. Mishra and colleagues observed no differences between the standard fasting and nonfasting groups with respect to in-hospital mortality (0.3% vs. 0.7%, respectively; P = .616), patient satisfaction score (a mean of 4.4 vs. a mean of 4.5; P = .257), and mean total cost of hospitalization ($8,446 vs. $6,960; P = .654).

“In this randomized, controlled trial, we found that there was no significant difference in the rate of overall adverse events with an approach of unrestricted oral intake prior to cardiac catheterization compared to strict fasting, and it was associated with better patient satisfaction and lower cost of care, especially for hospitalized patients,” concluded Dr. Mishra, who conducted the research during his fellowship at The Guthrie Clinic.

He acknowledged certain limitations of the trial, including the fact that results are applicable only to cardiac catheterization procedures, including coronary angiographies, percutaneous coronary interventions, and left heart catheterizations. “These results are not applicable to certain high-risk coronary procedures that required the use of a large-bore access or any valve procedures,” he said.

One of the session’s invited panelists, Cindy L. Grines, MD,, said that she and other interventional cardiologists have “gone around and around” on the issue of NPO prior to nonemergent cardiac catheterization. “I actually let my patients get fluids up until the time they’re put on the cath lab table,” said Dr. Grines, chief scientific officer of the Northside Cardiovascular Institute in Atlanta. “I haven’t been giving them solid food like this, though.”

Another panelist, Timothy D. Henry, MD, said that in his clinical experience, “patients don’t like being NPO, and I think we’ve all seen cases where patients are actually volume-depleted in the morning.” Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, pointed out that most NPO policy “is not dictated by us as interventional cardiologists; it’s dictated by hospital policies or by anesthesiologists. Will [the results of this study] change what we do?”

The Donald Guthrie Research Foundation funded the study. Daniel P. Sporn, MD, FACC, was the study’s principal investigator. Dr. Mishra reported having no financial disclosures.

[email protected]

SOURCE: Mishra A et al., SCAI 2020, abstract 11758.

No restriction of oral food intake prior to nonemergent cardiac catheterization is as safe as the current traditional NPO [nothing by mouth] strategy, results from a large, single-center, randomized controlled trial showed.

According to lead investigator Abhishek Mishra, MD, NPO after midnight has been a standard practice before major surgery requiring general anesthesia since Mendelson Syndrome was first described in 1946. “The rational for keeping NPO after midnight has been to keep the stomach empty, to reduce gastric contents and acidity – which would reduce emesis – and eventually reduce the risk of aspiration,” Dr. Mishra, a cardiologist at the Heart and Vascular Institute at Vidant Health in Greenville, N.C., said at the at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “The rationale of NPO in the setting of cardiac catheterization is to reduce the risk of aspiration, and more so, of a patient needing emergent cardiac surgery.” The clinical question was, do we really need to keep our patients NPO prior to elective cardiac catheterization? So far, no large randomized study has been done to answer this question.”

To find out, Dr. Mishra and colleagues carried out CHOW NOW (Can We Safely Have Our Patients Eat With Cardiac Catheterization – Nix or Allow), a single-center, prospective, randomized, single-blinded study that compared the safety of a nonfasting strategy with the current fasting protocol strategies in 599 patients who underwent nonemergent cardiac catheterization at The Guthrie Clinic/Robert Packer Hospital in Sayre, Pa.

Patients in the fasting group were instructed to be NPO after midnight, but could have clear liquids up to 2 hours prior to the procedure, while those in the nonfasting group had no restriction of oral intake, irrespective of time of cardiac catheterization. The primary outcome was a composite of aspiration pneumonia, preprocedural hypertension, preprocedural hypoglycemia or hyperglycemia, incidence of nausea/vomiting, and contrast-induced neuropathy. Secondary outcomes included total cost of the index hospitalization, patient satisfaction via a questionnaire containing seven questions, and in-hospital mortality.

Of the 599 patients, 306 were assigned to the standard fasting group and the remaining 293 to the nonfasting group. Their mean age was 67 years, 45% were on a proton pump inhibitor or H2 blockers, and 33% had diabetes. In addition, 40% had acute coronary syndrome, and 23% underwent percutaneous intervention.

The researchers observed no statistically significant difference in the primary or secondary outcomes between the study groups. In the nonfasting group, 11.3% of patients met the primary endpoint, compared with 9.8% of the patients in the standard fasting group (P = .65). In addition, the nonfasting strategy was found to be noninferior to the standard fasting strategy for the primary outcome at a noninferiority margin threshold of 0.059.

Dr. Mishra and colleagues observed no differences between the standard fasting and nonfasting groups with respect to in-hospital mortality (0.3% vs. 0.7%, respectively; P = .616), patient satisfaction score (a mean of 4.4 vs. a mean of 4.5; P = .257), and mean total cost of hospitalization ($8,446 vs. $6,960; P = .654).

“In this randomized, controlled trial, we found that there was no significant difference in the rate of overall adverse events with an approach of unrestricted oral intake prior to cardiac catheterization compared to strict fasting, and it was associated with better patient satisfaction and lower cost of care, especially for hospitalized patients,” concluded Dr. Mishra, who conducted the research during his fellowship at The Guthrie Clinic.

He acknowledged certain limitations of the trial, including the fact that results are applicable only to cardiac catheterization procedures, including coronary angiographies, percutaneous coronary interventions, and left heart catheterizations. “These results are not applicable to certain high-risk coronary procedures that required the use of a large-bore access or any valve procedures,” he said.

One of the session’s invited panelists, Cindy L. Grines, MD,, said that she and other interventional cardiologists have “gone around and around” on the issue of NPO prior to nonemergent cardiac catheterization. “I actually let my patients get fluids up until the time they’re put on the cath lab table,” said Dr. Grines, chief scientific officer of the Northside Cardiovascular Institute in Atlanta. “I haven’t been giving them solid food like this, though.”

Another panelist, Timothy D. Henry, MD, said that in his clinical experience, “patients don’t like being NPO, and I think we’ve all seen cases where patients are actually volume-depleted in the morning.” Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, pointed out that most NPO policy “is not dictated by us as interventional cardiologists; it’s dictated by hospital policies or by anesthesiologists. Will [the results of this study] change what we do?”

The Donald Guthrie Research Foundation funded the study. Daniel P. Sporn, MD, FACC, was the study’s principal investigator. Dr. Mishra reported having no financial disclosures.

[email protected]

SOURCE: Mishra A et al., SCAI 2020, abstract 11758.

A novel telemedicine approach to remotely guide ST-segment elevation myocardial infarction treatment in four Latin American countries screened more than 780,000 patients and resulted in a mortality rate of 5.2%, results from a 1-year, prospective, observational study showed.

“We have created a modality where the care of acute MI can be remotely guided,” lead investigator Sameer Mehta, MD, MBA, said during a press briefing at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “This flattens the disparity between the developed and the developing countries, particularly in the poorer parts of Africa, the Middle East, and Southeast Asia.”

Dr. Mehta, chairman of the Lumen Foundation in Miami, and colleagues developed a “hub and spoke” platform to expand STEMI access to more than 100 million people in Brazil, Colombia, Mexico, and Argentina. For the effort, known as the Latin America Telemedicine Infarct Network (LATIN), “spokes” consisted of small clinics and primary health care centers in remote locations, while the “hubs” were medical centers that provided percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery. There were 313 spokes, 47 hubs, and more than 2,000 health care professionals who participated in the endeavor, including about 600 physicians.

The study, which is the largest of its kind, implemented a 3T strategy: telemedicine, triage, and transport, “which was the hardest part,” Dr. Mehta said. “In some cases, the spokes were located up to 300 miles away from the hubs. Up to 11% of these spokes in the remote areas did not even have a physician. Some had nurses who were triaging the patients.”

Patients who presented at spoke sites were enrolled into LATIN and data were collected through a form that included patient demographics, previous medical history, and an ECG. This information was sent through an app to one of three telemedicine diagnosis centers with 24/7 access to a cardiologist: one in Colombia, one in Brazil, one in Argentina. Once STEMI was identified by ECG, the STEMI protocol was activated, sending alerts to both designated hub and spoke sites and triggering ambulance dispatch. At the spoke sites, thrombolysis, a pharmaco-invasive strategy, or a primary PCI was performed, depending on case and treatment availability. Patients with successful thrombolysis were stabilized for up to 24 hours before transferral to a hub. Patients for whom reperfusion failed were transferred immediately to a hub for rescue PCI.

Dr. Mehta reported findings from 780,234 telemedicine encounters that occurred in the LATIN network in 2018. Telemedicine experts diagnosed 8,395 patients (1%) with STEMI, of which 3,872 (46%) were urgently treated at 47 hubs. A total of 3,015 (78%) were reperfused with PCI. Time-to-telemedicine diagnosis averaged 3.5 minutes. “It used to take us 11 minutes of time to make a diagnosis by telemedicine,” Dr. Mehta said. “By the time we were done with the trial, the time to diagnosis was brought down to 3.5 minutes.” Average door-to-balloon time was 48 minutes and the STEMI mortality was 5.2%. This represents a 55% reduction in STEMI mortality from when LATIN began as a pilot project in 2013, Dr. Mehta said.

Hypertension was the most prevalent underlying disease (59%), followed by smoking (30%) and diabetes (29%), and the male to female STEMI diagnosis ratio was 1.71. The chief reason for nontreatment was coverage denial from insurance carriers (71%). “Getting payers onboard is extremely difficult, because being located here in Miami, is it very hard for me to convince them about the importance of supporting these people,” Dr. Mehta said. “However, as time has passed [and with] coverage of LATIN by the media, the program has become better known. We have been able to work mainly through the health secretaries [in these four countries], but is difficult from there onward.”

LATIN investigators faced other hurdles, which were unique in each of the four countries. “In Colombia, we were facing all sorts of geographical challenges; Brazil was challenging because of its size of the country and [difficulty establishing relationships with] some of the inner-city hospitals,” he said. “Mexico and Argentina were unique from the telemedicine point of view.” The fact that the care of LATIN patients was navigated from one of three telemedicine diagnosis centers “demonstrates the ability of telemedicine,” he said. “If I am able to guide a patient in Mexico from Bogotá, Colombia, it should be easy to guide a patient from Miami who’s presenting in Zambia.”

Dealing with the lack of ambulance services in Brazil, Colombia, Mexico, and Argentina has also been a hitch to the effort. “There is either a complete lack of ambulances or there is no central ambulance system,” he said. “In one of the earlier cities where we started the program in Colombia, 84% of patients used to self-transport. At the moment, 79% are being transported by ambulance. So, the halo effect of how LATIN has helped MI management has been impressive.”

Despite the lack of a comparator study as robust as LATIN, the program was estimated to reach between $39.6 million and $119 million USD total savings during the study period. This includes the cost of tele-emergency encounters, avoided transfers, and the cost of transportation. The investigators project that by the year 2026, 5 million patients could be triaged by this telemedicine pathway, saving $249 million. “As we are getting excited about the developments and the possibilities of telemedicine in the COVID-19 era, I think the work of LATIN becomes all the more relevant,” Dr. Mehta said during his main presentation.

During the press briefing, Timothy D. Henry, MD, praised the success of LATIN in reaching an underserved population. “The majority of these patients 10 years ago were not being treated with any reperfusion therapy at all,” said Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “With rapid diagnosis and the process of putting [LATIN] in place, that has increased to the point where 78% are now getting primary PCI. That is remarkable.”

[email protected]

A novel telemedicine approach to remotely guide ST-segment elevation myocardial infarction treatment in four Latin American countries screened more than 780,000 patients and resulted in a mortality rate of 5.2%, results from a 1-year, prospective, observational study showed.

“We have created a modality where the care of acute MI can be remotely guided,” lead investigator Sameer Mehta, MD, MBA, said during a press briefing at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “This flattens the disparity between the developed and the developing countries, particularly in the poorer parts of Africa, the Middle East, and Southeast Asia.”

Dr. Mehta, chairman of the Lumen Foundation in Miami, and colleagues developed a “hub and spoke” platform to expand STEMI access to more than 100 million people in Brazil, Colombia, Mexico, and Argentina. For the effort, known as the Latin America Telemedicine Infarct Network (LATIN), “spokes” consisted of small clinics and primary health care centers in remote locations, while the “hubs” were medical centers that provided percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery. There were 313 spokes, 47 hubs, and more than 2,000 health care professionals who participated in the endeavor, including about 600 physicians.

The study, which is the largest of its kind, implemented a 3T strategy: telemedicine, triage, and transport, “which was the hardest part,” Dr. Mehta said. “In some cases, the spokes were located up to 300 miles away from the hubs. Up to 11% of these spokes in the remote areas did not even have a physician. Some had nurses who were triaging the patients.”

Patients who presented at spoke sites were enrolled into LATIN and data were collected through a form that included patient demographics, previous medical history, and an ECG. This information was sent through an app to one of three telemedicine diagnosis centers with 24/7 access to a cardiologist: one in Colombia, one in Brazil, one in Argentina. Once STEMI was identified by ECG, the STEMI protocol was activated, sending alerts to both designated hub and spoke sites and triggering ambulance dispatch. At the spoke sites, thrombolysis, a pharmaco-invasive strategy, or a primary PCI was performed, depending on case and treatment availability. Patients with successful thrombolysis were stabilized for up to 24 hours before transferral to a hub. Patients for whom reperfusion failed were transferred immediately to a hub for rescue PCI.

Dr. Mehta reported findings from 780,234 telemedicine encounters that occurred in the LATIN network in 2018. Telemedicine experts diagnosed 8,395 patients (1%) with STEMI, of which 3,872 (46%) were urgently treated at 47 hubs. A total of 3,015 (78%) were reperfused with PCI. Time-to-telemedicine diagnosis averaged 3.5 minutes. “It used to take us 11 minutes of time to make a diagnosis by telemedicine,” Dr. Mehta said. “By the time we were done with the trial, the time to diagnosis was brought down to 3.5 minutes.” Average door-to-balloon time was 48 minutes and the STEMI mortality was 5.2%. This represents a 55% reduction in STEMI mortality from when LATIN began as a pilot project in 2013, Dr. Mehta said.

Hypertension was the most prevalent underlying disease (59%), followed by smoking (30%) and diabetes (29%), and the male to female STEMI diagnosis ratio was 1.71. The chief reason for nontreatment was coverage denial from insurance carriers (71%). “Getting payers onboard is extremely difficult, because being located here in Miami, is it very hard for me to convince them about the importance of supporting these people,” Dr. Mehta said. “However, as time has passed [and with] coverage of LATIN by the media, the program has become better known. We have been able to work mainly through the health secretaries [in these four countries], but is difficult from there onward.”

LATIN investigators faced other hurdles, which were unique in each of the four countries. “In Colombia, we were facing all sorts of geographical challenges; Brazil was challenging because of its size of the country and [difficulty establishing relationships with] some of the inner-city hospitals,” he said. “Mexico and Argentina were unique from the telemedicine point of view.” The fact that the care of LATIN patients was navigated from one of three telemedicine diagnosis centers “demonstrates the ability of telemedicine,” he said. “If I am able to guide a patient in Mexico from Bogotá, Colombia, it should be easy to guide a patient from Miami who’s presenting in Zambia.”

Dealing with the lack of ambulance services in Brazil, Colombia, Mexico, and Argentina has also been a hitch to the effort. “There is either a complete lack of ambulances or there is no central ambulance system,” he said. “In one of the earlier cities where we started the program in Colombia, 84% of patients used to self-transport. At the moment, 79% are being transported by ambulance. So, the halo effect of how LATIN has helped MI management has been impressive.”

Despite the lack of a comparator study as robust as LATIN, the program was estimated to reach between $39.6 million and $119 million USD total savings during the study period. This includes the cost of tele-emergency encounters, avoided transfers, and the cost of transportation. The investigators project that by the year 2026, 5 million patients could be triaged by this telemedicine pathway, saving $249 million. “As we are getting excited about the developments and the possibilities of telemedicine in the COVID-19 era, I think the work of LATIN becomes all the more relevant,” Dr. Mehta said during his main presentation.

During the press briefing, Timothy D. Henry, MD, praised the success of LATIN in reaching an underserved population. “The majority of these patients 10 years ago were not being treated with any reperfusion therapy at all,” said Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “With rapid diagnosis and the process of putting [LATIN] in place, that has increased to the point where 78% are now getting primary PCI. That is remarkable.”

[email protected]

A novel telemedicine approach to remotely guide ST-segment elevation myocardial infarction treatment in four Latin American countries screened more than 780,000 patients and resulted in a mortality rate of 5.2%, results from a 1-year, prospective, observational study showed.

“We have created a modality where the care of acute MI can be remotely guided,” lead investigator Sameer Mehta, MD, MBA, said during a press briefing at the Society for Cardiovascular Angiography & Interventions virtual annual scientific sessions. “This flattens the disparity between the developed and the developing countries, particularly in the poorer parts of Africa, the Middle East, and Southeast Asia.”

Dr. Mehta, chairman of the Lumen Foundation in Miami, and colleagues developed a “hub and spoke” platform to expand STEMI access to more than 100 million people in Brazil, Colombia, Mexico, and Argentina. For the effort, known as the Latin America Telemedicine Infarct Network (LATIN), “spokes” consisted of small clinics and primary health care centers in remote locations, while the “hubs” were medical centers that provided percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery. There were 313 spokes, 47 hubs, and more than 2,000 health care professionals who participated in the endeavor, including about 600 physicians.

The study, which is the largest of its kind, implemented a 3T strategy: telemedicine, triage, and transport, “which was the hardest part,” Dr. Mehta said. “In some cases, the spokes were located up to 300 miles away from the hubs. Up to 11% of these spokes in the remote areas did not even have a physician. Some had nurses who were triaging the patients.”

Patients who presented at spoke sites were enrolled into LATIN and data were collected through a form that included patient demographics, previous medical history, and an ECG. This information was sent through an app to one of three telemedicine diagnosis centers with 24/7 access to a cardiologist: one in Colombia, one in Brazil, one in Argentina. Once STEMI was identified by ECG, the STEMI protocol was activated, sending alerts to both designated hub and spoke sites and triggering ambulance dispatch. At the spoke sites, thrombolysis, a pharmaco-invasive strategy, or a primary PCI was performed, depending on case and treatment availability. Patients with successful thrombolysis were stabilized for up to 24 hours before transferral to a hub. Patients for whom reperfusion failed were transferred immediately to a hub for rescue PCI.

Dr. Mehta reported findings from 780,234 telemedicine encounters that occurred in the LATIN network in 2018. Telemedicine experts diagnosed 8,395 patients (1%) with STEMI, of which 3,872 (46%) were urgently treated at 47 hubs. A total of 3,015 (78%) were reperfused with PCI. Time-to-telemedicine diagnosis averaged 3.5 minutes. “It used to take us 11 minutes of time to make a diagnosis by telemedicine,” Dr. Mehta said. “By the time we were done with the trial, the time to diagnosis was brought down to 3.5 minutes.” Average door-to-balloon time was 48 minutes and the STEMI mortality was 5.2%. This represents a 55% reduction in STEMI mortality from when LATIN began as a pilot project in 2013, Dr. Mehta said.

Hypertension was the most prevalent underlying disease (59%), followed by smoking (30%) and diabetes (29%), and the male to female STEMI diagnosis ratio was 1.71. The chief reason for nontreatment was coverage denial from insurance carriers (71%). “Getting payers onboard is extremely difficult, because being located here in Miami, is it very hard for me to convince them about the importance of supporting these people,” Dr. Mehta said. “However, as time has passed [and with] coverage of LATIN by the media, the program has become better known. We have been able to work mainly through the health secretaries [in these four countries], but is difficult from there onward.”

LATIN investigators faced other hurdles, which were unique in each of the four countries. “In Colombia, we were facing all sorts of geographical challenges; Brazil was challenging because of its size of the country and [difficulty establishing relationships with] some of the inner-city hospitals,” he said. “Mexico and Argentina were unique from the telemedicine point of view.” The fact that the care of LATIN patients was navigated from one of three telemedicine diagnosis centers “demonstrates the ability of telemedicine,” he said. “If I am able to guide a patient in Mexico from Bogotá, Colombia, it should be easy to guide a patient from Miami who’s presenting in Zambia.”

Dealing with the lack of ambulance services in Brazil, Colombia, Mexico, and Argentina has also been a hitch to the effort. “There is either a complete lack of ambulances or there is no central ambulance system,” he said. “In one of the earlier cities where we started the program in Colombia, 84% of patients used to self-transport. At the moment, 79% are being transported by ambulance. So, the halo effect of how LATIN has helped MI management has been impressive.”

Despite the lack of a comparator study as robust as LATIN, the program was estimated to reach between $39.6 million and $119 million USD total savings during the study period. This includes the cost of tele-emergency encounters, avoided transfers, and the cost of transportation. The investigators project that by the year 2026, 5 million patients could be triaged by this telemedicine pathway, saving $249 million. “As we are getting excited about the developments and the possibilities of telemedicine in the COVID-19 era, I think the work of LATIN becomes all the more relevant,” Dr. Mehta said during his main presentation.

During the press briefing, Timothy D. Henry, MD, praised the success of LATIN in reaching an underserved population. “The majority of these patients 10 years ago were not being treated with any reperfusion therapy at all,” said Dr. Henry, medical director of The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati. “With rapid diagnosis and the process of putting [LATIN] in place, that has increased to the point where 78% are now getting primary PCI. That is remarkable.”

[email protected]

Results from a prospective, multicenter, uncontrolled series of just over 1,500 patients with high bleeding risk who underwent coronary revascularization with a polymer-based, zotarolimus-eluting stent showed that these patients could safely receive dual-antiplatelet therapy (DAPT)for just 1 month.

This finding sets the stage for a new labeled indication for this device and management strategy in this patient population.

Results from the Onyx ONE Clear study “met its primary endpoint, with favorable rates of ischemic outcomes from 1-12 months after DAPT discontinuation within a high risk population of HBR [high-bleeding-risk] patients,” Ajay J. Kirtane, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. The rate of cardiac death or MI during months 1-12 of follow-up while patients were on single-antiplatelet therapy (SAPT) with either aspirin or a P2Y12 inhibitor, usually clopidogrel, was 7.0%, compared with a prespecified performance goal of 9.7% or less, a goal set in consultation with and approval from the Food and Drug Administration based on the results from earlier, short DAPT studies in HBR patients.

“We hope these data will support our submission to the FDA for a 1-month DAPT indication for high-bleeding-risk patients treated with Resolute Onyx,” the polymer-based, zotarolimus-eluting stent tested in the study, said an officer with Medtronic, the company that sponsored this study and markets this stent, in a written statement. Currently, no stent has received a U.S. indication for just 1 month of DAPT treatment.

Mitchel L. Zoler/MDedge News

“The Onyx ONE Clear study represents the largest analysis of 1-month DAPT among commercially available DES [drug-eluting stents], and extends findings from the Onyx ONE [randomized, controlled trial] assuring the safety of a 1-month DAPT strategy among selected patients with high bleeding risk,” said David E. Kandzari, MD, director of interventional cardiology at Piedmont Healthcare in Atlanta and coprincipal investigator for the study along with Dr. Kirtane.

“Despite the patient complexity included in the study, the observation of a favorably low rate of ischemic events despite abbreviated DAPT is consistent with a theme from other contemporary studies that, among HBR patients, bleeding risk rather than ischemic risk should guide clinical decision making regarding DAPT duration,” Dr. Kandzari said in an interview.
 

Two similar trials

The Onyx ONE Clear results were consistent with findings from a study with a somewhat similar design, LEADERS FREE II, a single-arm study that assessed the safety and efficacy of BioFreedom, a polymer-free umirolimus-coated coronary stent, in HBR patients treated with DAPT for 1 month followed by SAPT.

LEADERS FREE II showed a 12-month cardiac death or MI rate of 8.6% that compared favorably with the 12.3% 1-year rate among similar patients who received bare-metal stents and a similar timing of DAPT and SAPT in a historical control group (Circ Cardiovasc Interv. 2020 Apr 13. doi: 10.1161/CIRCINTERVENTIONS.119.008603). The primary goal of LEADERS FREE II was to serve as the pivotal trial for FDA approval of the BioFreedom stent, but as of May 2020 the FDA had not approved this stent for U.S. use.

Results of another recent study, Onyx ONE, that supplied more than half the patients included in the Onyx ONE Clear analysis, showed that, in a head-to-head comparison of the Onxy and BioFreedom stents in 1,996 HBR patients treated with DAPT for 1 month followed by 11 months of SAPT, the Onyx stent was noninferior for both a primary safety outcome and a secondary efficacy outcome (N Engl J Med. 2020 Mar 26;382[13]:1208-18).

“The major differences” between the Onyx and BioFreedom stents in the patients studied in Onxy ONE Clear and in LEADERS FREE II “lie in the fact that BioFreedom is not approved in the U.S., and that Onyx is a current generation, preferred DES platform for both conventional and HBR patients,” Dr. Kirtane said in an interview.

“Because of the performance characteristics of Onyx, as well as the fact that ONYX ONE studied a far more complex group of patients than other shorter DAPT studies with conventional DES, I personally feel that there will be a preference to use this stent as a result of these data,” added Dr. Kirtane, professor of medicine at Columbia University and director of the coronary catheterization laboratory at New York–Presbyterian Hospital in New York.

The results from Onyx ONE “are critical for changing practice” among U.S. interventionalists, commented Sunil V. Rao, MD, an interventional cardiologist and professor of medicine at Duke University, Durham, N.C. Based on the new findings, U.S. operators performing percutaneous coronary interventions “will feel comfortable stopping DAPT in patients who are at high bleeding risk,” he said in an interview.

Although the results from LEADERS FREE II showed that the BioFreedom stent was superior to a bare-metal stent with 1 month of DAPT in HBR patients, and the results from Onyx ONE showed that the Onyx stent was noninferior to BioFreedom in this setting, “it’s important not to assume that there is a class effect across DES platforms. Each platform has a different drug and different stent design, so the interventional community needs to see these data for each DES,” Dr. Rao maintained.
 

Onyx ONE Clear design

Onyx ONE Clear enrolled a total of 1,506 patients, including more than 1,000 patients who received the Onyx stent in the Onyx ONE trial and an additional 752 patients enrolled in the United States and Japan, but 263 of these patients had an adverse event during their first 30 days or follow-up leaving 1,506 patients eligible to continue into the Onyx ONE Clear analysis, and with 1,491 patients followed through 12 months. Patients were an average age of 74 years, a little over two-thirds were men, 49% had a recent acute coronary syndrome event and 41% had chronic coronary syndrome. The choice of which antiplatelet agent to continue when patients transitioned to SAPT after 30 days on DAPT was left to the discretion of the physicians for each enrolled patient.

One issue these studies did not address was whether 1 month is the ideal duration for DAPT before switching to SAPT in HBR patients following coronary stenting, or whether longer DAPT durations produce even better outcomes. “It was important to establish what happens if we need to stop DAPT early.” The Onyx ONE and Onyx ONE Clear studies “provide much-needed data informing clinicians of the risks and safety of SAPT after 1 month in appropriately selected patients,” Dr. Kirtane said.

“The results do not indicate that all HBR patients should be treated with 1 month [of] DAPT, but instead demonstrate the safety and effectiveness of this strategy when clinically appropriate.” This scenario “is quite common, given that HBR patients represent up to a third” of patients undergoing percutaneous coronary intervention, Dr. Kandzari said.

Onyx ONE and Onyx ONE Clear were sponsored by Medtronic, the company that markets the Onyx coronary stent. Dr. Kirtane’s institution has received research support from Medtronic, and from Abbott Vascular, Abiomed, Boston Scientific, Cathworks, CSI, Philips, ReCor Medical, and Siemens. Dr. Kandzari has received personal fees and research grants from medtronic, personal fees from Biotronik and Cardiovascular Systems, and research grants from Biotronik, Boston Scientific, and Cardiovascular Systems. Dr. Rao has received personal fees from Medtronic, as well as from CSI and Philips.

[email protected]

SOURCE: Kirtane AJ et al. ACC 2020, Abstract 903-06.

Results from a prospective, multicenter, uncontrolled series of just over 1,500 patients with high bleeding risk who underwent coronary revascularization with a polymer-based, zotarolimus-eluting stent showed that these patients could safely receive dual-antiplatelet therapy (DAPT)for just 1 month.

This finding sets the stage for a new labeled indication for this device and management strategy in this patient population.

Results from the Onyx ONE Clear study “met its primary endpoint, with favorable rates of ischemic outcomes from 1-12 months after DAPT discontinuation within a high risk population of HBR [high-bleeding-risk] patients,” Ajay J. Kirtane, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. The rate of cardiac death or MI during months 1-12 of follow-up while patients were on single-antiplatelet therapy (SAPT) with either aspirin or a P2Y12 inhibitor, usually clopidogrel, was 7.0%, compared with a prespecified performance goal of 9.7% or less, a goal set in consultation with and approval from the Food and Drug Administration based on the results from earlier, short DAPT studies in HBR patients.

“We hope these data will support our submission to the FDA for a 1-month DAPT indication for high-bleeding-risk patients treated with Resolute Onyx,” the polymer-based, zotarolimus-eluting stent tested in the study, said an officer with Medtronic, the company that sponsored this study and markets this stent, in a written statement. Currently, no stent has received a U.S. indication for just 1 month of DAPT treatment.

Mitchel L. Zoler/MDedge News

“The Onyx ONE Clear study represents the largest analysis of 1-month DAPT among commercially available DES [drug-eluting stents], and extends findings from the Onyx ONE [randomized, controlled trial] assuring the safety of a 1-month DAPT strategy among selected patients with high bleeding risk,” said David E. Kandzari, MD, director of interventional cardiology at Piedmont Healthcare in Atlanta and coprincipal investigator for the study along with Dr. Kirtane.

“Despite the patient complexity included in the study, the observation of a favorably low rate of ischemic events despite abbreviated DAPT is consistent with a theme from other contemporary studies that, among HBR patients, bleeding risk rather than ischemic risk should guide clinical decision making regarding DAPT duration,” Dr. Kandzari said in an interview.
 

Two similar trials

The Onyx ONE Clear results were consistent with findings from a study with a somewhat similar design, LEADERS FREE II, a single-arm study that assessed the safety and efficacy of BioFreedom, a polymer-free umirolimus-coated coronary stent, in HBR patients treated with DAPT for 1 month followed by SAPT.

LEADERS FREE II showed a 12-month cardiac death or MI rate of 8.6% that compared favorably with the 12.3% 1-year rate among similar patients who received bare-metal stents and a similar timing of DAPT and SAPT in a historical control group (Circ Cardiovasc Interv. 2020 Apr 13. doi: 10.1161/CIRCINTERVENTIONS.119.008603). The primary goal of LEADERS FREE II was to serve as the pivotal trial for FDA approval of the BioFreedom stent, but as of May 2020 the FDA had not approved this stent for U.S. use.

Results of another recent study, Onyx ONE, that supplied more than half the patients included in the Onyx ONE Clear analysis, showed that, in a head-to-head comparison of the Onxy and BioFreedom stents in 1,996 HBR patients treated with DAPT for 1 month followed by 11 months of SAPT, the Onyx stent was noninferior for both a primary safety outcome and a secondary efficacy outcome (N Engl J Med. 2020 Mar 26;382[13]:1208-18).

“The major differences” between the Onyx and BioFreedom stents in the patients studied in Onxy ONE Clear and in LEADERS FREE II “lie in the fact that BioFreedom is not approved in the U.S., and that Onyx is a current generation, preferred DES platform for both conventional and HBR patients,” Dr. Kirtane said in an interview.

“Because of the performance characteristics of Onyx, as well as the fact that ONYX ONE studied a far more complex group of patients than other shorter DAPT studies with conventional DES, I personally feel that there will be a preference to use this stent as a result of these data,” added Dr. Kirtane, professor of medicine at Columbia University and director of the coronary catheterization laboratory at New York–Presbyterian Hospital in New York.

The results from Onyx ONE “are critical for changing practice” among U.S. interventionalists, commented Sunil V. Rao, MD, an interventional cardiologist and professor of medicine at Duke University, Durham, N.C. Based on the new findings, U.S. operators performing percutaneous coronary interventions “will feel comfortable stopping DAPT in patients who are at high bleeding risk,” he said in an interview.

Although the results from LEADERS FREE II showed that the BioFreedom stent was superior to a bare-metal stent with 1 month of DAPT in HBR patients, and the results from Onyx ONE showed that the Onyx stent was noninferior to BioFreedom in this setting, “it’s important not to assume that there is a class effect across DES platforms. Each platform has a different drug and different stent design, so the interventional community needs to see these data for each DES,” Dr. Rao maintained.
 

Onyx ONE Clear design

Onyx ONE Clear enrolled a total of 1,506 patients, including more than 1,000 patients who received the Onyx stent in the Onyx ONE trial and an additional 752 patients enrolled in the United States and Japan, but 263 of these patients had an adverse event during their first 30 days or follow-up leaving 1,506 patients eligible to continue into the Onyx ONE Clear analysis, and with 1,491 patients followed through 12 months. Patients were an average age of 74 years, a little over two-thirds were men, 49% had a recent acute coronary syndrome event and 41% had chronic coronary syndrome. The choice of which antiplatelet agent to continue when patients transitioned to SAPT after 30 days on DAPT was left to the discretion of the physicians for each enrolled patient.

One issue these studies did not address was whether 1 month is the ideal duration for DAPT before switching to SAPT in HBR patients following coronary stenting, or whether longer DAPT durations produce even better outcomes. “It was important to establish what happens if we need to stop DAPT early.” The Onyx ONE and Onyx ONE Clear studies “provide much-needed data informing clinicians of the risks and safety of SAPT after 1 month in appropriately selected patients,” Dr. Kirtane said.

“The results do not indicate that all HBR patients should be treated with 1 month [of] DAPT, but instead demonstrate the safety and effectiveness of this strategy when clinically appropriate.” This scenario “is quite common, given that HBR patients represent up to a third” of patients undergoing percutaneous coronary intervention, Dr. Kandzari said.

Onyx ONE and Onyx ONE Clear were sponsored by Medtronic, the company that markets the Onyx coronary stent. Dr. Kirtane’s institution has received research support from Medtronic, and from Abbott Vascular, Abiomed, Boston Scientific, Cathworks, CSI, Philips, ReCor Medical, and Siemens. Dr. Kandzari has received personal fees and research grants from medtronic, personal fees from Biotronik and Cardiovascular Systems, and research grants from Biotronik, Boston Scientific, and Cardiovascular Systems. Dr. Rao has received personal fees from Medtronic, as well as from CSI and Philips.

[email protected]

SOURCE: Kirtane AJ et al. ACC 2020, Abstract 903-06.

Results from a prospective, multicenter, uncontrolled series of just over 1,500 patients with high bleeding risk who underwent coronary revascularization with a polymer-based, zotarolimus-eluting stent showed that these patients could safely receive dual-antiplatelet therapy (DAPT)for just 1 month.

This finding sets the stage for a new labeled indication for this device and management strategy in this patient population.

Results from the Onyx ONE Clear study “met its primary endpoint, with favorable rates of ischemic outcomes from 1-12 months after DAPT discontinuation within a high risk population of HBR [high-bleeding-risk] patients,” Ajay J. Kirtane, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic. The rate of cardiac death or MI during months 1-12 of follow-up while patients were on single-antiplatelet therapy (SAPT) with either aspirin or a P2Y12 inhibitor, usually clopidogrel, was 7.0%, compared with a prespecified performance goal of 9.7% or less, a goal set in consultation with and approval from the Food and Drug Administration based on the results from earlier, short DAPT studies in HBR patients.

“We hope these data will support our submission to the FDA for a 1-month DAPT indication for high-bleeding-risk patients treated with Resolute Onyx,” the polymer-based, zotarolimus-eluting stent tested in the study, said an officer with Medtronic, the company that sponsored this study and markets this stent, in a written statement. Currently, no stent has received a U.S. indication for just 1 month of DAPT treatment.

Mitchel L. Zoler/MDedge News

“The Onyx ONE Clear study represents the largest analysis of 1-month DAPT among commercially available DES [drug-eluting stents], and extends findings from the Onyx ONE [randomized, controlled trial] assuring the safety of a 1-month DAPT strategy among selected patients with high bleeding risk,” said David E. Kandzari, MD, director of interventional cardiology at Piedmont Healthcare in Atlanta and coprincipal investigator for the study along with Dr. Kirtane.

“Despite the patient complexity included in the study, the observation of a favorably low rate of ischemic events despite abbreviated DAPT is consistent with a theme from other contemporary studies that, among HBR patients, bleeding risk rather than ischemic risk should guide clinical decision making regarding DAPT duration,” Dr. Kandzari said in an interview.
 

Two similar trials

The Onyx ONE Clear results were consistent with findings from a study with a somewhat similar design, LEADERS FREE II, a single-arm study that assessed the safety and efficacy of BioFreedom, a polymer-free umirolimus-coated coronary stent, in HBR patients treated with DAPT for 1 month followed by SAPT.

LEADERS FREE II showed a 12-month cardiac death or MI rate of 8.6% that compared favorably with the 12.3% 1-year rate among similar patients who received bare-metal stents and a similar timing of DAPT and SAPT in a historical control group (Circ Cardiovasc Interv. 2020 Apr 13. doi: 10.1161/CIRCINTERVENTIONS.119.008603). The primary goal of LEADERS FREE II was to serve as the pivotal trial for FDA approval of the BioFreedom stent, but as of May 2020 the FDA had not approved this stent for U.S. use.

Results of another recent study, Onyx ONE, that supplied more than half the patients included in the Onyx ONE Clear analysis, showed that, in a head-to-head comparison of the Onxy and BioFreedom stents in 1,996 HBR patients treated with DAPT for 1 month followed by 11 months of SAPT, the Onyx stent was noninferior for both a primary safety outcome and a secondary efficacy outcome (N Engl J Med. 2020 Mar 26;382[13]:1208-18).

“The major differences” between the Onyx and BioFreedom stents in the patients studied in Onxy ONE Clear and in LEADERS FREE II “lie in the fact that BioFreedom is not approved in the U.S., and that Onyx is a current generation, preferred DES platform for both conventional and HBR patients,” Dr. Kirtane said in an interview.

“Because of the performance characteristics of Onyx, as well as the fact that ONYX ONE studied a far more complex group of patients than other shorter DAPT studies with conventional DES, I personally feel that there will be a preference to use this stent as a result of these data,” added Dr. Kirtane, professor of medicine at Columbia University and director of the coronary catheterization laboratory at New York–Presbyterian Hospital in New York.

The results from Onyx ONE “are critical for changing practice” among U.S. interventionalists, commented Sunil V. Rao, MD, an interventional cardiologist and professor of medicine at Duke University, Durham, N.C. Based on the new findings, U.S. operators performing percutaneous coronary interventions “will feel comfortable stopping DAPT in patients who are at high bleeding risk,” he said in an interview.

Although the results from LEADERS FREE II showed that the BioFreedom stent was superior to a bare-metal stent with 1 month of DAPT in HBR patients, and the results from Onyx ONE showed that the Onyx stent was noninferior to BioFreedom in this setting, “it’s important not to assume that there is a class effect across DES platforms. Each platform has a different drug and different stent design, so the interventional community needs to see these data for each DES,” Dr. Rao maintained.
 

Onyx ONE Clear design

Onyx ONE Clear enrolled a total of 1,506 patients, including more than 1,000 patients who received the Onyx stent in the Onyx ONE trial and an additional 752 patients enrolled in the United States and Japan, but 263 of these patients had an adverse event during their first 30 days or follow-up leaving 1,506 patients eligible to continue into the Onyx ONE Clear analysis, and with 1,491 patients followed through 12 months. Patients were an average age of 74 years, a little over two-thirds were men, 49% had a recent acute coronary syndrome event and 41% had chronic coronary syndrome. The choice of which antiplatelet agent to continue when patients transitioned to SAPT after 30 days on DAPT was left to the discretion of the physicians for each enrolled patient.

One issue these studies did not address was whether 1 month is the ideal duration for DAPT before switching to SAPT in HBR patients following coronary stenting, or whether longer DAPT durations produce even better outcomes. “It was important to establish what happens if we need to stop DAPT early.” The Onyx ONE and Onyx ONE Clear studies “provide much-needed data informing clinicians of the risks and safety of SAPT after 1 month in appropriately selected patients,” Dr. Kirtane said.

“The results do not indicate that all HBR patients should be treated with 1 month [of] DAPT, but instead demonstrate the safety and effectiveness of this strategy when clinically appropriate.” This scenario “is quite common, given that HBR patients represent up to a third” of patients undergoing percutaneous coronary intervention, Dr. Kandzari said.

Onyx ONE and Onyx ONE Clear were sponsored by Medtronic, the company that markets the Onyx coronary stent. Dr. Kirtane’s institution has received research support from Medtronic, and from Abbott Vascular, Abiomed, Boston Scientific, Cathworks, CSI, Philips, ReCor Medical, and Siemens. Dr. Kandzari has received personal fees and research grants from medtronic, personal fees from Biotronik and Cardiovascular Systems, and research grants from Biotronik, Boston Scientific, and Cardiovascular Systems. Dr. Rao has received personal fees from Medtronic, as well as from CSI and Philips.

[email protected]

SOURCE: Kirtane AJ et al. ACC 2020, Abstract 903-06.

In patients with stable chest pain, the burden of low-attenuation noncalcified plaque on coronary CT angiography is a better predictor of future myocardial infarction risk than a cardiovascular risk score, an Agatson coronary artery calcium score, or angiographic severity of coronary stenoses, Michelle C. Williams, MBChB, PhD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

These findings from a post hoc analysis of the large multicenter SCOT-HEART trial challenge current concepts regarding the supposed superiority of the classic tools for MI risk prediction, noted Dr. Williams, a senior clinical research fellow at the University of Edinburgh.

Indeed, it’s likely that the current established predictors of risk – that is, coronary artery calcium, severity of stenosis, and cardiovascular risk score – are associated with clinical events only indirectly through their correlation with low-attenuated calcified plaque burden, which is the real driver of future MI, she continued.

Histologically, low-attenuated noncalcified plaque on coronary CT angiography (CCTA) is defined by a thin fibrous cap, a large, inflamed, lipid-rich necrotic core, and microcalcification. Previously, Dr. Williams and her coinvestigators demonstrated that visual identification of this unstable plaque subtype is of benefit in predicting future risk of MI (J Am Coll Cardiol. 2019 Jan 29;73[3]:291-301).

But visual identification of plaque subtypes is a crude and laborious process. In her current study, she and her coworkers have taken things a giant step further, using commercially available CCTA software to semiautomatically quantify the burden of this highest-risk plaque subtype as well as all the other subtypes.

This post hoc analysis of the previously reported main SCOT-HEART trial (N Engl J Med. 2018 Sep 6;379[10]:924-933) included 1,769 patients with stable chest pain randomized to standard care with or without CCTA guidance and followed for a median of 4.7 years, during which 41 patients had a fatal or nonfatal MI. At enrollment, 37% of participants had normal coronary arteries, 38% had nonobstructive coronary artery disease (CAD), and the remainder had obstructive CAD.

In a multivariate analysis, low-attenuation noncalcified plaque burden was the strongest predictor of future MI, with an adjusted hazard ratio of 1.6 per doubling. This metric was strongly correlated with coronary artery calcium score, underscoring the limited value of doing noncontrast CT in order to determine a coronary artery calcium score when CCTA is performed.

Low-attenuation plaque burden correlated very strongly with angiographic severity of stenosis, and only weakly with cardiovascular risk score, perhaps explaining the poor prognostic performance of cardiovascular risk scores in SCOT-HEART and other studies, according to Dr. Williams.

Patients with a low-attenuation noncalcified plaque burden greater than 4% in their coronary tree were 4.7 times more likely to have a subsequent MI than were those with a lesser burden. The predictive power was even greater in patients with nonobstructive CAD, where a low-attenuation noncalcified plaque burden in excess of 4% conferred a 6.6-fold greater likelihood of fatal or nonfatal MI, she observed.

Two things need to happen before measurement of low-attenuation noncalcified plaque via CCTA to predict MI risk is ready to be adopted in routine clinical practice, according to Dr. Williams. These SCOT-HEART results need to be validated in other cohorts, a process now underway in the SCOT-HEART 2 trial and other studies. Also, improved software incorporating machine learning is needed in order to speed up the semiautomated analysis of plaque subtypes, which now takes 20-30 minutes.

Dr. Williams reported having no financial conflicts regarding her study, funded by the National Health Service.

In conjunction with her virtual presentation at ACC 2020, the SCOT-HEART study results were published online (Circulation. 2020 Mar 16. doi: 10.1161/CIRCULATIONAHA.119.044720. [Epub ahead of print]).

[email protected]

SOURCE: Williams MC et al. ACC 2020, Abstract 909-06.

In patients with stable chest pain, the burden of low-attenuation noncalcified plaque on coronary CT angiography is a better predictor of future myocardial infarction risk than a cardiovascular risk score, an Agatson coronary artery calcium score, or angiographic severity of coronary stenoses, Michelle C. Williams, MBChB, PhD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

These findings from a post hoc analysis of the large multicenter SCOT-HEART trial challenge current concepts regarding the supposed superiority of the classic tools for MI risk prediction, noted Dr. Williams, a senior clinical research fellow at the University of Edinburgh.

Indeed, it’s likely that the current established predictors of risk – that is, coronary artery calcium, severity of stenosis, and cardiovascular risk score – are associated with clinical events only indirectly through their correlation with low-attenuated calcified plaque burden, which is the real driver of future MI, she continued.

Histologically, low-attenuated noncalcified plaque on coronary CT angiography (CCTA) is defined by a thin fibrous cap, a large, inflamed, lipid-rich necrotic core, and microcalcification. Previously, Dr. Williams and her coinvestigators demonstrated that visual identification of this unstable plaque subtype is of benefit in predicting future risk of MI (J Am Coll Cardiol. 2019 Jan 29;73[3]:291-301).

But visual identification of plaque subtypes is a crude and laborious process. In her current study, she and her coworkers have taken things a giant step further, using commercially available CCTA software to semiautomatically quantify the burden of this highest-risk plaque subtype as well as all the other subtypes.

This post hoc analysis of the previously reported main SCOT-HEART trial (N Engl J Med. 2018 Sep 6;379[10]:924-933) included 1,769 patients with stable chest pain randomized to standard care with or without CCTA guidance and followed for a median of 4.7 years, during which 41 patients had a fatal or nonfatal MI. At enrollment, 37% of participants had normal coronary arteries, 38% had nonobstructive coronary artery disease (CAD), and the remainder had obstructive CAD.

In a multivariate analysis, low-attenuation noncalcified plaque burden was the strongest predictor of future MI, with an adjusted hazard ratio of 1.6 per doubling. This metric was strongly correlated with coronary artery calcium score, underscoring the limited value of doing noncontrast CT in order to determine a coronary artery calcium score when CCTA is performed.

Low-attenuation plaque burden correlated very strongly with angiographic severity of stenosis, and only weakly with cardiovascular risk score, perhaps explaining the poor prognostic performance of cardiovascular risk scores in SCOT-HEART and other studies, according to Dr. Williams.

Patients with a low-attenuation noncalcified plaque burden greater than 4% in their coronary tree were 4.7 times more likely to have a subsequent MI than were those with a lesser burden. The predictive power was even greater in patients with nonobstructive CAD, where a low-attenuation noncalcified plaque burden in excess of 4% conferred a 6.6-fold greater likelihood of fatal or nonfatal MI, she observed.

Two things need to happen before measurement of low-attenuation noncalcified plaque via CCTA to predict MI risk is ready to be adopted in routine clinical practice, according to Dr. Williams. These SCOT-HEART results need to be validated in other cohorts, a process now underway in the SCOT-HEART 2 trial and other studies. Also, improved software incorporating machine learning is needed in order to speed up the semiautomated analysis of plaque subtypes, which now takes 20-30 minutes.

Dr. Williams reported having no financial conflicts regarding her study, funded by the National Health Service.

In conjunction with her virtual presentation at ACC 2020, the SCOT-HEART study results were published online (Circulation. 2020 Mar 16. doi: 10.1161/CIRCULATIONAHA.119.044720. [Epub ahead of print]).

[email protected]

SOURCE: Williams MC et al. ACC 2020, Abstract 909-06.

In patients with stable chest pain, the burden of low-attenuation noncalcified plaque on coronary CT angiography is a better predictor of future myocardial infarction risk than a cardiovascular risk score, an Agatson coronary artery calcium score, or angiographic severity of coronary stenoses, Michelle C. Williams, MBChB, PhD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

These findings from a post hoc analysis of the large multicenter SCOT-HEART trial challenge current concepts regarding the supposed superiority of the classic tools for MI risk prediction, noted Dr. Williams, a senior clinical research fellow at the University of Edinburgh.

Indeed, it’s likely that the current established predictors of risk – that is, coronary artery calcium, severity of stenosis, and cardiovascular risk score – are associated with clinical events only indirectly through their correlation with low-attenuated calcified plaque burden, which is the real driver of future MI, she continued.

Histologically, low-attenuated noncalcified plaque on coronary CT angiography (CCTA) is defined by a thin fibrous cap, a large, inflamed, lipid-rich necrotic core, and microcalcification. Previously, Dr. Williams and her coinvestigators demonstrated that visual identification of this unstable plaque subtype is of benefit in predicting future risk of MI (J Am Coll Cardiol. 2019 Jan 29;73[3]:291-301).

But visual identification of plaque subtypes is a crude and laborious process. In her current study, she and her coworkers have taken things a giant step further, using commercially available CCTA software to semiautomatically quantify the burden of this highest-risk plaque subtype as well as all the other subtypes.

This post hoc analysis of the previously reported main SCOT-HEART trial (N Engl J Med. 2018 Sep 6;379[10]:924-933) included 1,769 patients with stable chest pain randomized to standard care with or without CCTA guidance and followed for a median of 4.7 years, during which 41 patients had a fatal or nonfatal MI. At enrollment, 37% of participants had normal coronary arteries, 38% had nonobstructive coronary artery disease (CAD), and the remainder had obstructive CAD.

In a multivariate analysis, low-attenuation noncalcified plaque burden was the strongest predictor of future MI, with an adjusted hazard ratio of 1.6 per doubling. This metric was strongly correlated with coronary artery calcium score, underscoring the limited value of doing noncontrast CT in order to determine a coronary artery calcium score when CCTA is performed.

Low-attenuation plaque burden correlated very strongly with angiographic severity of stenosis, and only weakly with cardiovascular risk score, perhaps explaining the poor prognostic performance of cardiovascular risk scores in SCOT-HEART and other studies, according to Dr. Williams.

Patients with a low-attenuation noncalcified plaque burden greater than 4% in their coronary tree were 4.7 times more likely to have a subsequent MI than were those with a lesser burden. The predictive power was even greater in patients with nonobstructive CAD, where a low-attenuation noncalcified plaque burden in excess of 4% conferred a 6.6-fold greater likelihood of fatal or nonfatal MI, she observed.

Two things need to happen before measurement of low-attenuation noncalcified plaque via CCTA to predict MI risk is ready to be adopted in routine clinical practice, according to Dr. Williams. These SCOT-HEART results need to be validated in other cohorts, a process now underway in the SCOT-HEART 2 trial and other studies. Also, improved software incorporating machine learning is needed in order to speed up the semiautomated analysis of plaque subtypes, which now takes 20-30 minutes.

Dr. Williams reported having no financial conflicts regarding her study, funded by the National Health Service.

In conjunction with her virtual presentation at ACC 2020, the SCOT-HEART study results were published online (Circulation. 2020 Mar 16. doi: 10.1161/CIRCULATIONAHA.119.044720. [Epub ahead of print]).

[email protected]

SOURCE: Williams MC et al. ACC 2020, Abstract 909-06.

As COVID-19 case levels plateau in some regions, 16 North American cardiovascular societies have released a framework for reintroducing cardiovascular services disrupted by the pandemic.

The consensus document outlines a phased approach to restarting invasive cardiovascular (CV) procedures and diagnostic tests that aims to reduce patient and health care provider exposure to the coronavirus and still provide essential care. It also emphasizes some of the ethical considerations in patient selection and the need for a collaborative approach.

“The key message in our document is we need a new unprecedented collaboration with public health officials so that we can carefully monitor the situation and we’re aware of what’s happening with the penetrance of the pandemic in the community, but they’re aware of the morbidity and mortality that’s occurring on our ever-growing waiting list,” lead author David A. Wood, MD, told theheart.org | Medscape Cardiology.

The recommendations were jointly published May 4 in the Canadian Journal of Cardiology , the Journal of the American College of Cardiology, and The Annals of Thoracic Surgery, and are endorsed by, among others, the American Heart Association, American College of Cardiology (ACC), and Canadian Cardiovascular Society.

The guidance comes as hospitals are facing revenue shortfalls because of canceled elective procedures and resource-intensive COVID-19 cases, prompting some healthcare systems to furlough, lay off, or even fire staff.

“It’s obvious that volumes are down between 40% and 60%,” said Wood, director of the cardiac catheterization laboratory at Vancouver General Hospital and professor of medicine at the University of British Columbia, Canada. “Part of that is that some areas have restricted case volumes totally appropriately and it’s partly because patients are very afraid of coming to the hospital and, unfortunately, are having bad events at home. And some are dying.”

The new report features a detailed table outlining three different response levels: reintroduction of some services (level 2); reintroduction of most services (level 1); and regular services (level 0). It covers a range of services from transthoracic echocardiography and exercise testing with imaging to care for acute coronary syndrome and ST-segment elevation myocardial infarction.

“We’ve learned that we can very quickly turn off the tap and go to doing only 10% of our normal volumes, whether that’s surgery, cath lab, EP, diagnostic tests,” Wood said. “It’s much more difficult to thoughtfully turn the tap part way back on or restart the engine … you don’t just go from 0 to 100 [mph]. You go from 0 to 30 to 60 then maybe to 80 [mph].”

The document also includes eight guiding principles such as:
 

• The expectation that response levels will be different between regions, and even within a given region.
• A “transparent collaborative plan” for COVID-19 testing and personal protective equipment (PPE) must be in place before restarting cases.
• A less invasive test or alternate imaging modality should be considered, if both tests have similar efficacy.
• In general, a minimally invasive procedure with a shorter length of stay is preferable, if both strategies have similar efficacy and safety.

Although previous reports on cath lab considerations during the pandemic or restarting elective surgeries peg various actions to specific thresholds or time intervals, the language here is noticeably and intentionally broad.

Instead of stating when cardiovascular services should resume, for example, the experts say it’s appropriate to put the guidance document into place if there’s a “sustained reduction” in the rate of new COVID-19 admissions and deaths in the relevant geographic region for a “prespecified time interval.”

As for when or how frequently patients and healthcare providers should be tested for COVID-19, the document encourages “routine screening of all patients prior to any cardiovascular procedure or test.”

Overly prescriptive language in previous documents wasn’t felt to be that helpful, whereas language like “selective” cases and “some” or “most” cardiovascular procedures gives clinicians, health systems, and policy makers flexibility when moving between response levels, Wood explained.

“Different regions might be at different levels based on principles of public health as far as the penetrance of the pandemic in that community, as well as how can you actually do the physical distancing in your hospital or ambulatory clinic. Because, I tell you, that is the Achilles heel,” he said. “Our run rates are going to be determined by testing, the availability of PPE, but also how we’re going to use our existing infrastructure and maintain physical distancing.”

That may mean using telehealth for initial visits, having clinics open earlier in the morning or on weekends, or doing partial volumes for surgery or in the cath lab so patients can be staggered and recover at different times and in different areas of the hospital. “These are very granular, specific infrastructure things that we’ve never really had to consider before,” Wood observed.

The document also had to be flexible and nimble enough to respond to a potential rebound of COVID-19 cases, which in newly released models are projected to rise sharply to 200,000 cases a day and be accompanied by some 3,000 deaths each day by June 1.

“This is my own personal opinion but I think it’s foolish to think that we are going to be able to come back to 100% of the cases we were doing before, even with testing, PPE, and all of that until we have a vaccine,” he said.

Similar to decisions made in preparation for the initial COVID-19 surge, the consensus document outlines the need for ethical considerations when turning the tap back on. This means prioritizing procedures and tests that are likely to benefit more people and to a greater degree, and ensuring that patients are treated fairly and consistently, regardless of their ethnicity, perceived social worth, or ability to pay, said coauthor and ACC President Athena Poppas, MD, Brown University School of Medicine, Providence, Rhode Island.

“It’s an ethical tenet that exists in a lot of places but it’s usually not overtly called out,” Poppas told theheart.org | Medscape Cardiology. “It’s not rationing care; I think people jump to that but it’s actually the opposite of rationing care. It’s about being thoughtful about prioritizing patients.”

“There’s a variety of data that should help in the prioritization, not only how much hospital resources are utilized, that’s on one side, but there’s also the patient risk of delaying or doing a procedure, and then the societal risk,” she said.

Susheel Kodali, MD, of New York–Presbyterian Hospital/Columbia University Irving Medical Center, who recently published recommendations on restructuring structural heart disease practice during the pandemic, said the document is timely as centers, including his own, are trying to restart some outpatient visits, as early as next week.

“They made a point about talking about cohesive partnerships with regional public health officials and I think that’s great. The question is how does that happen,” he told theheart.org | Medscape Cardiology. “In New York, we’re not allowed to do elective cases but what’s considered elective is not so clearly defined. An AS [aortic stenosis] patient that had a syncopal episode 2 weeks ago, is that considered elective or is that semi-urgent? I think that’s one of the challenges and that’s where these partnerships would be useful.”

Other challenges include the need for regional partnerships to better align hospitals, which in the New York area means half a dozen large healthcare systems, and to coordinate care between hospital departments – all of which will be scheduling imaging and OR time for their own backlog of hernia, knee, or hip surgeries.

Finally, there’s the need for a lot of conversation with the patient and their family about returning to a hospital amid a deadly pandemic.

“I had a patient today and the daughter was very concerned about bringing her in,” Kodali said. “She’s in class IV heart failure but her [daughter’s] big concern was: who is she going to be exposed to when she gets the echo? What kind of protection is there for her? Is the tech wearing a mask?

“It’s not just the health care providers that have to have the comfort, but it’s the patients and their families who have to feel comfortable bringing their loved ones here for treatment,” he said. “Because everyone is concerned about the environment.”

Wood reports receiving unrestricted grant support from Edwards Lifesciences and Abbott Vascular and serving as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Poppas reports no relevant conflicts of interest. Kodali reports consultant (honoraria) from Admedus, Meril Life Sciences, JenaValve, and Abbott Vascular; SAB (equity) from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve.

This article first appeared on Medscape.com.

As COVID-19 case levels plateau in some regions, 16 North American cardiovascular societies have released a framework for reintroducing cardiovascular services disrupted by the pandemic.

The consensus document outlines a phased approach to restarting invasive cardiovascular (CV) procedures and diagnostic tests that aims to reduce patient and health care provider exposure to the coronavirus and still provide essential care. It also emphasizes some of the ethical considerations in patient selection and the need for a collaborative approach.

“The key message in our document is we need a new unprecedented collaboration with public health officials so that we can carefully monitor the situation and we’re aware of what’s happening with the penetrance of the pandemic in the community, but they’re aware of the morbidity and mortality that’s occurring on our ever-growing waiting list,” lead author David A. Wood, MD, told theheart.org | Medscape Cardiology.

The recommendations were jointly published May 4 in the Canadian Journal of Cardiology , the Journal of the American College of Cardiology, and The Annals of Thoracic Surgery, and are endorsed by, among others, the American Heart Association, American College of Cardiology (ACC), and Canadian Cardiovascular Society.

The guidance comes as hospitals are facing revenue shortfalls because of canceled elective procedures and resource-intensive COVID-19 cases, prompting some healthcare systems to furlough, lay off, or even fire staff.

“It’s obvious that volumes are down between 40% and 60%,” said Wood, director of the cardiac catheterization laboratory at Vancouver General Hospital and professor of medicine at the University of British Columbia, Canada. “Part of that is that some areas have restricted case volumes totally appropriately and it’s partly because patients are very afraid of coming to the hospital and, unfortunately, are having bad events at home. And some are dying.”

The new report features a detailed table outlining three different response levels: reintroduction of some services (level 2); reintroduction of most services (level 1); and regular services (level 0). It covers a range of services from transthoracic echocardiography and exercise testing with imaging to care for acute coronary syndrome and ST-segment elevation myocardial infarction.

“We’ve learned that we can very quickly turn off the tap and go to doing only 10% of our normal volumes, whether that’s surgery, cath lab, EP, diagnostic tests,” Wood said. “It’s much more difficult to thoughtfully turn the tap part way back on or restart the engine … you don’t just go from 0 to 100 [mph]. You go from 0 to 30 to 60 then maybe to 80 [mph].”

The document also includes eight guiding principles such as:
 

• The expectation that response levels will be different between regions, and even within a given region.
• A “transparent collaborative plan” for COVID-19 testing and personal protective equipment (PPE) must be in place before restarting cases.
• A less invasive test or alternate imaging modality should be considered, if both tests have similar efficacy.
• In general, a minimally invasive procedure with a shorter length of stay is preferable, if both strategies have similar efficacy and safety.

Although previous reports on cath lab considerations during the pandemic or restarting elective surgeries peg various actions to specific thresholds or time intervals, the language here is noticeably and intentionally broad.

Instead of stating when cardiovascular services should resume, for example, the experts say it’s appropriate to put the guidance document into place if there’s a “sustained reduction” in the rate of new COVID-19 admissions and deaths in the relevant geographic region for a “prespecified time interval.”

As for when or how frequently patients and healthcare providers should be tested for COVID-19, the document encourages “routine screening of all patients prior to any cardiovascular procedure or test.”

Overly prescriptive language in previous documents wasn’t felt to be that helpful, whereas language like “selective” cases and “some” or “most” cardiovascular procedures gives clinicians, health systems, and policy makers flexibility when moving between response levels, Wood explained.

“Different regions might be at different levels based on principles of public health as far as the penetrance of the pandemic in that community, as well as how can you actually do the physical distancing in your hospital or ambulatory clinic. Because, I tell you, that is the Achilles heel,” he said. “Our run rates are going to be determined by testing, the availability of PPE, but also how we’re going to use our existing infrastructure and maintain physical distancing.”

That may mean using telehealth for initial visits, having clinics open earlier in the morning or on weekends, or doing partial volumes for surgery or in the cath lab so patients can be staggered and recover at different times and in different areas of the hospital. “These are very granular, specific infrastructure things that we’ve never really had to consider before,” Wood observed.

The document also had to be flexible and nimble enough to respond to a potential rebound of COVID-19 cases, which in newly released models are projected to rise sharply to 200,000 cases a day and be accompanied by some 3,000 deaths each day by June 1.

“This is my own personal opinion but I think it’s foolish to think that we are going to be able to come back to 100% of the cases we were doing before, even with testing, PPE, and all of that until we have a vaccine,” he said.

Similar to decisions made in preparation for the initial COVID-19 surge, the consensus document outlines the need for ethical considerations when turning the tap back on. This means prioritizing procedures and tests that are likely to benefit more people and to a greater degree, and ensuring that patients are treated fairly and consistently, regardless of their ethnicity, perceived social worth, or ability to pay, said coauthor and ACC President Athena Poppas, MD, Brown University School of Medicine, Providence, Rhode Island.

“It’s an ethical tenet that exists in a lot of places but it’s usually not overtly called out,” Poppas told theheart.org | Medscape Cardiology. “It’s not rationing care; I think people jump to that but it’s actually the opposite of rationing care. It’s about being thoughtful about prioritizing patients.”

“There’s a variety of data that should help in the prioritization, not only how much hospital resources are utilized, that’s on one side, but there’s also the patient risk of delaying or doing a procedure, and then the societal risk,” she said.

Susheel Kodali, MD, of New York–Presbyterian Hospital/Columbia University Irving Medical Center, who recently published recommendations on restructuring structural heart disease practice during the pandemic, said the document is timely as centers, including his own, are trying to restart some outpatient visits, as early as next week.

“They made a point about talking about cohesive partnerships with regional public health officials and I think that’s great. The question is how does that happen,” he told theheart.org | Medscape Cardiology. “In New York, we’re not allowed to do elective cases but what’s considered elective is not so clearly defined. An AS [aortic stenosis] patient that had a syncopal episode 2 weeks ago, is that considered elective or is that semi-urgent? I think that’s one of the challenges and that’s where these partnerships would be useful.”

Other challenges include the need for regional partnerships to better align hospitals, which in the New York area means half a dozen large healthcare systems, and to coordinate care between hospital departments – all of which will be scheduling imaging and OR time for their own backlog of hernia, knee, or hip surgeries.

Finally, there’s the need for a lot of conversation with the patient and their family about returning to a hospital amid a deadly pandemic.

“I had a patient today and the daughter was very concerned about bringing her in,” Kodali said. “She’s in class IV heart failure but her [daughter’s] big concern was: who is she going to be exposed to when she gets the echo? What kind of protection is there for her? Is the tech wearing a mask?

“It’s not just the health care providers that have to have the comfort, but it’s the patients and their families who have to feel comfortable bringing their loved ones here for treatment,” he said. “Because everyone is concerned about the environment.”

Wood reports receiving unrestricted grant support from Edwards Lifesciences and Abbott Vascular and serving as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Poppas reports no relevant conflicts of interest. Kodali reports consultant (honoraria) from Admedus, Meril Life Sciences, JenaValve, and Abbott Vascular; SAB (equity) from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve.

This article first appeared on Medscape.com.

As COVID-19 case levels plateau in some regions, 16 North American cardiovascular societies have released a framework for reintroducing cardiovascular services disrupted by the pandemic.

The consensus document outlines a phased approach to restarting invasive cardiovascular (CV) procedures and diagnostic tests that aims to reduce patient and health care provider exposure to the coronavirus and still provide essential care. It also emphasizes some of the ethical considerations in patient selection and the need for a collaborative approach.

“The key message in our document is we need a new unprecedented collaboration with public health officials so that we can carefully monitor the situation and we’re aware of what’s happening with the penetrance of the pandemic in the community, but they’re aware of the morbidity and mortality that’s occurring on our ever-growing waiting list,” lead author David A. Wood, MD, told theheart.org | Medscape Cardiology.

The recommendations were jointly published May 4 in the Canadian Journal of Cardiology , the Journal of the American College of Cardiology, and The Annals of Thoracic Surgery, and are endorsed by, among others, the American Heart Association, American College of Cardiology (ACC), and Canadian Cardiovascular Society.

The guidance comes as hospitals are facing revenue shortfalls because of canceled elective procedures and resource-intensive COVID-19 cases, prompting some healthcare systems to furlough, lay off, or even fire staff.

“It’s obvious that volumes are down between 40% and 60%,” said Wood, director of the cardiac catheterization laboratory at Vancouver General Hospital and professor of medicine at the University of British Columbia, Canada. “Part of that is that some areas have restricted case volumes totally appropriately and it’s partly because patients are very afraid of coming to the hospital and, unfortunately, are having bad events at home. And some are dying.”

The new report features a detailed table outlining three different response levels: reintroduction of some services (level 2); reintroduction of most services (level 1); and regular services (level 0). It covers a range of services from transthoracic echocardiography and exercise testing with imaging to care for acute coronary syndrome and ST-segment elevation myocardial infarction.

“We’ve learned that we can very quickly turn off the tap and go to doing only 10% of our normal volumes, whether that’s surgery, cath lab, EP, diagnostic tests,” Wood said. “It’s much more difficult to thoughtfully turn the tap part way back on or restart the engine … you don’t just go from 0 to 100 [mph]. You go from 0 to 30 to 60 then maybe to 80 [mph].”

The document also includes eight guiding principles such as:
 

• The expectation that response levels will be different between regions, and even within a given region.
• A “transparent collaborative plan” for COVID-19 testing and personal protective equipment (PPE) must be in place before restarting cases.
• A less invasive test or alternate imaging modality should be considered, if both tests have similar efficacy.
• In general, a minimally invasive procedure with a shorter length of stay is preferable, if both strategies have similar efficacy and safety.

Although previous reports on cath lab considerations during the pandemic or restarting elective surgeries peg various actions to specific thresholds or time intervals, the language here is noticeably and intentionally broad.

Instead of stating when cardiovascular services should resume, for example, the experts say it’s appropriate to put the guidance document into place if there’s a “sustained reduction” in the rate of new COVID-19 admissions and deaths in the relevant geographic region for a “prespecified time interval.”

As for when or how frequently patients and healthcare providers should be tested for COVID-19, the document encourages “routine screening of all patients prior to any cardiovascular procedure or test.”

Overly prescriptive language in previous documents wasn’t felt to be that helpful, whereas language like “selective” cases and “some” or “most” cardiovascular procedures gives clinicians, health systems, and policy makers flexibility when moving between response levels, Wood explained.

“Different regions might be at different levels based on principles of public health as far as the penetrance of the pandemic in that community, as well as how can you actually do the physical distancing in your hospital or ambulatory clinic. Because, I tell you, that is the Achilles heel,” he said. “Our run rates are going to be determined by testing, the availability of PPE, but also how we’re going to use our existing infrastructure and maintain physical distancing.”

That may mean using telehealth for initial visits, having clinics open earlier in the morning or on weekends, or doing partial volumes for surgery or in the cath lab so patients can be staggered and recover at different times and in different areas of the hospital. “These are very granular, specific infrastructure things that we’ve never really had to consider before,” Wood observed.

The document also had to be flexible and nimble enough to respond to a potential rebound of COVID-19 cases, which in newly released models are projected to rise sharply to 200,000 cases a day and be accompanied by some 3,000 deaths each day by June 1.

“This is my own personal opinion but I think it’s foolish to think that we are going to be able to come back to 100% of the cases we were doing before, even with testing, PPE, and all of that until we have a vaccine,” he said.

Similar to decisions made in preparation for the initial COVID-19 surge, the consensus document outlines the need for ethical considerations when turning the tap back on. This means prioritizing procedures and tests that are likely to benefit more people and to a greater degree, and ensuring that patients are treated fairly and consistently, regardless of their ethnicity, perceived social worth, or ability to pay, said coauthor and ACC President Athena Poppas, MD, Brown University School of Medicine, Providence, Rhode Island.

“It’s an ethical tenet that exists in a lot of places but it’s usually not overtly called out,” Poppas told theheart.org | Medscape Cardiology. “It’s not rationing care; I think people jump to that but it’s actually the opposite of rationing care. It’s about being thoughtful about prioritizing patients.”

“There’s a variety of data that should help in the prioritization, not only how much hospital resources are utilized, that’s on one side, but there’s also the patient risk of delaying or doing a procedure, and then the societal risk,” she said.

Susheel Kodali, MD, of New York–Presbyterian Hospital/Columbia University Irving Medical Center, who recently published recommendations on restructuring structural heart disease practice during the pandemic, said the document is timely as centers, including his own, are trying to restart some outpatient visits, as early as next week.

“They made a point about talking about cohesive partnerships with regional public health officials and I think that’s great. The question is how does that happen,” he told theheart.org | Medscape Cardiology. “In New York, we’re not allowed to do elective cases but what’s considered elective is not so clearly defined. An AS [aortic stenosis] patient that had a syncopal episode 2 weeks ago, is that considered elective or is that semi-urgent? I think that’s one of the challenges and that’s where these partnerships would be useful.”

Other challenges include the need for regional partnerships to better align hospitals, which in the New York area means half a dozen large healthcare systems, and to coordinate care between hospital departments – all of which will be scheduling imaging and OR time for their own backlog of hernia, knee, or hip surgeries.

Finally, there’s the need for a lot of conversation with the patient and their family about returning to a hospital amid a deadly pandemic.

“I had a patient today and the daughter was very concerned about bringing her in,” Kodali said. “She’s in class IV heart failure but her [daughter’s] big concern was: who is she going to be exposed to when she gets the echo? What kind of protection is there for her? Is the tech wearing a mask?

“It’s not just the health care providers that have to have the comfort, but it’s the patients and their families who have to feel comfortable bringing their loved ones here for treatment,” he said. “Because everyone is concerned about the environment.”

Wood reports receiving unrestricted grant support from Edwards Lifesciences and Abbott Vascular and serving as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Poppas reports no relevant conflicts of interest. Kodali reports consultant (honoraria) from Admedus, Meril Life Sciences, JenaValve, and Abbott Vascular; SAB (equity) from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve.

This article first appeared on Medscape.com.