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Parity for prompt and staged STEMI complete revascularization: MULTISTARS-AMI
The conclusion comes from a randomized outcomes trial of 840 patients that compared prompt same-session CR with a staged procedure carried out weeks later.
That CR is a worthy goal in such cases is largely settled, unlike the question of when to pursue revascularization of nonculprit lesions for best results. So the timing varies in practice, often depending on the patient’s clinical stability, risk status, or practical issues like cath lab resources or personnel.
The new trial, MULTISTARS-AMI, supports that kind of flexibility as safe in practice. Immediate, same-session CR led to a 48% drop in risk for a broad composite primary endpoint at 1 year, compared with staged CR an average of 37 days later. The finding was significant for noninferiority in the study’s primary analysis and secondarily, was significant for superiority (P < .001 in both cases).
The composite endpoint included death from any cause, MI, stroke, unplanned ischemia-driven revascularization, or heart failure (HF) hospitalization.
CR’s immediate effect on outcomes was numerically pronounced, but because it was prespecified as a noninferiority trial, MULTISTARS-AMI could show only that the strategy is comparable to staged CR, emphasized Barbara E. Stähli, MD, MPH, MBA, at a press conference.
Still, it appears to be the first trial of its kind to show that operators and patients can safely choose either percutaneous coronary intervention (PCI) approach and attain similar outcomes, said Dr. Stähli, University Hospital Zurich, MULTISTARS-AMI’s principal investigator.
Not only were the two approaches similar with respect to safety, she noted, but immediate CR seemed to require less use of contrast agent and fluoroscopy. “And you have only one procedure, so there’s only one arterial puncture.”
Dr. Stähli formally presented MULTISTARS-AMI at the annual congress of the European Society of Cardiology, held in Amsterdam. She is also lead author on its publication in the New England Journal of Medicine.
After her presentation, invited discussant Robert A. Byrne, PhD, MD, MB, BCh, said that the trial’s central message is that STEMI patients with MVD having primary PCI “should undergo complete revascularization within the first 45 days, with the timing of the non–infarct-related artery procedure individualized according to clinical risk and logistical considerations.”
Still, the trial “provides evidence, but not strong evidence, of benefits with routine immediate PCI during the index procedure as compared with staged outpatient PCI,” said Dr. Byrne, Mater Private Hospital and RCSI University of Medicine and Health Sciences, Dublin.
MULTISTARS-AMI randomly assigned patients at 37 European sites to undergo same-session CR (418 patients) or CR staged 19-45 days later (422 patients).
Rates for the primary endpoint at 1 year were 8.5% and 16.3%, respectively, for a risk ratio of 0.52 (95% confidence interval, 0.38-0.72). The difference was driven by fewer instances of nonfatal MI, 0.36 (95% CI, 0.16-0.80), and unplanned ischemia-driven revascularization, 0.42 (95% CI, 0.24-0.74), in the immediate-CR group.
The wee hours
Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health System, New York, said that, in general at his center, patients who are stable with a good primary PCI outcome and whose lesions aren’t very high risk are often discharged to return later for the staged CR procedure.
But after the new insights from MULTISTARS-AMI, Dr. Rao, who is not connected to the study, said in an interview that immediate same-session CR is indeed likely preferable to staged CR performed weeks later.
Same-session CR, however, may not always be practical or wise, he observed. For example, some patients with STEMI can be pretty sick with MVD that involves very complex lesions that might be better handled later.
“The wee hours of the night may not be the best time to tackle such complex lesions,” Dr. Rao observed. If confronted with, for example, a bifurcation that requires a complex procedure, “2 o’clock in the morning is probably not the best time to address something like that.”
So the trial’s more realistic translational message, he proposed, may be to perform CR after the primary PCI but during the same hospitalization, “unless there are some real mitigating circumstances.”
The trial was supported by Boston Scientific. Dr. Stähli had no disclosures. Dr. Byrne discloses research funding to his institution from Abbott Vascular, Translumina, Biosensors, and Boston Scientific. Dr. Rao had no relevant disclosures.
A version of this article first appeared on Medscape.com.
The conclusion comes from a randomized outcomes trial of 840 patients that compared prompt same-session CR with a staged procedure carried out weeks later.
That CR is a worthy goal in such cases is largely settled, unlike the question of when to pursue revascularization of nonculprit lesions for best results. So the timing varies in practice, often depending on the patient’s clinical stability, risk status, or practical issues like cath lab resources or personnel.
The new trial, MULTISTARS-AMI, supports that kind of flexibility as safe in practice. Immediate, same-session CR led to a 48% drop in risk for a broad composite primary endpoint at 1 year, compared with staged CR an average of 37 days later. The finding was significant for noninferiority in the study’s primary analysis and secondarily, was significant for superiority (P < .001 in both cases).
The composite endpoint included death from any cause, MI, stroke, unplanned ischemia-driven revascularization, or heart failure (HF) hospitalization.
CR’s immediate effect on outcomes was numerically pronounced, but because it was prespecified as a noninferiority trial, MULTISTARS-AMI could show only that the strategy is comparable to staged CR, emphasized Barbara E. Stähli, MD, MPH, MBA, at a press conference.
Still, it appears to be the first trial of its kind to show that operators and patients can safely choose either percutaneous coronary intervention (PCI) approach and attain similar outcomes, said Dr. Stähli, University Hospital Zurich, MULTISTARS-AMI’s principal investigator.
Not only were the two approaches similar with respect to safety, she noted, but immediate CR seemed to require less use of contrast agent and fluoroscopy. “And you have only one procedure, so there’s only one arterial puncture.”
Dr. Stähli formally presented MULTISTARS-AMI at the annual congress of the European Society of Cardiology, held in Amsterdam. She is also lead author on its publication in the New England Journal of Medicine.
After her presentation, invited discussant Robert A. Byrne, PhD, MD, MB, BCh, said that the trial’s central message is that STEMI patients with MVD having primary PCI “should undergo complete revascularization within the first 45 days, with the timing of the non–infarct-related artery procedure individualized according to clinical risk and logistical considerations.”
Still, the trial “provides evidence, but not strong evidence, of benefits with routine immediate PCI during the index procedure as compared with staged outpatient PCI,” said Dr. Byrne, Mater Private Hospital and RCSI University of Medicine and Health Sciences, Dublin.
MULTISTARS-AMI randomly assigned patients at 37 European sites to undergo same-session CR (418 patients) or CR staged 19-45 days later (422 patients).
Rates for the primary endpoint at 1 year were 8.5% and 16.3%, respectively, for a risk ratio of 0.52 (95% confidence interval, 0.38-0.72). The difference was driven by fewer instances of nonfatal MI, 0.36 (95% CI, 0.16-0.80), and unplanned ischemia-driven revascularization, 0.42 (95% CI, 0.24-0.74), in the immediate-CR group.
The wee hours
Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health System, New York, said that, in general at his center, patients who are stable with a good primary PCI outcome and whose lesions aren’t very high risk are often discharged to return later for the staged CR procedure.
But after the new insights from MULTISTARS-AMI, Dr. Rao, who is not connected to the study, said in an interview that immediate same-session CR is indeed likely preferable to staged CR performed weeks later.
Same-session CR, however, may not always be practical or wise, he observed. For example, some patients with STEMI can be pretty sick with MVD that involves very complex lesions that might be better handled later.
“The wee hours of the night may not be the best time to tackle such complex lesions,” Dr. Rao observed. If confronted with, for example, a bifurcation that requires a complex procedure, “2 o’clock in the morning is probably not the best time to address something like that.”
So the trial’s more realistic translational message, he proposed, may be to perform CR after the primary PCI but during the same hospitalization, “unless there are some real mitigating circumstances.”
The trial was supported by Boston Scientific. Dr. Stähli had no disclosures. Dr. Byrne discloses research funding to his institution from Abbott Vascular, Translumina, Biosensors, and Boston Scientific. Dr. Rao had no relevant disclosures.
A version of this article first appeared on Medscape.com.
The conclusion comes from a randomized outcomes trial of 840 patients that compared prompt same-session CR with a staged procedure carried out weeks later.
That CR is a worthy goal in such cases is largely settled, unlike the question of when to pursue revascularization of nonculprit lesions for best results. So the timing varies in practice, often depending on the patient’s clinical stability, risk status, or practical issues like cath lab resources or personnel.
The new trial, MULTISTARS-AMI, supports that kind of flexibility as safe in practice. Immediate, same-session CR led to a 48% drop in risk for a broad composite primary endpoint at 1 year, compared with staged CR an average of 37 days later. The finding was significant for noninferiority in the study’s primary analysis and secondarily, was significant for superiority (P < .001 in both cases).
The composite endpoint included death from any cause, MI, stroke, unplanned ischemia-driven revascularization, or heart failure (HF) hospitalization.
CR’s immediate effect on outcomes was numerically pronounced, but because it was prespecified as a noninferiority trial, MULTISTARS-AMI could show only that the strategy is comparable to staged CR, emphasized Barbara E. Stähli, MD, MPH, MBA, at a press conference.
Still, it appears to be the first trial of its kind to show that operators and patients can safely choose either percutaneous coronary intervention (PCI) approach and attain similar outcomes, said Dr. Stähli, University Hospital Zurich, MULTISTARS-AMI’s principal investigator.
Not only were the two approaches similar with respect to safety, she noted, but immediate CR seemed to require less use of contrast agent and fluoroscopy. “And you have only one procedure, so there’s only one arterial puncture.”
Dr. Stähli formally presented MULTISTARS-AMI at the annual congress of the European Society of Cardiology, held in Amsterdam. She is also lead author on its publication in the New England Journal of Medicine.
After her presentation, invited discussant Robert A. Byrne, PhD, MD, MB, BCh, said that the trial’s central message is that STEMI patients with MVD having primary PCI “should undergo complete revascularization within the first 45 days, with the timing of the non–infarct-related artery procedure individualized according to clinical risk and logistical considerations.”
Still, the trial “provides evidence, but not strong evidence, of benefits with routine immediate PCI during the index procedure as compared with staged outpatient PCI,” said Dr. Byrne, Mater Private Hospital and RCSI University of Medicine and Health Sciences, Dublin.
MULTISTARS-AMI randomly assigned patients at 37 European sites to undergo same-session CR (418 patients) or CR staged 19-45 days later (422 patients).
Rates for the primary endpoint at 1 year were 8.5% and 16.3%, respectively, for a risk ratio of 0.52 (95% confidence interval, 0.38-0.72). The difference was driven by fewer instances of nonfatal MI, 0.36 (95% CI, 0.16-0.80), and unplanned ischemia-driven revascularization, 0.42 (95% CI, 0.24-0.74), in the immediate-CR group.
The wee hours
Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health System, New York, said that, in general at his center, patients who are stable with a good primary PCI outcome and whose lesions aren’t very high risk are often discharged to return later for the staged CR procedure.
But after the new insights from MULTISTARS-AMI, Dr. Rao, who is not connected to the study, said in an interview that immediate same-session CR is indeed likely preferable to staged CR performed weeks later.
Same-session CR, however, may not always be practical or wise, he observed. For example, some patients with STEMI can be pretty sick with MVD that involves very complex lesions that might be better handled later.
“The wee hours of the night may not be the best time to tackle such complex lesions,” Dr. Rao observed. If confronted with, for example, a bifurcation that requires a complex procedure, “2 o’clock in the morning is probably not the best time to address something like that.”
So the trial’s more realistic translational message, he proposed, may be to perform CR after the primary PCI but during the same hospitalization, “unless there are some real mitigating circumstances.”
The trial was supported by Boston Scientific. Dr. Stähli had no disclosures. Dr. Byrne discloses research funding to his institution from Abbott Vascular, Translumina, Biosensors, and Boston Scientific. Dr. Rao had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ESC CONGRESS 2023
FIRE a win for physiology-guided MI complete revascularization in older patients
(MVD) in a large, randomized trial.
In the study with more than 1,400 patients, CR was guided by assessments of the functional effect of coronary lesions other than the MI culprit, a process that selects or excludes the lesions, regardless of angiographic profile, as targets for percutaneous coronary intervention (PCI).
Such physiology-guided CR led to a significant 27% drop in risk for a composite primary endpoint over 1 year in the trial, called FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease), compared with the culprit-only approach. The endpoint included death, MI, stroke, or ischemia-driven revascularization.
Risk for cardiovascular (CV) death or MI fell by 36% in the trial, and all-cause mortality declined 30%. The differences were significant, although the study wasn’t powered for those secondary endpoints. Safety outcomes were similar for the two revascularization approaches.
FIRE was noteworthy for entering only patients with ST-segment elevation or non–ST-segment elevation MI (STEMI or NSTEMI) who were age 75 years or older, a higher-risk age group poorly represented in earlier CR trials. Such patients in practice are usually managed with the culprit lesion–only approach because of a lack of good evidence supporting CR, observed Simone Biscaglia, MD, the study’s principal investigator.
“This is the first trial actually showing a benefit” from physiology-guided CR in older patients with acute MI that is similar to what the strategy can offer younger patients, said Dr. Biscaglia, from Azienda Ospedaliera Universitaria S. Anna, Ferrara, Italy.
Biscaglia made the comments at a media briefing on FIRE held during the annual congress of the European Society of Cardiology, where he presented the study. He is also lead author on its publication in the New England Journal of Medicine.
“This is a remarkable trial that adds substantially to prior studies that examined the topic of complete versus culprit-only revascularization,” Deepak L. Bhatt, MD, MPH, Icahn School of Medicine at Mount Sinai, New York, said in an interview.
It shows “quite clearly” that physiology-guided CR is superior to the culprit-only approach in patients with acute MI, said Dr. Bhatt, who is also director of Mount Sinai Heart at Mount Sinai Hospital and not connected to FIRE.
The primary findings applied to a range of different patient subgroups, including those older than 80. That’s important, he said, because “it is sometimes incorrectly assumed that patients who are older may not benefit from complete revascularization in this setting.”
And the trial’s finding of reduced risk for CV death or MI in the CR group “really should make the complete revascularization approach the standard of care in MI patients without contraindications,” Dr. Bhatt said. And certainly, “age per se should no longer be considered a contraindication.”
“First and foremost, the FIRE trial confirms the benefit of complete revascularization that has been observed in previous trials and provides additional evidence for this approach in older patients,” wrote the author of an editorial accompanying the published report.
The mortality reduction with CR at 1 years “is particularly notable” and underscores that CR should be considered in all patients with acute MI, “regardless of age,” wrote Shamir R. Mehta, MD, McMaster University, Hamilton, Ont., and Hamilton Health Sciences.
Dr. Mehta was principal investigator for the 2019 COMPLETE trial, which made the case for CR, guided by standard angiography, in patients with MVD and STEMI; their age averaged about 62 years.
FIRE definitely ought to sway practice toward greater use of physiology-guided CR regardless of age, observed Vijay Kunadian, MBBS, MD, invited discussant for the Biscaglia presentation. “My oldest patient is 98,” she said, “and it is beneficial without a doubt.”
But Dr. Kunadian, from Newcastle (England) University, said that the trial results can’t be generalized to all older patients. That’s because their outcomes after CR could vary depending on, for example, their different frailties or comorbidities, cognition, or CV history. “So, there is an absolute need to individualize care.”
FIRE enrolled patients 75 years or older with MVD, about 64% male, who had been admitted with acute STEMI or NSTEMI at 34 sites in Italy, Spain, and Poland. All underwent successful culprit-lesion PCI using, as “strongly” recommended, the same model of sirolimus-eluting stent.
Patients were randomly assigned to physiology-guided CR of nonculprit lesions, at the same session or at least during the same hospitalization, or to no further revascularization: 720 and 725 patients, respectively.
The hazard ratio for the composite primary outcome, CR versus culprit-only PCI was 0.73 (95% confidence interval, 0.57-0.93; P = .01). The benefit was driven by reductions in three individual components of the primary endpoint: death, MI, and revascularization, but not stroke.
The HR for CV death or MI was 0.64 (95% CI, 0.47-0.88) and for death from any cause was 0.70 (95% CI, 0.51-0.96).
There was no significant difference in the primary safety outcome, a composite of contrast-related acute kidney injury, stroke, or Bleeding Academic Research Consortium grade 3 to 5 bleeding at 1 year. The rates were 22.5% in those assigned to CR and 20.4% in the culprit-only group.
The functional effect of individual lesions was assessed by either of two methods, crossing them with a standard “pressure wire” or by angiographic derivation of their quantitative flow ratio.
The choice was “left to operator discretion,” Dr. Biscaglia said in an interview, “because we wanted to mirror clinical practice at the participating centers.” Still, the CR primary benefit was independent of the physiology-guidance method.
FIRE’s sponsor – the nonprofit Consorzio Futuro in Ricerca, Italy – received grant support from Sahajanand Medical Technologies, Medis Medical Imaging systems, Eukon, Siemens Healthineers, General Electric Healthcare, and Insight Lifetech. Dr. Biscaglia had no other disclosures. Dr. Mehta reported receiving grants from Abbott Vascular and personal fees from Amgen, Janssen, and Bristol Myers Squibb. Dr. Bhatt reported numerous disclosures with various companies and organizations. Dr. Kunadian had no disclosures.
A version of this article first appeared on Medscape.com.
(MVD) in a large, randomized trial.
In the study with more than 1,400 patients, CR was guided by assessments of the functional effect of coronary lesions other than the MI culprit, a process that selects or excludes the lesions, regardless of angiographic profile, as targets for percutaneous coronary intervention (PCI).
Such physiology-guided CR led to a significant 27% drop in risk for a composite primary endpoint over 1 year in the trial, called FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease), compared with the culprit-only approach. The endpoint included death, MI, stroke, or ischemia-driven revascularization.
Risk for cardiovascular (CV) death or MI fell by 36% in the trial, and all-cause mortality declined 30%. The differences were significant, although the study wasn’t powered for those secondary endpoints. Safety outcomes were similar for the two revascularization approaches.
FIRE was noteworthy for entering only patients with ST-segment elevation or non–ST-segment elevation MI (STEMI or NSTEMI) who were age 75 years or older, a higher-risk age group poorly represented in earlier CR trials. Such patients in practice are usually managed with the culprit lesion–only approach because of a lack of good evidence supporting CR, observed Simone Biscaglia, MD, the study’s principal investigator.
“This is the first trial actually showing a benefit” from physiology-guided CR in older patients with acute MI that is similar to what the strategy can offer younger patients, said Dr. Biscaglia, from Azienda Ospedaliera Universitaria S. Anna, Ferrara, Italy.
Biscaglia made the comments at a media briefing on FIRE held during the annual congress of the European Society of Cardiology, where he presented the study. He is also lead author on its publication in the New England Journal of Medicine.
“This is a remarkable trial that adds substantially to prior studies that examined the topic of complete versus culprit-only revascularization,” Deepak L. Bhatt, MD, MPH, Icahn School of Medicine at Mount Sinai, New York, said in an interview.
It shows “quite clearly” that physiology-guided CR is superior to the culprit-only approach in patients with acute MI, said Dr. Bhatt, who is also director of Mount Sinai Heart at Mount Sinai Hospital and not connected to FIRE.
The primary findings applied to a range of different patient subgroups, including those older than 80. That’s important, he said, because “it is sometimes incorrectly assumed that patients who are older may not benefit from complete revascularization in this setting.”
And the trial’s finding of reduced risk for CV death or MI in the CR group “really should make the complete revascularization approach the standard of care in MI patients without contraindications,” Dr. Bhatt said. And certainly, “age per se should no longer be considered a contraindication.”
“First and foremost, the FIRE trial confirms the benefit of complete revascularization that has been observed in previous trials and provides additional evidence for this approach in older patients,” wrote the author of an editorial accompanying the published report.
The mortality reduction with CR at 1 years “is particularly notable” and underscores that CR should be considered in all patients with acute MI, “regardless of age,” wrote Shamir R. Mehta, MD, McMaster University, Hamilton, Ont., and Hamilton Health Sciences.
Dr. Mehta was principal investigator for the 2019 COMPLETE trial, which made the case for CR, guided by standard angiography, in patients with MVD and STEMI; their age averaged about 62 years.
FIRE definitely ought to sway practice toward greater use of physiology-guided CR regardless of age, observed Vijay Kunadian, MBBS, MD, invited discussant for the Biscaglia presentation. “My oldest patient is 98,” she said, “and it is beneficial without a doubt.”
But Dr. Kunadian, from Newcastle (England) University, said that the trial results can’t be generalized to all older patients. That’s because their outcomes after CR could vary depending on, for example, their different frailties or comorbidities, cognition, or CV history. “So, there is an absolute need to individualize care.”
FIRE enrolled patients 75 years or older with MVD, about 64% male, who had been admitted with acute STEMI or NSTEMI at 34 sites in Italy, Spain, and Poland. All underwent successful culprit-lesion PCI using, as “strongly” recommended, the same model of sirolimus-eluting stent.
Patients were randomly assigned to physiology-guided CR of nonculprit lesions, at the same session or at least during the same hospitalization, or to no further revascularization: 720 and 725 patients, respectively.
The hazard ratio for the composite primary outcome, CR versus culprit-only PCI was 0.73 (95% confidence interval, 0.57-0.93; P = .01). The benefit was driven by reductions in three individual components of the primary endpoint: death, MI, and revascularization, but not stroke.
The HR for CV death or MI was 0.64 (95% CI, 0.47-0.88) and for death from any cause was 0.70 (95% CI, 0.51-0.96).
There was no significant difference in the primary safety outcome, a composite of contrast-related acute kidney injury, stroke, or Bleeding Academic Research Consortium grade 3 to 5 bleeding at 1 year. The rates were 22.5% in those assigned to CR and 20.4% in the culprit-only group.
The functional effect of individual lesions was assessed by either of two methods, crossing them with a standard “pressure wire” or by angiographic derivation of their quantitative flow ratio.
The choice was “left to operator discretion,” Dr. Biscaglia said in an interview, “because we wanted to mirror clinical practice at the participating centers.” Still, the CR primary benefit was independent of the physiology-guidance method.
FIRE’s sponsor – the nonprofit Consorzio Futuro in Ricerca, Italy – received grant support from Sahajanand Medical Technologies, Medis Medical Imaging systems, Eukon, Siemens Healthineers, General Electric Healthcare, and Insight Lifetech. Dr. Biscaglia had no other disclosures. Dr. Mehta reported receiving grants from Abbott Vascular and personal fees from Amgen, Janssen, and Bristol Myers Squibb. Dr. Bhatt reported numerous disclosures with various companies and organizations. Dr. Kunadian had no disclosures.
A version of this article first appeared on Medscape.com.
(MVD) in a large, randomized trial.
In the study with more than 1,400 patients, CR was guided by assessments of the functional effect of coronary lesions other than the MI culprit, a process that selects or excludes the lesions, regardless of angiographic profile, as targets for percutaneous coronary intervention (PCI).
Such physiology-guided CR led to a significant 27% drop in risk for a composite primary endpoint over 1 year in the trial, called FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease), compared with the culprit-only approach. The endpoint included death, MI, stroke, or ischemia-driven revascularization.
Risk for cardiovascular (CV) death or MI fell by 36% in the trial, and all-cause mortality declined 30%. The differences were significant, although the study wasn’t powered for those secondary endpoints. Safety outcomes were similar for the two revascularization approaches.
FIRE was noteworthy for entering only patients with ST-segment elevation or non–ST-segment elevation MI (STEMI or NSTEMI) who were age 75 years or older, a higher-risk age group poorly represented in earlier CR trials. Such patients in practice are usually managed with the culprit lesion–only approach because of a lack of good evidence supporting CR, observed Simone Biscaglia, MD, the study’s principal investigator.
“This is the first trial actually showing a benefit” from physiology-guided CR in older patients with acute MI that is similar to what the strategy can offer younger patients, said Dr. Biscaglia, from Azienda Ospedaliera Universitaria S. Anna, Ferrara, Italy.
Biscaglia made the comments at a media briefing on FIRE held during the annual congress of the European Society of Cardiology, where he presented the study. He is also lead author on its publication in the New England Journal of Medicine.
“This is a remarkable trial that adds substantially to prior studies that examined the topic of complete versus culprit-only revascularization,” Deepak L. Bhatt, MD, MPH, Icahn School of Medicine at Mount Sinai, New York, said in an interview.
It shows “quite clearly” that physiology-guided CR is superior to the culprit-only approach in patients with acute MI, said Dr. Bhatt, who is also director of Mount Sinai Heart at Mount Sinai Hospital and not connected to FIRE.
The primary findings applied to a range of different patient subgroups, including those older than 80. That’s important, he said, because “it is sometimes incorrectly assumed that patients who are older may not benefit from complete revascularization in this setting.”
And the trial’s finding of reduced risk for CV death or MI in the CR group “really should make the complete revascularization approach the standard of care in MI patients without contraindications,” Dr. Bhatt said. And certainly, “age per se should no longer be considered a contraindication.”
“First and foremost, the FIRE trial confirms the benefit of complete revascularization that has been observed in previous trials and provides additional evidence for this approach in older patients,” wrote the author of an editorial accompanying the published report.
The mortality reduction with CR at 1 years “is particularly notable” and underscores that CR should be considered in all patients with acute MI, “regardless of age,” wrote Shamir R. Mehta, MD, McMaster University, Hamilton, Ont., and Hamilton Health Sciences.
Dr. Mehta was principal investigator for the 2019 COMPLETE trial, which made the case for CR, guided by standard angiography, in patients with MVD and STEMI; their age averaged about 62 years.
FIRE definitely ought to sway practice toward greater use of physiology-guided CR regardless of age, observed Vijay Kunadian, MBBS, MD, invited discussant for the Biscaglia presentation. “My oldest patient is 98,” she said, “and it is beneficial without a doubt.”
But Dr. Kunadian, from Newcastle (England) University, said that the trial results can’t be generalized to all older patients. That’s because their outcomes after CR could vary depending on, for example, their different frailties or comorbidities, cognition, or CV history. “So, there is an absolute need to individualize care.”
FIRE enrolled patients 75 years or older with MVD, about 64% male, who had been admitted with acute STEMI or NSTEMI at 34 sites in Italy, Spain, and Poland. All underwent successful culprit-lesion PCI using, as “strongly” recommended, the same model of sirolimus-eluting stent.
Patients were randomly assigned to physiology-guided CR of nonculprit lesions, at the same session or at least during the same hospitalization, or to no further revascularization: 720 and 725 patients, respectively.
The hazard ratio for the composite primary outcome, CR versus culprit-only PCI was 0.73 (95% confidence interval, 0.57-0.93; P = .01). The benefit was driven by reductions in three individual components of the primary endpoint: death, MI, and revascularization, but not stroke.
The HR for CV death or MI was 0.64 (95% CI, 0.47-0.88) and for death from any cause was 0.70 (95% CI, 0.51-0.96).
There was no significant difference in the primary safety outcome, a composite of contrast-related acute kidney injury, stroke, or Bleeding Academic Research Consortium grade 3 to 5 bleeding at 1 year. The rates were 22.5% in those assigned to CR and 20.4% in the culprit-only group.
The functional effect of individual lesions was assessed by either of two methods, crossing them with a standard “pressure wire” or by angiographic derivation of their quantitative flow ratio.
The choice was “left to operator discretion,” Dr. Biscaglia said in an interview, “because we wanted to mirror clinical practice at the participating centers.” Still, the CR primary benefit was independent of the physiology-guidance method.
FIRE’s sponsor – the nonprofit Consorzio Futuro in Ricerca, Italy – received grant support from Sahajanand Medical Technologies, Medis Medical Imaging systems, Eukon, Siemens Healthineers, General Electric Healthcare, and Insight Lifetech. Dr. Biscaglia had no other disclosures. Dr. Mehta reported receiving grants from Abbott Vascular and personal fees from Amgen, Janssen, and Bristol Myers Squibb. Dr. Bhatt reported numerous disclosures with various companies and organizations. Dr. Kunadian had no disclosures.
A version of this article first appeared on Medscape.com.
FROM THE ESC CONGRESS 2023
Recall for Impella RP Flex labeling short on safety cautions
The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.
The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.
Twelve related injuries but no deaths have been reported, the agency said.
The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.
However, “the use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.
Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”
A version of this article first appeared on Medscape.com.
The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.
The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.
Twelve related injuries but no deaths have been reported, the agency said.
The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.
However, “the use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.
Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”
A version of this article first appeared on Medscape.com.
The current labeling doesn’t adequately describe safety precautions clinicians can take when patients’ clotting times are below the recommended range, according to the company and cited by the FDA.
The action applies to 65 units of the Impella RP Flex with SmartAssist, model number 1000323, first distributed by the company in November 2022, the statement notes.
Twelve related injuries but no deaths have been reported, the agency said.
The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.
However, “the use of affected catheters may cause serious adverse health consequences, including the risk of blood clots or particle deposits forming or death,” says the statement, which outlines instructions for mitigating the risk.
Abiomed says it is revising the label’s Instructions for Use section “to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.”
A version of this article first appeared on Medscape.com.
Could colchicine replace aspirin after PCI for ACS?
Dual antiplatelet therapy (DAPT) consisting of aspirin plus a P2Y12 inhibitor has been the standard of care to prevent thrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
in these patients, while mitigating the increased bleeding risk associated with aspirin.
Investigators conducted a pilot trial in ACS patients treated with drug-eluting stents (DES) who received low-dose colchicine the day after PCI, together with P2Y12 inhibitor (ticagrelor or prasugrel) maintenance therapy. Aspirin use was discontinued.
At 3 months, only 1% of the patients experienced stent thrombosis, and only 1 patient showed high platelet reactivity. Moreover, at 1 month, high-sensitivity C-reactive protein (hs-CRP) and platelet reactivity both decreased, pointing to reduced inflammation.
“In ACS patients undergoing PCI, it is feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after PCI in addition to ticagrelor or prasugrel P2Y12 inhibitors,” write Seung-Yul Lee, MD, CHA Bundang Medical Center, CHA University, Seongnam, South Korea, and colleagues. “This approach is associated with favorable platelet function and inflammatory profiles.”
The study was published online in JACC: Cardiovascular Interventions.
Safety without compromised efficacy
The U.S. Food and Drug Administration recently approved colchicine 0.5-mg tablets (Lodoco, Agepha Pharma) as the first anti-inflammatory drug shown to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with either established atherosclerotic disease or multiple risk factors for cardiovascular disease. It targets residual inflammation as an underlying cause of cardiovascular events.
Patients after PCI are generally treated using DAPT, but given the risk for increased bleeding associated with aspirin – especially when used long-term – there is a “need to identify strategies associated with a more favorable safety profile without compromising efficacy,” the authors write.
Previous research has yielded mixed results in terms of the discontinuation of aspirin therapy after 1-3 months and maintenance on P2Y12 inhibitor monotherapy. But one trial found colchicine to be effective in reducing recurrent ischemia, and its benefits may be more beneficial with early initiation in the hospital.
In this new study, researchers tested a “strategy that substitutes aspirin with colchicine during the acute phase to maximize the treatment effect of reducing recurrent ischemia and bleeding,” they write. The Mono Antiplatelet and Colchicine Therapy (MACT) single-arm, open-label proof-of-concept study was designed to investigate this approach.
The researchers studied 200 patients with non–ST-segment elevation ACS and ST-segment elevation myocardial infarction (STEMI) who underwent PCI with DES (mean [SD] age, 61.4 [10.7] years; 90% male; 100% of Asian ethnicity), who were receiving either ticagrelor or prasugrel plus a loading dose of aspirin.
On the day after PCI, aspirin was discontinued, and low-dose colchicine (0.6 mg once daily) was administered in addition to the P2Y12 inhibitor. In the case of staged PCI, it was performed under the maintenance of colchicine and ticagrelor or prasugrel.
No other antiplatelet or anticoagulant agents were permitted.
Patients underwent platelet function testing using the VerifyNow P2Y12 assay before discharge. Levels of hs-CRP were measured at admission, at 24 and 48 hours after PCI, and at 1-month follow-up. Clinical follow-up was performed at 1 and at 3 months.
The primary outcome was stent thrombosis within 3 months of follow-up. Secondary outcomes included all-cause mortality, MI, revascularization, major bleeding, a composite of cardiac death, target vessel MI, or target lesion revascularization, P2Y12 reaction units (PRUs), and change in hs-CRP levels between 24 hours post-PCI and 1-month follow-up.
The role of inflammation
Of the original 200 patients, 190 completed the full protocol and were available for follow-up.
The primary outcome occurred in only two patients. It turned out that one of the patients had not been adherent with antiplatelet medications.
“Although bleeding occurred in 36 patients, major bleeding occurred in only 1 patient,” the authors report.
The level of platelet reactivity at discharge was 27 ± 42 PRUs. Most patients (91%) met the criteria for low platelet reactivity, while only 0.5% met the criteria for high platelet reactivity. Platelet reactivity was similar, regardless of which P2Y12 inhibitor (ticagrelor or prasugrel) the patients were taking.
In all patients, the level of inflammation was “reduced considerably” over time: After 1 month, the hs-CRP level decreased from 6.1 mg/L (interquartile range [IQR], 2.6-15.9 mg/L) at 24 hours after PCI to 0.6 mg/L (IQR, 0.4-1.2 mg/L; P < .001).
The prevalence of high-inflammation criteria, defined as hs-CRP ≥ 2 mg/L, decreased significantly, from 81.8% at 24 hours after PCI to 11.8% at 1 month (P < .001).
Major bleeding was rare, they report, with a 3-month incidence of 0.5%.
“Inflammation plays a fundamental role in the development and progression of the atherothrombotic process,” the authors explain. A series of factors also trigger “an intense inflammatory response” in the acute phase of MI, which may lead to adverse myocardial remodeling. In the present study, inflammatory levels were rapidly reduced.
They noted several limitations. For example, all enrolled patients were Asian and were at relatively low bleeding and ischemic risk. “Although ticagrelor or prasugrel is effective regardless of ethnicity, clinical data supporting this de-escalation strategy are limited,” they state. Additionally, there was no control group for comparison.
The findings warrant further investigation, they conclude.
Promising but preliminary
Commenting for this news organization, Francesco Costa, MD, PhD, interventional cardiologist and assistant professor, University of Messina, Sicily, Italy, said he thinks it’s “too early for extensive clinical translation of these findings.”
Rather, larger and more extensive randomized trials are “on their way to give more precise estimates regarding the risks and benefits of early aspirin withdrawal in ACS.”
However, added Dr. Costa, who was not involved with the current research, “in this setting, adding colchicine early looks very promising to mitigate potential thrombotic risk without increasing bleeding risk.”
In the meantime, the study “provides novel insights on early aspirin withdrawal and P2Y12 monotherapy in an unselected population, including [those with] STEMI,” said Dr. Costa, also the coauthor of an accompanying editorial. The findings “could be of particular interest for those patients at extremely high bleeding risk or who are truly intolerant to aspirin, a scenario in which options are limited.”
This study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Lee reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Costa has served on an advisory board for AstraZeneca and has received speaker fees from Chiesi Farmaceutici. His coauthor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
Dual antiplatelet therapy (DAPT) consisting of aspirin plus a P2Y12 inhibitor has been the standard of care to prevent thrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
in these patients, while mitigating the increased bleeding risk associated with aspirin.
Investigators conducted a pilot trial in ACS patients treated with drug-eluting stents (DES) who received low-dose colchicine the day after PCI, together with P2Y12 inhibitor (ticagrelor or prasugrel) maintenance therapy. Aspirin use was discontinued.
At 3 months, only 1% of the patients experienced stent thrombosis, and only 1 patient showed high platelet reactivity. Moreover, at 1 month, high-sensitivity C-reactive protein (hs-CRP) and platelet reactivity both decreased, pointing to reduced inflammation.
“In ACS patients undergoing PCI, it is feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after PCI in addition to ticagrelor or prasugrel P2Y12 inhibitors,” write Seung-Yul Lee, MD, CHA Bundang Medical Center, CHA University, Seongnam, South Korea, and colleagues. “This approach is associated with favorable platelet function and inflammatory profiles.”
The study was published online in JACC: Cardiovascular Interventions.
Safety without compromised efficacy
The U.S. Food and Drug Administration recently approved colchicine 0.5-mg tablets (Lodoco, Agepha Pharma) as the first anti-inflammatory drug shown to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with either established atherosclerotic disease or multiple risk factors for cardiovascular disease. It targets residual inflammation as an underlying cause of cardiovascular events.
Patients after PCI are generally treated using DAPT, but given the risk for increased bleeding associated with aspirin – especially when used long-term – there is a “need to identify strategies associated with a more favorable safety profile without compromising efficacy,” the authors write.
Previous research has yielded mixed results in terms of the discontinuation of aspirin therapy after 1-3 months and maintenance on P2Y12 inhibitor monotherapy. But one trial found colchicine to be effective in reducing recurrent ischemia, and its benefits may be more beneficial with early initiation in the hospital.
In this new study, researchers tested a “strategy that substitutes aspirin with colchicine during the acute phase to maximize the treatment effect of reducing recurrent ischemia and bleeding,” they write. The Mono Antiplatelet and Colchicine Therapy (MACT) single-arm, open-label proof-of-concept study was designed to investigate this approach.
The researchers studied 200 patients with non–ST-segment elevation ACS and ST-segment elevation myocardial infarction (STEMI) who underwent PCI with DES (mean [SD] age, 61.4 [10.7] years; 90% male; 100% of Asian ethnicity), who were receiving either ticagrelor or prasugrel plus a loading dose of aspirin.
On the day after PCI, aspirin was discontinued, and low-dose colchicine (0.6 mg once daily) was administered in addition to the P2Y12 inhibitor. In the case of staged PCI, it was performed under the maintenance of colchicine and ticagrelor or prasugrel.
No other antiplatelet or anticoagulant agents were permitted.
Patients underwent platelet function testing using the VerifyNow P2Y12 assay before discharge. Levels of hs-CRP were measured at admission, at 24 and 48 hours after PCI, and at 1-month follow-up. Clinical follow-up was performed at 1 and at 3 months.
The primary outcome was stent thrombosis within 3 months of follow-up. Secondary outcomes included all-cause mortality, MI, revascularization, major bleeding, a composite of cardiac death, target vessel MI, or target lesion revascularization, P2Y12 reaction units (PRUs), and change in hs-CRP levels between 24 hours post-PCI and 1-month follow-up.
The role of inflammation
Of the original 200 patients, 190 completed the full protocol and were available for follow-up.
The primary outcome occurred in only two patients. It turned out that one of the patients had not been adherent with antiplatelet medications.
“Although bleeding occurred in 36 patients, major bleeding occurred in only 1 patient,” the authors report.
The level of platelet reactivity at discharge was 27 ± 42 PRUs. Most patients (91%) met the criteria for low platelet reactivity, while only 0.5% met the criteria for high platelet reactivity. Platelet reactivity was similar, regardless of which P2Y12 inhibitor (ticagrelor or prasugrel) the patients were taking.
In all patients, the level of inflammation was “reduced considerably” over time: After 1 month, the hs-CRP level decreased from 6.1 mg/L (interquartile range [IQR], 2.6-15.9 mg/L) at 24 hours after PCI to 0.6 mg/L (IQR, 0.4-1.2 mg/L; P < .001).
The prevalence of high-inflammation criteria, defined as hs-CRP ≥ 2 mg/L, decreased significantly, from 81.8% at 24 hours after PCI to 11.8% at 1 month (P < .001).
Major bleeding was rare, they report, with a 3-month incidence of 0.5%.
“Inflammation plays a fundamental role in the development and progression of the atherothrombotic process,” the authors explain. A series of factors also trigger “an intense inflammatory response” in the acute phase of MI, which may lead to adverse myocardial remodeling. In the present study, inflammatory levels were rapidly reduced.
They noted several limitations. For example, all enrolled patients were Asian and were at relatively low bleeding and ischemic risk. “Although ticagrelor or prasugrel is effective regardless of ethnicity, clinical data supporting this de-escalation strategy are limited,” they state. Additionally, there was no control group for comparison.
The findings warrant further investigation, they conclude.
Promising but preliminary
Commenting for this news organization, Francesco Costa, MD, PhD, interventional cardiologist and assistant professor, University of Messina, Sicily, Italy, said he thinks it’s “too early for extensive clinical translation of these findings.”
Rather, larger and more extensive randomized trials are “on their way to give more precise estimates regarding the risks and benefits of early aspirin withdrawal in ACS.”
However, added Dr. Costa, who was not involved with the current research, “in this setting, adding colchicine early looks very promising to mitigate potential thrombotic risk without increasing bleeding risk.”
In the meantime, the study “provides novel insights on early aspirin withdrawal and P2Y12 monotherapy in an unselected population, including [those with] STEMI,” said Dr. Costa, also the coauthor of an accompanying editorial. The findings “could be of particular interest for those patients at extremely high bleeding risk or who are truly intolerant to aspirin, a scenario in which options are limited.”
This study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Lee reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Costa has served on an advisory board for AstraZeneca and has received speaker fees from Chiesi Farmaceutici. His coauthor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
Dual antiplatelet therapy (DAPT) consisting of aspirin plus a P2Y12 inhibitor has been the standard of care to prevent thrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
in these patients, while mitigating the increased bleeding risk associated with aspirin.
Investigators conducted a pilot trial in ACS patients treated with drug-eluting stents (DES) who received low-dose colchicine the day after PCI, together with P2Y12 inhibitor (ticagrelor or prasugrel) maintenance therapy. Aspirin use was discontinued.
At 3 months, only 1% of the patients experienced stent thrombosis, and only 1 patient showed high platelet reactivity. Moreover, at 1 month, high-sensitivity C-reactive protein (hs-CRP) and platelet reactivity both decreased, pointing to reduced inflammation.
“In ACS patients undergoing PCI, it is feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after PCI in addition to ticagrelor or prasugrel P2Y12 inhibitors,” write Seung-Yul Lee, MD, CHA Bundang Medical Center, CHA University, Seongnam, South Korea, and colleagues. “This approach is associated with favorable platelet function and inflammatory profiles.”
The study was published online in JACC: Cardiovascular Interventions.
Safety without compromised efficacy
The U.S. Food and Drug Administration recently approved colchicine 0.5-mg tablets (Lodoco, Agepha Pharma) as the first anti-inflammatory drug shown to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with either established atherosclerotic disease or multiple risk factors for cardiovascular disease. It targets residual inflammation as an underlying cause of cardiovascular events.
Patients after PCI are generally treated using DAPT, but given the risk for increased bleeding associated with aspirin – especially when used long-term – there is a “need to identify strategies associated with a more favorable safety profile without compromising efficacy,” the authors write.
Previous research has yielded mixed results in terms of the discontinuation of aspirin therapy after 1-3 months and maintenance on P2Y12 inhibitor monotherapy. But one trial found colchicine to be effective in reducing recurrent ischemia, and its benefits may be more beneficial with early initiation in the hospital.
In this new study, researchers tested a “strategy that substitutes aspirin with colchicine during the acute phase to maximize the treatment effect of reducing recurrent ischemia and bleeding,” they write. The Mono Antiplatelet and Colchicine Therapy (MACT) single-arm, open-label proof-of-concept study was designed to investigate this approach.
The researchers studied 200 patients with non–ST-segment elevation ACS and ST-segment elevation myocardial infarction (STEMI) who underwent PCI with DES (mean [SD] age, 61.4 [10.7] years; 90% male; 100% of Asian ethnicity), who were receiving either ticagrelor or prasugrel plus a loading dose of aspirin.
On the day after PCI, aspirin was discontinued, and low-dose colchicine (0.6 mg once daily) was administered in addition to the P2Y12 inhibitor. In the case of staged PCI, it was performed under the maintenance of colchicine and ticagrelor or prasugrel.
No other antiplatelet or anticoagulant agents were permitted.
Patients underwent platelet function testing using the VerifyNow P2Y12 assay before discharge. Levels of hs-CRP were measured at admission, at 24 and 48 hours after PCI, and at 1-month follow-up. Clinical follow-up was performed at 1 and at 3 months.
The primary outcome was stent thrombosis within 3 months of follow-up. Secondary outcomes included all-cause mortality, MI, revascularization, major bleeding, a composite of cardiac death, target vessel MI, or target lesion revascularization, P2Y12 reaction units (PRUs), and change in hs-CRP levels between 24 hours post-PCI and 1-month follow-up.
The role of inflammation
Of the original 200 patients, 190 completed the full protocol and were available for follow-up.
The primary outcome occurred in only two patients. It turned out that one of the patients had not been adherent with antiplatelet medications.
“Although bleeding occurred in 36 patients, major bleeding occurred in only 1 patient,” the authors report.
The level of platelet reactivity at discharge was 27 ± 42 PRUs. Most patients (91%) met the criteria for low platelet reactivity, while only 0.5% met the criteria for high platelet reactivity. Platelet reactivity was similar, regardless of which P2Y12 inhibitor (ticagrelor or prasugrel) the patients were taking.
In all patients, the level of inflammation was “reduced considerably” over time: After 1 month, the hs-CRP level decreased from 6.1 mg/L (interquartile range [IQR], 2.6-15.9 mg/L) at 24 hours after PCI to 0.6 mg/L (IQR, 0.4-1.2 mg/L; P < .001).
The prevalence of high-inflammation criteria, defined as hs-CRP ≥ 2 mg/L, decreased significantly, from 81.8% at 24 hours after PCI to 11.8% at 1 month (P < .001).
Major bleeding was rare, they report, with a 3-month incidence of 0.5%.
“Inflammation plays a fundamental role in the development and progression of the atherothrombotic process,” the authors explain. A series of factors also trigger “an intense inflammatory response” in the acute phase of MI, which may lead to adverse myocardial remodeling. In the present study, inflammatory levels were rapidly reduced.
They noted several limitations. For example, all enrolled patients were Asian and were at relatively low bleeding and ischemic risk. “Although ticagrelor or prasugrel is effective regardless of ethnicity, clinical data supporting this de-escalation strategy are limited,” they state. Additionally, there was no control group for comparison.
The findings warrant further investigation, they conclude.
Promising but preliminary
Commenting for this news organization, Francesco Costa, MD, PhD, interventional cardiologist and assistant professor, University of Messina, Sicily, Italy, said he thinks it’s “too early for extensive clinical translation of these findings.”
Rather, larger and more extensive randomized trials are “on their way to give more precise estimates regarding the risks and benefits of early aspirin withdrawal in ACS.”
However, added Dr. Costa, who was not involved with the current research, “in this setting, adding colchicine early looks very promising to mitigate potential thrombotic risk without increasing bleeding risk.”
In the meantime, the study “provides novel insights on early aspirin withdrawal and P2Y12 monotherapy in an unselected population, including [those with] STEMI,” said Dr. Costa, also the coauthor of an accompanying editorial. The findings “could be of particular interest for those patients at extremely high bleeding risk or who are truly intolerant to aspirin, a scenario in which options are limited.”
This study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Lee reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Costa has served on an advisory board for AstraZeneca and has received speaker fees from Chiesi Farmaceutici. His coauthor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JACC: CARIOVASCULAR INTERVENTIONS
Crossed wires: Ischemia testing and monomorphic VT storm
Patients with a severe form of ventricular arrhythmia who may be referred for catheter ablation are often first tested for coronary artery disease (CAD) or ischemia.
The findings, they say, question such routine CAD/ischemia testing in patients like those studied, who had episodes of monomorphic ventricular tachycardia (VT) storm but not an acute coronary syndrome (ACS) and ultimately went to ablation.
Of 97 such patients, about 44% underwent CAD/ischemia testing by invasive angiography, myocardial functional imaging, or both. But the tests didn’t predict important ablation outcomes, including pre- or postablation VT inducibility. Nor did they significantly affect the likelihood or outcomes of preablation revascularization or 2-year survival.
The findings “argue against performing routine evaluations to rule out coronary [disease] or myocardial ischemia as culprits in monomorphic VT storm” in patients without evidence of ACS, write Feras Alkhalaileh, MD, Heart and Vascular Institute, Cleveland Clinic, and colleagues in their report published in JACC: Clinical Electrophysiology.
They suggest it’s “reasonable” not to perform tests for CAD or ischemia in such patients, senior author Ayman A. Hussein, MD, from the same center, said in an interview. Although such tests may be considered “case by case,” performed routinely they “aren’t going to add much to patient care, and as a matter of fact, may delay proper care and expose them to risks,” Dr. Hussein said.
It’s “reasonable” to test for CAD or ischemia in patients with polymorphic VT storm, which is likely ischemia-driven, he observed. In contrast, monomorphic VT storm is likely caused by myocardial scar, which revascularization cannot treat. “Because there’s scar substrate, we find that ischemic evaluations are technically without much yield.”
These issues are “not very controversial” among cardiac electrophysiologists, Dr. Hussein said, but it remains “common practice” for other specialists to order angiography or ischemia testing for patients with monomorphic VT storm, typically in the cardiac care unit (CCU), before considering ablation.
“Sometimes, as electrophysiologists, we don’t get to see them before an ischemic evaluation has already been done,” he added.
It’s “very hard to convince interventional cardiologists, CCU intensivists, or general cardiologists” that a VT may not be caused by ischemia, said electrophysiologist Roderick Tung, MD, University of Arizona College of Medicine, Phoenix, who was not involved in the current study.
In patients with monomorphic VT storm, “by the time we’re consulted, they’ve already had a cath. And it’s probably just not necessary,” Dr. Tung said. “That’s why this is such a great paper, because it has an immediate message [for nonelectrophysiologist clinicians and] the potential to change clinical practice.”
The study included 97 patients with monomorphic VT storm from a prospective VT-ablation registry covering about 7 years at a major referral center. Their mean age was 64 years, and 88% were men. Two-thirds were known to have ischemic cardiomyopathy and were in NYHA functional class II.
As reported, 10% of the cohort underwent coronary angiography after presentation with monomorphic VT storm, 26% had CT or PET myocardial functional imaging, and 9% had both tests.
Only four patients ultimately underwent coronary revascularization; no acute coronary occlusions were involved. Monomorphic VT recurred in all four cases, the report notes.
The 43 and 54 patients who did or did not get the CAD/ischemia tests, respectively, showed no significant procedural differences in extent of scar modification, prevalence of clinical or hemodynamically stable VT, or use of mechanical circulatory support; or in postablation, VT inducibility or overall mortality during follow-up averaging 24.3 months.
To address possible concerns about selection bias in the main cohort, all of whom underwent ablation, a secondary analysis was conducted with 91 patients with known asymptomatic coronary disease and monomorphic VT storm who were selected from the registry without regard to whether they underwent catheter ablation.
Of that cohort, 21 went to invasive angiography and 25 underwent stress testing; six of the latter went on to coronary angiography, the report states. Monomorphic VT later recurred in four of the five patients, who then underwent coronary revascularization.
Such patients with known coronary disease, Dr. Hussein said, are those “possibly more likely to get an ischemic evaluation.” And yet, “regardless of whether they had ablation, the yield of ischemic evaluations in these patients was low.”
By far most of the CAD/ischemia tests in the study’s primary cohort were performed using noninvasive imaging, notes an editorial accompanying the new report. “This raises the possibility of false negatives with very proximal and multivessel CAD, and with balanced ischemia,” write Saurabh Kumar, BSc (Med)/MBBS, PhD, and Ashwin Bhaskaran, MBBS, MSc, University of Sydney.
Ideally, the issues addressed by the study should be tested in large randomized, controlled trials, they state. “Achieving sufficient recruitment to address this clinical question may be difficult, leaving clinicians with the challenge of applying observational data to their patients.”
A version of this article appeared on Medscape.com.
Patients with a severe form of ventricular arrhythmia who may be referred for catheter ablation are often first tested for coronary artery disease (CAD) or ischemia.
The findings, they say, question such routine CAD/ischemia testing in patients like those studied, who had episodes of monomorphic ventricular tachycardia (VT) storm but not an acute coronary syndrome (ACS) and ultimately went to ablation.
Of 97 such patients, about 44% underwent CAD/ischemia testing by invasive angiography, myocardial functional imaging, or both. But the tests didn’t predict important ablation outcomes, including pre- or postablation VT inducibility. Nor did they significantly affect the likelihood or outcomes of preablation revascularization or 2-year survival.
The findings “argue against performing routine evaluations to rule out coronary [disease] or myocardial ischemia as culprits in monomorphic VT storm” in patients without evidence of ACS, write Feras Alkhalaileh, MD, Heart and Vascular Institute, Cleveland Clinic, and colleagues in their report published in JACC: Clinical Electrophysiology.
They suggest it’s “reasonable” not to perform tests for CAD or ischemia in such patients, senior author Ayman A. Hussein, MD, from the same center, said in an interview. Although such tests may be considered “case by case,” performed routinely they “aren’t going to add much to patient care, and as a matter of fact, may delay proper care and expose them to risks,” Dr. Hussein said.
It’s “reasonable” to test for CAD or ischemia in patients with polymorphic VT storm, which is likely ischemia-driven, he observed. In contrast, monomorphic VT storm is likely caused by myocardial scar, which revascularization cannot treat. “Because there’s scar substrate, we find that ischemic evaluations are technically without much yield.”
These issues are “not very controversial” among cardiac electrophysiologists, Dr. Hussein said, but it remains “common practice” for other specialists to order angiography or ischemia testing for patients with monomorphic VT storm, typically in the cardiac care unit (CCU), before considering ablation.
“Sometimes, as electrophysiologists, we don’t get to see them before an ischemic evaluation has already been done,” he added.
It’s “very hard to convince interventional cardiologists, CCU intensivists, or general cardiologists” that a VT may not be caused by ischemia, said electrophysiologist Roderick Tung, MD, University of Arizona College of Medicine, Phoenix, who was not involved in the current study.
In patients with monomorphic VT storm, “by the time we’re consulted, they’ve already had a cath. And it’s probably just not necessary,” Dr. Tung said. “That’s why this is such a great paper, because it has an immediate message [for nonelectrophysiologist clinicians and] the potential to change clinical practice.”
The study included 97 patients with monomorphic VT storm from a prospective VT-ablation registry covering about 7 years at a major referral center. Their mean age was 64 years, and 88% were men. Two-thirds were known to have ischemic cardiomyopathy and were in NYHA functional class II.
As reported, 10% of the cohort underwent coronary angiography after presentation with monomorphic VT storm, 26% had CT or PET myocardial functional imaging, and 9% had both tests.
Only four patients ultimately underwent coronary revascularization; no acute coronary occlusions were involved. Monomorphic VT recurred in all four cases, the report notes.
The 43 and 54 patients who did or did not get the CAD/ischemia tests, respectively, showed no significant procedural differences in extent of scar modification, prevalence of clinical or hemodynamically stable VT, or use of mechanical circulatory support; or in postablation, VT inducibility or overall mortality during follow-up averaging 24.3 months.
To address possible concerns about selection bias in the main cohort, all of whom underwent ablation, a secondary analysis was conducted with 91 patients with known asymptomatic coronary disease and monomorphic VT storm who were selected from the registry without regard to whether they underwent catheter ablation.
Of that cohort, 21 went to invasive angiography and 25 underwent stress testing; six of the latter went on to coronary angiography, the report states. Monomorphic VT later recurred in four of the five patients, who then underwent coronary revascularization.
Such patients with known coronary disease, Dr. Hussein said, are those “possibly more likely to get an ischemic evaluation.” And yet, “regardless of whether they had ablation, the yield of ischemic evaluations in these patients was low.”
By far most of the CAD/ischemia tests in the study’s primary cohort were performed using noninvasive imaging, notes an editorial accompanying the new report. “This raises the possibility of false negatives with very proximal and multivessel CAD, and with balanced ischemia,” write Saurabh Kumar, BSc (Med)/MBBS, PhD, and Ashwin Bhaskaran, MBBS, MSc, University of Sydney.
Ideally, the issues addressed by the study should be tested in large randomized, controlled trials, they state. “Achieving sufficient recruitment to address this clinical question may be difficult, leaving clinicians with the challenge of applying observational data to their patients.”
A version of this article appeared on Medscape.com.
Patients with a severe form of ventricular arrhythmia who may be referred for catheter ablation are often first tested for coronary artery disease (CAD) or ischemia.
The findings, they say, question such routine CAD/ischemia testing in patients like those studied, who had episodes of monomorphic ventricular tachycardia (VT) storm but not an acute coronary syndrome (ACS) and ultimately went to ablation.
Of 97 such patients, about 44% underwent CAD/ischemia testing by invasive angiography, myocardial functional imaging, or both. But the tests didn’t predict important ablation outcomes, including pre- or postablation VT inducibility. Nor did they significantly affect the likelihood or outcomes of preablation revascularization or 2-year survival.
The findings “argue against performing routine evaluations to rule out coronary [disease] or myocardial ischemia as culprits in monomorphic VT storm” in patients without evidence of ACS, write Feras Alkhalaileh, MD, Heart and Vascular Institute, Cleveland Clinic, and colleagues in their report published in JACC: Clinical Electrophysiology.
They suggest it’s “reasonable” not to perform tests for CAD or ischemia in such patients, senior author Ayman A. Hussein, MD, from the same center, said in an interview. Although such tests may be considered “case by case,” performed routinely they “aren’t going to add much to patient care, and as a matter of fact, may delay proper care and expose them to risks,” Dr. Hussein said.
It’s “reasonable” to test for CAD or ischemia in patients with polymorphic VT storm, which is likely ischemia-driven, he observed. In contrast, monomorphic VT storm is likely caused by myocardial scar, which revascularization cannot treat. “Because there’s scar substrate, we find that ischemic evaluations are technically without much yield.”
These issues are “not very controversial” among cardiac electrophysiologists, Dr. Hussein said, but it remains “common practice” for other specialists to order angiography or ischemia testing for patients with monomorphic VT storm, typically in the cardiac care unit (CCU), before considering ablation.
“Sometimes, as electrophysiologists, we don’t get to see them before an ischemic evaluation has already been done,” he added.
It’s “very hard to convince interventional cardiologists, CCU intensivists, or general cardiologists” that a VT may not be caused by ischemia, said electrophysiologist Roderick Tung, MD, University of Arizona College of Medicine, Phoenix, who was not involved in the current study.
In patients with monomorphic VT storm, “by the time we’re consulted, they’ve already had a cath. And it’s probably just not necessary,” Dr. Tung said. “That’s why this is such a great paper, because it has an immediate message [for nonelectrophysiologist clinicians and] the potential to change clinical practice.”
The study included 97 patients with monomorphic VT storm from a prospective VT-ablation registry covering about 7 years at a major referral center. Their mean age was 64 years, and 88% were men. Two-thirds were known to have ischemic cardiomyopathy and were in NYHA functional class II.
As reported, 10% of the cohort underwent coronary angiography after presentation with monomorphic VT storm, 26% had CT or PET myocardial functional imaging, and 9% had both tests.
Only four patients ultimately underwent coronary revascularization; no acute coronary occlusions were involved. Monomorphic VT recurred in all four cases, the report notes.
The 43 and 54 patients who did or did not get the CAD/ischemia tests, respectively, showed no significant procedural differences in extent of scar modification, prevalence of clinical or hemodynamically stable VT, or use of mechanical circulatory support; or in postablation, VT inducibility or overall mortality during follow-up averaging 24.3 months.
To address possible concerns about selection bias in the main cohort, all of whom underwent ablation, a secondary analysis was conducted with 91 patients with known asymptomatic coronary disease and monomorphic VT storm who were selected from the registry without regard to whether they underwent catheter ablation.
Of that cohort, 21 went to invasive angiography and 25 underwent stress testing; six of the latter went on to coronary angiography, the report states. Monomorphic VT later recurred in four of the five patients, who then underwent coronary revascularization.
Such patients with known coronary disease, Dr. Hussein said, are those “possibly more likely to get an ischemic evaluation.” And yet, “regardless of whether they had ablation, the yield of ischemic evaluations in these patients was low.”
By far most of the CAD/ischemia tests in the study’s primary cohort were performed using noninvasive imaging, notes an editorial accompanying the new report. “This raises the possibility of false negatives with very proximal and multivessel CAD, and with balanced ischemia,” write Saurabh Kumar, BSc (Med)/MBBS, PhD, and Ashwin Bhaskaran, MBBS, MSc, University of Sydney.
Ideally, the issues addressed by the study should be tested in large randomized, controlled trials, they state. “Achieving sufficient recruitment to address this clinical question may be difficult, leaving clinicians with the challenge of applying observational data to their patients.”
A version of this article appeared on Medscape.com.
FROM JACC: CLINICAL ELECTROPHYSIOLOGY
Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
AHA/ACC issue updated chronic coronary disease guidelines
The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.
Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.
It was published online in Circulation and the Journal of the American College of Cardiology .
Among the key recommendations were the following.
- Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
- Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
- Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
- Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
- The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
- Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
- Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
- Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
- Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
- Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
Living document
The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.
“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.
“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.
“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.
The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.
Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.
It was published online in Circulation and the Journal of the American College of Cardiology .
Among the key recommendations were the following.
- Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
- Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
- Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
- Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
- The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
- Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
- Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
- Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
- Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
- Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
Living document
The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.
“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.
“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.
“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.
The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.
Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.
It was published online in Circulation and the Journal of the American College of Cardiology .
Among the key recommendations were the following.
- Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
- Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
- Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
- Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
- The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
- Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
- Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
- Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
- Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
- Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
Living document
The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.
“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.
“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.
“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.
The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
New AHA/ACC performance, quality metrics for coronary revascularization
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
“Performance measures are helpful to accelerate translation of scientific evidence into clinical practice and are intended to provide practitioners and institutions with tools to measure the quality of care provided and identify opportunities for improvement,” writing group chair Gregory J. Dehmer, MD, Carilion Clinic Cardiology, Roanoke, Va., said in an interview.
Performance measures are “evidence-based, have exceptions and exclusions supported by evidence, and should be actionable,” Dr. Dehmer added. They typically target meaningful gaps in the quality of care and are based on Class 1 clinical practice guidelines.
The 44-page document was published online in the Journal of the American College of Cardiology.
Topics addressed in the 15 performance measures include the following:
- The importance of using coronary physiological measurements rather than visual assessment of an intermediate severity lesion.
- Dual antiplatelet therapy (DAPT) with percutaneous coronary intervention (PCI), as a “cornerstone” of therapy for prevention of thrombotic complications and reduction of ischemic events.
- Antiplatelets and anticoagulation after PCI, which provide “an important outcome benefit” and represent “an existing gap in care,” especially in patients with atrial fibrillation (AF).
- P2Y12 inhibitors with fibrinolytic therapy to reduce recurrent ischemia and avoid increased risk of bleeding relative to aspirin.
Other performance measures address aspirin in patients undergoing coronary artery bypass grafting (CABG), lipid management, glycemic control during and after CABG, use of internal mammary artery for CABG, arterial access for PCI, noninfarct artery revascularization in ST-segment elevation myocardial infarction (STEMI), noninfarct artery PCI in STEMI with shock, management of ventricular arrhythmias, and referral to cardiac rehabilitation from inpatient and outpatient settings.
“The measures are structured in a typical format with the goal to seek a higher performance score, ideally nearing 100%,” Dr. Dehmer said.
The document also includes five quality measures. These measures are “important but are not based on Class 1 clinical practice guidelines or are lacking in other important characteristics (e.g., questions of feasibility, validity),” the writing group notes.
“If additional evidence supports the importance of the proposed quality measures, they may be changed to performance measures in the future,” they point out.
The quality measures emphasize shared decision-making and informed consent; periprocedural hydration in cardiovascular angiography; smoking cessation after revascularization; risk assessment before CABG; and reduction of AF after CABG.
The document also includes two structural measures. One focuses on preprocedural assessment and fostering collaborative efforts among cardiovascular specialists, and the other encourages registry participation to measure performance.
Areas for future research
The writing group notes that the field of coronary artery revascularization “continues to evolve rapidly.”
They say areas for further research include determining the optimal role and timing for revascularization in cardiogenic shock, research on conduits and techniques for CABG, the use of mechanical support for high-risk PCI, defining the role of drug-coated balloons, and the optimal duration of antiplatelet therapy after PCI and in the setting of AF.
New devices for PCI continue to enter the marketplace, and research is needed to better define their safety and effectiveness in real-world populations, they add.
Chronic total occlusions are another area in need of additional research.
“Whereas many chronic total occlusions were once thought too difficult to treat, newer techniques for the recanalization of these vessels are being developed, but more research is needed to determine the role of chronic total occlusion therapies on long-term outcomes such as death, heart failure events, and optimal case selection,” the writing group points out.
They also note that several studies have shown that an initial strategy of guideline-directed medical therapy alone, compared with guideline-directed medical therapy plus revascularization, in selected patients with chronic coronary disease has similar effects on cardiovascular outcomes such as death, MI, heart failure, and hospitalization for unstable angina.
More investigation is needed to compare the long-term effects of these two therapies and identify subgroups of stable patients that may have a mortality benefit from early revascularization as well as the effects of these two therapeutic strategies on symptoms and quality of life.
More research is also needed to identify gender-based differences in responses to available therapies.
The document was developed in collaboration with the American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions.
It has been endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Society for Preventive Cardiology, American Society of Health-System Pharmacists, Association of Black Cardiologists, Heart Failure Society of America, Heart Rhythm Society, International Society for Heart and Lung Transplantation, Outpatient Endovascular and Interventional Society, and the Preventive Cardiovascular Nurses Association.
This research had no commercial funding. Dr. Dehmer has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
U.S. News ranks top cardiology, heart surgery hospitals
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
Rheumatoid arthritis may raise risk for aortic stenosis
Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.
RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote.
In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019.
The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively).
The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death.
Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA.
The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.
Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).
After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.
The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote.
Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.
The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status.
Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded.
The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.
A version of this article appeared on Medscape.com.
Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.
RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote.
In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019.
The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively).
The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death.
Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA.
The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.
Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).
After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.
The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote.
Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.
The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status.
Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded.
The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.
A version of this article appeared on Medscape.com.
Adults with rheumatoid arthritis had a significantly higher risk than do those without RA for developing aortic stenosis (AS), according to a large national cohort of patients.
RA has been associated with an increased risk for ischemic cardiovascular disease, but the association of RA with the risk for AS remains unclear, Tate M. Johnson, MD, of VA Nebraska–Western Iowa Health Care System, Omaha, and colleagues wrote.
In a study published in JAMA Internal Medicine, the researchers identified 73,070 adults with RA and 639,268 matched control individuals without RA using data from Veterans Affairs and Centers for Medicare & Medicaid Services from 2000 to 2019.
The patients and control individuals were predominantly men (about 87%), and most were White (72.3% of patients and 61.7% of control individuals). The mean ages of the patients and control individuals were similar (63.0 vs. 61.9, respectively).
The main outcome of incident AS was defined as a composite of inpatient or outpatient AS diagnoses, surgical or transcatheter aortic valve intervention, or AS-related death.
Over a mean follow-up period of 7.9 years in patients with RA and 8.8 years in control individuals, the researchers found 16,109 composite AS outcomes over a period of 6,223,150 person-years, with 2,303 that occurred in patients with RA.
The multivariate model adjusted for race, ethnicity, smoking status, body mass index (BMI), rural versus urban residence, comorbidities, and health care use.
Overall, RA was associated with an increased risk for the composite AS outcome (hazard ratio, 1.66).
After adjusting for confounders, RA remained associated with an increased risk for composite AS diagnoses, aortic valve intervention, and AS-related death (adjusted HRs, 1.48, 1.34, and 1.26, respectively). Altogether, the incidence of composite AS events was 3.97 per 1,000 person-years in patients with RA versus 2.45 per 1,000 person-years in control individuals, with an absolute difference of 1.52 composite AS events per 1,000 person-years.
The results “emphasize that valvular heart disease may be an underrecognized contributor to the persistent CVD [cardiovascular disease]-related mortality gap in RA, particularly given the lack of improvement in AS-specific risk over time,” the researchers wrote.
Several traditional CVD risk factors (for example, smoking status, diabetes, and coronary artery disease) were not independently associated with AS onset in patients with RA. However, male sex, hypertension, stroke, and other noncoronary CVDs were associated with incident AS in the patients with RA, and increasing age and BMI were associated with stepwise increases in AS risk.
The findings were limited by several factors including the infrequency of AS-related events and consequent modest differences in absolute risk, the researchers noted. The predominantly male cohort may limit generalizability of results because RA is more common in women. Other limitations included the predominantly male population and possible misclassification of RA status.
Overall, the results demonstrate an increased risk for AS, AS-related intervention, and AS-related death in people with RA. More research is needed to examine AS and valvular heart disease as potential complications in this population, they concluded.
The study was supported by the Center of Excellence for Suicide Prevention, Joint Department of Veterans Affairs, and Department of Defense Mortality Data Repository National Death Index. Dr. Johnson disclosed grants from the Rheumatology Research Foundation during the conduct of the study but had no other financial conflicts to disclose. Other authors disclosed fees and honoraria from pharmaceutical companies outside the submitted work.
A version of this article appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE