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AHA adds recovery, emotional support to CPR guidelines
Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.
The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.
These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.
And new approaches do appear to save lives, at least in a hospital setting.
Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.
“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
Update adds sixth link to Chains of Survival: Recovery
“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.
Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.
The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
New advice on opioid overdoses and bystander training
Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.
In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.
“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.
While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.
According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.
This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.
“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”
The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.
According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.
“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”
Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.
When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.
“It’s always a personal choice,” she said.
More for clinicians
For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.
From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.
The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.
SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.
Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.
The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.
These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.
And new approaches do appear to save lives, at least in a hospital setting.
Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.
“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
Update adds sixth link to Chains of Survival: Recovery
“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.
Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.
The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
New advice on opioid overdoses and bystander training
Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.
In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.
“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.
While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.
According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.
This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.
“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”
The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.
According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.
“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”
Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.
When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.
“It’s always a personal choice,” she said.
More for clinicians
For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.
From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.
The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.
SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.
Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.
The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.
These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.
And new approaches do appear to save lives, at least in a hospital setting.
Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.
“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
Update adds sixth link to Chains of Survival: Recovery
“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.
Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.
The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
New advice on opioid overdoses and bystander training
Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.
In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.
“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.
While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.
According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.
This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.
“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”
The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.
According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.
“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”
Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.
When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.
“It’s always a personal choice,” she said.
More for clinicians
For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.
From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.
The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.
SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.
FROM CIRCULATION
Cardiogenic shock rate soars in COVID-positive ACS
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
FROM TCT 2020
MitraClip effective for post-MI acute mitral regurgitation with cardiogenic shock
Percutaneous mitral valve repair with the MitraClip appears to be a safe, effective, and life-saving new treatment for severe acute mitral regurgitation (MR) secondary to MI in surgical noncandidates, even when accompanied by cardiogenic shock, according to data from the international IREMMI registry.
“Cardiogenic shock, when adequately supported, does not seem to influence short- and mid-term outcomes, so the development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario,” Rodrigo Estevez-Loureiro, MD, PhD, said in presenting the IREMMI (International Registry of MitraClip in Acute Myocardial Infarction) findings reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
Commentators hailed the prospective IREMMI data as potentially practice changing in light of the dire prognosis of such patients when surgery is deemed unacceptably high risk because medical management, the traditionally the only alternative, has a 30-day mortality of up to 50%.
Severe acute MR occurs in an estimated 3% of acute MIs, and in roughly 10% of patients who present with acute MI complicated by cardiogenic shock (CS). The impact of intervening with the MitraClip in an effort to correct the acute MR arising from MI with CS has previously been addressed only in sparse case reports. The new IREMMI study is easily the largest dataset to date detailing clinical and echocardiographic outcomes, Dr. Estevez-Loureiro of Alvaro Cunqueiro Hospital in Vigo, Spain, said at the meeting, sponsored by the Cardiovascular Research Foundation.
He reported on 93 consecutive patients who underwent MitraClip implantation for acute MR arising in the setting of MI, including 50 patients in CS at the time of the procedure. All 93 patients had been turned down by their surgical team because of extreme surgical risk. Three-quarters of the MIs showed ST-segment elevation. Only six patients had a papillary muscle rupture; in the rest, the mechanism of acute MR involved left ventricular global remodeling associated with mitral valve leaflet tethering. Percutaneous valve repair was performed at 18 expert valvular heart centers in the United States, Canada, Israel, and five European countries.
Procedural success
Time from MI to MitraClip implantation averaged 24 days in the CS patients and 33 days in the comparator arm without CS.
“These patients had been turned down for surgery, so the attending physicians generally followed a strategy of trying to cool them down with mechanical circulatory support and vasopressors. MitraClip wasn’t an option at the beginning, but after two or three failed weanings from all the possible therapies, then MitraClip becomes an option. This is one of the reasons why the time lapse between MI and the clip is so large,” the cardiologist explained.
Procedural success rates were similar in the two groups: 90% in those with CS and 93% in those without. However, average procedure time was significantly longer in the CS patients: 143 minutes versus 83 minutes in the patients without CS.
At baseline, 86% of the CS group had grade 4+ MR, similar to the 79% rate in the non-CS patients. Postprocedurally, 60% of the CS group were MR grade 0/1 and 34% were grade 2, comparable to the rates of 65% and 23% in the non-CS group.
At 3 months’ follow-up, 83.4% of the CS group had MR grade 2 or less, again not significantly different from the 90.5% rate in non-CS patients. Systolic pulmonary artery pressure was also similar: 39.6 mm Hg in the CS patients, 44 mm Hg in those without. While everyone was New York Heart Association functional class IV preprocedurally, 79.5% of the CS group were NYHA class I or II at 3 months, not significantly different from the 86.5% prevalence in the comparator arm.
Longer-term clinical outcomes
At a median follow-up of 7 months, the composite primary clinical outcome composed of all-cause mortality or heart failure rehospitalization did not differ between the two groups: a 28% rate in the CS group and 25.6% in non-CS patients. All-cause mortality occurred in 16% with CS and 9.3% without, again not a significant difference.
In a Cox regression analysis, neither surgical risk score, patient age, left ventricular geometry, nor CS was independently associated with the primary composite endpoint. Indeed, the only independent predictor of freedom from mortality or heart failure readmission at follow-up was procedural success, which is very much a function of the experience of the heart team, Dr. Estevez-Loureiro continued.
Michael A. Borger, MD, PhD, who comoderated the late-breaking clinical science session, was wowed by the IREMMI results.
“The mortality rates, I can tell you, compared to traditional surgical series of acute MR in the face of ACS [acute cardiogenic shock] are very, very respectable,” commented Dr. Borger, director of the cardiac surgery clinic at the Leipzig (Ger.) University Heart Center.
“Extremely impressive,” agreed discussant Vinayak N. Bapat, MD, a cardiothoracic surgeon and valve scientist at the Minneapolis Heart Institute Foundation. He posed a practical question: “Should we take from this presentation that patients should be stabilized with something like ECMO [extracorporeal membrane oxygenation] or Impella [left ventricular assist device], then transferred to an expert center for the procedure?”
“I think that the stabilization is essential in the patients with cardiogenic shock,” Dr. Estevez-Loureiro replied. “Unlike with surgery, it’s very difficult to establish a MitraClip procedure in a couple of hours in the middle of the night. You have to stabilize them and then treat for shock with ECMO, Impella, or both. I think they should be transferred to a center than can deliver the best treatment. In centers with less experience, patients can be put on mechanical support and transferred to an expert valve center, not only for MitraClip implantation, but for discussion of all the treatment possibilities, including surgery.”
At a press conference in which Dr. Estevez-Loureiro presented highlights of the IREMMI study, discussant Dee Dee Wang, MD, said the international coinvestigators “need to be applauded” for this study.
“Having these outcomes is incredible,” declared Dr. Wang, a structural heart disease specialist at the Henry Ford Health System, Detroit.
While this is an observational study, it’s a high-quality dataset with excellent methodology. And conducting a randomized trial in patients with such high surgical risk scores – the CS group had an average EuroSCORE II of 21 – would be extremely difficult, according to the cardiologist.
Dr. Estevez-Loureiro reported receiving research grants from Abbott and serving as a consultant to that company as well as Boston Scientific.
SOURCE: Estevez-Loureiro, R. TCT 2020, LBCS session IV.
Percutaneous mitral valve repair with the MitraClip appears to be a safe, effective, and life-saving new treatment for severe acute mitral regurgitation (MR) secondary to MI in surgical noncandidates, even when accompanied by cardiogenic shock, according to data from the international IREMMI registry.
“Cardiogenic shock, when adequately supported, does not seem to influence short- and mid-term outcomes, so the development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario,” Rodrigo Estevez-Loureiro, MD, PhD, said in presenting the IREMMI (International Registry of MitraClip in Acute Myocardial Infarction) findings reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
Commentators hailed the prospective IREMMI data as potentially practice changing in light of the dire prognosis of such patients when surgery is deemed unacceptably high risk because medical management, the traditionally the only alternative, has a 30-day mortality of up to 50%.
Severe acute MR occurs in an estimated 3% of acute MIs, and in roughly 10% of patients who present with acute MI complicated by cardiogenic shock (CS). The impact of intervening with the MitraClip in an effort to correct the acute MR arising from MI with CS has previously been addressed only in sparse case reports. The new IREMMI study is easily the largest dataset to date detailing clinical and echocardiographic outcomes, Dr. Estevez-Loureiro of Alvaro Cunqueiro Hospital in Vigo, Spain, said at the meeting, sponsored by the Cardiovascular Research Foundation.
He reported on 93 consecutive patients who underwent MitraClip implantation for acute MR arising in the setting of MI, including 50 patients in CS at the time of the procedure. All 93 patients had been turned down by their surgical team because of extreme surgical risk. Three-quarters of the MIs showed ST-segment elevation. Only six patients had a papillary muscle rupture; in the rest, the mechanism of acute MR involved left ventricular global remodeling associated with mitral valve leaflet tethering. Percutaneous valve repair was performed at 18 expert valvular heart centers in the United States, Canada, Israel, and five European countries.
Procedural success
Time from MI to MitraClip implantation averaged 24 days in the CS patients and 33 days in the comparator arm without CS.
“These patients had been turned down for surgery, so the attending physicians generally followed a strategy of trying to cool them down with mechanical circulatory support and vasopressors. MitraClip wasn’t an option at the beginning, but after two or three failed weanings from all the possible therapies, then MitraClip becomes an option. This is one of the reasons why the time lapse between MI and the clip is so large,” the cardiologist explained.
Procedural success rates were similar in the two groups: 90% in those with CS and 93% in those without. However, average procedure time was significantly longer in the CS patients: 143 minutes versus 83 minutes in the patients without CS.
At baseline, 86% of the CS group had grade 4+ MR, similar to the 79% rate in the non-CS patients. Postprocedurally, 60% of the CS group were MR grade 0/1 and 34% were grade 2, comparable to the rates of 65% and 23% in the non-CS group.
At 3 months’ follow-up, 83.4% of the CS group had MR grade 2 or less, again not significantly different from the 90.5% rate in non-CS patients. Systolic pulmonary artery pressure was also similar: 39.6 mm Hg in the CS patients, 44 mm Hg in those without. While everyone was New York Heart Association functional class IV preprocedurally, 79.5% of the CS group were NYHA class I or II at 3 months, not significantly different from the 86.5% prevalence in the comparator arm.
Longer-term clinical outcomes
At a median follow-up of 7 months, the composite primary clinical outcome composed of all-cause mortality or heart failure rehospitalization did not differ between the two groups: a 28% rate in the CS group and 25.6% in non-CS patients. All-cause mortality occurred in 16% with CS and 9.3% without, again not a significant difference.
In a Cox regression analysis, neither surgical risk score, patient age, left ventricular geometry, nor CS was independently associated with the primary composite endpoint. Indeed, the only independent predictor of freedom from mortality or heart failure readmission at follow-up was procedural success, which is very much a function of the experience of the heart team, Dr. Estevez-Loureiro continued.
Michael A. Borger, MD, PhD, who comoderated the late-breaking clinical science session, was wowed by the IREMMI results.
“The mortality rates, I can tell you, compared to traditional surgical series of acute MR in the face of ACS [acute cardiogenic shock] are very, very respectable,” commented Dr. Borger, director of the cardiac surgery clinic at the Leipzig (Ger.) University Heart Center.
“Extremely impressive,” agreed discussant Vinayak N. Bapat, MD, a cardiothoracic surgeon and valve scientist at the Minneapolis Heart Institute Foundation. He posed a practical question: “Should we take from this presentation that patients should be stabilized with something like ECMO [extracorporeal membrane oxygenation] or Impella [left ventricular assist device], then transferred to an expert center for the procedure?”
“I think that the stabilization is essential in the patients with cardiogenic shock,” Dr. Estevez-Loureiro replied. “Unlike with surgery, it’s very difficult to establish a MitraClip procedure in a couple of hours in the middle of the night. You have to stabilize them and then treat for shock with ECMO, Impella, or both. I think they should be transferred to a center than can deliver the best treatment. In centers with less experience, patients can be put on mechanical support and transferred to an expert valve center, not only for MitraClip implantation, but for discussion of all the treatment possibilities, including surgery.”
At a press conference in which Dr. Estevez-Loureiro presented highlights of the IREMMI study, discussant Dee Dee Wang, MD, said the international coinvestigators “need to be applauded” for this study.
“Having these outcomes is incredible,” declared Dr. Wang, a structural heart disease specialist at the Henry Ford Health System, Detroit.
While this is an observational study, it’s a high-quality dataset with excellent methodology. And conducting a randomized trial in patients with such high surgical risk scores – the CS group had an average EuroSCORE II of 21 – would be extremely difficult, according to the cardiologist.
Dr. Estevez-Loureiro reported receiving research grants from Abbott and serving as a consultant to that company as well as Boston Scientific.
SOURCE: Estevez-Loureiro, R. TCT 2020, LBCS session IV.
Percutaneous mitral valve repair with the MitraClip appears to be a safe, effective, and life-saving new treatment for severe acute mitral regurgitation (MR) secondary to MI in surgical noncandidates, even when accompanied by cardiogenic shock, according to data from the international IREMMI registry.
“Cardiogenic shock, when adequately supported, does not seem to influence short- and mid-term outcomes, so the development of cardiogenic shock should not preclude percutaneous mitral valve repair in this scenario,” Rodrigo Estevez-Loureiro, MD, PhD, said in presenting the IREMMI (International Registry of MitraClip in Acute Myocardial Infarction) findings reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
Commentators hailed the prospective IREMMI data as potentially practice changing in light of the dire prognosis of such patients when surgery is deemed unacceptably high risk because medical management, the traditionally the only alternative, has a 30-day mortality of up to 50%.
Severe acute MR occurs in an estimated 3% of acute MIs, and in roughly 10% of patients who present with acute MI complicated by cardiogenic shock (CS). The impact of intervening with the MitraClip in an effort to correct the acute MR arising from MI with CS has previously been addressed only in sparse case reports. The new IREMMI study is easily the largest dataset to date detailing clinical and echocardiographic outcomes, Dr. Estevez-Loureiro of Alvaro Cunqueiro Hospital in Vigo, Spain, said at the meeting, sponsored by the Cardiovascular Research Foundation.
He reported on 93 consecutive patients who underwent MitraClip implantation for acute MR arising in the setting of MI, including 50 patients in CS at the time of the procedure. All 93 patients had been turned down by their surgical team because of extreme surgical risk. Three-quarters of the MIs showed ST-segment elevation. Only six patients had a papillary muscle rupture; in the rest, the mechanism of acute MR involved left ventricular global remodeling associated with mitral valve leaflet tethering. Percutaneous valve repair was performed at 18 expert valvular heart centers in the United States, Canada, Israel, and five European countries.
Procedural success
Time from MI to MitraClip implantation averaged 24 days in the CS patients and 33 days in the comparator arm without CS.
“These patients had been turned down for surgery, so the attending physicians generally followed a strategy of trying to cool them down with mechanical circulatory support and vasopressors. MitraClip wasn’t an option at the beginning, but after two or three failed weanings from all the possible therapies, then MitraClip becomes an option. This is one of the reasons why the time lapse between MI and the clip is so large,” the cardiologist explained.
Procedural success rates were similar in the two groups: 90% in those with CS and 93% in those without. However, average procedure time was significantly longer in the CS patients: 143 minutes versus 83 minutes in the patients without CS.
At baseline, 86% of the CS group had grade 4+ MR, similar to the 79% rate in the non-CS patients. Postprocedurally, 60% of the CS group were MR grade 0/1 and 34% were grade 2, comparable to the rates of 65% and 23% in the non-CS group.
At 3 months’ follow-up, 83.4% of the CS group had MR grade 2 or less, again not significantly different from the 90.5% rate in non-CS patients. Systolic pulmonary artery pressure was also similar: 39.6 mm Hg in the CS patients, 44 mm Hg in those without. While everyone was New York Heart Association functional class IV preprocedurally, 79.5% of the CS group were NYHA class I or II at 3 months, not significantly different from the 86.5% prevalence in the comparator arm.
Longer-term clinical outcomes
At a median follow-up of 7 months, the composite primary clinical outcome composed of all-cause mortality or heart failure rehospitalization did not differ between the two groups: a 28% rate in the CS group and 25.6% in non-CS patients. All-cause mortality occurred in 16% with CS and 9.3% without, again not a significant difference.
In a Cox regression analysis, neither surgical risk score, patient age, left ventricular geometry, nor CS was independently associated with the primary composite endpoint. Indeed, the only independent predictor of freedom from mortality or heart failure readmission at follow-up was procedural success, which is very much a function of the experience of the heart team, Dr. Estevez-Loureiro continued.
Michael A. Borger, MD, PhD, who comoderated the late-breaking clinical science session, was wowed by the IREMMI results.
“The mortality rates, I can tell you, compared to traditional surgical series of acute MR in the face of ACS [acute cardiogenic shock] are very, very respectable,” commented Dr. Borger, director of the cardiac surgery clinic at the Leipzig (Ger.) University Heart Center.
“Extremely impressive,” agreed discussant Vinayak N. Bapat, MD, a cardiothoracic surgeon and valve scientist at the Minneapolis Heart Institute Foundation. He posed a practical question: “Should we take from this presentation that patients should be stabilized with something like ECMO [extracorporeal membrane oxygenation] or Impella [left ventricular assist device], then transferred to an expert center for the procedure?”
“I think that the stabilization is essential in the patients with cardiogenic shock,” Dr. Estevez-Loureiro replied. “Unlike with surgery, it’s very difficult to establish a MitraClip procedure in a couple of hours in the middle of the night. You have to stabilize them and then treat for shock with ECMO, Impella, or both. I think they should be transferred to a center than can deliver the best treatment. In centers with less experience, patients can be put on mechanical support and transferred to an expert valve center, not only for MitraClip implantation, but for discussion of all the treatment possibilities, including surgery.”
At a press conference in which Dr. Estevez-Loureiro presented highlights of the IREMMI study, discussant Dee Dee Wang, MD, said the international coinvestigators “need to be applauded” for this study.
“Having these outcomes is incredible,” declared Dr. Wang, a structural heart disease specialist at the Henry Ford Health System, Detroit.
While this is an observational study, it’s a high-quality dataset with excellent methodology. And conducting a randomized trial in patients with such high surgical risk scores – the CS group had an average EuroSCORE II of 21 – would be extremely difficult, according to the cardiologist.
Dr. Estevez-Loureiro reported receiving research grants from Abbott and serving as a consultant to that company as well as Boston Scientific.
SOURCE: Estevez-Loureiro, R. TCT 2020, LBCS session IV.
FROM TCT 2020
NACMI: Clear benefit with PCI in STEMI COVID-19 patients
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Ticagrelor monotherapy beats DAPT in STEMI
, a major randomized trial.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).
TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).
The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.
Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.
In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.
Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.
“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.
Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.
“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.
“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.
Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.
“From a clinical standpoint, this strategy seems particularly appealing in high bleeding risk patients,” the cardiologist concluded at the at the meeting, which was sponsored by the Cardiovascular Research Foundation.
He added, however, that the TICO-STEMI data with respect to complex PCI “are not really reassuring and are probably worth another investigation.”
Dr. Kim reported having no financial conflicts regarding the TICO-STEMI trial, funded by Biotronik.
, a major randomized trial.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).
TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).
The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.
Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.
In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.
Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.
“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.
Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.
“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.
“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.
Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.
“From a clinical standpoint, this strategy seems particularly appealing in high bleeding risk patients,” the cardiologist concluded at the at the meeting, which was sponsored by the Cardiovascular Research Foundation.
He added, however, that the TICO-STEMI data with respect to complex PCI “are not really reassuring and are probably worth another investigation.”
Dr. Kim reported having no financial conflicts regarding the TICO-STEMI trial, funded by Biotronik.
, a major randomized trial.
“This is the first report assessing the feasibility of ticagrelor monotherapy after short-term DAPT for STEMI patients with drug-eluting stents,” Byeong-Keuk Kim, MD, PhD, noted at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.
The positive results were consistent with the earlier TWILIGHT study (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention), which also showed clinical benefit at 1 year for 3 months of DAPT followed by ticagrelor (Brilinta) monotherapy, albeit only in PCI patients without an acute coronary syndrome (ACS) or with non-STEMI ACS (N Engl J Med. 2019 Nov 21;381[21]:2032-42).
TICO-STEMI was a prespecified substudy involving the 1,103 STEMI patients included in the previously reported parent 38-center South Korean TICO (Ticagrelor With or Without Aspirin in Acute Coronary Syndrome After PCI) study of 3,056 ACS patients treated with a second-generation ultrathin biodegradable polymer-coated sirolimus-eluting stent (JAMA. 2020 Jun 16;323[23]:2407-16).
The primary outcome in TICO-STEMI was the 12-month composite rate of net adverse clinical events, composed of major bleeding, all-cause mortality, acute MI, stroke, stent thrombosis, or target vessel revascularization. In an intention-to-treat analysis, the rate was 5.0% in the 12-month DAPT group and 3.7% with ticagrelor monotherapy after 3 months of DAPT, for a 27% relative risk reduction which didn’t achieve statistical significance. However, in an as-treated analysis, the between-group difference in the primary endpoint was stronger: a 5.2% incidence with 12 months of DAPT and 2.3% with ticagrelor monotherapy, for a relative risk reduction of 56%, which was statistically significant.
Major bleeding, one of two key secondary endpoints, was a different story: The incidence within 12 months by intention-to-treat was 2.9% with 12 months of DAPT compared to 0.9% with ticagrelor monotherapy, for a statistically significant 68% relative risk reduction in favor of ticagrelor monotherapy. In contrast, there was no between-group difference in the other secondary endpoint composed of major adverse cardio- and cerebrovascular events: 2.7% with ticagrelor monotherapy, 2.5% with 12 months of DAPT.
In the subgroup of TICO-STEMI patients at high bleeding risk, ticagrelor monotherapy was associated with a 12-month major bleeding rate of 1.8%, compared to 6.3% with a full year of DAPT. Conversely, in patients who underwent complex PCI, ticagrelor monotherapy was associated with a 4.9% rate of major adverse cardio- and cerebrovascular events through 1 year, numerically greater than but not statistically significantly different from the 2.7% rate with 12 months of DAPT.
Dr. Kim noted that the study had several limitations: It was open label, had no placebo control, and was underpowered to draw definite conclusions regarding the merits of dropping aspirin and continuing ticagrelor after 3 months in STEMI patients.
“Our findings should be interpreted with caution and call for confirmatory randomized trials,” he stressed.
Session comoderator Roxana Mehran, MD, said she “wholeheartedly” agrees with that assessment.
“We really do need a future trial, and we’re working to design TWILIGHT-STEMI,” a large randomized follow-up to the TWILIGHT trial, which she directed.
“I often imagine that we can have an even shorter duration of aspirin and ticagrelor and go to monotherapy sooner than 3 months in this very, very important subgroup,” added Dr. Mehran, professor of medicine, professor of population science and policy, and director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, New York.
Discussant Marco Valgimigli, MD, PhD, of University Hospital in Bern, Switzerland, calculated that the number-needed-to-treat with ticagrelor monotherapy rather than 12 months of DAPT in order to prevent one additional major bleeding event in TICO-STEMI participants at high bleeding risk was 22, as compared to an NNT of 77 in those without high bleeding risk.
“From a clinical standpoint, this strategy seems particularly appealing in high bleeding risk patients,” the cardiologist concluded at the at the meeting, which was sponsored by the Cardiovascular Research Foundation.
He added, however, that the TICO-STEMI data with respect to complex PCI “are not really reassuring and are probably worth another investigation.”
Dr. Kim reported having no financial conflicts regarding the TICO-STEMI trial, funded by Biotronik.
AT TCT 2020
Female cardiac advantage essentially lost after MI
Women are known to lag 5-10 years behind men in experiencing coronary heart disease (CHD), but new research suggests the gap narrows substantially following a myocardial infarction.
“Women lose a considerable portion, but not all, of their coronary and survival advantage – i.e., the lower event rates – after suffering a MI,” study author Sanne Peters, PhD, George Institute for Global Health, Imperial College London, said in an interview.
Previous studies of sex differences in event rates after a coronary event have produced mixed results and were primarily focused on mortality following MI. Importantly, the studies also lacked a control group without a history of CHD and, thus, were unable to provide a reference point for the disparity in event rates, she explained.
Using the MarketScan and Medicare databases, however, Dr. Peters and colleagues matched 339,890 U.S. adults hospitalized for an MI between January 2015 and December 2016 with 1,359,560 U.S. adults without a history of CHD.
Over a median 1.3 years follow-up, there were 12,518 MIs in the non-CHD group and 27,115 recurrent MIs in the MI group.
The age-standardized rate of MI per 1,000 person-years was 4.0 in women and 6.1 in men without a history of CHD, compared with 57.6 in women and 62.7 in men with a prior MI.
After multivariate adjustment, the women-to-men hazard ratio for MI was 0.64 (95% confidence interval, 0.62-0.67) in the non-CHD group and 0.94 (95% CI, 0.92-0.96) in the prior MI group, the authors reported Oct. 5 in the Journal of the American College of Cardiology
Additional results show the multivariate adjusted women-to-men hazard ratios for three other cardiovascular outcomes follow a similar pattern in the non-CHD and prior MI groups:
- CHD events: 0.53 (95% CI, 0.51-0.54) and 0.87 (95% CI, 0.85-0.89).
- Heart failure hospitalization: 0.93 (95% CI, 0.90-0.96) and 1.02 (95% CI, 1.00-1.04).
- All-cause mortality: 0.72 (95% CI, 0.71-0.73) and 0.90 (95% CI, 0.89-0.92).
“By including a control group of individuals without CHD, we demonstrated that the magnitude of the sex difference in cardiac event rates and survival is considerably smaller among those with prior MI than among those without a history of CHD,” Dr. Peters said.
Of note, the sex differences were consistent across age and race/ethnicity groups for all events, except for heart failure hospitalizations, where the adjusted hazard ratio for women vs. men age 80 years or older was 0.95 for those without a history of CHD (95% CI, 0.91-0.98) and 0.99 (95% CI, 0.96-1.02) for participants with a previous MI.
Dr. Peters said it’s not clear why the female advantage is attenuated post-MI but that one explanation is that women are less likely than men to receive guideline-recommended treatments and dosages or to adhere to prescribed therapies after MI hospitalization, which could put them at a higher risk of subsequent events and worse outcomes than men.
“Sex differences in pathophysiology of CHD and its complications may also explain, to some extent, why the rates of recurrent events are considerably more similar between the sexes than incident event rates,” she said. Compared with men, women have a higher incidence of MI with nonobstructive coronary artery disease and of heart failure with preserved ejection fraction, and evidence-based treatment options are more limited for both conditions.
“After people read this, I think the important thing to recognize is we need to push– as much as we can, with what meds we have, and what data we have – secondary prevention in these women,” Laxmi Mehta, MD, director of preventive cardiology and women’s cardiovascular health at Ohio State University, Columbus, said in an interview.
The lack of a female advantage post-MI should also elicit a “really meaningful conversation with our patients on shared decision-making of why they need to be on medications, remembering on our part to prescribe the medications, remembering to prescribe cardiac rehab, and also reminding our community we do need more data and need to investigate this further,” she said.
In an accompanying editorial, Nanette Wenger, MD, of Emory University, Atlanta, also points out that nonobstructive coronary disease is more common in women and, “yet, guideline-based therapies are those validated for obstructive coronary disease in a predominantly male population but, nonetheless, are applied for nonobstructive coronary disease.”
She advocates for aggressive evaluation and treatment for women with chest pain symptoms as well as early identification of women at risk for CHD, specifically those with metabolic syndrome, preeclampsia, hypertensive disorders of pregnancy, chronic inflammatory conditions, and high-risk race/ethnicity.
“Next, when coronary angiography is undertaken, particularly in younger women, an assiduous search for spontaneous coronary artery dissection and its appropriate management, as well as prompt and evidence-based interventions and medical therapies for an acute coronary event [are indicated],” Dr. Wenger wrote. “However, basic to improving outcomes for women is the elucidation of the optimal noninvasive techniques to identify microvascular disease, which could then enable delineation of appropriate preventive and therapeutic approaches.”
Dr. Peters is supported by a U.K. Medical Research Council Skills Development Fellowship. Dr. Mehta and Dr. Wenger disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Women are known to lag 5-10 years behind men in experiencing coronary heart disease (CHD), but new research suggests the gap narrows substantially following a myocardial infarction.
“Women lose a considerable portion, but not all, of their coronary and survival advantage – i.e., the lower event rates – after suffering a MI,” study author Sanne Peters, PhD, George Institute for Global Health, Imperial College London, said in an interview.
Previous studies of sex differences in event rates after a coronary event have produced mixed results and were primarily focused on mortality following MI. Importantly, the studies also lacked a control group without a history of CHD and, thus, were unable to provide a reference point for the disparity in event rates, she explained.
Using the MarketScan and Medicare databases, however, Dr. Peters and colleagues matched 339,890 U.S. adults hospitalized for an MI between January 2015 and December 2016 with 1,359,560 U.S. adults without a history of CHD.
Over a median 1.3 years follow-up, there were 12,518 MIs in the non-CHD group and 27,115 recurrent MIs in the MI group.
The age-standardized rate of MI per 1,000 person-years was 4.0 in women and 6.1 in men without a history of CHD, compared with 57.6 in women and 62.7 in men with a prior MI.
After multivariate adjustment, the women-to-men hazard ratio for MI was 0.64 (95% confidence interval, 0.62-0.67) in the non-CHD group and 0.94 (95% CI, 0.92-0.96) in the prior MI group, the authors reported Oct. 5 in the Journal of the American College of Cardiology
Additional results show the multivariate adjusted women-to-men hazard ratios for three other cardiovascular outcomes follow a similar pattern in the non-CHD and prior MI groups:
- CHD events: 0.53 (95% CI, 0.51-0.54) and 0.87 (95% CI, 0.85-0.89).
- Heart failure hospitalization: 0.93 (95% CI, 0.90-0.96) and 1.02 (95% CI, 1.00-1.04).
- All-cause mortality: 0.72 (95% CI, 0.71-0.73) and 0.90 (95% CI, 0.89-0.92).
“By including a control group of individuals without CHD, we demonstrated that the magnitude of the sex difference in cardiac event rates and survival is considerably smaller among those with prior MI than among those without a history of CHD,” Dr. Peters said.
Of note, the sex differences were consistent across age and race/ethnicity groups for all events, except for heart failure hospitalizations, where the adjusted hazard ratio for women vs. men age 80 years or older was 0.95 for those without a history of CHD (95% CI, 0.91-0.98) and 0.99 (95% CI, 0.96-1.02) for participants with a previous MI.
Dr. Peters said it’s not clear why the female advantage is attenuated post-MI but that one explanation is that women are less likely than men to receive guideline-recommended treatments and dosages or to adhere to prescribed therapies after MI hospitalization, which could put them at a higher risk of subsequent events and worse outcomes than men.
“Sex differences in pathophysiology of CHD and its complications may also explain, to some extent, why the rates of recurrent events are considerably more similar between the sexes than incident event rates,” she said. Compared with men, women have a higher incidence of MI with nonobstructive coronary artery disease and of heart failure with preserved ejection fraction, and evidence-based treatment options are more limited for both conditions.
“After people read this, I think the important thing to recognize is we need to push– as much as we can, with what meds we have, and what data we have – secondary prevention in these women,” Laxmi Mehta, MD, director of preventive cardiology and women’s cardiovascular health at Ohio State University, Columbus, said in an interview.
The lack of a female advantage post-MI should also elicit a “really meaningful conversation with our patients on shared decision-making of why they need to be on medications, remembering on our part to prescribe the medications, remembering to prescribe cardiac rehab, and also reminding our community we do need more data and need to investigate this further,” she said.
In an accompanying editorial, Nanette Wenger, MD, of Emory University, Atlanta, also points out that nonobstructive coronary disease is more common in women and, “yet, guideline-based therapies are those validated for obstructive coronary disease in a predominantly male population but, nonetheless, are applied for nonobstructive coronary disease.”
She advocates for aggressive evaluation and treatment for women with chest pain symptoms as well as early identification of women at risk for CHD, specifically those with metabolic syndrome, preeclampsia, hypertensive disorders of pregnancy, chronic inflammatory conditions, and high-risk race/ethnicity.
“Next, when coronary angiography is undertaken, particularly in younger women, an assiduous search for spontaneous coronary artery dissection and its appropriate management, as well as prompt and evidence-based interventions and medical therapies for an acute coronary event [are indicated],” Dr. Wenger wrote. “However, basic to improving outcomes for women is the elucidation of the optimal noninvasive techniques to identify microvascular disease, which could then enable delineation of appropriate preventive and therapeutic approaches.”
Dr. Peters is supported by a U.K. Medical Research Council Skills Development Fellowship. Dr. Mehta and Dr. Wenger disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Women are known to lag 5-10 years behind men in experiencing coronary heart disease (CHD), but new research suggests the gap narrows substantially following a myocardial infarction.
“Women lose a considerable portion, but not all, of their coronary and survival advantage – i.e., the lower event rates – after suffering a MI,” study author Sanne Peters, PhD, George Institute for Global Health, Imperial College London, said in an interview.
Previous studies of sex differences in event rates after a coronary event have produced mixed results and were primarily focused on mortality following MI. Importantly, the studies also lacked a control group without a history of CHD and, thus, were unable to provide a reference point for the disparity in event rates, she explained.
Using the MarketScan and Medicare databases, however, Dr. Peters and colleagues matched 339,890 U.S. adults hospitalized for an MI between January 2015 and December 2016 with 1,359,560 U.S. adults without a history of CHD.
Over a median 1.3 years follow-up, there were 12,518 MIs in the non-CHD group and 27,115 recurrent MIs in the MI group.
The age-standardized rate of MI per 1,000 person-years was 4.0 in women and 6.1 in men without a history of CHD, compared with 57.6 in women and 62.7 in men with a prior MI.
After multivariate adjustment, the women-to-men hazard ratio for MI was 0.64 (95% confidence interval, 0.62-0.67) in the non-CHD group and 0.94 (95% CI, 0.92-0.96) in the prior MI group, the authors reported Oct. 5 in the Journal of the American College of Cardiology
Additional results show the multivariate adjusted women-to-men hazard ratios for three other cardiovascular outcomes follow a similar pattern in the non-CHD and prior MI groups:
- CHD events: 0.53 (95% CI, 0.51-0.54) and 0.87 (95% CI, 0.85-0.89).
- Heart failure hospitalization: 0.93 (95% CI, 0.90-0.96) and 1.02 (95% CI, 1.00-1.04).
- All-cause mortality: 0.72 (95% CI, 0.71-0.73) and 0.90 (95% CI, 0.89-0.92).
“By including a control group of individuals without CHD, we demonstrated that the magnitude of the sex difference in cardiac event rates and survival is considerably smaller among those with prior MI than among those without a history of CHD,” Dr. Peters said.
Of note, the sex differences were consistent across age and race/ethnicity groups for all events, except for heart failure hospitalizations, where the adjusted hazard ratio for women vs. men age 80 years or older was 0.95 for those without a history of CHD (95% CI, 0.91-0.98) and 0.99 (95% CI, 0.96-1.02) for participants with a previous MI.
Dr. Peters said it’s not clear why the female advantage is attenuated post-MI but that one explanation is that women are less likely than men to receive guideline-recommended treatments and dosages or to adhere to prescribed therapies after MI hospitalization, which could put them at a higher risk of subsequent events and worse outcomes than men.
“Sex differences in pathophysiology of CHD and its complications may also explain, to some extent, why the rates of recurrent events are considerably more similar between the sexes than incident event rates,” she said. Compared with men, women have a higher incidence of MI with nonobstructive coronary artery disease and of heart failure with preserved ejection fraction, and evidence-based treatment options are more limited for both conditions.
“After people read this, I think the important thing to recognize is we need to push– as much as we can, with what meds we have, and what data we have – secondary prevention in these women,” Laxmi Mehta, MD, director of preventive cardiology and women’s cardiovascular health at Ohio State University, Columbus, said in an interview.
The lack of a female advantage post-MI should also elicit a “really meaningful conversation with our patients on shared decision-making of why they need to be on medications, remembering on our part to prescribe the medications, remembering to prescribe cardiac rehab, and also reminding our community we do need more data and need to investigate this further,” she said.
In an accompanying editorial, Nanette Wenger, MD, of Emory University, Atlanta, also points out that nonobstructive coronary disease is more common in women and, “yet, guideline-based therapies are those validated for obstructive coronary disease in a predominantly male population but, nonetheless, are applied for nonobstructive coronary disease.”
She advocates for aggressive evaluation and treatment for women with chest pain symptoms as well as early identification of women at risk for CHD, specifically those with metabolic syndrome, preeclampsia, hypertensive disorders of pregnancy, chronic inflammatory conditions, and high-risk race/ethnicity.
“Next, when coronary angiography is undertaken, particularly in younger women, an assiduous search for spontaneous coronary artery dissection and its appropriate management, as well as prompt and evidence-based interventions and medical therapies for an acute coronary event [are indicated],” Dr. Wenger wrote. “However, basic to improving outcomes for women is the elucidation of the optimal noninvasive techniques to identify microvascular disease, which could then enable delineation of appropriate preventive and therapeutic approaches.”
Dr. Peters is supported by a U.K. Medical Research Council Skills Development Fellowship. Dr. Mehta and Dr. Wenger disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Repurposing cardiovascular drugs for serious mental illness
One of the hottest topics now in psychiatry is the possibility of repurposing long-established cardiovascular medications for treatment of patients with serious mental illness, Livia De Picker, MD, PhD, said at the virtual congress of the European College of Neuropsychopharmacology.
The appeal is multifold. A huge unmet need exists in psychiatry for new and better treatments with novel mechanisms of action. Many guideline-recommended cardiovascular medications have a long track record, including a well-established safety profile with no surprises, and are available in generic versions. They can be developed for a new indication at minimal cost, noted Dr. De Picker, a psychiatrist at the University of Antwerp (Belgium).
The idea of psychiatric repurposing of drugs originally developed for nonpsychiatric indications is nothing new, she added. Examples include lithium for gout, valproate for epilepsy, and ketamine for anesthesiology.
One hitch in efforts to repurpose cardiovascular medications is that, when psychiatric patients have been included in randomized trials of the drugs’ cardiovascular effects, the psychiatric outcomes often went untallied.
Indeed, the only high-quality randomized trial evidence of psychiatric benefits for any class of cardiovascular medications is for statins, where a modest-sized meta-analysis of six placebo-controlled trials in 339 patients with schizophrenia showed the lipid-lowering agents had benefit for both positive and negative symptoms (Psychiatry Res. 2018 Apr;262:84-93). But that’s not a body of data of sufficient size to be definitive, in Dr. De Picker’s view.
Much of the recent enthusiasm for exploring the potential of cardiovascular drugs for psychiatric conditions comes from hypothesis-generating big data analyses drawn from Scandinavian national patient registries. Danish investigators scrutinized all 1.6 million Danes exposed to six classes of drugs of interest during 2005-2015 and determined that those on long-term statins, low-dose aspirin, ACE inhibitors, angiotensin receptor blockers, or allopurinol were associated with a decreased rate of new-onset depression, while high-dose aspirin and non-aspirin NSAIDs were associated with an increased rate, compared with a 30% random sample of the country’s population (Acta Psychiatr Scand. 2019 Jan;1391:68-77).
Similarly, the Danish group found that continued use of statins, angiotensin agents, or low-dose aspirin was associated with a decreased rate of new-onset bipolar disorder, while high-dose aspirin and other NSAIDs were linked to increased risk (Bipolar Disord. 2019 Aug;[15]:410-8). What these agents have in common, the investigators observed, is that they act on inflammation and potentially on the stress response system.
Meanwhile, Swedish investigators examined the course of 142,691 Swedes with a diagnosis of bipolar disorder, schizophrenia, or nonaffective psychosis during 2005-2016. They determined that, during periods when those individuals were on a statin, calcium channel blocker, or metformin, they had reduced rates of psychiatric hospitalization and self-harm (JAMA Psychiatry. 2019 Apr 1;76[4]:382-90).
Scottish researchers analyzed the health records of 144,066 patients placed on monotherapy for hypertension and determined that the lowest risk for hospitalization for a mood disorder during follow-up was in those prescribed an ACE inhibitor or angiotensin receptor blocker. The risk was significantly higher in patients on a beta-blocker or calcium channel blocker, and intermediate in those on a thiazide diuretic (Hypertension. 2016 Nov;68[5:1132-8).
“Obviously, this is all at a very macro scale and we have no idea whatsoever what this means for individual patients, number needed to treat, or which type of patients would benefit, but it does provide us with some guidance for future research,” according to Dr. De Picker.
In the meantime, while physicians await definitive evidence of any impact of cardiovascular drugs might have on psychiatric outcomes, abundant data exist underscoring what she called “shockingly high levels” of inadequate management of cardiovascular risk factors in patients with serious mental illness. That problem needs to be addressed, and Dr. De Picker offered her personal recommendations for doing so in a manner consistent with the evidence to date suggestive of potential mental health benefits of some cardiovascular medications.
She advised that, for treatment of hypertension in patients with bipolar disorder or major depression, an ACE inhibitor or angiotensin-converting enzyme inhibitor is preferred as first-line. There is some evidence to suggest lipophilic beta-blockers, which cross the blood-brain barrier, improve anxiety symptoms and panic attacks, and prevent memory consolidation in patients with posttraumatic stress disorder. But the Scottish data suggest that they may worsen mood disorders.
“I would be careful in using beta-blockers as first-line treatment for hypertension. They’re not in the guidelines for anxiety disorders. British guidelines recommend them to prevent memory consolidation in PTSD, but do not use them as first-line in patients with major depressive disorder or bipolar disorder,” she said. As for calcium channel blockers, the jury is still out, with mixed and inconsistent evidence to date as to the impact of this drug class on mental illness outcomes.
She recommended a very low threshold for prescribing statin therapy in patients with serious mental illness in light of the superb risk/benefit ratio for this drug class. In her younger patients, she turns for guidance to an online calculator of an individual’s 10-year risk of a first acute MI or stroke.
Metformin has been shown to be beneficial for addressing the weight gain and other adverse metabolic effects caused by antipsychotic agents, and there is some preliminary evidence of improved psychiatric outcomes in patients with serious mental illness.
Christian Otte, MD, who also spoke at the session, noted that not only do emerging data point to the possibility that cardiovascular drugs might have benefit in terms of psychiatric outcomes, there is also some evidence, albeit mixed, that the converse is true: that is, psychiatric drugs may have cardiovascular benefits. He pointed to a South Korean trial in which 300 patients with a recent acute coronary syndrome and major depression were randomized to 24 weeks of escitalopram or placebo. At median 8.1 years of follow-up, the group that received the SSRI had a 31% relative risk reduction in the primary composite endpoint of all-cause mortality, acute MI, or percutaneous coronary intervention (JAMA. 2018 Jul 24; 320[4]:350–7).
“Potentially independent of their antidepressant effects, some SSRIs’ antiplatelet effects could be beneficial for patients with coronary heart disease, although the jury is still open regarding this question, with evidence in both directions,” said Dr. Otte, professor of psychiatry at Charite University Medical Center in Berlin.
Dr. De Picker offered an example as well: Finnish psychiatrists recently reported that cardiovascular mortality was reduced by an adjusted 38% during periods when 62,250 Finnish schizophrenia patients were on antipsychotic agents, compared with periods of nonuse of the drugs in a national study with a median 14.1 years of follow-up (World Psychiatry. 2020 Feb;19[1]:61-8).
“What they discovered – and this is quite contrary to what we are used to hearing about antipsychotic medication and cardiovascular risk – is that while the number of cardiovascular hospitalizations was not different in periods with or without antipsychotic use, the cardiovascular mortality was quite strikingly reduced when patients were on antipsychotic medication,” she said.
Asked by an audience member whether she personally prescribes metformin, Dr. De Picker replied: “Well, yes, why not? One of the very nice things about metformin is that it is actually a very safe drug, even in the hands of nonspecialists.
“I understand that maybe psychiatrists may not feel very comfortable in starting patients on metformin due to a lack of experience. But there are really only two things you need to take into account. About one-quarter of patients will experience GI side effects – nausea, vomiting, abdominal discomfort – and this can be reduced by gradually uptitrating the dose, dosing at mealtime, and using an extended-release formulation. And the second thing is that metformin can impair vitamin B12 absorption, so I think, especially in psychiatric patients, it would be good to do an annual measurement of vitamin B12 level and, if necessary, administer intramuscular supplements,” Dr. De Picker said.
She reported having no financial conflicts regarding her presentation.
SOURCE: De Picker L. ECNP 2020. Session EDU.05.
One of the hottest topics now in psychiatry is the possibility of repurposing long-established cardiovascular medications for treatment of patients with serious mental illness, Livia De Picker, MD, PhD, said at the virtual congress of the European College of Neuropsychopharmacology.
The appeal is multifold. A huge unmet need exists in psychiatry for new and better treatments with novel mechanisms of action. Many guideline-recommended cardiovascular medications have a long track record, including a well-established safety profile with no surprises, and are available in generic versions. They can be developed for a new indication at minimal cost, noted Dr. De Picker, a psychiatrist at the University of Antwerp (Belgium).
The idea of psychiatric repurposing of drugs originally developed for nonpsychiatric indications is nothing new, she added. Examples include lithium for gout, valproate for epilepsy, and ketamine for anesthesiology.
One hitch in efforts to repurpose cardiovascular medications is that, when psychiatric patients have been included in randomized trials of the drugs’ cardiovascular effects, the psychiatric outcomes often went untallied.
Indeed, the only high-quality randomized trial evidence of psychiatric benefits for any class of cardiovascular medications is for statins, where a modest-sized meta-analysis of six placebo-controlled trials in 339 patients with schizophrenia showed the lipid-lowering agents had benefit for both positive and negative symptoms (Psychiatry Res. 2018 Apr;262:84-93). But that’s not a body of data of sufficient size to be definitive, in Dr. De Picker’s view.
Much of the recent enthusiasm for exploring the potential of cardiovascular drugs for psychiatric conditions comes from hypothesis-generating big data analyses drawn from Scandinavian national patient registries. Danish investigators scrutinized all 1.6 million Danes exposed to six classes of drugs of interest during 2005-2015 and determined that those on long-term statins, low-dose aspirin, ACE inhibitors, angiotensin receptor blockers, or allopurinol were associated with a decreased rate of new-onset depression, while high-dose aspirin and non-aspirin NSAIDs were associated with an increased rate, compared with a 30% random sample of the country’s population (Acta Psychiatr Scand. 2019 Jan;1391:68-77).
Similarly, the Danish group found that continued use of statins, angiotensin agents, or low-dose aspirin was associated with a decreased rate of new-onset bipolar disorder, while high-dose aspirin and other NSAIDs were linked to increased risk (Bipolar Disord. 2019 Aug;[15]:410-8). What these agents have in common, the investigators observed, is that they act on inflammation and potentially on the stress response system.
Meanwhile, Swedish investigators examined the course of 142,691 Swedes with a diagnosis of bipolar disorder, schizophrenia, or nonaffective psychosis during 2005-2016. They determined that, during periods when those individuals were on a statin, calcium channel blocker, or metformin, they had reduced rates of psychiatric hospitalization and self-harm (JAMA Psychiatry. 2019 Apr 1;76[4]:382-90).
Scottish researchers analyzed the health records of 144,066 patients placed on monotherapy for hypertension and determined that the lowest risk for hospitalization for a mood disorder during follow-up was in those prescribed an ACE inhibitor or angiotensin receptor blocker. The risk was significantly higher in patients on a beta-blocker or calcium channel blocker, and intermediate in those on a thiazide diuretic (Hypertension. 2016 Nov;68[5:1132-8).
“Obviously, this is all at a very macro scale and we have no idea whatsoever what this means for individual patients, number needed to treat, or which type of patients would benefit, but it does provide us with some guidance for future research,” according to Dr. De Picker.
In the meantime, while physicians await definitive evidence of any impact of cardiovascular drugs might have on psychiatric outcomes, abundant data exist underscoring what she called “shockingly high levels” of inadequate management of cardiovascular risk factors in patients with serious mental illness. That problem needs to be addressed, and Dr. De Picker offered her personal recommendations for doing so in a manner consistent with the evidence to date suggestive of potential mental health benefits of some cardiovascular medications.
She advised that, for treatment of hypertension in patients with bipolar disorder or major depression, an ACE inhibitor or angiotensin-converting enzyme inhibitor is preferred as first-line. There is some evidence to suggest lipophilic beta-blockers, which cross the blood-brain barrier, improve anxiety symptoms and panic attacks, and prevent memory consolidation in patients with posttraumatic stress disorder. But the Scottish data suggest that they may worsen mood disorders.
“I would be careful in using beta-blockers as first-line treatment for hypertension. They’re not in the guidelines for anxiety disorders. British guidelines recommend them to prevent memory consolidation in PTSD, but do not use them as first-line in patients with major depressive disorder or bipolar disorder,” she said. As for calcium channel blockers, the jury is still out, with mixed and inconsistent evidence to date as to the impact of this drug class on mental illness outcomes.
She recommended a very low threshold for prescribing statin therapy in patients with serious mental illness in light of the superb risk/benefit ratio for this drug class. In her younger patients, she turns for guidance to an online calculator of an individual’s 10-year risk of a first acute MI or stroke.
Metformin has been shown to be beneficial for addressing the weight gain and other adverse metabolic effects caused by antipsychotic agents, and there is some preliminary evidence of improved psychiatric outcomes in patients with serious mental illness.
Christian Otte, MD, who also spoke at the session, noted that not only do emerging data point to the possibility that cardiovascular drugs might have benefit in terms of psychiatric outcomes, there is also some evidence, albeit mixed, that the converse is true: that is, psychiatric drugs may have cardiovascular benefits. He pointed to a South Korean trial in which 300 patients with a recent acute coronary syndrome and major depression were randomized to 24 weeks of escitalopram or placebo. At median 8.1 years of follow-up, the group that received the SSRI had a 31% relative risk reduction in the primary composite endpoint of all-cause mortality, acute MI, or percutaneous coronary intervention (JAMA. 2018 Jul 24; 320[4]:350–7).
“Potentially independent of their antidepressant effects, some SSRIs’ antiplatelet effects could be beneficial for patients with coronary heart disease, although the jury is still open regarding this question, with evidence in both directions,” said Dr. Otte, professor of psychiatry at Charite University Medical Center in Berlin.
Dr. De Picker offered an example as well: Finnish psychiatrists recently reported that cardiovascular mortality was reduced by an adjusted 38% during periods when 62,250 Finnish schizophrenia patients were on antipsychotic agents, compared with periods of nonuse of the drugs in a national study with a median 14.1 years of follow-up (World Psychiatry. 2020 Feb;19[1]:61-8).
“What they discovered – and this is quite contrary to what we are used to hearing about antipsychotic medication and cardiovascular risk – is that while the number of cardiovascular hospitalizations was not different in periods with or without antipsychotic use, the cardiovascular mortality was quite strikingly reduced when patients were on antipsychotic medication,” she said.
Asked by an audience member whether she personally prescribes metformin, Dr. De Picker replied: “Well, yes, why not? One of the very nice things about metformin is that it is actually a very safe drug, even in the hands of nonspecialists.
“I understand that maybe psychiatrists may not feel very comfortable in starting patients on metformin due to a lack of experience. But there are really only two things you need to take into account. About one-quarter of patients will experience GI side effects – nausea, vomiting, abdominal discomfort – and this can be reduced by gradually uptitrating the dose, dosing at mealtime, and using an extended-release formulation. And the second thing is that metformin can impair vitamin B12 absorption, so I think, especially in psychiatric patients, it would be good to do an annual measurement of vitamin B12 level and, if necessary, administer intramuscular supplements,” Dr. De Picker said.
She reported having no financial conflicts regarding her presentation.
SOURCE: De Picker L. ECNP 2020. Session EDU.05.
One of the hottest topics now in psychiatry is the possibility of repurposing long-established cardiovascular medications for treatment of patients with serious mental illness, Livia De Picker, MD, PhD, said at the virtual congress of the European College of Neuropsychopharmacology.
The appeal is multifold. A huge unmet need exists in psychiatry for new and better treatments with novel mechanisms of action. Many guideline-recommended cardiovascular medications have a long track record, including a well-established safety profile with no surprises, and are available in generic versions. They can be developed for a new indication at minimal cost, noted Dr. De Picker, a psychiatrist at the University of Antwerp (Belgium).
The idea of psychiatric repurposing of drugs originally developed for nonpsychiatric indications is nothing new, she added. Examples include lithium for gout, valproate for epilepsy, and ketamine for anesthesiology.
One hitch in efforts to repurpose cardiovascular medications is that, when psychiatric patients have been included in randomized trials of the drugs’ cardiovascular effects, the psychiatric outcomes often went untallied.
Indeed, the only high-quality randomized trial evidence of psychiatric benefits for any class of cardiovascular medications is for statins, where a modest-sized meta-analysis of six placebo-controlled trials in 339 patients with schizophrenia showed the lipid-lowering agents had benefit for both positive and negative symptoms (Psychiatry Res. 2018 Apr;262:84-93). But that’s not a body of data of sufficient size to be definitive, in Dr. De Picker’s view.
Much of the recent enthusiasm for exploring the potential of cardiovascular drugs for psychiatric conditions comes from hypothesis-generating big data analyses drawn from Scandinavian national patient registries. Danish investigators scrutinized all 1.6 million Danes exposed to six classes of drugs of interest during 2005-2015 and determined that those on long-term statins, low-dose aspirin, ACE inhibitors, angiotensin receptor blockers, or allopurinol were associated with a decreased rate of new-onset depression, while high-dose aspirin and non-aspirin NSAIDs were associated with an increased rate, compared with a 30% random sample of the country’s population (Acta Psychiatr Scand. 2019 Jan;1391:68-77).
Similarly, the Danish group found that continued use of statins, angiotensin agents, or low-dose aspirin was associated with a decreased rate of new-onset bipolar disorder, while high-dose aspirin and other NSAIDs were linked to increased risk (Bipolar Disord. 2019 Aug;[15]:410-8). What these agents have in common, the investigators observed, is that they act on inflammation and potentially on the stress response system.
Meanwhile, Swedish investigators examined the course of 142,691 Swedes with a diagnosis of bipolar disorder, schizophrenia, or nonaffective psychosis during 2005-2016. They determined that, during periods when those individuals were on a statin, calcium channel blocker, or metformin, they had reduced rates of psychiatric hospitalization and self-harm (JAMA Psychiatry. 2019 Apr 1;76[4]:382-90).
Scottish researchers analyzed the health records of 144,066 patients placed on monotherapy for hypertension and determined that the lowest risk for hospitalization for a mood disorder during follow-up was in those prescribed an ACE inhibitor or angiotensin receptor blocker. The risk was significantly higher in patients on a beta-blocker or calcium channel blocker, and intermediate in those on a thiazide diuretic (Hypertension. 2016 Nov;68[5:1132-8).
“Obviously, this is all at a very macro scale and we have no idea whatsoever what this means for individual patients, number needed to treat, or which type of patients would benefit, but it does provide us with some guidance for future research,” according to Dr. De Picker.
In the meantime, while physicians await definitive evidence of any impact of cardiovascular drugs might have on psychiatric outcomes, abundant data exist underscoring what she called “shockingly high levels” of inadequate management of cardiovascular risk factors in patients with serious mental illness. That problem needs to be addressed, and Dr. De Picker offered her personal recommendations for doing so in a manner consistent with the evidence to date suggestive of potential mental health benefits of some cardiovascular medications.
She advised that, for treatment of hypertension in patients with bipolar disorder or major depression, an ACE inhibitor or angiotensin-converting enzyme inhibitor is preferred as first-line. There is some evidence to suggest lipophilic beta-blockers, which cross the blood-brain barrier, improve anxiety symptoms and panic attacks, and prevent memory consolidation in patients with posttraumatic stress disorder. But the Scottish data suggest that they may worsen mood disorders.
“I would be careful in using beta-blockers as first-line treatment for hypertension. They’re not in the guidelines for anxiety disorders. British guidelines recommend them to prevent memory consolidation in PTSD, but do not use them as first-line in patients with major depressive disorder or bipolar disorder,” she said. As for calcium channel blockers, the jury is still out, with mixed and inconsistent evidence to date as to the impact of this drug class on mental illness outcomes.
She recommended a very low threshold for prescribing statin therapy in patients with serious mental illness in light of the superb risk/benefit ratio for this drug class. In her younger patients, she turns for guidance to an online calculator of an individual’s 10-year risk of a first acute MI or stroke.
Metformin has been shown to be beneficial for addressing the weight gain and other adverse metabolic effects caused by antipsychotic agents, and there is some preliminary evidence of improved psychiatric outcomes in patients with serious mental illness.
Christian Otte, MD, who also spoke at the session, noted that not only do emerging data point to the possibility that cardiovascular drugs might have benefit in terms of psychiatric outcomes, there is also some evidence, albeit mixed, that the converse is true: that is, psychiatric drugs may have cardiovascular benefits. He pointed to a South Korean trial in which 300 patients with a recent acute coronary syndrome and major depression were randomized to 24 weeks of escitalopram or placebo. At median 8.1 years of follow-up, the group that received the SSRI had a 31% relative risk reduction in the primary composite endpoint of all-cause mortality, acute MI, or percutaneous coronary intervention (JAMA. 2018 Jul 24; 320[4]:350–7).
“Potentially independent of their antidepressant effects, some SSRIs’ antiplatelet effects could be beneficial for patients with coronary heart disease, although the jury is still open regarding this question, with evidence in both directions,” said Dr. Otte, professor of psychiatry at Charite University Medical Center in Berlin.
Dr. De Picker offered an example as well: Finnish psychiatrists recently reported that cardiovascular mortality was reduced by an adjusted 38% during periods when 62,250 Finnish schizophrenia patients were on antipsychotic agents, compared with periods of nonuse of the drugs in a national study with a median 14.1 years of follow-up (World Psychiatry. 2020 Feb;19[1]:61-8).
“What they discovered – and this is quite contrary to what we are used to hearing about antipsychotic medication and cardiovascular risk – is that while the number of cardiovascular hospitalizations was not different in periods with or without antipsychotic use, the cardiovascular mortality was quite strikingly reduced when patients were on antipsychotic medication,” she said.
Asked by an audience member whether she personally prescribes metformin, Dr. De Picker replied: “Well, yes, why not? One of the very nice things about metformin is that it is actually a very safe drug, even in the hands of nonspecialists.
“I understand that maybe psychiatrists may not feel very comfortable in starting patients on metformin due to a lack of experience. But there are really only two things you need to take into account. About one-quarter of patients will experience GI side effects – nausea, vomiting, abdominal discomfort – and this can be reduced by gradually uptitrating the dose, dosing at mealtime, and using an extended-release formulation. And the second thing is that metformin can impair vitamin B12 absorption, so I think, especially in psychiatric patients, it would be good to do an annual measurement of vitamin B12 level and, if necessary, administer intramuscular supplements,” Dr. De Picker said.
She reported having no financial conflicts regarding her presentation.
SOURCE: De Picker L. ECNP 2020. Session EDU.05.
FROM ECNP 2020
Teen affective disorders raise risk for midlife acute MI
in a Swedish national registry study presented at the virtual annual congress of the European Society of Cardiology.
The association was mediated in part by poor stress resilience and lack of physical fitness among these teenagers with an affective disorder, reported Cecilia Bergh, PhD, of Obrero (Sweden) University.
Her study was made possible by Sweden’s comprehensive national health care registries coupled with the Nordic nation’s compulsory conscription for military service. The mandatory conscription evaluation during the study years included a semistructured interview with a psychologist to assess stress resilience through questions about coping with everyday life, a medical history and physical examination, and a cardiovascular fitness test using a bicycle ergometer.
The study included 238,013 males born in 1952-1956. They were aged 18-19 years when they underwent their conscription examination, at which time 34,503 of them either received or already had a diagnosis of depression or anxiety. During follow-up from 1987 to 2010, a first acute MI occurred in 5,891 of the men. The risk was increased 51% among those with an earlier teen diagnosis of depression or anxiety.
In a Cox regression analysis adjusted for levels of adolescent cardiovascular risk factors, including blood pressure, body mass index, and systemic inflammation, as well as additional potential confounders, such as cognitive function, parental socioeconomic index, and a summary disease score, the midlife MI risk associated with adolescent depression or anxiety was attenuated, but still significant, with a 24% increase. Upon further statistical adjustment incorporating adolescent stress resilience and cardiovascular fitness, the increased risk of acute MI in midlife associated with adolescent depression or anxiety was further attenuated yet remained significant, at 18%.
Dr. Bergh shared her thoughts on preventing this increased risk of acute MI at a relatively young age: “Effective prevention might focus on behavior, lifestyle, and psychosocial stress in early life. If a healthy lifestyle is encouraged as early as possible in childhood and adolescence, it is more likely to persist into adulthood and to improve longterm health. So look for signs of stress, depression, or anxiety that is beyond normal teenager behavior and a persistent problem. Teenagers with poor well-being could benefit from additional support to encourage exercise and also to develop strategies to deal with stress.”
She reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Bergh C et al. ESC 2020, Abstract 90524.
in a Swedish national registry study presented at the virtual annual congress of the European Society of Cardiology.
The association was mediated in part by poor stress resilience and lack of physical fitness among these teenagers with an affective disorder, reported Cecilia Bergh, PhD, of Obrero (Sweden) University.
Her study was made possible by Sweden’s comprehensive national health care registries coupled with the Nordic nation’s compulsory conscription for military service. The mandatory conscription evaluation during the study years included a semistructured interview with a psychologist to assess stress resilience through questions about coping with everyday life, a medical history and physical examination, and a cardiovascular fitness test using a bicycle ergometer.
The study included 238,013 males born in 1952-1956. They were aged 18-19 years when they underwent their conscription examination, at which time 34,503 of them either received or already had a diagnosis of depression or anxiety. During follow-up from 1987 to 2010, a first acute MI occurred in 5,891 of the men. The risk was increased 51% among those with an earlier teen diagnosis of depression or anxiety.
In a Cox regression analysis adjusted for levels of adolescent cardiovascular risk factors, including blood pressure, body mass index, and systemic inflammation, as well as additional potential confounders, such as cognitive function, parental socioeconomic index, and a summary disease score, the midlife MI risk associated with adolescent depression or anxiety was attenuated, but still significant, with a 24% increase. Upon further statistical adjustment incorporating adolescent stress resilience and cardiovascular fitness, the increased risk of acute MI in midlife associated with adolescent depression or anxiety was further attenuated yet remained significant, at 18%.
Dr. Bergh shared her thoughts on preventing this increased risk of acute MI at a relatively young age: “Effective prevention might focus on behavior, lifestyle, and psychosocial stress in early life. If a healthy lifestyle is encouraged as early as possible in childhood and adolescence, it is more likely to persist into adulthood and to improve longterm health. So look for signs of stress, depression, or anxiety that is beyond normal teenager behavior and a persistent problem. Teenagers with poor well-being could benefit from additional support to encourage exercise and also to develop strategies to deal with stress.”
She reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Bergh C et al. ESC 2020, Abstract 90524.
in a Swedish national registry study presented at the virtual annual congress of the European Society of Cardiology.
The association was mediated in part by poor stress resilience and lack of physical fitness among these teenagers with an affective disorder, reported Cecilia Bergh, PhD, of Obrero (Sweden) University.
Her study was made possible by Sweden’s comprehensive national health care registries coupled with the Nordic nation’s compulsory conscription for military service. The mandatory conscription evaluation during the study years included a semistructured interview with a psychologist to assess stress resilience through questions about coping with everyday life, a medical history and physical examination, and a cardiovascular fitness test using a bicycle ergometer.
The study included 238,013 males born in 1952-1956. They were aged 18-19 years when they underwent their conscription examination, at which time 34,503 of them either received or already had a diagnosis of depression or anxiety. During follow-up from 1987 to 2010, a first acute MI occurred in 5,891 of the men. The risk was increased 51% among those with an earlier teen diagnosis of depression or anxiety.
In a Cox regression analysis adjusted for levels of adolescent cardiovascular risk factors, including blood pressure, body mass index, and systemic inflammation, as well as additional potential confounders, such as cognitive function, parental socioeconomic index, and a summary disease score, the midlife MI risk associated with adolescent depression or anxiety was attenuated, but still significant, with a 24% increase. Upon further statistical adjustment incorporating adolescent stress resilience and cardiovascular fitness, the increased risk of acute MI in midlife associated with adolescent depression or anxiety was further attenuated yet remained significant, at 18%.
Dr. Bergh shared her thoughts on preventing this increased risk of acute MI at a relatively young age: “Effective prevention might focus on behavior, lifestyle, and psychosocial stress in early life. If a healthy lifestyle is encouraged as early as possible in childhood and adolescence, it is more likely to persist into adulthood and to improve longterm health. So look for signs of stress, depression, or anxiety that is beyond normal teenager behavior and a persistent problem. Teenagers with poor well-being could benefit from additional support to encourage exercise and also to develop strategies to deal with stress.”
She reported having no financial conflicts regarding her study, conducted free of commercial support.
SOURCE: Bergh C et al. ESC 2020, Abstract 90524.
FROM ESC CONGRESS 2020
MI recurrences drop, but women underestimate disease risk
The number of heart attack survivors in the United States who experienced repeat attacks within a year decreased between 2008 and 2017, especially among women, yet women’s awareness of their risk of death from heart disease also decreased, according to data from a pair of studies published in Circulation.
Recurrent MI rates drop, but not enough
Although the overall morbidity and mortality from coronary heart disease (CHD) in the United States has been on the decline for decades, CHD remains the leading cause of death and disability in both sexes, wrote Sanne A.E. Peters, PhD, of Imperial College London, and colleagues.
To better assess the rates of recurrent CHD by sex, the researchers reviewed data from 770,408 women and 700,477 men younger than 65 years with commercial health insurance or aged 66 years and older with Medicare who were hospitalized for myocardial infarction between 2008 and 2017. The patients were followed for 1 year for recurrent MIs, recurrent CHD events, heart failure hospitalization, and all-cause mortality.
In the study of recurrent heart disease, the rate of recurrent heart attacks per 1,000 person-years declined from 89.2 to 72.3 in women and from 94.2 to 81.3 in men. In addition, the rate of recurrent heart disease events (defined as either an MI or an artery-opening procedure), dropped per 1,000 person-years from 166.3 to 133.3 in women and from 198.1 to 176.8 in men. The reduction was significantly greater among women compared with men (P < .001 for both recurrent MIs and recurrent CHD events) and the differences by sex were consistent throughout the study period.
However, no significant difference occurred in recurrent MI rates among younger women (aged 21-54 years), or men aged 55-79 years, the researchers noted.
Heart failure rates per 1,000 person-years decreased from 177.4 to 158.1 in women and from 162.9 to 156.1 in men during the study period, and all-cause mortality decreased per 1,000 person-years from 403.2 to 389.5 for women and from 436.1 to 417.9 in men.
Potential contributing factors to the reductions in rates of recurrent events after a heart attack may include improved acute cardiac procedures, in-hospital therapy, and secondary prevention, the researchers noted. In addition, “changes in the type and definition of MI may also have contributed to the decline in recurrent events,” they said. “Also, the introduction and increasing sensitivity of cardiac biomarkers assays, especially cardiac troponin, may have contributed to an increased detection of less severe MIs over time, which, in turn, could have resulted in artifactual reductions in the consequences of MI,” they said.
The study findings were limited by several factors including the use of claims data, lack of information on the severity of heart attacks, and inability to analyze population subgroups, but the results were strengthened by the use of a large, multicultural database.
Despite the decline seen in this study, overall rates of recurrent MI, recurrent CHD events, heart failure hospitalization, and mortality remain high, the researchers said, and the results “highlight the need for interventions to ensure men and women receive guideline recommended treatment to lower the risk for recurrent MI, recurrent CHD, heart failure, and mortality after hospital discharge for MI,” they concluded.
Many women don’t recognize heart disease risk
Although women showed a greater reduction in recurrent MI and recurrent CHD events compared with men, the awareness of heart disease as the No. 1 killer of women has declined, according to a special report from the American Heart Association.
Based on survey data from 2009, 65% of women were aware that heart disease was their leading cause of death (LCOD); by 2019 the number dropped to 44%. The 10-year decline occurred across all races and ethnicities, as well as ages, with the exception of women aged 65 years and older.
The American Heart Association has conducted national surveys since 1997 to monitor awareness of cardiovascular disease among U.S. women. Data from earlier surveys showed increased awareness of heart disease as LCOD and increased awareness of heart attack symptoms between 1997 and 2012, wrote Mary Cushman, MD, of the University of Vermont, Burlington, chair of the writing group for the statement, and colleagues.
However, overall awareness and knowledge of heart disease among women remains poor, they wrote.
“Awareness programs designed to educate the public about CVD among women in the United States include Go Red for Women by the American Heart Association; The Heart Truth by the National Heart, Lung, and Blood Institute; and Make the Call, Don’t Miss a Beat by the U.S. Department of Health and Human Services,” the researchers noted. To determine the change in awareness of heart disease as the LCOD among women, the researchers conducted a multivariate analysis of 1,158 women who completed the 2009 survey and 1,345 who completed the 2019 survey. The average age was 50 years; roughly 70% of the participants in the 2009 survey and 62% in the 2019 survey were non-Hispanic White.
The greatest declines in awareness of heart disease as LCOD occurred among Hispanics and non-Hispanic Blacks and among all respondents aged 25-34 years.
Awareness of heart disease as LCOD was 30% lower among women with high blood pressure compared with women overall, the researchers noted.
“In both surveys, higher educational attainment was strongly related to awareness that heart disease is the LCOD,” the researchers said. However, the results highlight the need for renewed efforts to educate younger women, Hispanic women, and non-Hispanic Black women, they emphasized. Unpublished data from the AHA survey showed that “younger women were less likely to report leading a heart-healthy lifestyle and were more likely to identify multiple barriers to leading a heart-healthy lifestyle, including lack of time, stress, and lack of confidence,” they wrote.
In addition, awareness of heart attack warning signs declined overall and within each ethnic group between 2009 and 2019.
The survey results were limited by several factors including the use of an online-only model that might limit generalizability to populations without online access, and was conducted only in English, the researchers wrote.
Heart disease needs new PR plan
The study of heart disease risk awareness among women was an important update to understand how well the message about women’s risk is getting out, said Martha Gulati, MD, president-elect of the American Society of Preventive Cardiology, in an interview.
The issue remains that heart disease is the No. 1 killer of women, and the decrease in awareness “means we need to amplify our message,” she said.
“I also question whether the symbol of the red dress [for women’s heart disease] is working, and it seems that now is the time to change this symbol,” she emphasized. “I wear a red dress pin on my lab coat and every day someone asks what it means, and no one recognizes it,” she said. “I think ‘Go Red for Women’ is great and part of our outward campaign, but our symbol needs to change to increase the connection and awareness in women,” she said.
What might be a better symbol? Simply, a heart, said Dr. Gulati. But “we need to study whatever is next to really connect with women and make them understand their risk for heart disease,” she added.
“Additionally, we really need to get to minority women,” she said. “We are lagging there, and the survey was conducted in English so it missed many people,” she noted.
Dr. Gulati said she was shocked at how much awareness of heart disease risk has fallen among women, even in those with risk factors such as hypertension, who were 30% less likely to be aware that heart disease remains their leading cause of death. “Younger women as well as very unaware; what this means to me is that our public education efforts need to be amplified,” Dr. Gulati said.
Barriers to educating women about heart disease risk include language and access to affordable screening, Dr. Gulati emphasized. “We need to ensure screening for heart disease is always included as a covered cost for a preventive service,” she said.
“Research needs to be done to identify what works toward educating women about cardiac risk. We need to identify a marketing tool to increase awareness in women. It might be something different for one race versus another,” Dr. Gulati said. “Our messaging needs to improve, but how we improve it needs more than just health care professionals,” she said.
Focus on prevention to reduce MI recurrence
“The study regarding recurrent events after MI is important because we really don’t know much about recurrent coronary heart disease after a MI over time,” said Dr. Gulati. These data can be helpful in managing surviving patients and understanding future risk, she said. “But I was surprised to see fewer recurrent events in women, as women still have more heart failure than men even if it has declined with time,” she noted.
Dr. Gulati questioned several aspects of the study and highlighted some of the limitations. “These are claims data, so do they accurately reflect the U.S. population?” she asked. “Remember, this is a study of people who survived a heart attack; those who didn’t survive aren’t included, and that group is more likely to be women, especially women younger than 55 years,” she said.
In addition, Dr. Gulati noted the lack of data on type of heart attack and on treatment adherence or referral to cardiac rehab, as well as lack of data on long-term medication adherence or follow-up care.
Prevention is the key take-home message from both studies, “whether we are talking primary prevention for the heart disease awareness study or secondary prevention for the recurrent heart attack study,” Dr. Gulati said.
The recurrent heart disease study was supported in part by Amgen and the University of Alabama at Birmingham. Lead author Dr. Peters disclosed support from a UK Medical Research Council Skills Development Fellowship with no financial conflicts. Dr. Cushman had no financial conflicts to disclose; several coauthors on the writing committee disclosed relationships with companies including Amarin and Boehringer Ingelheim. Dr. Gulati had no financial conflicts to disclose.
SOURCE: Peters SAE et al. Circulation. 2020 Sep 21. doi: 10.1161/CIRCULATIONAHA.120.047065; Cushman M et al. Circulation. 2020 Sep 21. doi: 10.1161/CIR.0000000000000907.
The number of heart attack survivors in the United States who experienced repeat attacks within a year decreased between 2008 and 2017, especially among women, yet women’s awareness of their risk of death from heart disease also decreased, according to data from a pair of studies published in Circulation.
Recurrent MI rates drop, but not enough
Although the overall morbidity and mortality from coronary heart disease (CHD) in the United States has been on the decline for decades, CHD remains the leading cause of death and disability in both sexes, wrote Sanne A.E. Peters, PhD, of Imperial College London, and colleagues.
To better assess the rates of recurrent CHD by sex, the researchers reviewed data from 770,408 women and 700,477 men younger than 65 years with commercial health insurance or aged 66 years and older with Medicare who were hospitalized for myocardial infarction between 2008 and 2017. The patients were followed for 1 year for recurrent MIs, recurrent CHD events, heart failure hospitalization, and all-cause mortality.
In the study of recurrent heart disease, the rate of recurrent heart attacks per 1,000 person-years declined from 89.2 to 72.3 in women and from 94.2 to 81.3 in men. In addition, the rate of recurrent heart disease events (defined as either an MI or an artery-opening procedure), dropped per 1,000 person-years from 166.3 to 133.3 in women and from 198.1 to 176.8 in men. The reduction was significantly greater among women compared with men (P < .001 for both recurrent MIs and recurrent CHD events) and the differences by sex were consistent throughout the study period.
However, no significant difference occurred in recurrent MI rates among younger women (aged 21-54 years), or men aged 55-79 years, the researchers noted.
Heart failure rates per 1,000 person-years decreased from 177.4 to 158.1 in women and from 162.9 to 156.1 in men during the study period, and all-cause mortality decreased per 1,000 person-years from 403.2 to 389.5 for women and from 436.1 to 417.9 in men.
Potential contributing factors to the reductions in rates of recurrent events after a heart attack may include improved acute cardiac procedures, in-hospital therapy, and secondary prevention, the researchers noted. In addition, “changes in the type and definition of MI may also have contributed to the decline in recurrent events,” they said. “Also, the introduction and increasing sensitivity of cardiac biomarkers assays, especially cardiac troponin, may have contributed to an increased detection of less severe MIs over time, which, in turn, could have resulted in artifactual reductions in the consequences of MI,” they said.
The study findings were limited by several factors including the use of claims data, lack of information on the severity of heart attacks, and inability to analyze population subgroups, but the results were strengthened by the use of a large, multicultural database.
Despite the decline seen in this study, overall rates of recurrent MI, recurrent CHD events, heart failure hospitalization, and mortality remain high, the researchers said, and the results “highlight the need for interventions to ensure men and women receive guideline recommended treatment to lower the risk for recurrent MI, recurrent CHD, heart failure, and mortality after hospital discharge for MI,” they concluded.
Many women don’t recognize heart disease risk
Although women showed a greater reduction in recurrent MI and recurrent CHD events compared with men, the awareness of heart disease as the No. 1 killer of women has declined, according to a special report from the American Heart Association.
Based on survey data from 2009, 65% of women were aware that heart disease was their leading cause of death (LCOD); by 2019 the number dropped to 44%. The 10-year decline occurred across all races and ethnicities, as well as ages, with the exception of women aged 65 years and older.
The American Heart Association has conducted national surveys since 1997 to monitor awareness of cardiovascular disease among U.S. women. Data from earlier surveys showed increased awareness of heart disease as LCOD and increased awareness of heart attack symptoms between 1997 and 2012, wrote Mary Cushman, MD, of the University of Vermont, Burlington, chair of the writing group for the statement, and colleagues.
However, overall awareness and knowledge of heart disease among women remains poor, they wrote.
“Awareness programs designed to educate the public about CVD among women in the United States include Go Red for Women by the American Heart Association; The Heart Truth by the National Heart, Lung, and Blood Institute; and Make the Call, Don’t Miss a Beat by the U.S. Department of Health and Human Services,” the researchers noted. To determine the change in awareness of heart disease as the LCOD among women, the researchers conducted a multivariate analysis of 1,158 women who completed the 2009 survey and 1,345 who completed the 2019 survey. The average age was 50 years; roughly 70% of the participants in the 2009 survey and 62% in the 2019 survey were non-Hispanic White.
The greatest declines in awareness of heart disease as LCOD occurred among Hispanics and non-Hispanic Blacks and among all respondents aged 25-34 years.
Awareness of heart disease as LCOD was 30% lower among women with high blood pressure compared with women overall, the researchers noted.
“In both surveys, higher educational attainment was strongly related to awareness that heart disease is the LCOD,” the researchers said. However, the results highlight the need for renewed efforts to educate younger women, Hispanic women, and non-Hispanic Black women, they emphasized. Unpublished data from the AHA survey showed that “younger women were less likely to report leading a heart-healthy lifestyle and were more likely to identify multiple barriers to leading a heart-healthy lifestyle, including lack of time, stress, and lack of confidence,” they wrote.
In addition, awareness of heart attack warning signs declined overall and within each ethnic group between 2009 and 2019.
The survey results were limited by several factors including the use of an online-only model that might limit generalizability to populations without online access, and was conducted only in English, the researchers wrote.
Heart disease needs new PR plan
The study of heart disease risk awareness among women was an important update to understand how well the message about women’s risk is getting out, said Martha Gulati, MD, president-elect of the American Society of Preventive Cardiology, in an interview.
The issue remains that heart disease is the No. 1 killer of women, and the decrease in awareness “means we need to amplify our message,” she said.
“I also question whether the symbol of the red dress [for women’s heart disease] is working, and it seems that now is the time to change this symbol,” she emphasized. “I wear a red dress pin on my lab coat and every day someone asks what it means, and no one recognizes it,” she said. “I think ‘Go Red for Women’ is great and part of our outward campaign, but our symbol needs to change to increase the connection and awareness in women,” she said.
What might be a better symbol? Simply, a heart, said Dr. Gulati. But “we need to study whatever is next to really connect with women and make them understand their risk for heart disease,” she added.
“Additionally, we really need to get to minority women,” she said. “We are lagging there, and the survey was conducted in English so it missed many people,” she noted.
Dr. Gulati said she was shocked at how much awareness of heart disease risk has fallen among women, even in those with risk factors such as hypertension, who were 30% less likely to be aware that heart disease remains their leading cause of death. “Younger women as well as very unaware; what this means to me is that our public education efforts need to be amplified,” Dr. Gulati said.
Barriers to educating women about heart disease risk include language and access to affordable screening, Dr. Gulati emphasized. “We need to ensure screening for heart disease is always included as a covered cost for a preventive service,” she said.
“Research needs to be done to identify what works toward educating women about cardiac risk. We need to identify a marketing tool to increase awareness in women. It might be something different for one race versus another,” Dr. Gulati said. “Our messaging needs to improve, but how we improve it needs more than just health care professionals,” she said.
Focus on prevention to reduce MI recurrence
“The study regarding recurrent events after MI is important because we really don’t know much about recurrent coronary heart disease after a MI over time,” said Dr. Gulati. These data can be helpful in managing surviving patients and understanding future risk, she said. “But I was surprised to see fewer recurrent events in women, as women still have more heart failure than men even if it has declined with time,” she noted.
Dr. Gulati questioned several aspects of the study and highlighted some of the limitations. “These are claims data, so do they accurately reflect the U.S. population?” she asked. “Remember, this is a study of people who survived a heart attack; those who didn’t survive aren’t included, and that group is more likely to be women, especially women younger than 55 years,” she said.
In addition, Dr. Gulati noted the lack of data on type of heart attack and on treatment adherence or referral to cardiac rehab, as well as lack of data on long-term medication adherence or follow-up care.
Prevention is the key take-home message from both studies, “whether we are talking primary prevention for the heart disease awareness study or secondary prevention for the recurrent heart attack study,” Dr. Gulati said.
The recurrent heart disease study was supported in part by Amgen and the University of Alabama at Birmingham. Lead author Dr. Peters disclosed support from a UK Medical Research Council Skills Development Fellowship with no financial conflicts. Dr. Cushman had no financial conflicts to disclose; several coauthors on the writing committee disclosed relationships with companies including Amarin and Boehringer Ingelheim. Dr. Gulati had no financial conflicts to disclose.
SOURCE: Peters SAE et al. Circulation. 2020 Sep 21. doi: 10.1161/CIRCULATIONAHA.120.047065; Cushman M et al. Circulation. 2020 Sep 21. doi: 10.1161/CIR.0000000000000907.
The number of heart attack survivors in the United States who experienced repeat attacks within a year decreased between 2008 and 2017, especially among women, yet women’s awareness of their risk of death from heart disease also decreased, according to data from a pair of studies published in Circulation.
Recurrent MI rates drop, but not enough
Although the overall morbidity and mortality from coronary heart disease (CHD) in the United States has been on the decline for decades, CHD remains the leading cause of death and disability in both sexes, wrote Sanne A.E. Peters, PhD, of Imperial College London, and colleagues.
To better assess the rates of recurrent CHD by sex, the researchers reviewed data from 770,408 women and 700,477 men younger than 65 years with commercial health insurance or aged 66 years and older with Medicare who were hospitalized for myocardial infarction between 2008 and 2017. The patients were followed for 1 year for recurrent MIs, recurrent CHD events, heart failure hospitalization, and all-cause mortality.
In the study of recurrent heart disease, the rate of recurrent heart attacks per 1,000 person-years declined from 89.2 to 72.3 in women and from 94.2 to 81.3 in men. In addition, the rate of recurrent heart disease events (defined as either an MI or an artery-opening procedure), dropped per 1,000 person-years from 166.3 to 133.3 in women and from 198.1 to 176.8 in men. The reduction was significantly greater among women compared with men (P < .001 for both recurrent MIs and recurrent CHD events) and the differences by sex were consistent throughout the study period.
However, no significant difference occurred in recurrent MI rates among younger women (aged 21-54 years), or men aged 55-79 years, the researchers noted.
Heart failure rates per 1,000 person-years decreased from 177.4 to 158.1 in women and from 162.9 to 156.1 in men during the study period, and all-cause mortality decreased per 1,000 person-years from 403.2 to 389.5 for women and from 436.1 to 417.9 in men.
Potential contributing factors to the reductions in rates of recurrent events after a heart attack may include improved acute cardiac procedures, in-hospital therapy, and secondary prevention, the researchers noted. In addition, “changes in the type and definition of MI may also have contributed to the decline in recurrent events,” they said. “Also, the introduction and increasing sensitivity of cardiac biomarkers assays, especially cardiac troponin, may have contributed to an increased detection of less severe MIs over time, which, in turn, could have resulted in artifactual reductions in the consequences of MI,” they said.
The study findings were limited by several factors including the use of claims data, lack of information on the severity of heart attacks, and inability to analyze population subgroups, but the results were strengthened by the use of a large, multicultural database.
Despite the decline seen in this study, overall rates of recurrent MI, recurrent CHD events, heart failure hospitalization, and mortality remain high, the researchers said, and the results “highlight the need for interventions to ensure men and women receive guideline recommended treatment to lower the risk for recurrent MI, recurrent CHD, heart failure, and mortality after hospital discharge for MI,” they concluded.
Many women don’t recognize heart disease risk
Although women showed a greater reduction in recurrent MI and recurrent CHD events compared with men, the awareness of heart disease as the No. 1 killer of women has declined, according to a special report from the American Heart Association.
Based on survey data from 2009, 65% of women were aware that heart disease was their leading cause of death (LCOD); by 2019 the number dropped to 44%. The 10-year decline occurred across all races and ethnicities, as well as ages, with the exception of women aged 65 years and older.
The American Heart Association has conducted national surveys since 1997 to monitor awareness of cardiovascular disease among U.S. women. Data from earlier surveys showed increased awareness of heart disease as LCOD and increased awareness of heart attack symptoms between 1997 and 2012, wrote Mary Cushman, MD, of the University of Vermont, Burlington, chair of the writing group for the statement, and colleagues.
However, overall awareness and knowledge of heart disease among women remains poor, they wrote.
“Awareness programs designed to educate the public about CVD among women in the United States include Go Red for Women by the American Heart Association; The Heart Truth by the National Heart, Lung, and Blood Institute; and Make the Call, Don’t Miss a Beat by the U.S. Department of Health and Human Services,” the researchers noted. To determine the change in awareness of heart disease as the LCOD among women, the researchers conducted a multivariate analysis of 1,158 women who completed the 2009 survey and 1,345 who completed the 2019 survey. The average age was 50 years; roughly 70% of the participants in the 2009 survey and 62% in the 2019 survey were non-Hispanic White.
The greatest declines in awareness of heart disease as LCOD occurred among Hispanics and non-Hispanic Blacks and among all respondents aged 25-34 years.
Awareness of heart disease as LCOD was 30% lower among women with high blood pressure compared with women overall, the researchers noted.
“In both surveys, higher educational attainment was strongly related to awareness that heart disease is the LCOD,” the researchers said. However, the results highlight the need for renewed efforts to educate younger women, Hispanic women, and non-Hispanic Black women, they emphasized. Unpublished data from the AHA survey showed that “younger women were less likely to report leading a heart-healthy lifestyle and were more likely to identify multiple barriers to leading a heart-healthy lifestyle, including lack of time, stress, and lack of confidence,” they wrote.
In addition, awareness of heart attack warning signs declined overall and within each ethnic group between 2009 and 2019.
The survey results were limited by several factors including the use of an online-only model that might limit generalizability to populations without online access, and was conducted only in English, the researchers wrote.
Heart disease needs new PR plan
The study of heart disease risk awareness among women was an important update to understand how well the message about women’s risk is getting out, said Martha Gulati, MD, president-elect of the American Society of Preventive Cardiology, in an interview.
The issue remains that heart disease is the No. 1 killer of women, and the decrease in awareness “means we need to amplify our message,” she said.
“I also question whether the symbol of the red dress [for women’s heart disease] is working, and it seems that now is the time to change this symbol,” she emphasized. “I wear a red dress pin on my lab coat and every day someone asks what it means, and no one recognizes it,” she said. “I think ‘Go Red for Women’ is great and part of our outward campaign, but our symbol needs to change to increase the connection and awareness in women,” she said.
What might be a better symbol? Simply, a heart, said Dr. Gulati. But “we need to study whatever is next to really connect with women and make them understand their risk for heart disease,” she added.
“Additionally, we really need to get to minority women,” she said. “We are lagging there, and the survey was conducted in English so it missed many people,” she noted.
Dr. Gulati said she was shocked at how much awareness of heart disease risk has fallen among women, even in those with risk factors such as hypertension, who were 30% less likely to be aware that heart disease remains their leading cause of death. “Younger women as well as very unaware; what this means to me is that our public education efforts need to be amplified,” Dr. Gulati said.
Barriers to educating women about heart disease risk include language and access to affordable screening, Dr. Gulati emphasized. “We need to ensure screening for heart disease is always included as a covered cost for a preventive service,” she said.
“Research needs to be done to identify what works toward educating women about cardiac risk. We need to identify a marketing tool to increase awareness in women. It might be something different for one race versus another,” Dr. Gulati said. “Our messaging needs to improve, but how we improve it needs more than just health care professionals,” she said.
Focus on prevention to reduce MI recurrence
“The study regarding recurrent events after MI is important because we really don’t know much about recurrent coronary heart disease after a MI over time,” said Dr. Gulati. These data can be helpful in managing surviving patients and understanding future risk, she said. “But I was surprised to see fewer recurrent events in women, as women still have more heart failure than men even if it has declined with time,” she noted.
Dr. Gulati questioned several aspects of the study and highlighted some of the limitations. “These are claims data, so do they accurately reflect the U.S. population?” she asked. “Remember, this is a study of people who survived a heart attack; those who didn’t survive aren’t included, and that group is more likely to be women, especially women younger than 55 years,” she said.
In addition, Dr. Gulati noted the lack of data on type of heart attack and on treatment adherence or referral to cardiac rehab, as well as lack of data on long-term medication adherence or follow-up care.
Prevention is the key take-home message from both studies, “whether we are talking primary prevention for the heart disease awareness study or secondary prevention for the recurrent heart attack study,” Dr. Gulati said.
The recurrent heart disease study was supported in part by Amgen and the University of Alabama at Birmingham. Lead author Dr. Peters disclosed support from a UK Medical Research Council Skills Development Fellowship with no financial conflicts. Dr. Cushman had no financial conflicts to disclose; several coauthors on the writing committee disclosed relationships with companies including Amarin and Boehringer Ingelheim. Dr. Gulati had no financial conflicts to disclose.
SOURCE: Peters SAE et al. Circulation. 2020 Sep 21. doi: 10.1161/CIRCULATIONAHA.120.047065; Cushman M et al. Circulation. 2020 Sep 21. doi: 10.1161/CIR.0000000000000907.
FROM CIRCULATION
Nationwide study questions routine long-term beta-blocker post MI
Current American and European guidelines recommending long-term beta-blocker therapy following an acute MI appear to be obsolete in the modern reperfusion era, suggests an analysis of Danish registry data.
Those guidelines are based on old randomized trials of beta-blocker therapy conducted prior to introduction of routine percutaneous coronary intervention and modern multidrug optimal medical therapy for acute MI. There have been no prospective controlled studies in the reperfusion era. And a new Danish national observational study strongly suggests it’s time to reexamine the beta-blocker recommendation, Anders Holt, MD, said at the virtual annual congress of the European Society of Cardiology.
“Stable, optimally treated MI patients do not seem to benefit from beta-blocker treatment exceeding 3 months post hospitalization – bearing in mind this doesn’t apply to patients with other indications for beta-blockers, like heart failure or atrial fibrillation,” said Dr. Holt of Copenhagen University Hospital.
His analysis of Danish national registry data on more than 30,000 patients hospitalized for acute MI during 2003-2018 earned him the annual ESC Young Investigator Award in Population Science.
“This was a crisp and clear presentation of a very creative use of observational epidemiology to try to understand the length of therapy that may or may not be appropriate,” commented award session cochair Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.
Dr. Holt reported on 30,177 patients optimally treated for a first MI in Danish hospitals during 2003-2018, none of whom had a prior indication or contraindication for beta-blocker therapy. “Optimally treated” meant they underwent percutaneous coronary revascularization and were discharged on a statin and aspirin. As a study requirement, all had to be stable 90 days post hospitalization, at which point 24,770 of the patients were on long-term beta-blocker therapy, and 5,407 (18%) were not. The two groups were comparable in terms of age, sex, comorbidities, and baseline medications. All patients were followed through the registries for a maximum of 3 years, the duration of beta-blocker therapy post MI recommended in American Heart Association/American College of Cardiology guidelines. (The Danish Society of Cardiology recommends 2 years.)
At 3 years post MI, there was no between-group difference in a composite outcome comprising cardiovascular death, recurrent MI, heart failure, stroke, angina, or a cardiac procedure, with a rate of 22.9% in the beta-blocker group and 21.6% in patients not on long-term beta-blocker therapy. The rate of recurrent MI was identical at 6.7% in both groups. Cardiovascular death occurred during 3 years of follow-up in 1.4% of patients on beta-blocker therapy and 1.7% who weren’t, a nonsignificant difference.
“We saw no evidence of any cardioprotective effect, but no increased risk of adverse events resulting in hospitalization, either,” Dr. Holt observed. “I would like to acknowledge that no evidence of effect does not necessarily equal evidence of no effect, but even if there was an effect we can with fair certainty say that it’s probably quite minimal.”
He noted that the Danish registry data indicates that each year since 2012 has shown a growing trend for Danish patients to dispense with long-term beta-blocker therapy after an acute MI.
“This might indicate we are nudging toward a change in practice, where more physicians are thinking that long-term beta-blocker therapy might not be indicated for all MI patients in the reperfusion era,” according to Dr. Holt.
Asked by the four-judge award panel about the possibility of unmeasured confounding in this observational study, Dr Holt responded: “I would be very cautious about asking patients to stop beta-blocker therapy after 3 months just based on this observational data. We can’t speak to causality in an observational study.” But he added that “well-designed observational studies provide valuable data regarding this topic and should not be ignored. They should possibly influence the guidelines and the designs for upcoming randomized trials.”
He conducted several supplementary analyses designed to address the possibility of unevenly distributed unmeasured confounding in the registry study. These analyses proved reassuring. A positive exposure control analysis compared 3-year outcomes in patients who remained on long-term statin therapy and those who didn’t. As expected, outcomes were significantly better in those who did: a 3-year composite outcome rate of 22.1%, compared with 32.1% in patients not on a statin; a cardiovascular death rate of 1.3% with and 2.1% without statin therapy; a recurrent MI rate of 6.6%, compared with 10.1% without a statin; and a 2.8% all-cause mortality with and 5.4% without statin therapy.
In contrast, all-cause mortality was unaffected by whether or not patients were on long-term beta-blocker therapy. And in a negative exposure outcome analysis, no association was found between beta-blocker therapy and the risk of hospitalization for pneumonia, as to be expected if the beta-blocker and no-beta-blocker groups were comparable in key respects.
Dr. Holt reported having no financial conflicts regarding his study.
Current American and European guidelines recommending long-term beta-blocker therapy following an acute MI appear to be obsolete in the modern reperfusion era, suggests an analysis of Danish registry data.
Those guidelines are based on old randomized trials of beta-blocker therapy conducted prior to introduction of routine percutaneous coronary intervention and modern multidrug optimal medical therapy for acute MI. There have been no prospective controlled studies in the reperfusion era. And a new Danish national observational study strongly suggests it’s time to reexamine the beta-blocker recommendation, Anders Holt, MD, said at the virtual annual congress of the European Society of Cardiology.
“Stable, optimally treated MI patients do not seem to benefit from beta-blocker treatment exceeding 3 months post hospitalization – bearing in mind this doesn’t apply to patients with other indications for beta-blockers, like heart failure or atrial fibrillation,” said Dr. Holt of Copenhagen University Hospital.
His analysis of Danish national registry data on more than 30,000 patients hospitalized for acute MI during 2003-2018 earned him the annual ESC Young Investigator Award in Population Science.
“This was a crisp and clear presentation of a very creative use of observational epidemiology to try to understand the length of therapy that may or may not be appropriate,” commented award session cochair Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.
Dr. Holt reported on 30,177 patients optimally treated for a first MI in Danish hospitals during 2003-2018, none of whom had a prior indication or contraindication for beta-blocker therapy. “Optimally treated” meant they underwent percutaneous coronary revascularization and were discharged on a statin and aspirin. As a study requirement, all had to be stable 90 days post hospitalization, at which point 24,770 of the patients were on long-term beta-blocker therapy, and 5,407 (18%) were not. The two groups were comparable in terms of age, sex, comorbidities, and baseline medications. All patients were followed through the registries for a maximum of 3 years, the duration of beta-blocker therapy post MI recommended in American Heart Association/American College of Cardiology guidelines. (The Danish Society of Cardiology recommends 2 years.)
At 3 years post MI, there was no between-group difference in a composite outcome comprising cardiovascular death, recurrent MI, heart failure, stroke, angina, or a cardiac procedure, with a rate of 22.9% in the beta-blocker group and 21.6% in patients not on long-term beta-blocker therapy. The rate of recurrent MI was identical at 6.7% in both groups. Cardiovascular death occurred during 3 years of follow-up in 1.4% of patients on beta-blocker therapy and 1.7% who weren’t, a nonsignificant difference.
“We saw no evidence of any cardioprotective effect, but no increased risk of adverse events resulting in hospitalization, either,” Dr. Holt observed. “I would like to acknowledge that no evidence of effect does not necessarily equal evidence of no effect, but even if there was an effect we can with fair certainty say that it’s probably quite minimal.”
He noted that the Danish registry data indicates that each year since 2012 has shown a growing trend for Danish patients to dispense with long-term beta-blocker therapy after an acute MI.
“This might indicate we are nudging toward a change in practice, where more physicians are thinking that long-term beta-blocker therapy might not be indicated for all MI patients in the reperfusion era,” according to Dr. Holt.
Asked by the four-judge award panel about the possibility of unmeasured confounding in this observational study, Dr Holt responded: “I would be very cautious about asking patients to stop beta-blocker therapy after 3 months just based on this observational data. We can’t speak to causality in an observational study.” But he added that “well-designed observational studies provide valuable data regarding this topic and should not be ignored. They should possibly influence the guidelines and the designs for upcoming randomized trials.”
He conducted several supplementary analyses designed to address the possibility of unevenly distributed unmeasured confounding in the registry study. These analyses proved reassuring. A positive exposure control analysis compared 3-year outcomes in patients who remained on long-term statin therapy and those who didn’t. As expected, outcomes were significantly better in those who did: a 3-year composite outcome rate of 22.1%, compared with 32.1% in patients not on a statin; a cardiovascular death rate of 1.3% with and 2.1% without statin therapy; a recurrent MI rate of 6.6%, compared with 10.1% without a statin; and a 2.8% all-cause mortality with and 5.4% without statin therapy.
In contrast, all-cause mortality was unaffected by whether or not patients were on long-term beta-blocker therapy. And in a negative exposure outcome analysis, no association was found between beta-blocker therapy and the risk of hospitalization for pneumonia, as to be expected if the beta-blocker and no-beta-blocker groups were comparable in key respects.
Dr. Holt reported having no financial conflicts regarding his study.
Current American and European guidelines recommending long-term beta-blocker therapy following an acute MI appear to be obsolete in the modern reperfusion era, suggests an analysis of Danish registry data.
Those guidelines are based on old randomized trials of beta-blocker therapy conducted prior to introduction of routine percutaneous coronary intervention and modern multidrug optimal medical therapy for acute MI. There have been no prospective controlled studies in the reperfusion era. And a new Danish national observational study strongly suggests it’s time to reexamine the beta-blocker recommendation, Anders Holt, MD, said at the virtual annual congress of the European Society of Cardiology.
“Stable, optimally treated MI patients do not seem to benefit from beta-blocker treatment exceeding 3 months post hospitalization – bearing in mind this doesn’t apply to patients with other indications for beta-blockers, like heart failure or atrial fibrillation,” said Dr. Holt of Copenhagen University Hospital.
His analysis of Danish national registry data on more than 30,000 patients hospitalized for acute MI during 2003-2018 earned him the annual ESC Young Investigator Award in Population Science.
“This was a crisp and clear presentation of a very creative use of observational epidemiology to try to understand the length of therapy that may or may not be appropriate,” commented award session cochair Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.
Dr. Holt reported on 30,177 patients optimally treated for a first MI in Danish hospitals during 2003-2018, none of whom had a prior indication or contraindication for beta-blocker therapy. “Optimally treated” meant they underwent percutaneous coronary revascularization and were discharged on a statin and aspirin. As a study requirement, all had to be stable 90 days post hospitalization, at which point 24,770 of the patients were on long-term beta-blocker therapy, and 5,407 (18%) were not. The two groups were comparable in terms of age, sex, comorbidities, and baseline medications. All patients were followed through the registries for a maximum of 3 years, the duration of beta-blocker therapy post MI recommended in American Heart Association/American College of Cardiology guidelines. (The Danish Society of Cardiology recommends 2 years.)
At 3 years post MI, there was no between-group difference in a composite outcome comprising cardiovascular death, recurrent MI, heart failure, stroke, angina, or a cardiac procedure, with a rate of 22.9% in the beta-blocker group and 21.6% in patients not on long-term beta-blocker therapy. The rate of recurrent MI was identical at 6.7% in both groups. Cardiovascular death occurred during 3 years of follow-up in 1.4% of patients on beta-blocker therapy and 1.7% who weren’t, a nonsignificant difference.
“We saw no evidence of any cardioprotective effect, but no increased risk of adverse events resulting in hospitalization, either,” Dr. Holt observed. “I would like to acknowledge that no evidence of effect does not necessarily equal evidence of no effect, but even if there was an effect we can with fair certainty say that it’s probably quite minimal.”
He noted that the Danish registry data indicates that each year since 2012 has shown a growing trend for Danish patients to dispense with long-term beta-blocker therapy after an acute MI.
“This might indicate we are nudging toward a change in practice, where more physicians are thinking that long-term beta-blocker therapy might not be indicated for all MI patients in the reperfusion era,” according to Dr. Holt.
Asked by the four-judge award panel about the possibility of unmeasured confounding in this observational study, Dr Holt responded: “I would be very cautious about asking patients to stop beta-blocker therapy after 3 months just based on this observational data. We can’t speak to causality in an observational study.” But he added that “well-designed observational studies provide valuable data regarding this topic and should not be ignored. They should possibly influence the guidelines and the designs for upcoming randomized trials.”
He conducted several supplementary analyses designed to address the possibility of unevenly distributed unmeasured confounding in the registry study. These analyses proved reassuring. A positive exposure control analysis compared 3-year outcomes in patients who remained on long-term statin therapy and those who didn’t. As expected, outcomes were significantly better in those who did: a 3-year composite outcome rate of 22.1%, compared with 32.1% in patients not on a statin; a cardiovascular death rate of 1.3% with and 2.1% without statin therapy; a recurrent MI rate of 6.6%, compared with 10.1% without a statin; and a 2.8% all-cause mortality with and 5.4% without statin therapy.
In contrast, all-cause mortality was unaffected by whether or not patients were on long-term beta-blocker therapy. And in a negative exposure outcome analysis, no association was found between beta-blocker therapy and the risk of hospitalization for pneumonia, as to be expected if the beta-blocker and no-beta-blocker groups were comparable in key respects.
Dr. Holt reported having no financial conflicts regarding his study.
FROM ESC CONGRESS 2020