User login
Single Antiplatelet After TAVR Lowers Risk
Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.
“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.
Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.
In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.
Balancing Risks and Benefits
The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.
A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.
Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.
Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.
By the Numbers
Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.
Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.
“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.
A version of this article first appeared on Medscape.com.
Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.
“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.
Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.
In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.
Balancing Risks and Benefits
The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.
A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.
Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.
Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.
By the Numbers
Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.
Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.
“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.
A version of this article first appeared on Medscape.com.
Patients who received a single antiplatelet drug therapy — usually aspirin — after transcatheter aortic valve replacement (TAVR) had about half the risk of dying in the subsequent 6 months compared with patients who received dual antiplatelet drug therapy. The findings were similar in men and women and in patients with and without coronary artery disease.
“This is one of the first demonstrations in real-world data that single antiplatelet therapy is not only associated with a lower risk of bleeding but also lower mortality,” said lead author Francesco Pelliccia, MD, PhD, a cardiologist at Sapienza University in Rome, Italy. Mortality rates for those who received dual antiplatelet therapy increased steadily during the 6 months after the procedure, he reported at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC.
Ischemic and major bleeding events were dramatically reduced in those receiving a single drug, according to a real-world study of 5514 patients undergoing TAVR at 20 centers. The centers participate in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry.
In the 6 months after the procedure, 2.4% of the 3197 patients who received a single antiplatelet drug died of any cause, as did 5.4% of 2317 patients who received two antiplatelet drugs (hazard ratio [HR], 1.65). Dual therapy was associated with a higher risk for death in both men (HR, 2.08) and women (HR, 1.53). Risk for death was also higher in patients with coronary artery disease (HR, 1.83) and without coronary artery disease (HR, 1.52). All results were statistically significant.
Balancing Risks and Benefits
The popularity of TAVR, which was introduced in 2002, has grown to the point that, in 2019, it surpassed the use of surgical aortic valve replacement. But the procedure is associated with an increased risk for both thrombosis and bleeding. Antiplatelet therapy with aspirin and clopidogrel helps prevent thrombosis but can increase the risk of bleeding. This has led to a debate about the best balance for antiplatelet therapy after TAVR with either single therapy — usually with aspirin — or dual therapy with both aspirin and clopidogrel.
A series of studies have addressed this problem. Dual therapy did not show any benefits over single therapy in terms of major adverse cardiac and cerebrovascular events in a 2011 small randomized study. A 2014 small randomized study also showed no benefit for morbidity or mortality from dual therapy. A larger 2017 randomized trial showed that single therapy reduced the risk for major or life-threatening events but did not increase the risk for myocardial infarction or stroke.
Bleeding and bleeding plus thromboembolic events were significantly lower with aspirin than with aspirin plus clopidogrel after a year’s follow-up in the 2020 POPular TAVI trial. Findings from three of these trials were pooled in a 2018 meta-analysis, which showed that dual therapy increased the risk for major adverse events after TAVR and did not prevent ischemic events any more than single therapy.
Based on this evidence, many centers changed their practice. And current European guidelines recommend a single antiplatelet drug for patients undergoing TAVR who do not have additional indications for oral anticoagulation therapy.
By the Numbers
Randomized trials are generally considered the best evidence for medical questions such as this one. “But randomized trials often do not reflect real-world reality. We have to look at what really happens,” Pelliccia said.
Retrospective data from registries can also provide large numbers of patients; in this case, TRITAVI provided data on thousands of patients rather than the hundreds examined in combined randomized trials.
“The results, for the first time, provide clinicians more information on how to treat their patients who are at high risk for bleeding and provide evidence that single antiplatelet therapy should be considered the standard of care in all patients undergoing TAVR,” Pelliccia said.
A version of this article first appeared on Medscape.com.
FROM SCAI 2025
Proteins in Plasma Linked to MI, Especially for Women
Forty-five circulating proteins in plasma are linked to the risk for myocardial infarction (MI), showed a new study that confirms some known associations and identifies new ones. Several proteins are associated with MI in women but not men, and some proteins linked with MI in both men and women are more strongly associated with MI in women.
“We hope that our study will shed light on pathways in MI,” said principal author Olga Titova, PhD, an epidemiologist at Uppsala University in Uppsala, Sweden. The work was published in the European Heart Journal.
Martha Gulati, MD, a cardiologist and associate director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles and coauthor of an accompanying editorial, said the novel discovery of different patterns between men and women makes this an exciting study. The findings “highlight that sex differences in disease phenotype begin at the molecular level,” she said.
Titova and her team analyzed thousands of patients in two databases — one in Sweden (11,751 patients), the other in the United Kingdom (51,613 patients) — to discover proteins in the patients who went on to have an MI. Using one database to discover biomarkers and a second to replicate the findings is a common approach, said Titova.
Casting a Wide Net to Catch Proteins
The two databases “make findings more generalizable, allow us to confirm robust associations, and help minimize the risk of false positives.” The two databases mean researchers are more confident that the findings can be applied across populations, Titova added.
A total of 44 proteins were associated with later MI in both databases, adjusted for common MI risk factors as well as such factors as education, diet, physical activity, and alcohol intake, Titova explained. An additional protein was included from the first database that was unavailable in the second. Some of the proteins have been found in other studies, and this study confirms the link. Others were new, and a few appear to protect patients from MI.
“Most of the proteins are related to or involved in inflammation and atherosclerosis,” said Titova.
This is the first study to cast such a wide net, Titova pointed out. While several proteins have previously been linked to MI, most earlier studies have focused on specific proteins in populations that already have coronary artery disease or have involved cohorts of men only.
But she stresses that this study poses more questions than it answers. More research is needed to determine how proteins are involved in pathways leading to MI. The study found that some proteins may be mediators of general cardiovascular disease risk, whereas others are involved in mechanisms specifically linked to MI. Many proteins are involved in atherosclerosis, thrombosis, inflammation, immune system–related pathways, injury and tissue repair, coagulation, bone homeostasis, and iron metabolism.
“At this point, some [proteins] appear to be causal, some seem to be an association,” said Titova. It remains to be determined “which are on the causal path, which are potential biomarkers, which are going to shed light on the mechanisms” of MI.
The study took a step toward determining which proteins might be involved in causing MI through an analysis of some protein levels determined by genetics. This found three proteins linked to a higher risk for MI and three linked to a lower risk.
It’s Different for Women
Thirteen of the proteins were linked with later MI in women, either exclusively or more strongly than in men. Many of these associations were replicated in the second database, showing an alignment across populations.
Titova said the reason for the sex difference remains a mystery. “We have to go to the molecular level. It could be a consequence of risk factors affecting the sexes differently or different biology” between men and women.
Gulati, who specializes in women’s heart health, explained, “We know inflammation is much more prevalent in women and is the pathway to cardiovascular disease.” She points out that noncardiac inflammatory diseases are also more prevalent in women. Other biomarkers for inflammation, such as C-reactive protein, are higher in women than in men. She thinks the underlying mechanisms could involve “how we [women] make our proteins and how we respond to hormones.”
By identifying proteins linked to MI in women, the study helps to fill an important gap in our knowledge. “I can’t tell you how many papers don’t even look at sex differences. If we don’t look, we won’t know there are differences,” Gulati said. “In much of our cardiac research, women are underrepresented.”
The findings of this trial and others like it may lead to new approaches to prevention and treatment, Titova and Gulati agreed. Several proteins found in this study that may have a causal link with MI are already targets of drug development, they added.
Titova said other proteins may be useful in the future as biomarkers that indicate a need for preventive action.
Gulati asked, “If we can show some of the proteins are involved in the inflammatory response — if they are causal and we can prevent them upfront — can we reduce the chance of MI?” She and Titova said the many questions remaining should prove a rewarding avenue for research.
A version of this article appeared on Medscape.com.
Forty-five circulating proteins in plasma are linked to the risk for myocardial infarction (MI), showed a new study that confirms some known associations and identifies new ones. Several proteins are associated with MI in women but not men, and some proteins linked with MI in both men and women are more strongly associated with MI in women.
“We hope that our study will shed light on pathways in MI,” said principal author Olga Titova, PhD, an epidemiologist at Uppsala University in Uppsala, Sweden. The work was published in the European Heart Journal.
Martha Gulati, MD, a cardiologist and associate director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles and coauthor of an accompanying editorial, said the novel discovery of different patterns between men and women makes this an exciting study. The findings “highlight that sex differences in disease phenotype begin at the molecular level,” she said.
Titova and her team analyzed thousands of patients in two databases — one in Sweden (11,751 patients), the other in the United Kingdom (51,613 patients) — to discover proteins in the patients who went on to have an MI. Using one database to discover biomarkers and a second to replicate the findings is a common approach, said Titova.
Casting a Wide Net to Catch Proteins
The two databases “make findings more generalizable, allow us to confirm robust associations, and help minimize the risk of false positives.” The two databases mean researchers are more confident that the findings can be applied across populations, Titova added.
A total of 44 proteins were associated with later MI in both databases, adjusted for common MI risk factors as well as such factors as education, diet, physical activity, and alcohol intake, Titova explained. An additional protein was included from the first database that was unavailable in the second. Some of the proteins have been found in other studies, and this study confirms the link. Others were new, and a few appear to protect patients from MI.
“Most of the proteins are related to or involved in inflammation and atherosclerosis,” said Titova.
This is the first study to cast such a wide net, Titova pointed out. While several proteins have previously been linked to MI, most earlier studies have focused on specific proteins in populations that already have coronary artery disease or have involved cohorts of men only.
But she stresses that this study poses more questions than it answers. More research is needed to determine how proteins are involved in pathways leading to MI. The study found that some proteins may be mediators of general cardiovascular disease risk, whereas others are involved in mechanisms specifically linked to MI. Many proteins are involved in atherosclerosis, thrombosis, inflammation, immune system–related pathways, injury and tissue repair, coagulation, bone homeostasis, and iron metabolism.
“At this point, some [proteins] appear to be causal, some seem to be an association,” said Titova. It remains to be determined “which are on the causal path, which are potential biomarkers, which are going to shed light on the mechanisms” of MI.
The study took a step toward determining which proteins might be involved in causing MI through an analysis of some protein levels determined by genetics. This found three proteins linked to a higher risk for MI and three linked to a lower risk.
It’s Different for Women
Thirteen of the proteins were linked with later MI in women, either exclusively or more strongly than in men. Many of these associations were replicated in the second database, showing an alignment across populations.
Titova said the reason for the sex difference remains a mystery. “We have to go to the molecular level. It could be a consequence of risk factors affecting the sexes differently or different biology” between men and women.
Gulati, who specializes in women’s heart health, explained, “We know inflammation is much more prevalent in women and is the pathway to cardiovascular disease.” She points out that noncardiac inflammatory diseases are also more prevalent in women. Other biomarkers for inflammation, such as C-reactive protein, are higher in women than in men. She thinks the underlying mechanisms could involve “how we [women] make our proteins and how we respond to hormones.”
By identifying proteins linked to MI in women, the study helps to fill an important gap in our knowledge. “I can’t tell you how many papers don’t even look at sex differences. If we don’t look, we won’t know there are differences,” Gulati said. “In much of our cardiac research, women are underrepresented.”
The findings of this trial and others like it may lead to new approaches to prevention and treatment, Titova and Gulati agreed. Several proteins found in this study that may have a causal link with MI are already targets of drug development, they added.
Titova said other proteins may be useful in the future as biomarkers that indicate a need for preventive action.
Gulati asked, “If we can show some of the proteins are involved in the inflammatory response — if they are causal and we can prevent them upfront — can we reduce the chance of MI?” She and Titova said the many questions remaining should prove a rewarding avenue for research.
A version of this article appeared on Medscape.com.
Forty-five circulating proteins in plasma are linked to the risk for myocardial infarction (MI), showed a new study that confirms some known associations and identifies new ones. Several proteins are associated with MI in women but not men, and some proteins linked with MI in both men and women are more strongly associated with MI in women.
“We hope that our study will shed light on pathways in MI,” said principal author Olga Titova, PhD, an epidemiologist at Uppsala University in Uppsala, Sweden. The work was published in the European Heart Journal.
Martha Gulati, MD, a cardiologist and associate director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles and coauthor of an accompanying editorial, said the novel discovery of different patterns between men and women makes this an exciting study. The findings “highlight that sex differences in disease phenotype begin at the molecular level,” she said.
Titova and her team analyzed thousands of patients in two databases — one in Sweden (11,751 patients), the other in the United Kingdom (51,613 patients) — to discover proteins in the patients who went on to have an MI. Using one database to discover biomarkers and a second to replicate the findings is a common approach, said Titova.
Casting a Wide Net to Catch Proteins
The two databases “make findings more generalizable, allow us to confirm robust associations, and help minimize the risk of false positives.” The two databases mean researchers are more confident that the findings can be applied across populations, Titova added.
A total of 44 proteins were associated with later MI in both databases, adjusted for common MI risk factors as well as such factors as education, diet, physical activity, and alcohol intake, Titova explained. An additional protein was included from the first database that was unavailable in the second. Some of the proteins have been found in other studies, and this study confirms the link. Others were new, and a few appear to protect patients from MI.
“Most of the proteins are related to or involved in inflammation and atherosclerosis,” said Titova.
This is the first study to cast such a wide net, Titova pointed out. While several proteins have previously been linked to MI, most earlier studies have focused on specific proteins in populations that already have coronary artery disease or have involved cohorts of men only.
But she stresses that this study poses more questions than it answers. More research is needed to determine how proteins are involved in pathways leading to MI. The study found that some proteins may be mediators of general cardiovascular disease risk, whereas others are involved in mechanisms specifically linked to MI. Many proteins are involved in atherosclerosis, thrombosis, inflammation, immune system–related pathways, injury and tissue repair, coagulation, bone homeostasis, and iron metabolism.
“At this point, some [proteins] appear to be causal, some seem to be an association,” said Titova. It remains to be determined “which are on the causal path, which are potential biomarkers, which are going to shed light on the mechanisms” of MI.
The study took a step toward determining which proteins might be involved in causing MI through an analysis of some protein levels determined by genetics. This found three proteins linked to a higher risk for MI and three linked to a lower risk.
It’s Different for Women
Thirteen of the proteins were linked with later MI in women, either exclusively or more strongly than in men. Many of these associations were replicated in the second database, showing an alignment across populations.
Titova said the reason for the sex difference remains a mystery. “We have to go to the molecular level. It could be a consequence of risk factors affecting the sexes differently or different biology” between men and women.
Gulati, who specializes in women’s heart health, explained, “We know inflammation is much more prevalent in women and is the pathway to cardiovascular disease.” She points out that noncardiac inflammatory diseases are also more prevalent in women. Other biomarkers for inflammation, such as C-reactive protein, are higher in women than in men. She thinks the underlying mechanisms could involve “how we [women] make our proteins and how we respond to hormones.”
By identifying proteins linked to MI in women, the study helps to fill an important gap in our knowledge. “I can’t tell you how many papers don’t even look at sex differences. If we don’t look, we won’t know there are differences,” Gulati said. “In much of our cardiac research, women are underrepresented.”
The findings of this trial and others like it may lead to new approaches to prevention and treatment, Titova and Gulati agreed. Several proteins found in this study that may have a causal link with MI are already targets of drug development, they added.
Titova said other proteins may be useful in the future as biomarkers that indicate a need for preventive action.
Gulati asked, “If we can show some of the proteins are involved in the inflammatory response — if they are causal and we can prevent them upfront — can we reduce the chance of MI?” She and Titova said the many questions remaining should prove a rewarding avenue for research.
A version of this article appeared on Medscape.com.
Just Minutes of Daily Vigorous Exercise Improve Heart Health
Middle-aged women who did many short bursts of vigorous-intensity exercise — amounting to as little as 3 min/d — had a 45% lower risk for major adverse cardiovascular events, reported investigators.
This doesn’t mean just a walk in the park, explained Emmanuel Stamatakis, PhD, a researcher with the University of Sydney in Australia. He said the activity can be as short as 20-30 seconds, but it must be high intensity — “movement that gets us out of breath, gets our heart rate up” — and repeated several times daily.
Stamatakis and colleagues call this type of exercise vigorous intermittent lifestyle physical activity, and it involves intense movement in very short bouts that are part of daily life, like a quick stair climb or running for a bus.
In their study, published in The British Journal of Sports Medicine, most exercise bursts were less than a minute, and few were over 2 minutes.
They are upending the common view that “any physical activity under 10 minutes doesn’t count for health,” said Stamatakis.
Bursts of Energy
The three studies looked at data for thousands of middle-aged men and women aged 40-69 years collected in the UK Biobank. Their daily activity was measured using accelerometers worn on the wrist for 7 days. This is preferable to survey data, which Stamatakis said is often unreliable.
The analysis looked at people who reported that they did not do any other exercise, taking no more than a single walk during the week. Then their cardiovascular health was tracked for almost 8 years.
Previous studies of the same data have shown benefits of vigorous physical activity for risk for cancer and for risk for death, both overall and due to cardiovascular disease or cancer.
In this study, women who did even less than 2 minutes of vigorous physical activity a day but no other exercise had a lower risk for all major cardiovascular events and for heart attack and heart failure. Women who did the median daily vigorous exercise time — 3.4 minutes — had an even lower risk. In fact, in women, there was a direct relationship between daily exercise time and risk reduction.
In men, the study showed some benefit of vigorous physical activity, but the relationship was not as clear, said Stamatakis. “The effects were much subtler and, in most cases, did not reach statistical significance.”
Good News for Women
Stamatakis said it is unclear why there was such a gap in the benefits between men and women. “Studies like ours are not designed to explain the difference,” he added.
“This study does not show that [vigorous physical activity] is effective in women but not men,” said Yasina Somani, PhD, an exercise physiology researcher at the University of Leeds in England, who was not involved in the work. Because the study just observed people’s behavior, rather than studying people in controlled conditions such as a lab, she said you cannot reach conclusions about the benefits for men. “You still need some further research.”
Somani pointed out that a study like this one cannot determine how vigorous physical activity protects the heart. In her research, she has studied the ways that exercise exerts effects on the heart. Exercise stresses the cardiovascular system, leading to physiological adaptation, and this may differ between men and women.
“Seeing this article motivates me to understand why women are responding even more than men. Do men need a greater volume of this exercise? If you’re carrying a 10-pound grocery bag up a flight of stairs, who is getting the greater stimulus?”
In fact, the study researchers think women’s exercise bursts might simply be harder for them. For some of the sample, the researchers had data on maximal oxygen consumption (VO2 max), a measure of cardiovascular fitness. During vigorous physical activity bouts, this measure showed that the effort for women averaged 83.2% of VO2 max, whereas it was 70.5% for men.
Somani said, “For men, there needs to be more clarity and more understanding of what it is that provides that stimulus — the intensity, the mode of exercise.”
“People are very surprised that 20-30 seconds of high-intensity exercise several times a day can make a difference to their health,” said Stamatakis. “They think they need to do structured exercise,” such as at a gym, to benefit.
He said the message that even quick exercise hits are beneficial can help healthcare professionals foster preventive behavior. “Any health professional who deals with patients on a regular basis knows that physical activity is important for people’s overall well-being and prevention of chronic disease.” The difficulty is that many people cannot or simply do not exercise. “Some people cannot afford it, and some do not have the motivation to stick to a structured exercise program.”
But anyone can do vigorous physical activity, he said. “The entry level is very low. There are no special preparations, no special clothes, no money to spend, no time commitment. You are interspersing exercise across your day.”
The researchers are currently studying how to foster vigorous physical activity in everyday behavior. “We are codesigning programs with participants, engaging with middle-aged people who have never exercised, so that the program has the highest chance to be successful.” Stamatakis is looking at encouraging vigorous physical activity through wearable devices and coaching, including online options.
Somani said the study adds weight to the message that any exercise is worthwhile. “These are simple choices that you can make that don’t require engaging in more structured exercise. Whatever you can do — little things outside of a gym — can have a lot of benefit for you.”
A version of this article first appeared on Medscape.com.
Middle-aged women who did many short bursts of vigorous-intensity exercise — amounting to as little as 3 min/d — had a 45% lower risk for major adverse cardiovascular events, reported investigators.
This doesn’t mean just a walk in the park, explained Emmanuel Stamatakis, PhD, a researcher with the University of Sydney in Australia. He said the activity can be as short as 20-30 seconds, but it must be high intensity — “movement that gets us out of breath, gets our heart rate up” — and repeated several times daily.
Stamatakis and colleagues call this type of exercise vigorous intermittent lifestyle physical activity, and it involves intense movement in very short bouts that are part of daily life, like a quick stair climb or running for a bus.
In their study, published in The British Journal of Sports Medicine, most exercise bursts were less than a minute, and few were over 2 minutes.
They are upending the common view that “any physical activity under 10 minutes doesn’t count for health,” said Stamatakis.
Bursts of Energy
The three studies looked at data for thousands of middle-aged men and women aged 40-69 years collected in the UK Biobank. Their daily activity was measured using accelerometers worn on the wrist for 7 days. This is preferable to survey data, which Stamatakis said is often unreliable.
The analysis looked at people who reported that they did not do any other exercise, taking no more than a single walk during the week. Then their cardiovascular health was tracked for almost 8 years.
Previous studies of the same data have shown benefits of vigorous physical activity for risk for cancer and for risk for death, both overall and due to cardiovascular disease or cancer.
In this study, women who did even less than 2 minutes of vigorous physical activity a day but no other exercise had a lower risk for all major cardiovascular events and for heart attack and heart failure. Women who did the median daily vigorous exercise time — 3.4 minutes — had an even lower risk. In fact, in women, there was a direct relationship between daily exercise time and risk reduction.
In men, the study showed some benefit of vigorous physical activity, but the relationship was not as clear, said Stamatakis. “The effects were much subtler and, in most cases, did not reach statistical significance.”
Good News for Women
Stamatakis said it is unclear why there was such a gap in the benefits between men and women. “Studies like ours are not designed to explain the difference,” he added.
“This study does not show that [vigorous physical activity] is effective in women but not men,” said Yasina Somani, PhD, an exercise physiology researcher at the University of Leeds in England, who was not involved in the work. Because the study just observed people’s behavior, rather than studying people in controlled conditions such as a lab, she said you cannot reach conclusions about the benefits for men. “You still need some further research.”
Somani pointed out that a study like this one cannot determine how vigorous physical activity protects the heart. In her research, she has studied the ways that exercise exerts effects on the heart. Exercise stresses the cardiovascular system, leading to physiological adaptation, and this may differ between men and women.
“Seeing this article motivates me to understand why women are responding even more than men. Do men need a greater volume of this exercise? If you’re carrying a 10-pound grocery bag up a flight of stairs, who is getting the greater stimulus?”
In fact, the study researchers think women’s exercise bursts might simply be harder for them. For some of the sample, the researchers had data on maximal oxygen consumption (VO2 max), a measure of cardiovascular fitness. During vigorous physical activity bouts, this measure showed that the effort for women averaged 83.2% of VO2 max, whereas it was 70.5% for men.
Somani said, “For men, there needs to be more clarity and more understanding of what it is that provides that stimulus — the intensity, the mode of exercise.”
“People are very surprised that 20-30 seconds of high-intensity exercise several times a day can make a difference to their health,” said Stamatakis. “They think they need to do structured exercise,” such as at a gym, to benefit.
He said the message that even quick exercise hits are beneficial can help healthcare professionals foster preventive behavior. “Any health professional who deals with patients on a regular basis knows that physical activity is important for people’s overall well-being and prevention of chronic disease.” The difficulty is that many people cannot or simply do not exercise. “Some people cannot afford it, and some do not have the motivation to stick to a structured exercise program.”
But anyone can do vigorous physical activity, he said. “The entry level is very low. There are no special preparations, no special clothes, no money to spend, no time commitment. You are interspersing exercise across your day.”
The researchers are currently studying how to foster vigorous physical activity in everyday behavior. “We are codesigning programs with participants, engaging with middle-aged people who have never exercised, so that the program has the highest chance to be successful.” Stamatakis is looking at encouraging vigorous physical activity through wearable devices and coaching, including online options.
Somani said the study adds weight to the message that any exercise is worthwhile. “These are simple choices that you can make that don’t require engaging in more structured exercise. Whatever you can do — little things outside of a gym — can have a lot of benefit for you.”
A version of this article first appeared on Medscape.com.
Middle-aged women who did many short bursts of vigorous-intensity exercise — amounting to as little as 3 min/d — had a 45% lower risk for major adverse cardiovascular events, reported investigators.
This doesn’t mean just a walk in the park, explained Emmanuel Stamatakis, PhD, a researcher with the University of Sydney in Australia. He said the activity can be as short as 20-30 seconds, but it must be high intensity — “movement that gets us out of breath, gets our heart rate up” — and repeated several times daily.
Stamatakis and colleagues call this type of exercise vigorous intermittent lifestyle physical activity, and it involves intense movement in very short bouts that are part of daily life, like a quick stair climb or running for a bus.
In their study, published in The British Journal of Sports Medicine, most exercise bursts were less than a minute, and few were over 2 minutes.
They are upending the common view that “any physical activity under 10 minutes doesn’t count for health,” said Stamatakis.
Bursts of Energy
The three studies looked at data for thousands of middle-aged men and women aged 40-69 years collected in the UK Biobank. Their daily activity was measured using accelerometers worn on the wrist for 7 days. This is preferable to survey data, which Stamatakis said is often unreliable.
The analysis looked at people who reported that they did not do any other exercise, taking no more than a single walk during the week. Then their cardiovascular health was tracked for almost 8 years.
Previous studies of the same data have shown benefits of vigorous physical activity for risk for cancer and for risk for death, both overall and due to cardiovascular disease or cancer.
In this study, women who did even less than 2 minutes of vigorous physical activity a day but no other exercise had a lower risk for all major cardiovascular events and for heart attack and heart failure. Women who did the median daily vigorous exercise time — 3.4 minutes — had an even lower risk. In fact, in women, there was a direct relationship between daily exercise time and risk reduction.
In men, the study showed some benefit of vigorous physical activity, but the relationship was not as clear, said Stamatakis. “The effects were much subtler and, in most cases, did not reach statistical significance.”
Good News for Women
Stamatakis said it is unclear why there was such a gap in the benefits between men and women. “Studies like ours are not designed to explain the difference,” he added.
“This study does not show that [vigorous physical activity] is effective in women but not men,” said Yasina Somani, PhD, an exercise physiology researcher at the University of Leeds in England, who was not involved in the work. Because the study just observed people’s behavior, rather than studying people in controlled conditions such as a lab, she said you cannot reach conclusions about the benefits for men. “You still need some further research.”
Somani pointed out that a study like this one cannot determine how vigorous physical activity protects the heart. In her research, she has studied the ways that exercise exerts effects on the heart. Exercise stresses the cardiovascular system, leading to physiological adaptation, and this may differ between men and women.
“Seeing this article motivates me to understand why women are responding even more than men. Do men need a greater volume of this exercise? If you’re carrying a 10-pound grocery bag up a flight of stairs, who is getting the greater stimulus?”
In fact, the study researchers think women’s exercise bursts might simply be harder for them. For some of the sample, the researchers had data on maximal oxygen consumption (VO2 max), a measure of cardiovascular fitness. During vigorous physical activity bouts, this measure showed that the effort for women averaged 83.2% of VO2 max, whereas it was 70.5% for men.
Somani said, “For men, there needs to be more clarity and more understanding of what it is that provides that stimulus — the intensity, the mode of exercise.”
“People are very surprised that 20-30 seconds of high-intensity exercise several times a day can make a difference to their health,” said Stamatakis. “They think they need to do structured exercise,” such as at a gym, to benefit.
He said the message that even quick exercise hits are beneficial can help healthcare professionals foster preventive behavior. “Any health professional who deals with patients on a regular basis knows that physical activity is important for people’s overall well-being and prevention of chronic disease.” The difficulty is that many people cannot or simply do not exercise. “Some people cannot afford it, and some do not have the motivation to stick to a structured exercise program.”
But anyone can do vigorous physical activity, he said. “The entry level is very low. There are no special preparations, no special clothes, no money to spend, no time commitment. You are interspersing exercise across your day.”
The researchers are currently studying how to foster vigorous physical activity in everyday behavior. “We are codesigning programs with participants, engaging with middle-aged people who have never exercised, so that the program has the highest chance to be successful.” Stamatakis is looking at encouraging vigorous physical activity through wearable devices and coaching, including online options.
Somani said the study adds weight to the message that any exercise is worthwhile. “These are simple choices that you can make that don’t require engaging in more structured exercise. Whatever you can do — little things outside of a gym — can have a lot of benefit for you.”
A version of this article first appeared on Medscape.com.
FROM THE BRITISH JOURNAL OF SPORTS MEDICINE
New Evidence That Plaque Buildup Shouldn’t Be Ignored
Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.
The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”
Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.
Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.
“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.
David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”
“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
Predicting Risk Early
The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.
Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.
Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”
Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
3D Vascular Ultrasound vs Coronary Artery Calcium
While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.
For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.
But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.
Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.
3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
Progression Increases Risk
Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further.
The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.
Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”
He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
A version of this article appeared on Medscape.com.
Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.
The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”
Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.
Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.
“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.
David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”
“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
Predicting Risk Early
The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.
Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.
Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”
Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
3D Vascular Ultrasound vs Coronary Artery Calcium
While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.
For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.
But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.
Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.
3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
Progression Increases Risk
Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further.
The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.
Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”
He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
A version of this article appeared on Medscape.com.
Subclinical disease detected on imaging predicts death, report investigators who show that plaque burden found on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.
The work not only highlights the importance of early detection, but it also has clinical implications, said Valentin Fuster, MD, president of the Mount Sinai Fuster Heart Hospital in New York. “It’s going to change things,” he said. “What I believe is going to happen is that we will begin to evaluate people with risk factors at age 30 using imaging. Today, we evaluate people at age 50 using clinical practice guidelines.”
Fuster’s team developed 3D vascular ultrasound to assess plaque burden and applied it in a prospective cohort study known as BioImage. The researchers assessed 6102 patients in Chicago, Illinois, and Fort Lauderdale, Florida, using 3D vascular ultrasound of the carotid artery and another well-established modality — coronary artery calcium, determined by CT.
Participants had no cardiovascular symptoms, yet their plaque burden and calcium scores at the beginning of the study were significantly associated with death during the 15 years of follow-up, even after taking risk factors and medication into account. The results are published in the Journal of the American College of Cardiology.
“Now, there is no question that subclinical disease on imaging predicts mortality,” said Fuster.
David J. Maron, MD, a preventive cardiologist at the Stanford University School of Medicine in California, calls the finding “very important.”
“The presence of atherosclerosis is powerful knowledge to guide the intensity of therapy and to motivate patients and clinicians to treat it,” said Maron, who is the co-author of an accompanying editorial and was not involved in the study.
Predicting Risk Early
The research also showed that the risk for death increases if the burden of plaque in the carotid artery increases over time. Both plaque burden shown on 3D vascular ultrasound and coronary artery calcium on CT were better predictors of death than traditional risk factors.
Maron says recent studies of younger populations, such as Progression of Early Subclinical Atherosclerosis (PESA) and Coronary Artery Risk Development in Young Adults (CARDIA), show that “risk factors at a young age have much more impact on arterial disease than when we measure risk factors at older age.” The CARDIA study showed signs of atherosclerosis in patients as young as in their twenties. This paradigm shift to early detection will now be possible thanks to technological advances like 3D vascular ultrasound.
Maron said he agrees with screening earlier in life. “The risk of having an event is related to the plaque burden and the number of years that a patient has been exposed to that burden. The earlier in life we can identify the burden to slow, arrest, or even reverse the plaque, the better.”
Maron points out that the study looked at an older population and did not include information on cause of death. While a study of younger people and data on cardiac causes of death would be useful, he says the study’s conclusions remain significant.
3D Vascular Ultrasound vs Coronary Artery Calcium
While both imaging methods in the study predicted death better than cardiovascular risk factors alone, each option has advantages.
For coronary artery calcium, “there’s a huge amount of literature demonstrating the association with cardiovascular events, there’s a standardized scoring system, there are widespread facilities for computed tomography, and there is not a lot of variability in the measurement — it’s not dependent on the operator,” said Maron.
But there is one drawback. The scoring system –— the Agatston score — can paradoxically go up following aggressive lowering of low-density lipoprotein cholesterol. “Once coronary calcium is present, it is challenging to interpret a repeat scan because we don’t know if the increase in score is due to progression or increasing density of the calcium, which is a sign of healing,” said Maron.
Vascular ultrasound avoids this problem and can also identify early noncalcified plaques and monitor their progression before they would appear on CT. Furthermore, the imaging does not add to lifetime radiation dose, as CT does, Fuster said.
3D ultrasound technology will soon be available in an inexpensive, automated, and easy-to-use format, he explains. Fuster envisions a scenario in which a nurse in a low-income country, using a cell phone app, will be able to assess atherosclerosis in a patient’s femoral artery. “In less than 1 hour, we can predict disease much more rigorously than with risk factors alone,” he said. “I think this is very exciting.”
Progression Increases Risk
Finding any atherosclerosis means an increased risk for death, but a greater burden or amount of atherosclerosis increases that risk, said Fuster. Progression of atherosclerosis increases risk even further.
The study looked at changes in atherosclerosis burden on vascular ultrasound in a subset of 732 patients a median of 8.9 years after their first test. Those with progression had a higher risk for death than those with regression or no atherosclerosis. “Progression is much more significant in predicting mortality than atherosclerosis findings alone,” Fuster said.
Maron said this finding points to “two great values from noninvasive imaging of atherosclerosis.” Not only does imaging detect atherosclerosis, but it can also characterize the burden and any calcification. Further, it allows doctors to monitor the response to interventions such as lifestyle changes and medical therapy. “Serial imaging of plaque burden will really enhance the management of atherosclerosis,” said Maron. “If we discover that someone is progressing rapidly, we can intensify therapy.”
He says imaging results also provide needed motivation for both clinicians and patients to take action that would prevent the deaths that result from atherosclerosis.
A version of this article appeared on Medscape.com.
Trial of Impella Heart Pump Stopped
An international trial of the Impella heart pump in patients with ST elevation myocardial infarction (STEMI) and cardiogenic shock has been stopped by the sponsor, Abiomed Inc. The termination followed news that another international trial, DanGer Shock, found that the pump improved survival in these patients.
“I was convinced that the study could not continue,” one of the principal investigators William O’Neill, MD, an interventional cardiologist with the Henry Ford Health in Detroit, said in an interview. After 3.5 years of work and thousands of person-hours, he added, “It’s not a decision that people took lightly.”
The trial already had three sites in Europe and one in the United States up and running, with two more US sites slated to join the trial. It had started enrolling patients, although few to date.
DanGer Shock trial results were expected to have a serious effect on how RECOVER IV would unfold. It was previously uncertain whether the Impella heart pump would save lives vs existing approaches, said O’Neill and co-principal investigator Navin Kapur, MD, an interventional cardiologist at Tufts Medical Center in Boston. Once the DanGer Shock trial showed the benefits of using the heart pump, that equipoise vanished.
Loss of Clinical Equipoise
“The clinicians were challenged in getting consent from patients where they had to say, ‘If you are randomized to the control arm, we are not able to use an Impella,’ ” said Dr. Kapur. He pointed out that patients would be unlikely to agree to participate in a trial where they might not get the treatment already shown to improve survival.
Dr. Kapur and Dr. O’Neill said the clinicians participating in the trial expressed discomfort at continuing. The RECOVER IV trial was expected to take many years to enroll the targeted number of patients. To participate, hospitals had to have the equipment and expertise to use the Impella heart pump, as well as the control treatments — balloon-pump support and extracorporeal membrane oxygenation (ECMO), Dr. Kapur explained. He said most patients with STEMI and cardiogenic shock would present to their nearest community hospitals, many of which would not have these treatments and would be unable to participate in the study.
Patients with STEMI and cardiogenic shock are uncommon. About 80,000 patients in the United States each year present with cardiogenic shock, of whom about 40% are not experiencing a STEMI, said Dr. O’Neill.
But those who do fit into the population of both STEMI and cardiogenic shock are at very high risk, said Dr. Kapur. “One in three or one in two patients with STEMI and cardiogenic shock will die in hospital.”
Getting Hearts Pumping
The Impella heart pump was originally developed by Impella Cardiosystems in Aachen, Germany, which was acquired by Abiomed in 2005, according to the Abiomed website. And Abiomed was acquired by Johnson & Johnson MedTech in 2022. The company has developed a series of models over the years and said that Impella CP — the model used in DanGer Shock and RECOVER IV trials — is the world’s smallest heart pump.
“Impella is the only heart pump that can be introduced percutaneously through the leg,” said Dr. O’Neill, whereas other pumps available are used only in open-heart surgery. While Impella is the first pump to be used this way, he said it won’t be the last. Other, more powerful pumps are being developed.
DanGer Shock: A Leap Forward
Despite leading to the halt of another trial, the DanGer Shock results are a good news story, said the RECOVER IV investigators.
“The DanGer trial is a huge advance,” said Dr. O’Neill. “It’s the first study this century that shows something that improves survival in cardiogenic shock. You treat eight patients, and you save one life.” Dr. O’Neill said this is one of the best outcomes he has seen during his long career.
Dr. Kapur said the DanGer trial is also a leap forward in designing trials for cardiogenic shock. He said previous trials of mechanical support in cardiogenic shock had neutral results, probably due to broad inclusion criteria for patients.
“The DanGer trial was selective in its inclusion and exclusion criteria. That made it more difficult to enroll the population, so it took a lot longer. But it used the right device at the right time in the right patient, and it was successful,” he said.
“The DanGer investigators need to be applauded,” he added. “The lesson is, we have to design the right trials.”
New Cardiogenic Shock Trials
Dr. O’Neill and Dr. Kapur said the groundwork they laid for RECOVER IV can be used for new trials.
“We have 50 sites in the US, Germany, and Denmark. They’re interested, and they’re waiting,” said Dr. O’Neill. The researchers are poised to begin new trials once protocols are developed.
What will the next trials investigate?
DanGer Shock results showed higher rates of adverse events following Impella use than after standard care. “We need to come up with strategies to decrease bleeding problems and renal failure,” said Dr. O’Neill, and these could be tested in trials.
Other questions he would like to see investigated are using the Impella heart pump before or after angioplasty, and multi-vessel vs culprit-vessel percutaneous coronary intervention in cardiogenic shock with Impella support.
Dr. Kapur mentioned studying patients excluded from the DanGer Shock trial — such as those needing right ventricular support — because DanGer Shock covered only left ventricular support and those suffering cardiac arrest outside hospital. He said trials could compare differences between models of Impella and investigate the role of ECMO.
“I’m optimistic that we can design more randomized controlled trials with the right patient population and right treatment algorithm,” Dr. Kapur said. This is a critical step toward better outcomes for patients, he added. Another step is optimizing the design of heart pumps, which should decrease the rates of adverse events, he said. “I have a lot of optimism for the future of device design.”
A version of this article first appeared on Medscape.com.
An international trial of the Impella heart pump in patients with ST elevation myocardial infarction (STEMI) and cardiogenic shock has been stopped by the sponsor, Abiomed Inc. The termination followed news that another international trial, DanGer Shock, found that the pump improved survival in these patients.
“I was convinced that the study could not continue,” one of the principal investigators William O’Neill, MD, an interventional cardiologist with the Henry Ford Health in Detroit, said in an interview. After 3.5 years of work and thousands of person-hours, he added, “It’s not a decision that people took lightly.”
The trial already had three sites in Europe and one in the United States up and running, with two more US sites slated to join the trial. It had started enrolling patients, although few to date.
DanGer Shock trial results were expected to have a serious effect on how RECOVER IV would unfold. It was previously uncertain whether the Impella heart pump would save lives vs existing approaches, said O’Neill and co-principal investigator Navin Kapur, MD, an interventional cardiologist at Tufts Medical Center in Boston. Once the DanGer Shock trial showed the benefits of using the heart pump, that equipoise vanished.
Loss of Clinical Equipoise
“The clinicians were challenged in getting consent from patients where they had to say, ‘If you are randomized to the control arm, we are not able to use an Impella,’ ” said Dr. Kapur. He pointed out that patients would be unlikely to agree to participate in a trial where they might not get the treatment already shown to improve survival.
Dr. Kapur and Dr. O’Neill said the clinicians participating in the trial expressed discomfort at continuing. The RECOVER IV trial was expected to take many years to enroll the targeted number of patients. To participate, hospitals had to have the equipment and expertise to use the Impella heart pump, as well as the control treatments — balloon-pump support and extracorporeal membrane oxygenation (ECMO), Dr. Kapur explained. He said most patients with STEMI and cardiogenic shock would present to their nearest community hospitals, many of which would not have these treatments and would be unable to participate in the study.
Patients with STEMI and cardiogenic shock are uncommon. About 80,000 patients in the United States each year present with cardiogenic shock, of whom about 40% are not experiencing a STEMI, said Dr. O’Neill.
But those who do fit into the population of both STEMI and cardiogenic shock are at very high risk, said Dr. Kapur. “One in three or one in two patients with STEMI and cardiogenic shock will die in hospital.”
Getting Hearts Pumping
The Impella heart pump was originally developed by Impella Cardiosystems in Aachen, Germany, which was acquired by Abiomed in 2005, according to the Abiomed website. And Abiomed was acquired by Johnson & Johnson MedTech in 2022. The company has developed a series of models over the years and said that Impella CP — the model used in DanGer Shock and RECOVER IV trials — is the world’s smallest heart pump.
“Impella is the only heart pump that can be introduced percutaneously through the leg,” said Dr. O’Neill, whereas other pumps available are used only in open-heart surgery. While Impella is the first pump to be used this way, he said it won’t be the last. Other, more powerful pumps are being developed.
DanGer Shock: A Leap Forward
Despite leading to the halt of another trial, the DanGer Shock results are a good news story, said the RECOVER IV investigators.
“The DanGer trial is a huge advance,” said Dr. O’Neill. “It’s the first study this century that shows something that improves survival in cardiogenic shock. You treat eight patients, and you save one life.” Dr. O’Neill said this is one of the best outcomes he has seen during his long career.
Dr. Kapur said the DanGer trial is also a leap forward in designing trials for cardiogenic shock. He said previous trials of mechanical support in cardiogenic shock had neutral results, probably due to broad inclusion criteria for patients.
“The DanGer trial was selective in its inclusion and exclusion criteria. That made it more difficult to enroll the population, so it took a lot longer. But it used the right device at the right time in the right patient, and it was successful,” he said.
“The DanGer investigators need to be applauded,” he added. “The lesson is, we have to design the right trials.”
New Cardiogenic Shock Trials
Dr. O’Neill and Dr. Kapur said the groundwork they laid for RECOVER IV can be used for new trials.
“We have 50 sites in the US, Germany, and Denmark. They’re interested, and they’re waiting,” said Dr. O’Neill. The researchers are poised to begin new trials once protocols are developed.
What will the next trials investigate?
DanGer Shock results showed higher rates of adverse events following Impella use than after standard care. “We need to come up with strategies to decrease bleeding problems and renal failure,” said Dr. O’Neill, and these could be tested in trials.
Other questions he would like to see investigated are using the Impella heart pump before or after angioplasty, and multi-vessel vs culprit-vessel percutaneous coronary intervention in cardiogenic shock with Impella support.
Dr. Kapur mentioned studying patients excluded from the DanGer Shock trial — such as those needing right ventricular support — because DanGer Shock covered only left ventricular support and those suffering cardiac arrest outside hospital. He said trials could compare differences between models of Impella and investigate the role of ECMO.
“I’m optimistic that we can design more randomized controlled trials with the right patient population and right treatment algorithm,” Dr. Kapur said. This is a critical step toward better outcomes for patients, he added. Another step is optimizing the design of heart pumps, which should decrease the rates of adverse events, he said. “I have a lot of optimism for the future of device design.”
A version of this article first appeared on Medscape.com.
An international trial of the Impella heart pump in patients with ST elevation myocardial infarction (STEMI) and cardiogenic shock has been stopped by the sponsor, Abiomed Inc. The termination followed news that another international trial, DanGer Shock, found that the pump improved survival in these patients.
“I was convinced that the study could not continue,” one of the principal investigators William O’Neill, MD, an interventional cardiologist with the Henry Ford Health in Detroit, said in an interview. After 3.5 years of work and thousands of person-hours, he added, “It’s not a decision that people took lightly.”
The trial already had three sites in Europe and one in the United States up and running, with two more US sites slated to join the trial. It had started enrolling patients, although few to date.
DanGer Shock trial results were expected to have a serious effect on how RECOVER IV would unfold. It was previously uncertain whether the Impella heart pump would save lives vs existing approaches, said O’Neill and co-principal investigator Navin Kapur, MD, an interventional cardiologist at Tufts Medical Center in Boston. Once the DanGer Shock trial showed the benefits of using the heart pump, that equipoise vanished.
Loss of Clinical Equipoise
“The clinicians were challenged in getting consent from patients where they had to say, ‘If you are randomized to the control arm, we are not able to use an Impella,’ ” said Dr. Kapur. He pointed out that patients would be unlikely to agree to participate in a trial where they might not get the treatment already shown to improve survival.
Dr. Kapur and Dr. O’Neill said the clinicians participating in the trial expressed discomfort at continuing. The RECOVER IV trial was expected to take many years to enroll the targeted number of patients. To participate, hospitals had to have the equipment and expertise to use the Impella heart pump, as well as the control treatments — balloon-pump support and extracorporeal membrane oxygenation (ECMO), Dr. Kapur explained. He said most patients with STEMI and cardiogenic shock would present to their nearest community hospitals, many of which would not have these treatments and would be unable to participate in the study.
Patients with STEMI and cardiogenic shock are uncommon. About 80,000 patients in the United States each year present with cardiogenic shock, of whom about 40% are not experiencing a STEMI, said Dr. O’Neill.
But those who do fit into the population of both STEMI and cardiogenic shock are at very high risk, said Dr. Kapur. “One in three or one in two patients with STEMI and cardiogenic shock will die in hospital.”
Getting Hearts Pumping
The Impella heart pump was originally developed by Impella Cardiosystems in Aachen, Germany, which was acquired by Abiomed in 2005, according to the Abiomed website. And Abiomed was acquired by Johnson & Johnson MedTech in 2022. The company has developed a series of models over the years and said that Impella CP — the model used in DanGer Shock and RECOVER IV trials — is the world’s smallest heart pump.
“Impella is the only heart pump that can be introduced percutaneously through the leg,” said Dr. O’Neill, whereas other pumps available are used only in open-heart surgery. While Impella is the first pump to be used this way, he said it won’t be the last. Other, more powerful pumps are being developed.
DanGer Shock: A Leap Forward
Despite leading to the halt of another trial, the DanGer Shock results are a good news story, said the RECOVER IV investigators.
“The DanGer trial is a huge advance,” said Dr. O’Neill. “It’s the first study this century that shows something that improves survival in cardiogenic shock. You treat eight patients, and you save one life.” Dr. O’Neill said this is one of the best outcomes he has seen during his long career.
Dr. Kapur said the DanGer trial is also a leap forward in designing trials for cardiogenic shock. He said previous trials of mechanical support in cardiogenic shock had neutral results, probably due to broad inclusion criteria for patients.
“The DanGer trial was selective in its inclusion and exclusion criteria. That made it more difficult to enroll the population, so it took a lot longer. But it used the right device at the right time in the right patient, and it was successful,” he said.
“The DanGer investigators need to be applauded,” he added. “The lesson is, we have to design the right trials.”
New Cardiogenic Shock Trials
Dr. O’Neill and Dr. Kapur said the groundwork they laid for RECOVER IV can be used for new trials.
“We have 50 sites in the US, Germany, and Denmark. They’re interested, and they’re waiting,” said Dr. O’Neill. The researchers are poised to begin new trials once protocols are developed.
What will the next trials investigate?
DanGer Shock results showed higher rates of adverse events following Impella use than after standard care. “We need to come up with strategies to decrease bleeding problems and renal failure,” said Dr. O’Neill, and these could be tested in trials.
Other questions he would like to see investigated are using the Impella heart pump before or after angioplasty, and multi-vessel vs culprit-vessel percutaneous coronary intervention in cardiogenic shock with Impella support.
Dr. Kapur mentioned studying patients excluded from the DanGer Shock trial — such as those needing right ventricular support — because DanGer Shock covered only left ventricular support and those suffering cardiac arrest outside hospital. He said trials could compare differences between models of Impella and investigate the role of ECMO.
“I’m optimistic that we can design more randomized controlled trials with the right patient population and right treatment algorithm,” Dr. Kapur said. This is a critical step toward better outcomes for patients, he added. Another step is optimizing the design of heart pumps, which should decrease the rates of adverse events, he said. “I have a lot of optimism for the future of device design.”
A version of this article first appeared on Medscape.com.