Stroke

This transcript has been edited for clarity.

I’d like to talk about a recent report in the journal Menopause linking menopausal symptoms to increased risk for cognitive impairment. I’d also like to discuss some of the recent studies that have addressed whether hot flashes are linked to increased risk for heart disease and other forms of cardiovascular disease (CVD). 

Given that 75%-80% of perimenopausal and postmenopausal women have hot flashes and vasomotor symptoms, it’s undoubtedly a more complex relationship between hot flashes and these outcomes than a simple one-size-fits-all, yes-or-no question.

Increasing evidence shows that several additional factors are important, including the age at which the symptoms are occurring, the time since menopause, the severity of the symptoms, whether they co-occur with night sweats and sleep disruption, and the cardiovascular status of the woman.

Several studies suggest that women who have more severe hot flashes and vasomotor symptoms are more likely to have prevalent cardiovascular risk factors — hypertension, dyslipidemia, high body mass index, endothelial dysfunction — as measured by flow-mediated vasodilation and other measures.

It is quite plausible that hot flashes could be a marker for increased risk for cognitive impairment. But the question remains, are hot flashes associated with cognitive impairment independent of these other risk factors? It appears that the associations between hot flashes, vasomotor symptoms, and CVD, and other adverse outcomes, may be more likely when hot flashes persist after age 60 or are newly occurring in later menopause. In the Women’s Health Initiative observational study, the presence of hot flashes and vasomotor symptoms in early menopause was not linked to any increased risk for heart attack, stroke, total CVD, or all-cause mortality.

However, the onset of these symptoms, especially new onset of these symptoms after age 60 or in later menopause, was in fact linked to increased risk for CVD and all-cause mortality. With respect to cognitive impairment, if a woman is having hot flashes and night sweats with regular sleep disruption, performance on cognitive testing would not be as favorable as it would be in the absence of these symptoms.

This brings us to the new study in Menopause that included approximately 1300 Latino women in nine Latin American countries, with an average age of 55 years. Looking at the association between severe menopausal symptoms and cognitive impairment, researchers found that women with severe symptoms were more likely to have cognitive impairment.

Conversely, they found that the women who had a favorable CVD risk factor status (physically active, lower BMI, healthier) and were ever users of estrogen were less likely to have cognitive impairment.

Clearly, for estrogen therapy, we need randomized clinical trials of the presence or absence of vasomotor symptoms and cognitive and CVD outcomes. Such analyses are ongoing, and new randomized trials focused specifically on women in early menopause would be very beneficial.

At the present time, it’s important that we not alarm women about the associations seen in some of these studies because often they are not independent associations; they aren’t independent of other risk factors that are commonly linked to hot flashes and night sweats. There are many other complexities in the relationship between hot flashes and cognitive impairment.

We need to appreciate that women who have moderate to severe hot flashes (especially when associated with disrupted sleep) do have impaired quality of life. It’s important to treat these symptoms, especially in early menopause, and very effective hormonal and nonhormonal treatments are available.

For women with symptoms that persist into later menopause or who have new onset of symptoms in later menopause, it’s important to prioritize cardiovascular health. For example, be more vigilant about behavioral lifestyle counseling to lower risk, and be even more aggressive in treating dyslipidemia and diabetes.

JoAnn E. Manson, Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School; Chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and Past President, North American Menopause Society, 2011-2012, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

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

This transcript has been edited for clarity.

I’d like to talk about a recent report in the journal Menopause linking menopausal symptoms to increased risk for cognitive impairment. I’d also like to discuss some of the recent studies that have addressed whether hot flashes are linked to increased risk for heart disease and other forms of cardiovascular disease (CVD). 

Given that 75%-80% of perimenopausal and postmenopausal women have hot flashes and vasomotor symptoms, it’s undoubtedly a more complex relationship between hot flashes and these outcomes than a simple one-size-fits-all, yes-or-no question.

Increasing evidence shows that several additional factors are important, including the age at which the symptoms are occurring, the time since menopause, the severity of the symptoms, whether they co-occur with night sweats and sleep disruption, and the cardiovascular status of the woman.

Several studies suggest that women who have more severe hot flashes and vasomotor symptoms are more likely to have prevalent cardiovascular risk factors — hypertension, dyslipidemia, high body mass index, endothelial dysfunction — as measured by flow-mediated vasodilation and other measures.

It is quite plausible that hot flashes could be a marker for increased risk for cognitive impairment. But the question remains, are hot flashes associated with cognitive impairment independent of these other risk factors? It appears that the associations between hot flashes, vasomotor symptoms, and CVD, and other adverse outcomes, may be more likely when hot flashes persist after age 60 or are newly occurring in later menopause. In the Women’s Health Initiative observational study, the presence of hot flashes and vasomotor symptoms in early menopause was not linked to any increased risk for heart attack, stroke, total CVD, or all-cause mortality.

However, the onset of these symptoms, especially new onset of these symptoms after age 60 or in later menopause, was in fact linked to increased risk for CVD and all-cause mortality. With respect to cognitive impairment, if a woman is having hot flashes and night sweats with regular sleep disruption, performance on cognitive testing would not be as favorable as it would be in the absence of these symptoms.

This brings us to the new study in Menopause that included approximately 1300 Latino women in nine Latin American countries, with an average age of 55 years. Looking at the association between severe menopausal symptoms and cognitive impairment, researchers found that women with severe symptoms were more likely to have cognitive impairment.

Conversely, they found that the women who had a favorable CVD risk factor status (physically active, lower BMI, healthier) and were ever users of estrogen were less likely to have cognitive impairment.

Clearly, for estrogen therapy, we need randomized clinical trials of the presence or absence of vasomotor symptoms and cognitive and CVD outcomes. Such analyses are ongoing, and new randomized trials focused specifically on women in early menopause would be very beneficial.

At the present time, it’s important that we not alarm women about the associations seen in some of these studies because often they are not independent associations; they aren’t independent of other risk factors that are commonly linked to hot flashes and night sweats. There are many other complexities in the relationship between hot flashes and cognitive impairment.

We need to appreciate that women who have moderate to severe hot flashes (especially when associated with disrupted sleep) do have impaired quality of life. It’s important to treat these symptoms, especially in early menopause, and very effective hormonal and nonhormonal treatments are available.

For women with symptoms that persist into later menopause or who have new onset of symptoms in later menopause, it’s important to prioritize cardiovascular health. For example, be more vigilant about behavioral lifestyle counseling to lower risk, and be even more aggressive in treating dyslipidemia and diabetes.

JoAnn E. Manson, Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School; Chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and Past President, North American Menopause Society, 2011-2012, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

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

This transcript has been edited for clarity.

I’d like to talk about a recent report in the journal Menopause linking menopausal symptoms to increased risk for cognitive impairment. I’d also like to discuss some of the recent studies that have addressed whether hot flashes are linked to increased risk for heart disease and other forms of cardiovascular disease (CVD). 

Given that 75%-80% of perimenopausal and postmenopausal women have hot flashes and vasomotor symptoms, it’s undoubtedly a more complex relationship between hot flashes and these outcomes than a simple one-size-fits-all, yes-or-no question.

Increasing evidence shows that several additional factors are important, including the age at which the symptoms are occurring, the time since menopause, the severity of the symptoms, whether they co-occur with night sweats and sleep disruption, and the cardiovascular status of the woman.

Several studies suggest that women who have more severe hot flashes and vasomotor symptoms are more likely to have prevalent cardiovascular risk factors — hypertension, dyslipidemia, high body mass index, endothelial dysfunction — as measured by flow-mediated vasodilation and other measures.

It is quite plausible that hot flashes could be a marker for increased risk for cognitive impairment. But the question remains, are hot flashes associated with cognitive impairment independent of these other risk factors? It appears that the associations between hot flashes, vasomotor symptoms, and CVD, and other adverse outcomes, may be more likely when hot flashes persist after age 60 or are newly occurring in later menopause. In the Women’s Health Initiative observational study, the presence of hot flashes and vasomotor symptoms in early menopause was not linked to any increased risk for heart attack, stroke, total CVD, or all-cause mortality.

However, the onset of these symptoms, especially new onset of these symptoms after age 60 or in later menopause, was in fact linked to increased risk for CVD and all-cause mortality. With respect to cognitive impairment, if a woman is having hot flashes and night sweats with regular sleep disruption, performance on cognitive testing would not be as favorable as it would be in the absence of these symptoms.

This brings us to the new study in Menopause that included approximately 1300 Latino women in nine Latin American countries, with an average age of 55 years. Looking at the association between severe menopausal symptoms and cognitive impairment, researchers found that women with severe symptoms were more likely to have cognitive impairment.

Conversely, they found that the women who had a favorable CVD risk factor status (physically active, lower BMI, healthier) and were ever users of estrogen were less likely to have cognitive impairment.

Clearly, for estrogen therapy, we need randomized clinical trials of the presence or absence of vasomotor symptoms and cognitive and CVD outcomes. Such analyses are ongoing, and new randomized trials focused specifically on women in early menopause would be very beneficial.

At the present time, it’s important that we not alarm women about the associations seen in some of these studies because often they are not independent associations; they aren’t independent of other risk factors that are commonly linked to hot flashes and night sweats. There are many other complexities in the relationship between hot flashes and cognitive impairment.

We need to appreciate that women who have moderate to severe hot flashes (especially when associated with disrupted sleep) do have impaired quality of life. It’s important to treat these symptoms, especially in early menopause, and very effective hormonal and nonhormonal treatments are available.

For women with symptoms that persist into later menopause or who have new onset of symptoms in later menopause, it’s important to prioritize cardiovascular health. For example, be more vigilant about behavioral lifestyle counseling to lower risk, and be even more aggressive in treating dyslipidemia and diabetes.

JoAnn E. Manson, Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School; Chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and Past President, North American Menopause Society, 2011-2012, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

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

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

A version of this article first appeared on WebMD.com.

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

A version of this article first appeared on WebMD.com.

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

A version of this article first appeared on WebMD.com.

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

• Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
• They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
• Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
• Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
• The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

• Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
• The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
• No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

• Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
• They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
• Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
• Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
• The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

• Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
• The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
• No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

• Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
• They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
• Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
• Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
• The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

• Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
• The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
• No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

• Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
• They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
• They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
• The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
• The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

• At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
• Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
• Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

• Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
• They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
• They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
• The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
• The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

• At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
• Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
• Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

• Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
• They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
• They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
• The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
• The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

• At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
• Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
• Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

This discussion was recorded on August 2, 2024. This transcript has been edited for clarity. 

Robert D. Glatter, MD: Today, we’ll be discussing the results of a new study published in The Journal of Emergency Medicine, looking at the incidence of delayed intracranial hemorrhage among older patients taking preinjury anticoagulants who present to the emergency department (ED) with blunt head trauma.

Joining me today is the lead author of the study, Dr. Richard Shih, professor of emergency medicine at Florida Atlantic University. Also joining me is Dr. Christina Shenvi, associate professor of emergency medicine at the University of North Carolina (UNC) Chapel Hill, with fellowship training in geriatric emergency medicine. 

Welcome to both of you.

Richard D. Shih, MD: Thanks, Rob. 

Christina L. Shenvi, MD, PhD, MBA: Thanks. Pleasure to be here. 
 

ICH Study Methodology

Dr. Glatter: It’s a pleasure to have you. Rich, this is a great study and targeted toward a population we see daily in the emergency department. I want you to describe your methodology, patient selection, and how you went about organizing your study to look at this important finding of delayed intracranial hemorrhage, especially in those on anticoagulants.

Dr. Shih: This all started for our research team when we first read the 2012 Annals of Emergency Medicine paper. The first author was Vincenzo Menditto, and he looked at a group of patients that had minor head injury, were anticoagulated, and had negative initial head CTs. 

There were about 100 patients, of which about 10 of them did not consent, but they hospitalized all these patients. These were anticoagulated, negative-first head CTs. They hospitalized the patients and then did a routine second CT at about 24 hours. They also followed them for a week, and it turned out a little over 7% of them had delayed head CT. 

We were wondering how many delayed intracranial hemorrhages we had missed because current practice for us was that, if patients had a good physical exam, their head CT was normal, and everything looked good, we would send them home.

Because of that, a number of people across the country wanted to verify those findings from the Menditto study. We tried to design a good study to answer that question. We happen to have a very large geriatric population in Florida, and our ED census is very high for age over 65, at nearly 60%. 

There are two Level I trauma centers in Palm Beach County. We included a second multicenter hospital, and we prospectively enrolled patients. We know the current state of practice is not to routinely do second CTs, so we followed these patients over time and followed their medical records to try to identify delayed bleeding. That’s how we set up our methodology.
 

Is It Safe to Discharge Patients With Trauma After 24 Hours?

Dr. Glatter: For the bulk of these patients with negative head CTs, it’s been my practice that when they’re stable and they look fine and there’s no other apparent, distracting painful trauma, injuries and so forth, they’re safe to discharge. 

The secondary outcome in your study is interesting: the need for neurosurgical intervention in terms of those with delayed intracranial hemorrhage.

Dr. Shih: I do believe that it’s certainly not the problem that Menditto described, which is 7%. There are two other prospective studies that have looked at this issue with delayed bleeding on anticoagulants. Both of these also showed a relatively low rate of delayed bleeding, which is between like 0.2% and 1.0%. In our study, it was 0.4%. 

The difference in the studies is that Menditto and colleagues routinely did 24-hour head CTs. They admitted everybody. For these other studies, routine head CT was not part of it. My bet is that there is a rate of delayed bleeding somewhere in between that seen in the Menditto study and that in all the other studies.

However, talking about significant intracranial hemorrhage, ones that perhaps need neurosurgery, I believe most of them are not significant. There’s some number that do occur, but the vast majority of those probably don’t need neurosurgery. We had 14 delayed bleeds out of 6000 patients with head trauma. One of them ended up requiring neurosurgery, so the answer is not zero, but I don’t think it’s 7% either. 

Dr. Glatter: Dr. Shenvi, I want to bring you into the conversation to talk about your experience at UNC, and how you run things in terms of older patients with blunt head trauma on preinjury anticoagulants.

Dr. Shenvi: Thanks, Rob. I remember when this paper came out showing this 7% rate of delayed bleeding and the question was, “Should we be admitting all these people?” Partly just from an overwhelming need for capacity that that would bring, it just wasn’t practical to say, “We’re going to admit every patient with a negative head CT to the hospital and rescan them.” That would be hundreds or thousands of patients each year in any given facility. 

The other thing is that delayed bleeds don’t always happen just in the first 24 hours. It’s not even a matter of bringing patients into observation for 24 hours, watching them, and rescanning them if they have symptoms. It can occur several days out. That never, in almost any institution that I know of, became standard practice. 

The way that it did change my care was to give good return precautions to patients, to make sure they have somebody with them to say, “Hey, sometimes you can have bleeding several days out after a fall, even though your CT scan here today looks perfect,” and to alert them that if they start having severe headaches, vomiting, or other symptoms of intracranial hemorrhage, that they should come back. 

I don’t think it ever became standard practice, and for good reason, because that was one study. The subsequent studies that Richard mentioned, pretty quickly on the heels of that initial one, showed a much lower rate of delayed ICH with the caveats that the methodology was different. 
 

Shift in Anticoagulants

Dr. Shenvi: One other big change from that original study, and now to Richard’s study, is the shift in anticoagulants. Back in the initial study you mentioned, it was all warfarin. We know from other studies looking at warfarin vs the direct oral anticoagulants (DOACs) that DOACs have lower rates of ICH after a head injury, lower rates of need for neurosurgical intervention, and lower rates of discharge to a skilled nursing facility after an intracranial hemorrhage.

Across the board, we know that the DOACs tend to do better. It’s difficult to compare newer studies because it’s a different medication. It did inform my practice to have an awareness of delayed intracranial hemorrhage so that I warn patients more proactively. 

Dr. Glatter: I haven’t seen a patient on warfarin in years. I don’t know if either of you have, but it’s all DOACs now unless there’s some other reason. That shift is quite apparent.

Dr. Shih: The problem with looking at delayed bleeding for DOACs vs warfarin is the numbers were so low. I think we had 13 people, and seven were in the no-anticoagulant group. The numbers are even lower, so it’s hard to say. 

I just wanted to comment on something that Dr. Shenvi said, and I pretty much agree with everything that she said. Anticoagulants and warfarin, and that Menditto study, have a carryover effect. People group DOACs with warfarin similarly. When a patient is brought in, the first thing they talk about with head trauma is, “Oh, they’re on an anticoagulant” or “They’re not on an anticoagulant.” It’s so ingrained.

I believe that, in emergency medicine, we’re pressed for space and time and we’re not as affected by that 24-hour observation. Maybe many of our surgeons will automatically admit those patients. 

I haven’t seen a guideline from the United States, but there are two international guidelines. One is from Austria from 2019, and one is from Scandinavia. Both recommended 24-hour observation if you’re on an anticoagulant.

There is a bit of controversy left over with that. Hopefully, as more and more of information, like in our study, comes out, people will be a little bit more clear about it. I don’t think there’s a need to routinely admit them. 

I do want to mention that the Menditto study had such a massive impact on everybody. They pointed out one subgroup (and it’s such a small number of patients). They had seven cases of delayed bleeding; four or five of them were within that 24 hours, and a couple were diagnosed later over the next couple days.

Of those seven people, four of them had international normalized ratios (INRs) greater than 3. Of those four patients, I’ve heard people talk about this and recommend, “Okay, that’s the subgroup I would admit.” There’s a toss-up with what to do with DOAC because it’s very hard to tell whether there’s an issue, whether there are problems with their dosing, and whatever. 

We actually recently looked at that. We have a much larger sample than four: close to 300 patients who were on warfarin. We looked at patients who had INRs below 3 and above 3, and we didn’t show a difference. We still don’t believe that warfarin is a big issue with delayed bleeding.
 

Should We Be Asking: ‘Are They on Blood Thinners?’

Dr. Shenvi: One of the interesting trends related to warfarin and the DOACs vs no anticoagulant is that as you mentioned, Dr Shih, the first question out of people’s mouths or the first piece of information emergency medical services gives you when they come in with a patient who’s had a head injury is, “Are they on blood thinners or not?”

Yet, the paradigm is shifting to say it’s not actually the blood thinners themselves that are giving older patients the higher risk for bleeding; it’s age and other comorbidities.

Certainly, if you’re on an anticoagulant and you start to bleed, your prognosis is much worse because the bleeding doesn’t stop. In terms of who has a bleeding event, there’s much less impact of anticoagulation than we used to think. That, in part, may be due to the change from warfarin to other medications.

Some of the experts I’ve talked to who have done the research on this have said, “Well, actually, warfarin was more of a marker for being much older and more frail, because it was primarily prescribed to older patients who have significant heart disease, atrial fibrillation, and so on.” It was more a marker for somebody who is at risk for an intracranial hemorrhage. There are many changes that have happened in the past 10 years with medications and also our understanding. 
 

Challenges in Patient Follow-up

Dr. Glatter: That’s a great point. One thing, Rich, I want to ask you about is in terms of your proxy outcome assessment. When you use that at 14 and 60 days with telephone follow-up and then chart review at 60 and 90 days (because, obviously, everyone can’t get another head CT or it’s difficult to follow patients up), did you find that worked out well in your prospective cohort study, in terms of using that as a proxy, so to speak? 

Dr. Shih: I would say to a certain extent. Unfortunately, we don’t have access to the patients to come back to follow up all of them, and there was obviously a large number of patients in our study. 

The next best thing was that we had dedicated research assistants calling all of the patients at 14 days and 60 days. I’ve certainly read research studies where, when they call them, they get 80%-90% follow-up, but we did not achieve that.

I don’t know if people are more inundated with spam phone calls now, or the older people are just afraid of picking up their phone sometimes with all the scams and so forth. I totally understand, but in all honesty, we only had about a 30%-35% follow-up using that follow-up pathway. 

Then the proxy pathway was to look at their charts at 60 and 90 days. Also, we looked at the Florida death registry, which is pretty good, and then finally, we had both Level I trauma centers in the county that we were in participating. It’s standard practice that if you have an intracranial hemorrhage at a non–Level I trauma center, you would be transferred to a Level I trauma center. That’s the protocol. I know that’s not followed 100% of the time, but that’s part of the proxy follow-up. You could criticize the study for not having closer to 90% actual contact, but that’s the best we could do. 

Dr. Glatter: I think that’s admirable. Using that paradigm of what you described certainly allows the reader to understand the difficulty in assessing patients that don’t get follow-up head CT, and hardly anyone does that, as we know.

To your point of having both Level I trauma centers in the county, that makes it pretty secure. If we’re going to do a study encompassing a similar type of regional aspect, it would be similar.

Dr. Shenvi: I think your proxies, to your credit, were as good as you can get. You can never get a 100% follow-up, but you really looked at all the different avenues by which patients might present, either in the death registry or a Level I center. Well done on that aspect.

 

Determining When to Admit Patients for Observation

Dr. Glatter: In terms of admissions: You admit a patient, then you hear back that this patient should not have been admitted because they had a negative head CT, but you put them in anyway in the sense of delayed bleeding happening or not happening.

It’s interesting. Maybe the insurers will start looking at this in some capacity, based on your study, that because it’s so infrequent that you see delayed bleeding, that admitting someone for any reason whatsoever would be declined. Do you see that being an issue? In other words, [do you see] this leading to a pattern in terms of the payers?

Dr. Shih: Certainly, you could interpret it that way, and that would be unfortunate. The [incidence of] delayed bleeding is definitely not zero. That’s the first thing. 

The second thing is that when you’re dealing with an older population, having some sense that they’re not doing well is an important contributor to trying to fully assess what’s going on — whether or not they have a bleed or whether they’re at risk for falling again and then hitting their head and causing a second bleed, and making sure they can do the activities of daily life. There really should be some room for a physician to say, “They just got here, and we don’t know him that well. There’s something that bothers me about this person” and have the ability to watch them for at least another 24 hours. That’s how I feel. 

Dr. Shenvi: In my location, it would be difficult to try to admit somebody purely for observation for delayed bleeding. I think we would get a lot of pushback on that. The reasons I might admit a patient after a fall with a negative head CT, though, are all the things that, Rob, you alluded to earlier — which are, what made them fall in the first place and were they unable to get up? 

I had this happen just this week. A patient who fell couldn’t get off the ground for 12 hours, and so now she’s dehydrated and delirious with slight rhabdomyolysis. Then you’re admitting them either for the sequelae of the fall that are not related to the intracranial hemorrhage, or the fact that they are so debilitated and deconditioned that they cannot take care of themselves. They need physical therapy. Often, we will have physical and occupational therapists come see them in the ED during business hours and help make an assessment of whether they are safe to go home or whether they fall again. That can give more evidence for the need for admission.

Dr. Glatter: To bring artificial intelligence into this discussion, algorithms that are out there that say, “Push a button and the patient’s safe for discharge.” Well, this argues for a clinical gestalt and a human being to make an assessment because you can use these predictive models, which are coming and they’re going to be here soon, and they already are in some sense. Again, we have to use clinical human judgment. 

Dr. Shih: I agree. 
 

Advice for Primary Care Physicians

Dr. Glatter: What return precautions do you discuss with patients who’ve had blunt head trauma that maybe had a head CT, or even didn’t? What are the main things we’re looking for?

Dr. Shenvi: What I usually tell people is if you start to have a worse headache, nausea or vomiting, any weakness in one area of your body, or vision changes, and if there’s a family member or friend there, I’ll say, “If you notice that they’re acting differently or seem confused, come back.”

Dr. Shih: I agree with what she said, and I’m also going to add one thing. The most important part is they are trying to prevent a subsequent fall. We know that when they’ve fallen and they present to the ED, they’re at even higher risk for falling and reinjuring themselves, and that’s a population that’s already at risk.

One of the secondary studies that we published out of this project was looking at follow-up with their primary care physicians, and there were two things that we wanted to address. The first was, how often did they do it? Then, when they did do it, did their primary care physicians try to address and prevent subsequent falls?

Both the answers are actually bad. Amazingly, just over like 60% followed up. 

In some of our subsequent research, because we’re in the midst of a randomized, controlled trial where we do a home visit, when we initially see these individuals that have fallen, they’ll schedule a home visit for us. Then a week or two later, when we schedule the home visit, many of them cancel because they think, Oh, that was a one-off and it’s not going to happen again. Part of the problem is the patients, because many of them believe that they just slipped and fell and it’s not going to happen again, or they’re not prone to it.

The second issue was when patients did go to a primary care physician, we have found that some primary care physicians believe that falling and injuring themselves is just part of the normal aging process. A percentage of them don’t go over assessment for fall risk or even initiate fall prevention treatments or programs. 

I try to take that time to tell them that this is very common in their age group, and believe it or not, a fall from standing is the way people really injure themselves, and there may be ways to prevent subsequent falls and injuries. 

Dr. Glatter: Absolutely. Do you find that their medications are a contributor in some sense? Say they’re antihypertensive, have issues of orthostasis, or a new medication was added in the last week. 

Dr. Shenvi: It’s all of the above. Sometimes it’s one thing, like they just started tamsulosin for their kidney stone, they stood up, they felt lightheaded, and they fell. Usually, it’s multifactorial with some changes in their gait, vision, balance, reflex time, and strength, plus the medications or the need for assistive devices. Maybe they can’t take care of their home as well as they used to and there are things on the floor. It’s really all of the above.
 

‘Harder to Unlearn Something Than to Learn It’

Dr. Glatter: Would either of you like to add any additional points to the discussion or add a few pearls? 

Dr. Shenvi: This just highlights the challenge of how it’s harder to unlearn something than to learn it, where one study that maybe wasn’t quite looking at what we needed to, or practice and prescribing patterns have changed, so it’s no longer really relevant. 

The things that we learned from that, or the fears that we instilled in our minds of, Uh oh, they could go home and have delayed bleeding, are much harder to unlearn, and it takes more studies to unlearn that idea than it did to actually put it into place. 

I’m glad that your team has done this much larger, prospective study and hopefully will reduce the concern about this entity. 

Dr. Shih: I appreciate that segue. It is amazing that, for paramedics and medical students, the first thing out of their mouth is, “Are they on an anticoagulant?”

In terms of the risk of developing an intracranial hemorrhage, I think it’s much less than the weight we’ve put on it before. However, I believe if they have a bleed, the bleeds are worse. It’s kind of a double-edged sword. It’s still an important factor, but it doesn’t come with the Oh my gosh, they’re on an anticoagulant that everybody thinks about.
 

No. 1 Cause of Traumatic Injury Is a Fall from Standing

Dr. Glatter: These are obviously ground-level falls in most patients and not motor vehicle crashes. That’s an important part in the population that you looked at that should be mentioned clearly. 

Dr. Shih: It’s astonishing. I’ve been a program director for over 20 years, and geriatrics is not well taught in the curriculum. It’s astonishing for many of our trainees and emergency physicians in general that the number-one cause for traumatic injury is a fall from standing.

Certainly, we get patients coming in the trauma center like a 95-year-old person who’s on a ladder putting up his Christmas lights. I’m like, oh my God. 

For the vast majority, it’s closer to 90%, but in our study, for the patients we looked at, it was 80% that fall from standing. That’s the mechanism that causes these bleeds and these major injuries. 

Dr. Shenvi: That’s reflective of what we see, so it’s good that that’s what you looked at also. 

Dr. Glatter: Absolutely. Well, thank you both. This has been a very informative discussion. I appreciate your time, and our readers will certainly benefit from your knowledge and expertise. Thank you again.

Dr. Glatter, assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, is a medical adviser for this news organization. He disclosed having no relevant financial conflicts. Dr. Shih is professor of emergency medicine at the Charles E. Schmidt College of Medicine at Florida Atlantic University, Boca Raton. His current grant funding and area of research interest involves geriatric emergency department patients with head injury and fall-related injury. He disclosed receiving a research grant from The Florida Medical Malpractice Joint Underwriting Association Grant for Safety of Health Care Services). Dr. Shenvi, associate professor of emergency medicine at the University of North Carolina at Chapel Hill, disclosed ties with the American College of Emergency Physicians, Institute for Healthcare Improvement, AstraZeneca, and CurvaFix.

A version of this article appeared on Medscape.com.

This discussion was recorded on August 2, 2024. This transcript has been edited for clarity. 

Robert D. Glatter, MD: Today, we’ll be discussing the results of a new study published in The Journal of Emergency Medicine, looking at the incidence of delayed intracranial hemorrhage among older patients taking preinjury anticoagulants who present to the emergency department (ED) with blunt head trauma.

Joining me today is the lead author of the study, Dr. Richard Shih, professor of emergency medicine at Florida Atlantic University. Also joining me is Dr. Christina Shenvi, associate professor of emergency medicine at the University of North Carolina (UNC) Chapel Hill, with fellowship training in geriatric emergency medicine. 

Welcome to both of you.

Richard D. Shih, MD: Thanks, Rob. 

Christina L. Shenvi, MD, PhD, MBA: Thanks. Pleasure to be here. 
 

ICH Study Methodology

Dr. Glatter: It’s a pleasure to have you. Rich, this is a great study and targeted toward a population we see daily in the emergency department. I want you to describe your methodology, patient selection, and how you went about organizing your study to look at this important finding of delayed intracranial hemorrhage, especially in those on anticoagulants.

Dr. Shih: This all started for our research team when we first read the 2012 Annals of Emergency Medicine paper. The first author was Vincenzo Menditto, and he looked at a group of patients that had minor head injury, were anticoagulated, and had negative initial head CTs. 

There were about 100 patients, of which about 10 of them did not consent, but they hospitalized all these patients. These were anticoagulated, negative-first head CTs. They hospitalized the patients and then did a routine second CT at about 24 hours. They also followed them for a week, and it turned out a little over 7% of them had delayed head CT. 

We were wondering how many delayed intracranial hemorrhages we had missed because current practice for us was that, if patients had a good physical exam, their head CT was normal, and everything looked good, we would send them home.

Because of that, a number of people across the country wanted to verify those findings from the Menditto study. We tried to design a good study to answer that question. We happen to have a very large geriatric population in Florida, and our ED census is very high for age over 65, at nearly 60%. 

There are two Level I trauma centers in Palm Beach County. We included a second multicenter hospital, and we prospectively enrolled patients. We know the current state of practice is not to routinely do second CTs, so we followed these patients over time and followed their medical records to try to identify delayed bleeding. That’s how we set up our methodology.
 

Is It Safe to Discharge Patients With Trauma After 24 Hours?

Dr. Glatter: For the bulk of these patients with negative head CTs, it’s been my practice that when they’re stable and they look fine and there’s no other apparent, distracting painful trauma, injuries and so forth, they’re safe to discharge. 

The secondary outcome in your study is interesting: the need for neurosurgical intervention in terms of those with delayed intracranial hemorrhage.

Dr. Shih: I do believe that it’s certainly not the problem that Menditto described, which is 7%. There are two other prospective studies that have looked at this issue with delayed bleeding on anticoagulants. Both of these also showed a relatively low rate of delayed bleeding, which is between like 0.2% and 1.0%. In our study, it was 0.4%. 

The difference in the studies is that Menditto and colleagues routinely did 24-hour head CTs. They admitted everybody. For these other studies, routine head CT was not part of it. My bet is that there is a rate of delayed bleeding somewhere in between that seen in the Menditto study and that in all the other studies.

However, talking about significant intracranial hemorrhage, ones that perhaps need neurosurgery, I believe most of them are not significant. There’s some number that do occur, but the vast majority of those probably don’t need neurosurgery. We had 14 delayed bleeds out of 6000 patients with head trauma. One of them ended up requiring neurosurgery, so the answer is not zero, but I don’t think it’s 7% either. 

Dr. Glatter: Dr. Shenvi, I want to bring you into the conversation to talk about your experience at UNC, and how you run things in terms of older patients with blunt head trauma on preinjury anticoagulants.

Dr. Shenvi: Thanks, Rob. I remember when this paper came out showing this 7% rate of delayed bleeding and the question was, “Should we be admitting all these people?” Partly just from an overwhelming need for capacity that that would bring, it just wasn’t practical to say, “We’re going to admit every patient with a negative head CT to the hospital and rescan them.” That would be hundreds or thousands of patients each year in any given facility. 

The other thing is that delayed bleeds don’t always happen just in the first 24 hours. It’s not even a matter of bringing patients into observation for 24 hours, watching them, and rescanning them if they have symptoms. It can occur several days out. That never, in almost any institution that I know of, became standard practice. 

The way that it did change my care was to give good return precautions to patients, to make sure they have somebody with them to say, “Hey, sometimes you can have bleeding several days out after a fall, even though your CT scan here today looks perfect,” and to alert them that if they start having severe headaches, vomiting, or other symptoms of intracranial hemorrhage, that they should come back. 

I don’t think it ever became standard practice, and for good reason, because that was one study. The subsequent studies that Richard mentioned, pretty quickly on the heels of that initial one, showed a much lower rate of delayed ICH with the caveats that the methodology was different. 
 

Shift in Anticoagulants

Dr. Shenvi: One other big change from that original study, and now to Richard’s study, is the shift in anticoagulants. Back in the initial study you mentioned, it was all warfarin. We know from other studies looking at warfarin vs the direct oral anticoagulants (DOACs) that DOACs have lower rates of ICH after a head injury, lower rates of need for neurosurgical intervention, and lower rates of discharge to a skilled nursing facility after an intracranial hemorrhage.

Across the board, we know that the DOACs tend to do better. It’s difficult to compare newer studies because it’s a different medication. It did inform my practice to have an awareness of delayed intracranial hemorrhage so that I warn patients more proactively. 

Dr. Glatter: I haven’t seen a patient on warfarin in years. I don’t know if either of you have, but it’s all DOACs now unless there’s some other reason. That shift is quite apparent.

Dr. Shih: The problem with looking at delayed bleeding for DOACs vs warfarin is the numbers were so low. I think we had 13 people, and seven were in the no-anticoagulant group. The numbers are even lower, so it’s hard to say. 

I just wanted to comment on something that Dr. Shenvi said, and I pretty much agree with everything that she said. Anticoagulants and warfarin, and that Menditto study, have a carryover effect. People group DOACs with warfarin similarly. When a patient is brought in, the first thing they talk about with head trauma is, “Oh, they’re on an anticoagulant” or “They’re not on an anticoagulant.” It’s so ingrained.

I believe that, in emergency medicine, we’re pressed for space and time and we’re not as affected by that 24-hour observation. Maybe many of our surgeons will automatically admit those patients. 

I haven’t seen a guideline from the United States, but there are two international guidelines. One is from Austria from 2019, and one is from Scandinavia. Both recommended 24-hour observation if you’re on an anticoagulant.

There is a bit of controversy left over with that. Hopefully, as more and more of information, like in our study, comes out, people will be a little bit more clear about it. I don’t think there’s a need to routinely admit them. 

I do want to mention that the Menditto study had such a massive impact on everybody. They pointed out one subgroup (and it’s such a small number of patients). They had seven cases of delayed bleeding; four or five of them were within that 24 hours, and a couple were diagnosed later over the next couple days.

Of those seven people, four of them had international normalized ratios (INRs) greater than 3. Of those four patients, I’ve heard people talk about this and recommend, “Okay, that’s the subgroup I would admit.” There’s a toss-up with what to do with DOAC because it’s very hard to tell whether there’s an issue, whether there are problems with their dosing, and whatever. 

We actually recently looked at that. We have a much larger sample than four: close to 300 patients who were on warfarin. We looked at patients who had INRs below 3 and above 3, and we didn’t show a difference. We still don’t believe that warfarin is a big issue with delayed bleeding.
 

Should We Be Asking: ‘Are They on Blood Thinners?’

Dr. Shenvi: One of the interesting trends related to warfarin and the DOACs vs no anticoagulant is that as you mentioned, Dr Shih, the first question out of people’s mouths or the first piece of information emergency medical services gives you when they come in with a patient who’s had a head injury is, “Are they on blood thinners or not?”

Yet, the paradigm is shifting to say it’s not actually the blood thinners themselves that are giving older patients the higher risk for bleeding; it’s age and other comorbidities.

Certainly, if you’re on an anticoagulant and you start to bleed, your prognosis is much worse because the bleeding doesn’t stop. In terms of who has a bleeding event, there’s much less impact of anticoagulation than we used to think. That, in part, may be due to the change from warfarin to other medications.

Some of the experts I’ve talked to who have done the research on this have said, “Well, actually, warfarin was more of a marker for being much older and more frail, because it was primarily prescribed to older patients who have significant heart disease, atrial fibrillation, and so on.” It was more a marker for somebody who is at risk for an intracranial hemorrhage. There are many changes that have happened in the past 10 years with medications and also our understanding. 
 

Challenges in Patient Follow-up

Dr. Glatter: That’s a great point. One thing, Rich, I want to ask you about is in terms of your proxy outcome assessment. When you use that at 14 and 60 days with telephone follow-up and then chart review at 60 and 90 days (because, obviously, everyone can’t get another head CT or it’s difficult to follow patients up), did you find that worked out well in your prospective cohort study, in terms of using that as a proxy, so to speak? 

Dr. Shih: I would say to a certain extent. Unfortunately, we don’t have access to the patients to come back to follow up all of them, and there was obviously a large number of patients in our study. 

The next best thing was that we had dedicated research assistants calling all of the patients at 14 days and 60 days. I’ve certainly read research studies where, when they call them, they get 80%-90% follow-up, but we did not achieve that.

I don’t know if people are more inundated with spam phone calls now, or the older people are just afraid of picking up their phone sometimes with all the scams and so forth. I totally understand, but in all honesty, we only had about a 30%-35% follow-up using that follow-up pathway. 

Then the proxy pathway was to look at their charts at 60 and 90 days. Also, we looked at the Florida death registry, which is pretty good, and then finally, we had both Level I trauma centers in the county that we were in participating. It’s standard practice that if you have an intracranial hemorrhage at a non–Level I trauma center, you would be transferred to a Level I trauma center. That’s the protocol. I know that’s not followed 100% of the time, but that’s part of the proxy follow-up. You could criticize the study for not having closer to 90% actual contact, but that’s the best we could do. 

Dr. Glatter: I think that’s admirable. Using that paradigm of what you described certainly allows the reader to understand the difficulty in assessing patients that don’t get follow-up head CT, and hardly anyone does that, as we know.

To your point of having both Level I trauma centers in the county, that makes it pretty secure. If we’re going to do a study encompassing a similar type of regional aspect, it would be similar.

Dr. Shenvi: I think your proxies, to your credit, were as good as you can get. You can never get a 100% follow-up, but you really looked at all the different avenues by which patients might present, either in the death registry or a Level I center. Well done on that aspect.

 

Determining When to Admit Patients for Observation

Dr. Glatter: In terms of admissions: You admit a patient, then you hear back that this patient should not have been admitted because they had a negative head CT, but you put them in anyway in the sense of delayed bleeding happening or not happening.

It’s interesting. Maybe the insurers will start looking at this in some capacity, based on your study, that because it’s so infrequent that you see delayed bleeding, that admitting someone for any reason whatsoever would be declined. Do you see that being an issue? In other words, [do you see] this leading to a pattern in terms of the payers?

Dr. Shih: Certainly, you could interpret it that way, and that would be unfortunate. The [incidence of] delayed bleeding is definitely not zero. That’s the first thing. 

The second thing is that when you’re dealing with an older population, having some sense that they’re not doing well is an important contributor to trying to fully assess what’s going on — whether or not they have a bleed or whether they’re at risk for falling again and then hitting their head and causing a second bleed, and making sure they can do the activities of daily life. There really should be some room for a physician to say, “They just got here, and we don’t know him that well. There’s something that bothers me about this person” and have the ability to watch them for at least another 24 hours. That’s how I feel. 

Dr. Shenvi: In my location, it would be difficult to try to admit somebody purely for observation for delayed bleeding. I think we would get a lot of pushback on that. The reasons I might admit a patient after a fall with a negative head CT, though, are all the things that, Rob, you alluded to earlier — which are, what made them fall in the first place and were they unable to get up? 

I had this happen just this week. A patient who fell couldn’t get off the ground for 12 hours, and so now she’s dehydrated and delirious with slight rhabdomyolysis. Then you’re admitting them either for the sequelae of the fall that are not related to the intracranial hemorrhage, or the fact that they are so debilitated and deconditioned that they cannot take care of themselves. They need physical therapy. Often, we will have physical and occupational therapists come see them in the ED during business hours and help make an assessment of whether they are safe to go home or whether they fall again. That can give more evidence for the need for admission.

Dr. Glatter: To bring artificial intelligence into this discussion, algorithms that are out there that say, “Push a button and the patient’s safe for discharge.” Well, this argues for a clinical gestalt and a human being to make an assessment because you can use these predictive models, which are coming and they’re going to be here soon, and they already are in some sense. Again, we have to use clinical human judgment. 

Dr. Shih: I agree. 
 

Advice for Primary Care Physicians

Dr. Glatter: What return precautions do you discuss with patients who’ve had blunt head trauma that maybe had a head CT, or even didn’t? What are the main things we’re looking for?

Dr. Shenvi: What I usually tell people is if you start to have a worse headache, nausea or vomiting, any weakness in one area of your body, or vision changes, and if there’s a family member or friend there, I’ll say, “If you notice that they’re acting differently or seem confused, come back.”

Dr. Shih: I agree with what she said, and I’m also going to add one thing. The most important part is they are trying to prevent a subsequent fall. We know that when they’ve fallen and they present to the ED, they’re at even higher risk for falling and reinjuring themselves, and that’s a population that’s already at risk.

One of the secondary studies that we published out of this project was looking at follow-up with their primary care physicians, and there were two things that we wanted to address. The first was, how often did they do it? Then, when they did do it, did their primary care physicians try to address and prevent subsequent falls?

Both the answers are actually bad. Amazingly, just over like 60% followed up. 

In some of our subsequent research, because we’re in the midst of a randomized, controlled trial where we do a home visit, when we initially see these individuals that have fallen, they’ll schedule a home visit for us. Then a week or two later, when we schedule the home visit, many of them cancel because they think, Oh, that was a one-off and it’s not going to happen again. Part of the problem is the patients, because many of them believe that they just slipped and fell and it’s not going to happen again, or they’re not prone to it.

The second issue was when patients did go to a primary care physician, we have found that some primary care physicians believe that falling and injuring themselves is just part of the normal aging process. A percentage of them don’t go over assessment for fall risk or even initiate fall prevention treatments or programs. 

I try to take that time to tell them that this is very common in their age group, and believe it or not, a fall from standing is the way people really injure themselves, and there may be ways to prevent subsequent falls and injuries. 

Dr. Glatter: Absolutely. Do you find that their medications are a contributor in some sense? Say they’re antihypertensive, have issues of orthostasis, or a new medication was added in the last week. 

Dr. Shenvi: It’s all of the above. Sometimes it’s one thing, like they just started tamsulosin for their kidney stone, they stood up, they felt lightheaded, and they fell. Usually, it’s multifactorial with some changes in their gait, vision, balance, reflex time, and strength, plus the medications or the need for assistive devices. Maybe they can’t take care of their home as well as they used to and there are things on the floor. It’s really all of the above.
 

‘Harder to Unlearn Something Than to Learn It’

Dr. Glatter: Would either of you like to add any additional points to the discussion or add a few pearls? 

Dr. Shenvi: This just highlights the challenge of how it’s harder to unlearn something than to learn it, where one study that maybe wasn’t quite looking at what we needed to, or practice and prescribing patterns have changed, so it’s no longer really relevant. 

The things that we learned from that, or the fears that we instilled in our minds of, Uh oh, they could go home and have delayed bleeding, are much harder to unlearn, and it takes more studies to unlearn that idea than it did to actually put it into place. 

I’m glad that your team has done this much larger, prospective study and hopefully will reduce the concern about this entity. 

Dr. Shih: I appreciate that segue. It is amazing that, for paramedics and medical students, the first thing out of their mouth is, “Are they on an anticoagulant?”

In terms of the risk of developing an intracranial hemorrhage, I think it’s much less than the weight we’ve put on it before. However, I believe if they have a bleed, the bleeds are worse. It’s kind of a double-edged sword. It’s still an important factor, but it doesn’t come with the Oh my gosh, they’re on an anticoagulant that everybody thinks about.
 

No. 1 Cause of Traumatic Injury Is a Fall from Standing

Dr. Glatter: These are obviously ground-level falls in most patients and not motor vehicle crashes. That’s an important part in the population that you looked at that should be mentioned clearly. 

Dr. Shih: It’s astonishing. I’ve been a program director for over 20 years, and geriatrics is not well taught in the curriculum. It’s astonishing for many of our trainees and emergency physicians in general that the number-one cause for traumatic injury is a fall from standing.

Certainly, we get patients coming in the trauma center like a 95-year-old person who’s on a ladder putting up his Christmas lights. I’m like, oh my God. 

For the vast majority, it’s closer to 90%, but in our study, for the patients we looked at, it was 80% that fall from standing. That’s the mechanism that causes these bleeds and these major injuries. 

Dr. Shenvi: That’s reflective of what we see, so it’s good that that’s what you looked at also. 

Dr. Glatter: Absolutely. Well, thank you both. This has been a very informative discussion. I appreciate your time, and our readers will certainly benefit from your knowledge and expertise. Thank you again.

Dr. Glatter, assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, is a medical adviser for this news organization. He disclosed having no relevant financial conflicts. Dr. Shih is professor of emergency medicine at the Charles E. Schmidt College of Medicine at Florida Atlantic University, Boca Raton. His current grant funding and area of research interest involves geriatric emergency department patients with head injury and fall-related injury. He disclosed receiving a research grant from The Florida Medical Malpractice Joint Underwriting Association Grant for Safety of Health Care Services). Dr. Shenvi, associate professor of emergency medicine at the University of North Carolina at Chapel Hill, disclosed ties with the American College of Emergency Physicians, Institute for Healthcare Improvement, AstraZeneca, and CurvaFix.

A version of this article appeared on Medscape.com.

This discussion was recorded on August 2, 2024. This transcript has been edited for clarity. 

Robert D. Glatter, MD: Today, we’ll be discussing the results of a new study published in The Journal of Emergency Medicine, looking at the incidence of delayed intracranial hemorrhage among older patients taking preinjury anticoagulants who present to the emergency department (ED) with blunt head trauma.

Joining me today is the lead author of the study, Dr. Richard Shih, professor of emergency medicine at Florida Atlantic University. Also joining me is Dr. Christina Shenvi, associate professor of emergency medicine at the University of North Carolina (UNC) Chapel Hill, with fellowship training in geriatric emergency medicine. 

Welcome to both of you.

Richard D. Shih, MD: Thanks, Rob. 

Christina L. Shenvi, MD, PhD, MBA: Thanks. Pleasure to be here. 
 

ICH Study Methodology

Dr. Glatter: It’s a pleasure to have you. Rich, this is a great study and targeted toward a population we see daily in the emergency department. I want you to describe your methodology, patient selection, and how you went about organizing your study to look at this important finding of delayed intracranial hemorrhage, especially in those on anticoagulants.

Dr. Shih: This all started for our research team when we first read the 2012 Annals of Emergency Medicine paper. The first author was Vincenzo Menditto, and he looked at a group of patients that had minor head injury, were anticoagulated, and had negative initial head CTs. 

There were about 100 patients, of which about 10 of them did not consent, but they hospitalized all these patients. These were anticoagulated, negative-first head CTs. They hospitalized the patients and then did a routine second CT at about 24 hours. They also followed them for a week, and it turned out a little over 7% of them had delayed head CT. 

We were wondering how many delayed intracranial hemorrhages we had missed because current practice for us was that, if patients had a good physical exam, their head CT was normal, and everything looked good, we would send them home.

Because of that, a number of people across the country wanted to verify those findings from the Menditto study. We tried to design a good study to answer that question. We happen to have a very large geriatric population in Florida, and our ED census is very high for age over 65, at nearly 60%. 

There are two Level I trauma centers in Palm Beach County. We included a second multicenter hospital, and we prospectively enrolled patients. We know the current state of practice is not to routinely do second CTs, so we followed these patients over time and followed their medical records to try to identify delayed bleeding. That’s how we set up our methodology.
 

Is It Safe to Discharge Patients With Trauma After 24 Hours?

Dr. Glatter: For the bulk of these patients with negative head CTs, it’s been my practice that when they’re stable and they look fine and there’s no other apparent, distracting painful trauma, injuries and so forth, they’re safe to discharge. 

The secondary outcome in your study is interesting: the need for neurosurgical intervention in terms of those with delayed intracranial hemorrhage.

Dr. Shih: I do believe that it’s certainly not the problem that Menditto described, which is 7%. There are two other prospective studies that have looked at this issue with delayed bleeding on anticoagulants. Both of these also showed a relatively low rate of delayed bleeding, which is between like 0.2% and 1.0%. In our study, it was 0.4%. 

The difference in the studies is that Menditto and colleagues routinely did 24-hour head CTs. They admitted everybody. For these other studies, routine head CT was not part of it. My bet is that there is a rate of delayed bleeding somewhere in between that seen in the Menditto study and that in all the other studies.

However, talking about significant intracranial hemorrhage, ones that perhaps need neurosurgery, I believe most of them are not significant. There’s some number that do occur, but the vast majority of those probably don’t need neurosurgery. We had 14 delayed bleeds out of 6000 patients with head trauma. One of them ended up requiring neurosurgery, so the answer is not zero, but I don’t think it’s 7% either. 

Dr. Glatter: Dr. Shenvi, I want to bring you into the conversation to talk about your experience at UNC, and how you run things in terms of older patients with blunt head trauma on preinjury anticoagulants.

Dr. Shenvi: Thanks, Rob. I remember when this paper came out showing this 7% rate of delayed bleeding and the question was, “Should we be admitting all these people?” Partly just from an overwhelming need for capacity that that would bring, it just wasn’t practical to say, “We’re going to admit every patient with a negative head CT to the hospital and rescan them.” That would be hundreds or thousands of patients each year in any given facility. 

The other thing is that delayed bleeds don’t always happen just in the first 24 hours. It’s not even a matter of bringing patients into observation for 24 hours, watching them, and rescanning them if they have symptoms. It can occur several days out. That never, in almost any institution that I know of, became standard practice. 

The way that it did change my care was to give good return precautions to patients, to make sure they have somebody with them to say, “Hey, sometimes you can have bleeding several days out after a fall, even though your CT scan here today looks perfect,” and to alert them that if they start having severe headaches, vomiting, or other symptoms of intracranial hemorrhage, that they should come back. 

I don’t think it ever became standard practice, and for good reason, because that was one study. The subsequent studies that Richard mentioned, pretty quickly on the heels of that initial one, showed a much lower rate of delayed ICH with the caveats that the methodology was different. 
 

Shift in Anticoagulants

Dr. Shenvi: One other big change from that original study, and now to Richard’s study, is the shift in anticoagulants. Back in the initial study you mentioned, it was all warfarin. We know from other studies looking at warfarin vs the direct oral anticoagulants (DOACs) that DOACs have lower rates of ICH after a head injury, lower rates of need for neurosurgical intervention, and lower rates of discharge to a skilled nursing facility after an intracranial hemorrhage.

Across the board, we know that the DOACs tend to do better. It’s difficult to compare newer studies because it’s a different medication. It did inform my practice to have an awareness of delayed intracranial hemorrhage so that I warn patients more proactively. 

Dr. Glatter: I haven’t seen a patient on warfarin in years. I don’t know if either of you have, but it’s all DOACs now unless there’s some other reason. That shift is quite apparent.

Dr. Shih: The problem with looking at delayed bleeding for DOACs vs warfarin is the numbers were so low. I think we had 13 people, and seven were in the no-anticoagulant group. The numbers are even lower, so it’s hard to say. 

I just wanted to comment on something that Dr. Shenvi said, and I pretty much agree with everything that she said. Anticoagulants and warfarin, and that Menditto study, have a carryover effect. People group DOACs with warfarin similarly. When a patient is brought in, the first thing they talk about with head trauma is, “Oh, they’re on an anticoagulant” or “They’re not on an anticoagulant.” It’s so ingrained.

I believe that, in emergency medicine, we’re pressed for space and time and we’re not as affected by that 24-hour observation. Maybe many of our surgeons will automatically admit those patients. 

I haven’t seen a guideline from the United States, but there are two international guidelines. One is from Austria from 2019, and one is from Scandinavia. Both recommended 24-hour observation if you’re on an anticoagulant.

There is a bit of controversy left over with that. Hopefully, as more and more of information, like in our study, comes out, people will be a little bit more clear about it. I don’t think there’s a need to routinely admit them. 

I do want to mention that the Menditto study had such a massive impact on everybody. They pointed out one subgroup (and it’s such a small number of patients). They had seven cases of delayed bleeding; four or five of them were within that 24 hours, and a couple were diagnosed later over the next couple days.

Of those seven people, four of them had international normalized ratios (INRs) greater than 3. Of those four patients, I’ve heard people talk about this and recommend, “Okay, that’s the subgroup I would admit.” There’s a toss-up with what to do with DOAC because it’s very hard to tell whether there’s an issue, whether there are problems with their dosing, and whatever. 

We actually recently looked at that. We have a much larger sample than four: close to 300 patients who were on warfarin. We looked at patients who had INRs below 3 and above 3, and we didn’t show a difference. We still don’t believe that warfarin is a big issue with delayed bleeding.
 

Should We Be Asking: ‘Are They on Blood Thinners?’

Dr. Shenvi: One of the interesting trends related to warfarin and the DOACs vs no anticoagulant is that as you mentioned, Dr Shih, the first question out of people’s mouths or the first piece of information emergency medical services gives you when they come in with a patient who’s had a head injury is, “Are they on blood thinners or not?”

Yet, the paradigm is shifting to say it’s not actually the blood thinners themselves that are giving older patients the higher risk for bleeding; it’s age and other comorbidities.

Certainly, if you’re on an anticoagulant and you start to bleed, your prognosis is much worse because the bleeding doesn’t stop. In terms of who has a bleeding event, there’s much less impact of anticoagulation than we used to think. That, in part, may be due to the change from warfarin to other medications.

Some of the experts I’ve talked to who have done the research on this have said, “Well, actually, warfarin was more of a marker for being much older and more frail, because it was primarily prescribed to older patients who have significant heart disease, atrial fibrillation, and so on.” It was more a marker for somebody who is at risk for an intracranial hemorrhage. There are many changes that have happened in the past 10 years with medications and also our understanding. 
 

Challenges in Patient Follow-up

Dr. Glatter: That’s a great point. One thing, Rich, I want to ask you about is in terms of your proxy outcome assessment. When you use that at 14 and 60 days with telephone follow-up and then chart review at 60 and 90 days (because, obviously, everyone can’t get another head CT or it’s difficult to follow patients up), did you find that worked out well in your prospective cohort study, in terms of using that as a proxy, so to speak? 

Dr. Shih: I would say to a certain extent. Unfortunately, we don’t have access to the patients to come back to follow up all of them, and there was obviously a large number of patients in our study. 

The next best thing was that we had dedicated research assistants calling all of the patients at 14 days and 60 days. I’ve certainly read research studies where, when they call them, they get 80%-90% follow-up, but we did not achieve that.

I don’t know if people are more inundated with spam phone calls now, or the older people are just afraid of picking up their phone sometimes with all the scams and so forth. I totally understand, but in all honesty, we only had about a 30%-35% follow-up using that follow-up pathway. 

Then the proxy pathway was to look at their charts at 60 and 90 days. Also, we looked at the Florida death registry, which is pretty good, and then finally, we had both Level I trauma centers in the county that we were in participating. It’s standard practice that if you have an intracranial hemorrhage at a non–Level I trauma center, you would be transferred to a Level I trauma center. That’s the protocol. I know that’s not followed 100% of the time, but that’s part of the proxy follow-up. You could criticize the study for not having closer to 90% actual contact, but that’s the best we could do. 

Dr. Glatter: I think that’s admirable. Using that paradigm of what you described certainly allows the reader to understand the difficulty in assessing patients that don’t get follow-up head CT, and hardly anyone does that, as we know.

To your point of having both Level I trauma centers in the county, that makes it pretty secure. If we’re going to do a study encompassing a similar type of regional aspect, it would be similar.

Dr. Shenvi: I think your proxies, to your credit, were as good as you can get. You can never get a 100% follow-up, but you really looked at all the different avenues by which patients might present, either in the death registry or a Level I center. Well done on that aspect.

 

Determining When to Admit Patients for Observation

Dr. Glatter: In terms of admissions: You admit a patient, then you hear back that this patient should not have been admitted because they had a negative head CT, but you put them in anyway in the sense of delayed bleeding happening or not happening.

It’s interesting. Maybe the insurers will start looking at this in some capacity, based on your study, that because it’s so infrequent that you see delayed bleeding, that admitting someone for any reason whatsoever would be declined. Do you see that being an issue? In other words, [do you see] this leading to a pattern in terms of the payers?

Dr. Shih: Certainly, you could interpret it that way, and that would be unfortunate. The [incidence of] delayed bleeding is definitely not zero. That’s the first thing. 

The second thing is that when you’re dealing with an older population, having some sense that they’re not doing well is an important contributor to trying to fully assess what’s going on — whether or not they have a bleed or whether they’re at risk for falling again and then hitting their head and causing a second bleed, and making sure they can do the activities of daily life. There really should be some room for a physician to say, “They just got here, and we don’t know him that well. There’s something that bothers me about this person” and have the ability to watch them for at least another 24 hours. That’s how I feel. 

Dr. Shenvi: In my location, it would be difficult to try to admit somebody purely for observation for delayed bleeding. I think we would get a lot of pushback on that. The reasons I might admit a patient after a fall with a negative head CT, though, are all the things that, Rob, you alluded to earlier — which are, what made them fall in the first place and were they unable to get up? 

I had this happen just this week. A patient who fell couldn’t get off the ground for 12 hours, and so now she’s dehydrated and delirious with slight rhabdomyolysis. Then you’re admitting them either for the sequelae of the fall that are not related to the intracranial hemorrhage, or the fact that they are so debilitated and deconditioned that they cannot take care of themselves. They need physical therapy. Often, we will have physical and occupational therapists come see them in the ED during business hours and help make an assessment of whether they are safe to go home or whether they fall again. That can give more evidence for the need for admission.

Dr. Glatter: To bring artificial intelligence into this discussion, algorithms that are out there that say, “Push a button and the patient’s safe for discharge.” Well, this argues for a clinical gestalt and a human being to make an assessment because you can use these predictive models, which are coming and they’re going to be here soon, and they already are in some sense. Again, we have to use clinical human judgment. 

Dr. Shih: I agree. 
 

Advice for Primary Care Physicians

Dr. Glatter: What return precautions do you discuss with patients who’ve had blunt head trauma that maybe had a head CT, or even didn’t? What are the main things we’re looking for?

Dr. Shenvi: What I usually tell people is if you start to have a worse headache, nausea or vomiting, any weakness in one area of your body, or vision changes, and if there’s a family member or friend there, I’ll say, “If you notice that they’re acting differently or seem confused, come back.”

Dr. Shih: I agree with what she said, and I’m also going to add one thing. The most important part is they are trying to prevent a subsequent fall. We know that when they’ve fallen and they present to the ED, they’re at even higher risk for falling and reinjuring themselves, and that’s a population that’s already at risk.

One of the secondary studies that we published out of this project was looking at follow-up with their primary care physicians, and there were two things that we wanted to address. The first was, how often did they do it? Then, when they did do it, did their primary care physicians try to address and prevent subsequent falls?

Both the answers are actually bad. Amazingly, just over like 60% followed up. 

In some of our subsequent research, because we’re in the midst of a randomized, controlled trial where we do a home visit, when we initially see these individuals that have fallen, they’ll schedule a home visit for us. Then a week or two later, when we schedule the home visit, many of them cancel because they think, Oh, that was a one-off and it’s not going to happen again. Part of the problem is the patients, because many of them believe that they just slipped and fell and it’s not going to happen again, or they’re not prone to it.

The second issue was when patients did go to a primary care physician, we have found that some primary care physicians believe that falling and injuring themselves is just part of the normal aging process. A percentage of them don’t go over assessment for fall risk or even initiate fall prevention treatments or programs. 

I try to take that time to tell them that this is very common in their age group, and believe it or not, a fall from standing is the way people really injure themselves, and there may be ways to prevent subsequent falls and injuries. 

Dr. Glatter: Absolutely. Do you find that their medications are a contributor in some sense? Say they’re antihypertensive, have issues of orthostasis, or a new medication was added in the last week. 

Dr. Shenvi: It’s all of the above. Sometimes it’s one thing, like they just started tamsulosin for their kidney stone, they stood up, they felt lightheaded, and they fell. Usually, it’s multifactorial with some changes in their gait, vision, balance, reflex time, and strength, plus the medications or the need for assistive devices. Maybe they can’t take care of their home as well as they used to and there are things on the floor. It’s really all of the above.
 

‘Harder to Unlearn Something Than to Learn It’

Dr. Glatter: Would either of you like to add any additional points to the discussion or add a few pearls? 

Dr. Shenvi: This just highlights the challenge of how it’s harder to unlearn something than to learn it, where one study that maybe wasn’t quite looking at what we needed to, or practice and prescribing patterns have changed, so it’s no longer really relevant. 

The things that we learned from that, or the fears that we instilled in our minds of, Uh oh, they could go home and have delayed bleeding, are much harder to unlearn, and it takes more studies to unlearn that idea than it did to actually put it into place. 

I’m glad that your team has done this much larger, prospective study and hopefully will reduce the concern about this entity. 

Dr. Shih: I appreciate that segue. It is amazing that, for paramedics and medical students, the first thing out of their mouth is, “Are they on an anticoagulant?”

In terms of the risk of developing an intracranial hemorrhage, I think it’s much less than the weight we’ve put on it before. However, I believe if they have a bleed, the bleeds are worse. It’s kind of a double-edged sword. It’s still an important factor, but it doesn’t come with the Oh my gosh, they’re on an anticoagulant that everybody thinks about.
 

No. 1 Cause of Traumatic Injury Is a Fall from Standing

Dr. Glatter: These are obviously ground-level falls in most patients and not motor vehicle crashes. That’s an important part in the population that you looked at that should be mentioned clearly. 

Dr. Shih: It’s astonishing. I’ve been a program director for over 20 years, and geriatrics is not well taught in the curriculum. It’s astonishing for many of our trainees and emergency physicians in general that the number-one cause for traumatic injury is a fall from standing.

Certainly, we get patients coming in the trauma center like a 95-year-old person who’s on a ladder putting up his Christmas lights. I’m like, oh my God. 

For the vast majority, it’s closer to 90%, but in our study, for the patients we looked at, it was 80% that fall from standing. That’s the mechanism that causes these bleeds and these major injuries. 

Dr. Shenvi: That’s reflective of what we see, so it’s good that that’s what you looked at also. 

Dr. Glatter: Absolutely. Well, thank you both. This has been a very informative discussion. I appreciate your time, and our readers will certainly benefit from your knowledge and expertise. Thank you again.

Dr. Glatter, assistant professor of emergency medicine at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, is a medical adviser for this news organization. He disclosed having no relevant financial conflicts. Dr. Shih is professor of emergency medicine at the Charles E. Schmidt College of Medicine at Florida Atlantic University, Boca Raton. His current grant funding and area of research interest involves geriatric emergency department patients with head injury and fall-related injury. He disclosed receiving a research grant from The Florida Medical Malpractice Joint Underwriting Association Grant for Safety of Health Care Services). Dr. Shenvi, associate professor of emergency medicine at the University of North Carolina at Chapel Hill, disclosed ties with the American College of Emergency Physicians, Institute for Healthcare Improvement, AstraZeneca, and CurvaFix.

A version of this article appeared on Medscape.com.

The ABYSS trial found that interruption of beta-blocker therapy in patients after myocardial infarction (MI) was not noninferior to continuing the drugs. 

I will argue why I think it is okay to stop beta-blockers after MI — despite this conclusion. The results of ABYSS are, in fact, similar to REDUCE-AMI, which compared beta-blocker use or nonuse immediately after MI, and found no difference in a composite endpoint of death or MI. 

Translation of the ABYSS trial results to patient care is a case where we must look past the paper’s abstract and conclusions. The key problem is the authors’ choice of primary endpoint, which obscures the correct clinical answer.
 

The ABYSS Trial

ABYSS investigators randomly assigned nearly 3700 patients who had MI and were prescribed a beta-blocker to either continue (control arm) or stop (active arm) the drug at 1 year. 

Patients had to have a left ventricular ejection fraction (LVEF) at least 40%; the median was 60%. 

The composite primary endpoint included death, MI, stroke, or hospitalization for any cardiovascular reason. ABYSS authors chose a noninferiority design. The assumption must have been that the interruption arm offered an easier option for patients — eg, fewer pills. 

Over 3 years, a primary endpoint occurred in 23.8% of the interruption group vs 21.1% in the continuation group. 

In ABYSS, the noninferiority margin was set at a 3% absolute risk increase. The 2.7% absolute risk increase had an upper bound of the 95% CI (worst case) of 5.5% leading to the not-noninferior conclusion (5.5% exceeds the noninferiority margins). 

More simply stated, the primary outcome event rate was higher in the interruption arm. 
 

Does This Mean we Should Continue Beta-Blockers in Post-MI Patients?

This led some to conclude that we should continue beta-blockers. I disagree. To properly interpret the ABYSS trial, you must consider trial procedures, components of the primary endpoint, and then compare ABYSS with REDUCE-AMI. 

It’s also reasonable to have extremely pessimistic prior beliefs about post-MI beta-blockade because the evidence establishing benefit comes from trials conducted before urgent revascularization became the standard therapy. 

ABYSS was a pragmatic open-label trial. The core problem with this design is that one of the components of the primary outcome (hospitalization for cardiovascular reasons) requires clinical judgment — and is therefore susceptible to bias, particularly in an open-label trial. 

This becomes apparent when we look at the components of the primary outcome in the two arms of the trial (interrupt vs continue): 

• For death, the rates were 4.1 and 4.0%
• For MI, the rates were 2.5 and 2.4%
• For stroke, the rates were 1.0% in both arms
• For CV hospitalization, the rates were 18.9% vs 16.6%

The higher rate CV hospitalization alone drove the results of ABYSS. Death, MI, and stroke rates were nearly identical. 

The most common reason for admission to the hospital in this category was for angiography. In fact, the rate of angiography was 2.3% higher in the interruption arm — identical to the rate increase in the CV hospitalization component of the primary endpoint. 

The results of ABYSS, therefore, were driven by higher rates of angiography in the interrupt arm. 

You need not imply malfeasance to speculate that patients who had their beta-blocker stopped might be treated differently regarding hospital admissions or angiography than those who stayed on beta-blockers. Researchers from Imperial College London called such a bias in unblinded trials “subtraction anxiety and faith healing.”

Had the ABYSS investigators chosen the simpler, less bias-prone endpoints of death, MI, or stroke, their results would have been the same as REDUCE-AMI. 
 

My Final Two Conclusions

I would conclude that interruption of beta-blockers at 1 year vs continuation in post-MI patients did not lead to an increase in death, MI, or stroke. 

ABYSS, therefore, is consistent with REDUCE-AMI. Taken together, along with the pessimistic priors, these are important findings because they allow us to stop a medicine and reduce the work of being a patient. 

My second conclusion concerns ways of knowing in medicine. I’ve long felt that randomized controlled trials (RCTs) are the best way to sort out causation. This idea led me to the believe that medicine should have more RCTs rather than follow expert opinion or therapeutic fashion. 

I’ve now modified my love of RCTs — a little. The ABYSS trial is yet another example of the need to be super careful with their design.

Something as seemingly simple as choosing what to measure can alter the way clinicians interpret and use the data. 

So, let’s have (slightly) more trials, but we should be really careful in their design. Slow and careful is the best way to practice medicine. And it’s surely the best way to do research as well.

Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The ABYSS trial found that interruption of beta-blocker therapy in patients after myocardial infarction (MI) was not noninferior to continuing the drugs. 

I will argue why I think it is okay to stop beta-blockers after MI — despite this conclusion. The results of ABYSS are, in fact, similar to REDUCE-AMI, which compared beta-blocker use or nonuse immediately after MI, and found no difference in a composite endpoint of death or MI. 

Translation of the ABYSS trial results to patient care is a case where we must look past the paper’s abstract and conclusions. The key problem is the authors’ choice of primary endpoint, which obscures the correct clinical answer.
 

The ABYSS Trial

ABYSS investigators randomly assigned nearly 3700 patients who had MI and were prescribed a beta-blocker to either continue (control arm) or stop (active arm) the drug at 1 year. 

Patients had to have a left ventricular ejection fraction (LVEF) at least 40%; the median was 60%. 

The composite primary endpoint included death, MI, stroke, or hospitalization for any cardiovascular reason. ABYSS authors chose a noninferiority design. The assumption must have been that the interruption arm offered an easier option for patients — eg, fewer pills. 

Over 3 years, a primary endpoint occurred in 23.8% of the interruption group vs 21.1% in the continuation group. 

In ABYSS, the noninferiority margin was set at a 3% absolute risk increase. The 2.7% absolute risk increase had an upper bound of the 95% CI (worst case) of 5.5% leading to the not-noninferior conclusion (5.5% exceeds the noninferiority margins). 

More simply stated, the primary outcome event rate was higher in the interruption arm. 
 

Does This Mean we Should Continue Beta-Blockers in Post-MI Patients?

This led some to conclude that we should continue beta-blockers. I disagree. To properly interpret the ABYSS trial, you must consider trial procedures, components of the primary endpoint, and then compare ABYSS with REDUCE-AMI. 

It’s also reasonable to have extremely pessimistic prior beliefs about post-MI beta-blockade because the evidence establishing benefit comes from trials conducted before urgent revascularization became the standard therapy. 

ABYSS was a pragmatic open-label trial. The core problem with this design is that one of the components of the primary outcome (hospitalization for cardiovascular reasons) requires clinical judgment — and is therefore susceptible to bias, particularly in an open-label trial. 

This becomes apparent when we look at the components of the primary outcome in the two arms of the trial (interrupt vs continue): 

• For death, the rates were 4.1 and 4.0%
• For MI, the rates were 2.5 and 2.4%
• For stroke, the rates were 1.0% in both arms
• For CV hospitalization, the rates were 18.9% vs 16.6%

The higher rate CV hospitalization alone drove the results of ABYSS. Death, MI, and stroke rates were nearly identical. 

The most common reason for admission to the hospital in this category was for angiography. In fact, the rate of angiography was 2.3% higher in the interruption arm — identical to the rate increase in the CV hospitalization component of the primary endpoint. 

The results of ABYSS, therefore, were driven by higher rates of angiography in the interrupt arm. 

You need not imply malfeasance to speculate that patients who had their beta-blocker stopped might be treated differently regarding hospital admissions or angiography than those who stayed on beta-blockers. Researchers from Imperial College London called such a bias in unblinded trials “subtraction anxiety and faith healing.”

Had the ABYSS investigators chosen the simpler, less bias-prone endpoints of death, MI, or stroke, their results would have been the same as REDUCE-AMI. 
 

My Final Two Conclusions

I would conclude that interruption of beta-blockers at 1 year vs continuation in post-MI patients did not lead to an increase in death, MI, or stroke. 

ABYSS, therefore, is consistent with REDUCE-AMI. Taken together, along with the pessimistic priors, these are important findings because they allow us to stop a medicine and reduce the work of being a patient. 

My second conclusion concerns ways of knowing in medicine. I’ve long felt that randomized controlled trials (RCTs) are the best way to sort out causation. This idea led me to the believe that medicine should have more RCTs rather than follow expert opinion or therapeutic fashion. 

I’ve now modified my love of RCTs — a little. The ABYSS trial is yet another example of the need to be super careful with their design.

Something as seemingly simple as choosing what to measure can alter the way clinicians interpret and use the data. 

So, let’s have (slightly) more trials, but we should be really careful in their design. Slow and careful is the best way to practice medicine. And it’s surely the best way to do research as well.

Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The ABYSS trial found that interruption of beta-blocker therapy in patients after myocardial infarction (MI) was not noninferior to continuing the drugs. 

I will argue why I think it is okay to stop beta-blockers after MI — despite this conclusion. The results of ABYSS are, in fact, similar to REDUCE-AMI, which compared beta-blocker use or nonuse immediately after MI, and found no difference in a composite endpoint of death or MI. 

Translation of the ABYSS trial results to patient care is a case where we must look past the paper’s abstract and conclusions. The key problem is the authors’ choice of primary endpoint, which obscures the correct clinical answer.
 

The ABYSS Trial

ABYSS investigators randomly assigned nearly 3700 patients who had MI and were prescribed a beta-blocker to either continue (control arm) or stop (active arm) the drug at 1 year. 

Patients had to have a left ventricular ejection fraction (LVEF) at least 40%; the median was 60%. 

The composite primary endpoint included death, MI, stroke, or hospitalization for any cardiovascular reason. ABYSS authors chose a noninferiority design. The assumption must have been that the interruption arm offered an easier option for patients — eg, fewer pills. 

Over 3 years, a primary endpoint occurred in 23.8% of the interruption group vs 21.1% in the continuation group. 

In ABYSS, the noninferiority margin was set at a 3% absolute risk increase. The 2.7% absolute risk increase had an upper bound of the 95% CI (worst case) of 5.5% leading to the not-noninferior conclusion (5.5% exceeds the noninferiority margins). 

More simply stated, the primary outcome event rate was higher in the interruption arm. 
 

Does This Mean we Should Continue Beta-Blockers in Post-MI Patients?

This led some to conclude that we should continue beta-blockers. I disagree. To properly interpret the ABYSS trial, you must consider trial procedures, components of the primary endpoint, and then compare ABYSS with REDUCE-AMI. 

It’s also reasonable to have extremely pessimistic prior beliefs about post-MI beta-blockade because the evidence establishing benefit comes from trials conducted before urgent revascularization became the standard therapy. 

ABYSS was a pragmatic open-label trial. The core problem with this design is that one of the components of the primary outcome (hospitalization for cardiovascular reasons) requires clinical judgment — and is therefore susceptible to bias, particularly in an open-label trial. 

This becomes apparent when we look at the components of the primary outcome in the two arms of the trial (interrupt vs continue): 

• For death, the rates were 4.1 and 4.0%
• For MI, the rates were 2.5 and 2.4%
• For stroke, the rates were 1.0% in both arms
• For CV hospitalization, the rates were 18.9% vs 16.6%

The higher rate CV hospitalization alone drove the results of ABYSS. Death, MI, and stroke rates were nearly identical. 

The most common reason for admission to the hospital in this category was for angiography. In fact, the rate of angiography was 2.3% higher in the interruption arm — identical to the rate increase in the CV hospitalization component of the primary endpoint. 

The results of ABYSS, therefore, were driven by higher rates of angiography in the interrupt arm. 

You need not imply malfeasance to speculate that patients who had their beta-blocker stopped might be treated differently regarding hospital admissions or angiography than those who stayed on beta-blockers. Researchers from Imperial College London called such a bias in unblinded trials “subtraction anxiety and faith healing.”

Had the ABYSS investigators chosen the simpler, less bias-prone endpoints of death, MI, or stroke, their results would have been the same as REDUCE-AMI. 
 

My Final Two Conclusions

I would conclude that interruption of beta-blockers at 1 year vs continuation in post-MI patients did not lead to an increase in death, MI, or stroke. 

ABYSS, therefore, is consistent with REDUCE-AMI. Taken together, along with the pessimistic priors, these are important findings because they allow us to stop a medicine and reduce the work of being a patient. 

My second conclusion concerns ways of knowing in medicine. I’ve long felt that randomized controlled trials (RCTs) are the best way to sort out causation. This idea led me to the believe that medicine should have more RCTs rather than follow expert opinion or therapeutic fashion. 

I’ve now modified my love of RCTs — a little. The ABYSS trial is yet another example of the need to be super careful with their design.

Something as seemingly simple as choosing what to measure can alter the way clinicians interpret and use the data. 

So, let’s have (slightly) more trials, but we should be really careful in their design. Slow and careful is the best way to practice medicine. And it’s surely the best way to do research as well.

Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

LONDON — It may not be advisable for patients with a history of myocardial infarction and preserved left ventricular function to discontinue long-term beta-blocker therapy, warn investigators.

In the randomized ABYSS trial, although there was no difference in death, MI, or stroke between patients who discontinued and those who continued taking beta-blockers, those who stopped taking the drugs had a higher rate of cardiovascular hospitalization.

Discontinuation was also associated with an increase in blood pressure and heart rate, without any improvement in quality of life.

“We thought we would be able to withdraw beta-blockers safely and that this would result in improved quality of life, but our trial results suggest this is not the case,” said lead investigator Johanne Silvain, MD, PhD, from Pitié-Salpêtrière University Hospital in Paris, who presented the ABYSS findings here at the European Society of Cardiology (ESC) Congress. 

The results, which were simultaneously published online in The New England Journal of Medicine, call into question current guidelines, which suggest that beta-blockers may be discontinued after 1 year in certain patient groups.

Beta-blockers have long been considered the standard of care for patients after MI, but trials showing the benefit of these drugs were conducted before the modern era of myocardial reperfusion and pharmacotherapy, which have led to sharp decreases in the risk for heart failure and for death after MI, Dr. Silvain explained. 

This has led to questions about the add-on benefits of lifelong beta-blocker treatment for patients with MI and a preserved left ventricular ejection fraction and no other primary indication for beta-blocker therapy.
 

The ABYSS Trial

To explore this issue, the open-label, non-inferiority ABYSS trial randomly assigned 3698 patients with a history of MI to the discontinuation or continuation of beta-blocker treatment. All study participants had a left ventricular ejection fraction of at least 40%, were receiving long-term beta-blocker treatment, and had experienced no cardiovascular event in the previous 6 months. 

At a median follow-up of 3 years, the primary endpoint — a composite of death, MI, stroke, and hospitalization for cardiovascular reasons — occurred more often in the discontinuation group than in the continuation group (23.8% vs 21.1%; hazard ratio, 1.16; 95% CI, 1.01-1.33). This did not meet the criteria for non-inferiority of discontinuation, compared with continuation, of beta-blocker therapy (P for non-inferiority = .44).

The difference in event rates between the two groups was driven by cardiovascular hospitalizations, which occurred more often in the discontinuation group than in the continuation group (18.9% vs 16.6%).

Other key results showed that there was no difference in quality of life between the two groups.

However, 6 months after randomization, there were increases in blood pressure and heart rate in the discontinuation group. Systolic blood pressure increased by 3.7 mm Hg and diastolic blood pressure increased by 3.9 mm Hg. Resting heart rate increased by 9.8 beats per minute.

“We were not able to show the non-inferiority of stopping beta-blockers in terms of cardiovascular events, [but we] showed a safety signal with this strategy of an increase in blood pressure and heart rate, with no improvement in quality of life,” Dr. Sylvain said.

“While recent guidelines suggest it may be reasonable to stop beta-blockers in this population, after these results, I will not be stopping these drugs if they are being well tolerated,” he said.

Sylvain said he was surprised that there was not an improvement in quality of life in the group that discontinued beta-blockers. “We are always told that beta-blockers have many side effects, so we expected to see an improvement in quality of life in the patients who stopped these drugs.”

One possible reason for the lack of improvement in quality of life is that the trial participants had been taking beta-blockers for several years. “We may have, therefore, selected patients who tolerate these drugs quite well. Those who had tolerance issues had probably already stopped taking them,” he explained.

In addition, the patient population had relatively high quality-of-life scores at baseline. “They were well treated and the therapies they were taking were well tolerated, so maybe it is difficult to improve quality of life further,” he said.
 

The REDUCE-AMI Trial

The ABYSS results appear at first to differ from results from the recent REDUCE-AMI trial, which failed to show the superiority of beta-blocker therapy, compared with no beta-blocker therapy, in acute MI patients with preserved ejection fraction.

But the REDUCE-AMI primary endpoint was a composite of death from any cause or new myocardial infarction; it did not include cardiovascular hospitalization, which was the main driver of the difference in outcomes in the ABYSS study, Dr. Sylvain pointed out.

“We showed an increase in coronary cases of hospitalization with stopping beta-blockers, and you have to remember that beta-blockers were developed to reduce coronary disease,” he said.
 

‘Slightly Inconclusive’

Jane Armitage, MBBS, University of Oxford, England, the ABYSS discussant for the ESC HOTLINE session, pointed out some limitations of the study, which led her to report that the result was “slightly inconclusive.” 

The open-label design may have allowed some bias regarding the cardiovascular hospitalization endpoint, she said.

“The decision whether to admit a patient to [the] hospital is somewhat subjective and could be influenced by a physician’s knowledge of treatment allocation. That is why, ideally, we prefer blinded trials. I think there are questions there,” she explained.

She also questioned whether the non-inferiority margin could have been increased, given the higher-than-expected event rate.

More data on this issue will come from several trials that are currently ongoing, Dr. Armitage said.

The ABYSS and REDUCE-AMI trials together suggest that it is safe, with respect to serious cardiac events, to stop beta-blocker treatment in MI patients with preserved ejection fraction, writes Tomas Jernberg, MD, PhD, from the Karolinska Institute in Stockholm, Sweden, in an accompanying editorial.

However, “because of the anti-ischemic effects of beta-blockers, an interruption may increase the risk of recurrent angina and the need for rehospitalization,” he adds.

“It is prudent to wait for the results of additional ongoing trials of beta-blockers involving patients with MI and a preserved left ventricular ejection fraction before definitively updating guidelines,” Dr. Jernberg concludes.

The ABYSS trial was funded by the French Ministry of Health and the ACTION Study Group. Dr. Sylvain, Dr. Armitage, and Dr. Jernberg report no relevant financial relationships.

A version of this article appeared on Medscape.com.

LONDON — It may not be advisable for patients with a history of myocardial infarction and preserved left ventricular function to discontinue long-term beta-blocker therapy, warn investigators.

In the randomized ABYSS trial, although there was no difference in death, MI, or stroke between patients who discontinued and those who continued taking beta-blockers, those who stopped taking the drugs had a higher rate of cardiovascular hospitalization.

Discontinuation was also associated with an increase in blood pressure and heart rate, without any improvement in quality of life.

“We thought we would be able to withdraw beta-blockers safely and that this would result in improved quality of life, but our trial results suggest this is not the case,” said lead investigator Johanne Silvain, MD, PhD, from Pitié-Salpêtrière University Hospital in Paris, who presented the ABYSS findings here at the European Society of Cardiology (ESC) Congress. 

The results, which were simultaneously published online in The New England Journal of Medicine, call into question current guidelines, which suggest that beta-blockers may be discontinued after 1 year in certain patient groups.

Beta-blockers have long been considered the standard of care for patients after MI, but trials showing the benefit of these drugs were conducted before the modern era of myocardial reperfusion and pharmacotherapy, which have led to sharp decreases in the risk for heart failure and for death after MI, Dr. Silvain explained. 

This has led to questions about the add-on benefits of lifelong beta-blocker treatment for patients with MI and a preserved left ventricular ejection fraction and no other primary indication for beta-blocker therapy.
 

The ABYSS Trial

To explore this issue, the open-label, non-inferiority ABYSS trial randomly assigned 3698 patients with a history of MI to the discontinuation or continuation of beta-blocker treatment. All study participants had a left ventricular ejection fraction of at least 40%, were receiving long-term beta-blocker treatment, and had experienced no cardiovascular event in the previous 6 months. 

At a median follow-up of 3 years, the primary endpoint — a composite of death, MI, stroke, and hospitalization for cardiovascular reasons — occurred more often in the discontinuation group than in the continuation group (23.8% vs 21.1%; hazard ratio, 1.16; 95% CI, 1.01-1.33). This did not meet the criteria for non-inferiority of discontinuation, compared with continuation, of beta-blocker therapy (P for non-inferiority = .44).

The difference in event rates between the two groups was driven by cardiovascular hospitalizations, which occurred more often in the discontinuation group than in the continuation group (18.9% vs 16.6%).

Other key results showed that there was no difference in quality of life between the two groups.

However, 6 months after randomization, there were increases in blood pressure and heart rate in the discontinuation group. Systolic blood pressure increased by 3.7 mm Hg and diastolic blood pressure increased by 3.9 mm Hg. Resting heart rate increased by 9.8 beats per minute.

“We were not able to show the non-inferiority of stopping beta-blockers in terms of cardiovascular events, [but we] showed a safety signal with this strategy of an increase in blood pressure and heart rate, with no improvement in quality of life,” Dr. Sylvain said.

“While recent guidelines suggest it may be reasonable to stop beta-blockers in this population, after these results, I will not be stopping these drugs if they are being well tolerated,” he said.

Sylvain said he was surprised that there was not an improvement in quality of life in the group that discontinued beta-blockers. “We are always told that beta-blockers have many side effects, so we expected to see an improvement in quality of life in the patients who stopped these drugs.”

One possible reason for the lack of improvement in quality of life is that the trial participants had been taking beta-blockers for several years. “We may have, therefore, selected patients who tolerate these drugs quite well. Those who had tolerance issues had probably already stopped taking them,” he explained.

In addition, the patient population had relatively high quality-of-life scores at baseline. “They were well treated and the therapies they were taking were well tolerated, so maybe it is difficult to improve quality of life further,” he said.
 

The REDUCE-AMI Trial

The ABYSS results appear at first to differ from results from the recent REDUCE-AMI trial, which failed to show the superiority of beta-blocker therapy, compared with no beta-blocker therapy, in acute MI patients with preserved ejection fraction.

But the REDUCE-AMI primary endpoint was a composite of death from any cause or new myocardial infarction; it did not include cardiovascular hospitalization, which was the main driver of the difference in outcomes in the ABYSS study, Dr. Sylvain pointed out.

“We showed an increase in coronary cases of hospitalization with stopping beta-blockers, and you have to remember that beta-blockers were developed to reduce coronary disease,” he said.
 

‘Slightly Inconclusive’

Jane Armitage, MBBS, University of Oxford, England, the ABYSS discussant for the ESC HOTLINE session, pointed out some limitations of the study, which led her to report that the result was “slightly inconclusive.” 

The open-label design may have allowed some bias regarding the cardiovascular hospitalization endpoint, she said.

“The decision whether to admit a patient to [the] hospital is somewhat subjective and could be influenced by a physician’s knowledge of treatment allocation. That is why, ideally, we prefer blinded trials. I think there are questions there,” she explained.

She also questioned whether the non-inferiority margin could have been increased, given the higher-than-expected event rate.

More data on this issue will come from several trials that are currently ongoing, Dr. Armitage said.

The ABYSS and REDUCE-AMI trials together suggest that it is safe, with respect to serious cardiac events, to stop beta-blocker treatment in MI patients with preserved ejection fraction, writes Tomas Jernberg, MD, PhD, from the Karolinska Institute in Stockholm, Sweden, in an accompanying editorial.

However, “because of the anti-ischemic effects of beta-blockers, an interruption may increase the risk of recurrent angina and the need for rehospitalization,” he adds.

“It is prudent to wait for the results of additional ongoing trials of beta-blockers involving patients with MI and a preserved left ventricular ejection fraction before definitively updating guidelines,” Dr. Jernberg concludes.

The ABYSS trial was funded by the French Ministry of Health and the ACTION Study Group. Dr. Sylvain, Dr. Armitage, and Dr. Jernberg report no relevant financial relationships.

A version of this article appeared on Medscape.com.

LONDON — It may not be advisable for patients with a history of myocardial infarction and preserved left ventricular function to discontinue long-term beta-blocker therapy, warn investigators.

In the randomized ABYSS trial, although there was no difference in death, MI, or stroke between patients who discontinued and those who continued taking beta-blockers, those who stopped taking the drugs had a higher rate of cardiovascular hospitalization.

Discontinuation was also associated with an increase in blood pressure and heart rate, without any improvement in quality of life.

“We thought we would be able to withdraw beta-blockers safely and that this would result in improved quality of life, but our trial results suggest this is not the case,” said lead investigator Johanne Silvain, MD, PhD, from Pitié-Salpêtrière University Hospital in Paris, who presented the ABYSS findings here at the European Society of Cardiology (ESC) Congress. 

The results, which were simultaneously published online in The New England Journal of Medicine, call into question current guidelines, which suggest that beta-blockers may be discontinued after 1 year in certain patient groups.

Beta-blockers have long been considered the standard of care for patients after MI, but trials showing the benefit of these drugs were conducted before the modern era of myocardial reperfusion and pharmacotherapy, which have led to sharp decreases in the risk for heart failure and for death after MI, Dr. Silvain explained. 

This has led to questions about the add-on benefits of lifelong beta-blocker treatment for patients with MI and a preserved left ventricular ejection fraction and no other primary indication for beta-blocker therapy.
 

The ABYSS Trial

To explore this issue, the open-label, non-inferiority ABYSS trial randomly assigned 3698 patients with a history of MI to the discontinuation or continuation of beta-blocker treatment. All study participants had a left ventricular ejection fraction of at least 40%, were receiving long-term beta-blocker treatment, and had experienced no cardiovascular event in the previous 6 months. 

At a median follow-up of 3 years, the primary endpoint — a composite of death, MI, stroke, and hospitalization for cardiovascular reasons — occurred more often in the discontinuation group than in the continuation group (23.8% vs 21.1%; hazard ratio, 1.16; 95% CI, 1.01-1.33). This did not meet the criteria for non-inferiority of discontinuation, compared with continuation, of beta-blocker therapy (P for non-inferiority = .44).

The difference in event rates between the two groups was driven by cardiovascular hospitalizations, which occurred more often in the discontinuation group than in the continuation group (18.9% vs 16.6%).

Other key results showed that there was no difference in quality of life between the two groups.

However, 6 months after randomization, there were increases in blood pressure and heart rate in the discontinuation group. Systolic blood pressure increased by 3.7 mm Hg and diastolic blood pressure increased by 3.9 mm Hg. Resting heart rate increased by 9.8 beats per minute.

“We were not able to show the non-inferiority of stopping beta-blockers in terms of cardiovascular events, [but we] showed a safety signal with this strategy of an increase in blood pressure and heart rate, with no improvement in quality of life,” Dr. Sylvain said.

“While recent guidelines suggest it may be reasonable to stop beta-blockers in this population, after these results, I will not be stopping these drugs if they are being well tolerated,” he said.

Sylvain said he was surprised that there was not an improvement in quality of life in the group that discontinued beta-blockers. “We are always told that beta-blockers have many side effects, so we expected to see an improvement in quality of life in the patients who stopped these drugs.”

One possible reason for the lack of improvement in quality of life is that the trial participants had been taking beta-blockers for several years. “We may have, therefore, selected patients who tolerate these drugs quite well. Those who had tolerance issues had probably already stopped taking them,” he explained.

In addition, the patient population had relatively high quality-of-life scores at baseline. “They were well treated and the therapies they were taking were well tolerated, so maybe it is difficult to improve quality of life further,” he said.
 

The REDUCE-AMI Trial

The ABYSS results appear at first to differ from results from the recent REDUCE-AMI trial, which failed to show the superiority of beta-blocker therapy, compared with no beta-blocker therapy, in acute MI patients with preserved ejection fraction.

But the REDUCE-AMI primary endpoint was a composite of death from any cause or new myocardial infarction; it did not include cardiovascular hospitalization, which was the main driver of the difference in outcomes in the ABYSS study, Dr. Sylvain pointed out.

“We showed an increase in coronary cases of hospitalization with stopping beta-blockers, and you have to remember that beta-blockers were developed to reduce coronary disease,” he said.
 

‘Slightly Inconclusive’

Jane Armitage, MBBS, University of Oxford, England, the ABYSS discussant for the ESC HOTLINE session, pointed out some limitations of the study, which led her to report that the result was “slightly inconclusive.” 

The open-label design may have allowed some bias regarding the cardiovascular hospitalization endpoint, she said.

“The decision whether to admit a patient to [the] hospital is somewhat subjective and could be influenced by a physician’s knowledge of treatment allocation. That is why, ideally, we prefer blinded trials. I think there are questions there,” she explained.

She also questioned whether the non-inferiority margin could have been increased, given the higher-than-expected event rate.

More data on this issue will come from several trials that are currently ongoing, Dr. Armitage said.

The ABYSS and REDUCE-AMI trials together suggest that it is safe, with respect to serious cardiac events, to stop beta-blocker treatment in MI patients with preserved ejection fraction, writes Tomas Jernberg, MD, PhD, from the Karolinska Institute in Stockholm, Sweden, in an accompanying editorial.

However, “because of the anti-ischemic effects of beta-blockers, an interruption may increase the risk of recurrent angina and the need for rehospitalization,” he adds.

“It is prudent to wait for the results of additional ongoing trials of beta-blockers involving patients with MI and a preserved left ventricular ejection fraction before definitively updating guidelines,” Dr. Jernberg concludes.

The ABYSS trial was funded by the French Ministry of Health and the ACTION Study Group. Dr. Sylvain, Dr. Armitage, and Dr. Jernberg report no relevant financial relationships.

A version of this article appeared on Medscape.com.

LONDON — Updated guidelines for the management of atrial fibrillation released by the European Society of Cardiology are revamping the approach to care for this complex, multifactorial disease.

The identification and treatment of comorbidities and risk factors are the initial and central components of patient management, and are crucial for all other aspects of care for patients with atrial fibrillation (AF), Isabelle Van Gelder, MD, PhD, professor of cardiology at the University Medical Center in Groningen, the Netherlands, explained at the European Society of Cardiology (ESC) Congress.

It is not just appropriate to place the same emphasis on the control of comorbidities as on the rhythm disturbance, it is critical, said Dr. Van Gelder, who served as chair of the ESC-AF guidelines task force.

Comorbidities are the drivers of both the onset and recurrence of atrial fibrillation, and a dynamic approach to comorbidities is “central for the success of AF management.”
 

Class I Recommendation

In fact, on the basis of overwhelming evidence, a class I recommendation has been issued for a large number of goals in the comorbidity and risk factor management step of atrial fibrillation management, including those for hypertension, components of heart failure, obesity, diabetes, alcohol consumption, and exercise.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors “should be offered to all patients with AF,” according to Dr. Van Gelder, who identified this as a new class I recommendation.

Patients who are not managed aggressively for the listed comorbidities ultimately face “treatment failure, poor patient outcomes, and a waste of healthcare resources,” she said.

Control of sleep apnea is also noted as a key target, although Van Gelder acknowledged that the supporting evidence only allows for a class IIb recommendation.

Control of comorbidities is not a new idea. In the 2023 joint guideline, led by a consortium of professional groups, including the American Heart Association (AHA) and the American College of Cardiology (ACC), the control of comorbidities, including most of those identified in the new ESC guidelines, was second in a list of 10 key take-home messages.

However, the new ESC guidelines have prioritized comorbidity management by listing it first in each of the specific patient-care pathways developed to define optimized care. 

These pathways, defined in algorithms for newly diagnosed AF, paroxysmal AF, and persistent AF, always start with the assessment of comorbidities, followed by step A — avoiding stroke — largely with anticoagulation.

Direct oral anticoagulants should be used, “except in those with a mechanical valve or mitral stenosis,” Dr. Van Gelder said. This includes, essentially, all patients with a CHA2DS2-VASc score of 2 or greater, and it should be “considered” in those with a score of 1. 

The ESC framework has been identified with the acronym AF-CARE, in which the C stands for comorbidities.

In the A step of the framework, identifying and treating all modifiable bleeding risk factors in AF patients is a class I recommendation. On the basis of a class III recommendation, she cautioned against withholding anticoagulants because of CHA2DS2-VASc risk factors alone. Rather, Dr. Van Gelder called the decision to administer or withhold anticoagulation — like all decisions — one that should be individualized in consultation with the patient.

For reducing AF symptoms and rhythm control, the specific pathways diverge for newly diagnosed AF, paroxysmal AF, and persistent AF. Like all of the guidelines, the specific options for symptom management and AF ablation are color coded, with green signifying level 1 evidence.

The evaluation and dynamic reassessment step refers to the need to periodically assess patients for new modifiable risk factors related to comorbidities, risk for stroke, risk for bleeding, and risk for AF. 

The management of risk factors for AF has long been emphasized in guidelines, but a previous focus on AF with attention to comorbidities has been replaced by a focus on comorbidities with an expectation of more durable AF control. The success of this pivot is based on multidisciplinary care, chosen in collaboration with the patient, to reduce or eliminate the triggers of AF and the risks of its complications.
 

Pathways Are Appropriate for All Patients

A very important recommendation — and this is new — is “to treat all our patients with atrial fibrillation, whether they are young or old, men or women, Black or White, or at high or low risk, according to our patient-centered integrated AF-CARE approach,” Dr. Van Gelder said.

The changes reflect a shared appreciation for the tight relation between the control of comorbidities and the control of AF, according to José A. Joglar, MD, professor of cardiac electrophysiologic research at the University of Texas Southwestern Medical Center in Dallas. Dr. Joglar was chair of the writing committee for the joint 2023 AF guidelines released by the AHA, ACC, the American College of Clinical Pharmacy, and the Heart Rhythm Society.

“It is increasingly clear that AF in many cases is the consequence of underlying risk factors and comorbidities, which cannot be separated from AF alone,” Dr. Joglar explained in an interview.

This was placed first “to emphasize the importance of viewing AFib as a complex disease that requires a holistic, multidisciplinary approach to care, as opposed to being viewed just as a rhythm abnormality,” he said.
 

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

LONDON — Updated guidelines for the management of atrial fibrillation released by the European Society of Cardiology are revamping the approach to care for this complex, multifactorial disease.

The identification and treatment of comorbidities and risk factors are the initial and central components of patient management, and are crucial for all other aspects of care for patients with atrial fibrillation (AF), Isabelle Van Gelder, MD, PhD, professor of cardiology at the University Medical Center in Groningen, the Netherlands, explained at the European Society of Cardiology (ESC) Congress.

It is not just appropriate to place the same emphasis on the control of comorbidities as on the rhythm disturbance, it is critical, said Dr. Van Gelder, who served as chair of the ESC-AF guidelines task force.

Comorbidities are the drivers of both the onset and recurrence of atrial fibrillation, and a dynamic approach to comorbidities is “central for the success of AF management.”
 

Class I Recommendation

In fact, on the basis of overwhelming evidence, a class I recommendation has been issued for a large number of goals in the comorbidity and risk factor management step of atrial fibrillation management, including those for hypertension, components of heart failure, obesity, diabetes, alcohol consumption, and exercise.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors “should be offered to all patients with AF,” according to Dr. Van Gelder, who identified this as a new class I recommendation.

Patients who are not managed aggressively for the listed comorbidities ultimately face “treatment failure, poor patient outcomes, and a waste of healthcare resources,” she said.

Control of sleep apnea is also noted as a key target, although Van Gelder acknowledged that the supporting evidence only allows for a class IIb recommendation.

Control of comorbidities is not a new idea. In the 2023 joint guideline, led by a consortium of professional groups, including the American Heart Association (AHA) and the American College of Cardiology (ACC), the control of comorbidities, including most of those identified in the new ESC guidelines, was second in a list of 10 key take-home messages.

However, the new ESC guidelines have prioritized comorbidity management by listing it first in each of the specific patient-care pathways developed to define optimized care. 

These pathways, defined in algorithms for newly diagnosed AF, paroxysmal AF, and persistent AF, always start with the assessment of comorbidities, followed by step A — avoiding stroke — largely with anticoagulation.

Direct oral anticoagulants should be used, “except in those with a mechanical valve or mitral stenosis,” Dr. Van Gelder said. This includes, essentially, all patients with a CHA2DS2-VASc score of 2 or greater, and it should be “considered” in those with a score of 1. 

The ESC framework has been identified with the acronym AF-CARE, in which the C stands for comorbidities.

In the A step of the framework, identifying and treating all modifiable bleeding risk factors in AF patients is a class I recommendation. On the basis of a class III recommendation, she cautioned against withholding anticoagulants because of CHA2DS2-VASc risk factors alone. Rather, Dr. Van Gelder called the decision to administer or withhold anticoagulation — like all decisions — one that should be individualized in consultation with the patient.

For reducing AF symptoms and rhythm control, the specific pathways diverge for newly diagnosed AF, paroxysmal AF, and persistent AF. Like all of the guidelines, the specific options for symptom management and AF ablation are color coded, with green signifying level 1 evidence.

The evaluation and dynamic reassessment step refers to the need to periodically assess patients for new modifiable risk factors related to comorbidities, risk for stroke, risk for bleeding, and risk for AF. 

The management of risk factors for AF has long been emphasized in guidelines, but a previous focus on AF with attention to comorbidities has been replaced by a focus on comorbidities with an expectation of more durable AF control. The success of this pivot is based on multidisciplinary care, chosen in collaboration with the patient, to reduce or eliminate the triggers of AF and the risks of its complications.
 

Pathways Are Appropriate for All Patients

A very important recommendation — and this is new — is “to treat all our patients with atrial fibrillation, whether they are young or old, men or women, Black or White, or at high or low risk, according to our patient-centered integrated AF-CARE approach,” Dr. Van Gelder said.

The changes reflect a shared appreciation for the tight relation between the control of comorbidities and the control of AF, according to José A. Joglar, MD, professor of cardiac electrophysiologic research at the University of Texas Southwestern Medical Center in Dallas. Dr. Joglar was chair of the writing committee for the joint 2023 AF guidelines released by the AHA, ACC, the American College of Clinical Pharmacy, and the Heart Rhythm Society.

“It is increasingly clear that AF in many cases is the consequence of underlying risk factors and comorbidities, which cannot be separated from AF alone,” Dr. Joglar explained in an interview.

This was placed first “to emphasize the importance of viewing AFib as a complex disease that requires a holistic, multidisciplinary approach to care, as opposed to being viewed just as a rhythm abnormality,” he said.
 

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

LONDON — Updated guidelines for the management of atrial fibrillation released by the European Society of Cardiology are revamping the approach to care for this complex, multifactorial disease.

The identification and treatment of comorbidities and risk factors are the initial and central components of patient management, and are crucial for all other aspects of care for patients with atrial fibrillation (AF), Isabelle Van Gelder, MD, PhD, professor of cardiology at the University Medical Center in Groningen, the Netherlands, explained at the European Society of Cardiology (ESC) Congress.

It is not just appropriate to place the same emphasis on the control of comorbidities as on the rhythm disturbance, it is critical, said Dr. Van Gelder, who served as chair of the ESC-AF guidelines task force.

Comorbidities are the drivers of both the onset and recurrence of atrial fibrillation, and a dynamic approach to comorbidities is “central for the success of AF management.”
 

Class I Recommendation

In fact, on the basis of overwhelming evidence, a class I recommendation has been issued for a large number of goals in the comorbidity and risk factor management step of atrial fibrillation management, including those for hypertension, components of heart failure, obesity, diabetes, alcohol consumption, and exercise.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors “should be offered to all patients with AF,” according to Dr. Van Gelder, who identified this as a new class I recommendation.

Patients who are not managed aggressively for the listed comorbidities ultimately face “treatment failure, poor patient outcomes, and a waste of healthcare resources,” she said.

Control of sleep apnea is also noted as a key target, although Van Gelder acknowledged that the supporting evidence only allows for a class IIb recommendation.

Control of comorbidities is not a new idea. In the 2023 joint guideline, led by a consortium of professional groups, including the American Heart Association (AHA) and the American College of Cardiology (ACC), the control of comorbidities, including most of those identified in the new ESC guidelines, was second in a list of 10 key take-home messages.

However, the new ESC guidelines have prioritized comorbidity management by listing it first in each of the specific patient-care pathways developed to define optimized care. 

These pathways, defined in algorithms for newly diagnosed AF, paroxysmal AF, and persistent AF, always start with the assessment of comorbidities, followed by step A — avoiding stroke — largely with anticoagulation.

Direct oral anticoagulants should be used, “except in those with a mechanical valve or mitral stenosis,” Dr. Van Gelder said. This includes, essentially, all patients with a CHA2DS2-VASc score of 2 or greater, and it should be “considered” in those with a score of 1. 

The ESC framework has been identified with the acronym AF-CARE, in which the C stands for comorbidities.

In the A step of the framework, identifying and treating all modifiable bleeding risk factors in AF patients is a class I recommendation. On the basis of a class III recommendation, she cautioned against withholding anticoagulants because of CHA2DS2-VASc risk factors alone. Rather, Dr. Van Gelder called the decision to administer or withhold anticoagulation — like all decisions — one that should be individualized in consultation with the patient.

For reducing AF symptoms and rhythm control, the specific pathways diverge for newly diagnosed AF, paroxysmal AF, and persistent AF. Like all of the guidelines, the specific options for symptom management and AF ablation are color coded, with green signifying level 1 evidence.

The evaluation and dynamic reassessment step refers to the need to periodically assess patients for new modifiable risk factors related to comorbidities, risk for stroke, risk for bleeding, and risk for AF. 

The management of risk factors for AF has long been emphasized in guidelines, but a previous focus on AF with attention to comorbidities has been replaced by a focus on comorbidities with an expectation of more durable AF control. The success of this pivot is based on multidisciplinary care, chosen in collaboration with the patient, to reduce or eliminate the triggers of AF and the risks of its complications.
 

Pathways Are Appropriate for All Patients

A very important recommendation — and this is new — is “to treat all our patients with atrial fibrillation, whether they are young or old, men or women, Black or White, or at high or low risk, according to our patient-centered integrated AF-CARE approach,” Dr. Van Gelder said.

The changes reflect a shared appreciation for the tight relation between the control of comorbidities and the control of AF, according to José A. Joglar, MD, professor of cardiac electrophysiologic research at the University of Texas Southwestern Medical Center in Dallas. Dr. Joglar was chair of the writing committee for the joint 2023 AF guidelines released by the AHA, ACC, the American College of Clinical Pharmacy, and the Heart Rhythm Society.

“It is increasingly clear that AF in many cases is the consequence of underlying risk factors and comorbidities, which cannot be separated from AF alone,” Dr. Joglar explained in an interview.

This was placed first “to emphasize the importance of viewing AFib as a complex disease that requires a holistic, multidisciplinary approach to care, as opposed to being viewed just as a rhythm abnormality,” he said.
 

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

Repeated 1-minute bursts of high-intensity interval training (HIIT) are more effective than conventional moderate, continuous exercise for improving aerobic fitness after stroke, according to a multicenter randomized controlled trial.

“We hoped that we would see improvements in cardiovascular fitness after HIIT and anticipated that these improvements would be greater than in the moderate-intensity group, but we were pleasantly surprised by the degree of improvement we observed,” said Ada Tang, PT, PhD, associate professor of health sciences at McMaster University in Hamilton, Ontario, Canada. “The improvements seen in the HIIT group were twofold higher than in the other group.”

The results were published in Stroke.
 

Clinically Meaningful

Researchers compared the effects of 12 weeks of short-interval HIIT with those of moderate-intensity continuous training (MICT) on peak oxygen uptake (VO₂peak), cardiovascular risk factors, and mobility outcomes after stroke.

They randomly assigned participants to receive 3 days per week of HIIT or traditional moderate exercise sessions for 12 weeks. Participants’ mean age was 65 years, and 39% were women. They enrolled at a mean age of 1.8 years after sustaining a mild stroke.

A total of 42 participants were randomized to HIIT and 40 to MICT. There were no significant differences between the groups at baseline, and both groups exercised on adaptive recumbent steppers, which are suitable for stroke survivors with varying abilities.

The short-interval HIIT protocol involved 10 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for a total of 19 minutes. HIIT intervals targeted 80% heart rate reserve (HRR) and progressed by 10% every 4 weeks up to 100% HRR. The low-intensity intervals targeted 30% HRR.

The traditional MICT protocol for stroke rehabilitation targeted 40% HRR for 20 minutes and progressed by 10% HRR and 5 minutes every 4 weeks, up to 60% HRR for 30 minutes.

The HIIT group’s cardiorespiratory fitness levels (VO₂peak) improved twice as much as those of the MICT group: 3.5 mL of oxygen consumed in 1 minute per kg of body weight (mL/kg/min) compared with 1.8 mL/kg/min.

Of note, changes in VO₂peak from baseline remained above the clinically important threshold of 1.0 mL/kg/min at 8-week follow-up in the HIIT group (1.71 mL/kg/min) but not in the MICT group (0.67 mL/kg/min).

Both groups increased their 6-minute walk test distances by 8.8 m at 12 weeks and by 18.5 m at 20 weeks. No between-group differences were found for cardiovascular risk or mobility outcomes, and no adverse events occurred in either group.

On average, the HIIT group spent 36% of total training time exercising at intensities above 80% HRR throughout the intervention, while the MICT group spent 42% of time at intensities of 40%-59% HRR.

The study was limited by a small sample size of high-functioning individuals who sustained a mild stroke. Enrollment was halted for 2 years due to the COVID-19 lockdowns, limiting the study’s statistical power.

Nevertheless, the authors concluded, “Given that a lack of time is a significant barrier to the implementation of aerobic exercise in stroke clinical practice, our findings suggest that short-interval HIIT may be an effective alternative to traditional MICT for improving VO₂peak after stroke, with potential clinically meaningful benefits sustained in the short-term.”

“Our findings show that a short HIIT protocol is possible in people with stroke, which is exciting to see,” said Tang. “But there are different factors that clinicians should consider before recommending this training for their patients, such as their health status and their physical status. Stroke rehabilitation specialists, including stroke physical therapists, can advise on how to proceed to ensure the safety and effectiveness of HIIT.”
 

Selected Patients May Benefit

“Broad implementation of this intervention may be premature without further research,” said Ryan Glatt, CPT, senior brain health coach and director of the FitBrain Program at Pacific Neuroscience Institute in Santa Monica, California. “The study focused on relatively high-functioning stroke survivors, which raises questions about the applicability of the results to those with more severe impairments.” Mr. Glatt did not participate in the research.

“Additional studies are needed to confirm whether these findings are applicable to more diverse and severely affected populations and to assess the long-term sustainability of the benefits observed,” he said. “Also, the lack of significant improvements in other critical outcomes, such as mobility, suggests limitations in the broader application of HIIT for stroke rehabilitation.”

“While HIIT shows potential, it should be approached with caution,” Mr. Glatt continued. “It may benefit select patients, but replacing traditional exercise protocols with HIIT should not be done in all cases. More robust evidence and careful consideration of individual patient needs are essential.”

This study was funded by an operating grant from the Canadian Institutes of Health Research. Dr. Tang reported grants from the Canadian Institutes of Health Research, the Physiotherapy Foundation of Canada, and the Heart and Stroke Foundation of Canada. Mr. Glatt declared no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Repeated 1-minute bursts of high-intensity interval training (HIIT) are more effective than conventional moderate, continuous exercise for improving aerobic fitness after stroke, according to a multicenter randomized controlled trial.

“We hoped that we would see improvements in cardiovascular fitness after HIIT and anticipated that these improvements would be greater than in the moderate-intensity group, but we were pleasantly surprised by the degree of improvement we observed,” said Ada Tang, PT, PhD, associate professor of health sciences at McMaster University in Hamilton, Ontario, Canada. “The improvements seen in the HIIT group were twofold higher than in the other group.”

The results were published in Stroke.
 

Clinically Meaningful

Researchers compared the effects of 12 weeks of short-interval HIIT with those of moderate-intensity continuous training (MICT) on peak oxygen uptake (VO₂peak), cardiovascular risk factors, and mobility outcomes after stroke.

They randomly assigned participants to receive 3 days per week of HIIT or traditional moderate exercise sessions for 12 weeks. Participants’ mean age was 65 years, and 39% were women. They enrolled at a mean age of 1.8 years after sustaining a mild stroke.

A total of 42 participants were randomized to HIIT and 40 to MICT. There were no significant differences between the groups at baseline, and both groups exercised on adaptive recumbent steppers, which are suitable for stroke survivors with varying abilities.

The short-interval HIIT protocol involved 10 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for a total of 19 minutes. HIIT intervals targeted 80% heart rate reserve (HRR) and progressed by 10% every 4 weeks up to 100% HRR. The low-intensity intervals targeted 30% HRR.

The traditional MICT protocol for stroke rehabilitation targeted 40% HRR for 20 minutes and progressed by 10% HRR and 5 minutes every 4 weeks, up to 60% HRR for 30 minutes.

The HIIT group’s cardiorespiratory fitness levels (VO₂peak) improved twice as much as those of the MICT group: 3.5 mL of oxygen consumed in 1 minute per kg of body weight (mL/kg/min) compared with 1.8 mL/kg/min.

Of note, changes in VO₂peak from baseline remained above the clinically important threshold of 1.0 mL/kg/min at 8-week follow-up in the HIIT group (1.71 mL/kg/min) but not in the MICT group (0.67 mL/kg/min).

Both groups increased their 6-minute walk test distances by 8.8 m at 12 weeks and by 18.5 m at 20 weeks. No between-group differences were found for cardiovascular risk or mobility outcomes, and no adverse events occurred in either group.

On average, the HIIT group spent 36% of total training time exercising at intensities above 80% HRR throughout the intervention, while the MICT group spent 42% of time at intensities of 40%-59% HRR.

The study was limited by a small sample size of high-functioning individuals who sustained a mild stroke. Enrollment was halted for 2 years due to the COVID-19 lockdowns, limiting the study’s statistical power.

Nevertheless, the authors concluded, “Given that a lack of time is a significant barrier to the implementation of aerobic exercise in stroke clinical practice, our findings suggest that short-interval HIIT may be an effective alternative to traditional MICT for improving VO₂peak after stroke, with potential clinically meaningful benefits sustained in the short-term.”

“Our findings show that a short HIIT protocol is possible in people with stroke, which is exciting to see,” said Tang. “But there are different factors that clinicians should consider before recommending this training for their patients, such as their health status and their physical status. Stroke rehabilitation specialists, including stroke physical therapists, can advise on how to proceed to ensure the safety and effectiveness of HIIT.”
 

Selected Patients May Benefit

“Broad implementation of this intervention may be premature without further research,” said Ryan Glatt, CPT, senior brain health coach and director of the FitBrain Program at Pacific Neuroscience Institute in Santa Monica, California. “The study focused on relatively high-functioning stroke survivors, which raises questions about the applicability of the results to those with more severe impairments.” Mr. Glatt did not participate in the research.

“Additional studies are needed to confirm whether these findings are applicable to more diverse and severely affected populations and to assess the long-term sustainability of the benefits observed,” he said. “Also, the lack of significant improvements in other critical outcomes, such as mobility, suggests limitations in the broader application of HIIT for stroke rehabilitation.”

“While HIIT shows potential, it should be approached with caution,” Mr. Glatt continued. “It may benefit select patients, but replacing traditional exercise protocols with HIIT should not be done in all cases. More robust evidence and careful consideration of individual patient needs are essential.”

This study was funded by an operating grant from the Canadian Institutes of Health Research. Dr. Tang reported grants from the Canadian Institutes of Health Research, the Physiotherapy Foundation of Canada, and the Heart and Stroke Foundation of Canada. Mr. Glatt declared no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Repeated 1-minute bursts of high-intensity interval training (HIIT) are more effective than conventional moderate, continuous exercise for improving aerobic fitness after stroke, according to a multicenter randomized controlled trial.

“We hoped that we would see improvements in cardiovascular fitness after HIIT and anticipated that these improvements would be greater than in the moderate-intensity group, but we were pleasantly surprised by the degree of improvement we observed,” said Ada Tang, PT, PhD, associate professor of health sciences at McMaster University in Hamilton, Ontario, Canada. “The improvements seen in the HIIT group were twofold higher than in the other group.”

The results were published in Stroke.
 

Clinically Meaningful

Researchers compared the effects of 12 weeks of short-interval HIIT with those of moderate-intensity continuous training (MICT) on peak oxygen uptake (VO₂peak), cardiovascular risk factors, and mobility outcomes after stroke.

They randomly assigned participants to receive 3 days per week of HIIT or traditional moderate exercise sessions for 12 weeks. Participants’ mean age was 65 years, and 39% were women. They enrolled at a mean age of 1.8 years after sustaining a mild stroke.

A total of 42 participants were randomized to HIIT and 40 to MICT. There were no significant differences between the groups at baseline, and both groups exercised on adaptive recumbent steppers, which are suitable for stroke survivors with varying abilities.

The short-interval HIIT protocol involved 10 1-minute intervals of high-intensity exercise, interspersed with nine 1-minute low-intensity intervals, for a total of 19 minutes. HIIT intervals targeted 80% heart rate reserve (HRR) and progressed by 10% every 4 weeks up to 100% HRR. The low-intensity intervals targeted 30% HRR.

The traditional MICT protocol for stroke rehabilitation targeted 40% HRR for 20 minutes and progressed by 10% HRR and 5 minutes every 4 weeks, up to 60% HRR for 30 minutes.

The HIIT group’s cardiorespiratory fitness levels (VO₂peak) improved twice as much as those of the MICT group: 3.5 mL of oxygen consumed in 1 minute per kg of body weight (mL/kg/min) compared with 1.8 mL/kg/min.

Of note, changes in VO₂peak from baseline remained above the clinically important threshold of 1.0 mL/kg/min at 8-week follow-up in the HIIT group (1.71 mL/kg/min) but not in the MICT group (0.67 mL/kg/min).

Both groups increased their 6-minute walk test distances by 8.8 m at 12 weeks and by 18.5 m at 20 weeks. No between-group differences were found for cardiovascular risk or mobility outcomes, and no adverse events occurred in either group.

On average, the HIIT group spent 36% of total training time exercising at intensities above 80% HRR throughout the intervention, while the MICT group spent 42% of time at intensities of 40%-59% HRR.

The study was limited by a small sample size of high-functioning individuals who sustained a mild stroke. Enrollment was halted for 2 years due to the COVID-19 lockdowns, limiting the study’s statistical power.

Nevertheless, the authors concluded, “Given that a lack of time is a significant barrier to the implementation of aerobic exercise in stroke clinical practice, our findings suggest that short-interval HIIT may be an effective alternative to traditional MICT for improving VO₂peak after stroke, with potential clinically meaningful benefits sustained in the short-term.”

“Our findings show that a short HIIT protocol is possible in people with stroke, which is exciting to see,” said Tang. “But there are different factors that clinicians should consider before recommending this training for their patients, such as their health status and their physical status. Stroke rehabilitation specialists, including stroke physical therapists, can advise on how to proceed to ensure the safety and effectiveness of HIIT.”
 

Selected Patients May Benefit

“Broad implementation of this intervention may be premature without further research,” said Ryan Glatt, CPT, senior brain health coach and director of the FitBrain Program at Pacific Neuroscience Institute in Santa Monica, California. “The study focused on relatively high-functioning stroke survivors, which raises questions about the applicability of the results to those with more severe impairments.” Mr. Glatt did not participate in the research.

“Additional studies are needed to confirm whether these findings are applicable to more diverse and severely affected populations and to assess the long-term sustainability of the benefits observed,” he said. “Also, the lack of significant improvements in other critical outcomes, such as mobility, suggests limitations in the broader application of HIIT for stroke rehabilitation.”

“While HIIT shows potential, it should be approached with caution,” Mr. Glatt continued. “It may benefit select patients, but replacing traditional exercise protocols with HIIT should not be done in all cases. More robust evidence and careful consideration of individual patient needs are essential.”

This study was funded by an operating grant from the Canadian Institutes of Health Research. Dr. Tang reported grants from the Canadian Institutes of Health Research, the Physiotherapy Foundation of Canada, and the Heart and Stroke Foundation of Canada. Mr. Glatt declared no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Rates of major adverse cardiovascular events (MACE) do not differ significantly among individual biologics used for psoriasis or psoriatic arthritis (PsA), a database analysis finds. 

METHODOLOGY:

• Data from the TriNetX health records database included 32,758 patients treated with TNF inhibitors (TNFi, 62.9%), interleukin-17 inhibitors (IL-17i, 15.4%), IL-23i (10.7%), and IL-12i/IL-23i (10.7%).
• The researchers calculated time-dependent risk for MACE using multinomial Cox proportional hazard ratios. The reference was TNFi exposure.
• Subset analyses compared MACE in patients with and without existing cardiovascular disease.

TAKEAWAY:

• Compared with TNFi use, there was no difference in the incidence of MACE events in the IL-17i, IL-23i, or IL-12i/IL-23i group.
• There were also no significant differences between biologic groups in the incidence of congestive heart failure, myocardial infarction, or cerebral vascular accident/stroke.

IN PRACTICE:

Despite some concern about increased risk for MACE with TNFi use, this study suggests no special risk for patients with psoriasis or PsA associated with TNFi vs other biologics. “Given our results, as it pertains to MACE, prescribers shouldn’t favor any one biologic class over another,” said lead investigator Shikha Singla, MD, medical director of the Psoriatic Arthritis Program at Medical College of Wisconsin in Milwaukee, Wisconsin.

SOURCE:

Bonit Gill, MD, a second-year fellow at Medical College of Wisconsin, presented the study as a poster at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. 

LIMITATIONS:

The study’s retrospective nature makes it impossible to prove causation and the patients included in the study were from Wisconsin, which may limit generalizability.

DISCLOSURES:

Dr. Gill had no relevant financial disclosures. Other study authors participated in trials or consulted for AbbVie, AstraZeneca, Novartis, Eli Lilly, Janssen, and UCB.

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

TOPLINE:

Rates of major adverse cardiovascular events (MACE) do not differ significantly among individual biologics used for psoriasis or psoriatic arthritis (PsA), a database analysis finds. 

METHODOLOGY:

• Data from the TriNetX health records database included 32,758 patients treated with TNF inhibitors (TNFi, 62.9%), interleukin-17 inhibitors (IL-17i, 15.4%), IL-23i (10.7%), and IL-12i/IL-23i (10.7%).
• The researchers calculated time-dependent risk for MACE using multinomial Cox proportional hazard ratios. The reference was TNFi exposure.
• Subset analyses compared MACE in patients with and without existing cardiovascular disease.

TAKEAWAY:

• Compared with TNFi use, there was no difference in the incidence of MACE events in the IL-17i, IL-23i, or IL-12i/IL-23i group.
• There were also no significant differences between biologic groups in the incidence of congestive heart failure, myocardial infarction, or cerebral vascular accident/stroke.

IN PRACTICE:

Despite some concern about increased risk for MACE with TNFi use, this study suggests no special risk for patients with psoriasis or PsA associated with TNFi vs other biologics. “Given our results, as it pertains to MACE, prescribers shouldn’t favor any one biologic class over another,” said lead investigator Shikha Singla, MD, medical director of the Psoriatic Arthritis Program at Medical College of Wisconsin in Milwaukee, Wisconsin.

SOURCE:

Bonit Gill, MD, a second-year fellow at Medical College of Wisconsin, presented the study as a poster at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. 

LIMITATIONS:

The study’s retrospective nature makes it impossible to prove causation and the patients included in the study were from Wisconsin, which may limit generalizability.

DISCLOSURES:

Dr. Gill had no relevant financial disclosures. Other study authors participated in trials or consulted for AbbVie, AstraZeneca, Novartis, Eli Lilly, Janssen, and UCB.

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

TOPLINE:

Rates of major adverse cardiovascular events (MACE) do not differ significantly among individual biologics used for psoriasis or psoriatic arthritis (PsA), a database analysis finds. 

METHODOLOGY:

• Data from the TriNetX health records database included 32,758 patients treated with TNF inhibitors (TNFi, 62.9%), interleukin-17 inhibitors (IL-17i, 15.4%), IL-23i (10.7%), and IL-12i/IL-23i (10.7%).
• The researchers calculated time-dependent risk for MACE using multinomial Cox proportional hazard ratios. The reference was TNFi exposure.
• Subset analyses compared MACE in patients with and without existing cardiovascular disease.

TAKEAWAY:

• Compared with TNFi use, there was no difference in the incidence of MACE events in the IL-17i, IL-23i, or IL-12i/IL-23i group.
• There were also no significant differences between biologic groups in the incidence of congestive heart failure, myocardial infarction, or cerebral vascular accident/stroke.

IN PRACTICE:

Despite some concern about increased risk for MACE with TNFi use, this study suggests no special risk for patients with psoriasis or PsA associated with TNFi vs other biologics. “Given our results, as it pertains to MACE, prescribers shouldn’t favor any one biologic class over another,” said lead investigator Shikha Singla, MD, medical director of the Psoriatic Arthritis Program at Medical College of Wisconsin in Milwaukee, Wisconsin.

SOURCE:

Bonit Gill, MD, a second-year fellow at Medical College of Wisconsin, presented the study as a poster at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. 

LIMITATIONS:

The study’s retrospective nature makes it impossible to prove causation and the patients included in the study were from Wisconsin, which may limit generalizability.

DISCLOSURES:

Dr. Gill had no relevant financial disclosures. Other study authors participated in trials or consulted for AbbVie, AstraZeneca, Novartis, Eli Lilly, Janssen, and UCB.

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