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New AFib Guidelines Address Underlying Illness, Comorbidities
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.
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.
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.
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.
FROM ESC 2024
HIIT May Best Moderate Exercise for Poststroke Fitness
, 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.
, 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.
, 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.
Risk of MACE Comparable Among Biologic Classes for Psoriasis, PsA
TOPLINE:
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:
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:
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.
The Disturbing Sexual Trend With Real Health Consequences
This transcript has been edited for clarity.
Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?
Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices.
Now, there’s always been a lot of sexual diversity in the world throughout history. But . The increase is mostly seen in teenagers and young adults.
We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow.
Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing?
Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate.
For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms.
Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving.
Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.
This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail?
Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too.
We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody.
They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations.
Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about?
Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention.
Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there?
Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation.
Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.
Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?
Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices.
Now, there’s always been a lot of sexual diversity in the world throughout history. But . The increase is mostly seen in teenagers and young adults.
We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow.
Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing?
Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate.
For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms.
Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving.
Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.
This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail?
Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too.
We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody.
They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations.
Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about?
Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention.
Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there?
Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation.
Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.
Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?
Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices.
Now, there’s always been a lot of sexual diversity in the world throughout history. But . The increase is mostly seen in teenagers and young adults.
We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow.
Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing?
Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate.
For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms.
Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving.
Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.
This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail?
Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too.
We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody.
They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations.
Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about?
Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention.
Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there?
Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation.
Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.
Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
Diabetes-Related Outcomes and Costs Have Mostly Improved
TOPLINE:
Over the past 20 years in Denmark, the incidence of type 2 diabetes–related outcomes and many treatment-related harms have both decreased without increased medication expenses despite an aging and more comorbid population; however, challenges remain.
METHODOLOGY:
- Analysis of data from 461,805 individuals in the Danish population with type 2 diabetes between 2002 and 2020.
- Multivariate analyses adjusted for potential confounders, including age, sex, and socioeconomic status.
TAKEAWAY:
- The population grew 2.7-fold from 2002 to 2020 (n = 113,105 to 306,962), the median age increased from 66 to 68 years, and the mean number of diseases per person increased from 5.2 to 8.8, with an increase in Charlson Comorbidity Index from 1.78 to 1.93.
- After adjustments, mortality per 1000 person-years decreased by 28% from 2002 to 2020, with the largest risk reduction, 63%, in acute myocardial infarction.
- The mean number of annually redeemed medications per person increased from 8.1 to 9.0, with statin and antihypertensive use increasing to 65% and 69%, respectively.
- Antiplatelet medication (aspirin and clopidogrel) use peaked at 48% in 2009 and dropped to 31% in 2020.
- Anticoagulant (warfarin and direct-acting oral anticoagulants) use gradually increased from 5% in 2002 to 14% in 2020.
- For glucose-lowering treatment, there was a shift away from using sulfonylureas to metformin and other medications.
- Diagnoses of hypoglycemia, falls, and gastric bleeding decreased over the study period, but incidences of volume depletion, ketoacidosis, infections, and electrolyte imbalances requiring hospitalization increased.
- Cumulative expenses for the population increased from €132,000,000 to €327,000,000 (approximately $144,406,680 to $357,734,730), corresponding to a 148% increase over the study period.
- However, the average medication cost per individual was 8% less in 2020 compared with 2002 despite increasing medication use, mainly driven by reduced costs of antiplatelets, antihypertensives, and statins, among others.
- In contrast, expenses for glucose-lowering medications have gradually increased, with the average more than doubling (138% increase) from €220 ($240) in 2002 to €524 ($573) in 2020.
IN PRACTICE:
“Although these trends suggest improvements in rational pharmacotherapy, they cannot be solely attributed to improved pharmacotherapy and appear to be multifactorial,” the authors wrote.
“Advancements in diabetes management have improved the balance between medication benefits, harms, and costs ... Remaining challenges, such as an increased risk of ketoacidosis and electrolyte imbalances as well as rising costs for glucose-lowering medications, highlight the importance of individualized treatment and continuous risk-benefits evaluations,” they added.
SOURCE:
This study was conducted by Karl Sebastian Johansson, of the Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark, and colleagues and was published online in Diabetes Care.
LIMITATIONS:
Analysis was confined to events diagnosed in hospital-based inpatient and outpatient settings, not primary healthcare. Only predefined adverse events were analyzed.
DISCLOSURES:
The study was funded by the Capital Region of Denmark. The authors reported no potential conflicts of interest relevant to this article.
A version of this article first appeared on Medscape.com.
TOPLINE:
Over the past 20 years in Denmark, the incidence of type 2 diabetes–related outcomes and many treatment-related harms have both decreased without increased medication expenses despite an aging and more comorbid population; however, challenges remain.
METHODOLOGY:
- Analysis of data from 461,805 individuals in the Danish population with type 2 diabetes between 2002 and 2020.
- Multivariate analyses adjusted for potential confounders, including age, sex, and socioeconomic status.
TAKEAWAY:
- The population grew 2.7-fold from 2002 to 2020 (n = 113,105 to 306,962), the median age increased from 66 to 68 years, and the mean number of diseases per person increased from 5.2 to 8.8, with an increase in Charlson Comorbidity Index from 1.78 to 1.93.
- After adjustments, mortality per 1000 person-years decreased by 28% from 2002 to 2020, with the largest risk reduction, 63%, in acute myocardial infarction.
- The mean number of annually redeemed medications per person increased from 8.1 to 9.0, with statin and antihypertensive use increasing to 65% and 69%, respectively.
- Antiplatelet medication (aspirin and clopidogrel) use peaked at 48% in 2009 and dropped to 31% in 2020.
- Anticoagulant (warfarin and direct-acting oral anticoagulants) use gradually increased from 5% in 2002 to 14% in 2020.
- For glucose-lowering treatment, there was a shift away from using sulfonylureas to metformin and other medications.
- Diagnoses of hypoglycemia, falls, and gastric bleeding decreased over the study period, but incidences of volume depletion, ketoacidosis, infections, and electrolyte imbalances requiring hospitalization increased.
- Cumulative expenses for the population increased from €132,000,000 to €327,000,000 (approximately $144,406,680 to $357,734,730), corresponding to a 148% increase over the study period.
- However, the average medication cost per individual was 8% less in 2020 compared with 2002 despite increasing medication use, mainly driven by reduced costs of antiplatelets, antihypertensives, and statins, among others.
- In contrast, expenses for glucose-lowering medications have gradually increased, with the average more than doubling (138% increase) from €220 ($240) in 2002 to €524 ($573) in 2020.
IN PRACTICE:
“Although these trends suggest improvements in rational pharmacotherapy, they cannot be solely attributed to improved pharmacotherapy and appear to be multifactorial,” the authors wrote.
“Advancements in diabetes management have improved the balance between medication benefits, harms, and costs ... Remaining challenges, such as an increased risk of ketoacidosis and electrolyte imbalances as well as rising costs for glucose-lowering medications, highlight the importance of individualized treatment and continuous risk-benefits evaluations,” they added.
SOURCE:
This study was conducted by Karl Sebastian Johansson, of the Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark, and colleagues and was published online in Diabetes Care.
LIMITATIONS:
Analysis was confined to events diagnosed in hospital-based inpatient and outpatient settings, not primary healthcare. Only predefined adverse events were analyzed.
DISCLOSURES:
The study was funded by the Capital Region of Denmark. The authors reported no potential conflicts of interest relevant to this article.
A version of this article first appeared on Medscape.com.
TOPLINE:
Over the past 20 years in Denmark, the incidence of type 2 diabetes–related outcomes and many treatment-related harms have both decreased without increased medication expenses despite an aging and more comorbid population; however, challenges remain.
METHODOLOGY:
- Analysis of data from 461,805 individuals in the Danish population with type 2 diabetes between 2002 and 2020.
- Multivariate analyses adjusted for potential confounders, including age, sex, and socioeconomic status.
TAKEAWAY:
- The population grew 2.7-fold from 2002 to 2020 (n = 113,105 to 306,962), the median age increased from 66 to 68 years, and the mean number of diseases per person increased from 5.2 to 8.8, with an increase in Charlson Comorbidity Index from 1.78 to 1.93.
- After adjustments, mortality per 1000 person-years decreased by 28% from 2002 to 2020, with the largest risk reduction, 63%, in acute myocardial infarction.
- The mean number of annually redeemed medications per person increased from 8.1 to 9.0, with statin and antihypertensive use increasing to 65% and 69%, respectively.
- Antiplatelet medication (aspirin and clopidogrel) use peaked at 48% in 2009 and dropped to 31% in 2020.
- Anticoagulant (warfarin and direct-acting oral anticoagulants) use gradually increased from 5% in 2002 to 14% in 2020.
- For glucose-lowering treatment, there was a shift away from using sulfonylureas to metformin and other medications.
- Diagnoses of hypoglycemia, falls, and gastric bleeding decreased over the study period, but incidences of volume depletion, ketoacidosis, infections, and electrolyte imbalances requiring hospitalization increased.
- Cumulative expenses for the population increased from €132,000,000 to €327,000,000 (approximately $144,406,680 to $357,734,730), corresponding to a 148% increase over the study period.
- However, the average medication cost per individual was 8% less in 2020 compared with 2002 despite increasing medication use, mainly driven by reduced costs of antiplatelets, antihypertensives, and statins, among others.
- In contrast, expenses for glucose-lowering medications have gradually increased, with the average more than doubling (138% increase) from €220 ($240) in 2002 to €524 ($573) in 2020.
IN PRACTICE:
“Although these trends suggest improvements in rational pharmacotherapy, they cannot be solely attributed to improved pharmacotherapy and appear to be multifactorial,” the authors wrote.
“Advancements in diabetes management have improved the balance between medication benefits, harms, and costs ... Remaining challenges, such as an increased risk of ketoacidosis and electrolyte imbalances as well as rising costs for glucose-lowering medications, highlight the importance of individualized treatment and continuous risk-benefits evaluations,” they added.
SOURCE:
This study was conducted by Karl Sebastian Johansson, of the Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark, and colleagues and was published online in Diabetes Care.
LIMITATIONS:
Analysis was confined to events diagnosed in hospital-based inpatient and outpatient settings, not primary healthcare. Only predefined adverse events were analyzed.
DISCLOSURES:
The study was funded by the Capital Region of Denmark. The authors reported no potential conflicts of interest relevant to this article.
A version of this article first appeared on Medscape.com.
Stroke Recurrence Risk Doubles in Patients With AF Who Stop Anticoagulation Therapy
, a new Danish nationwide cohort study finds.
Among 8,119 patients aged 50 years and older (54.1% male, mean age 78.4), 4.3% had a recurrent stroke within 1 year following discharge for the initial stroke, reported David Gaist, PhD, of Odense University Hospital, Odense, Denmark, and colleagues in JAMA Neurology.
An adjusted analysis found that those who stopped therapy were more than twice as likely to experience another stroke over a mean 2.9 years (13.4% vs 6.8%, adjusted odds ratio [aOR] = 2.13; 95% confidence interval [CI], 1.57-2.89).
The findings highlight the preventive power of OAC therapy, Dr. Gaist said in an interview, and point to the importance of counseling patients about the benefits of the drugs. “Clinicians can provide balanced information on the pros and cons of discontinuing oral anticoagulants as well as lay out plans on when to restart the medication,” he said.
The researchers launched the study “to provide data on how often recurrent ischemic strokes occur in a large, unselected cohort of patients with atrial fibrillation who had a stroke and started or restarted oral anticoagulants, a situation mirroring what we see in our everyday lives as clinicians,” Dr. Gaist said. “We also wanted to see if patients with breakthrough strokes had particular characteristics compared with patients who did not have a recurrent stroke. Finally, we wanted to quantify a very simple cause of breakthrough stroke by answering the following question: How many of these patients had stopped taking their oral anticoagulant?”
A Large, Unselected Patient Cohort
Dr. Gaist and colleagues tracked 8,119 patients with ischemic stroke and atrial fibrillation who started or restarted OAC therapy within 30 days following their discharge between 2014 and 2021. Patients either had atrial fibrillation before their stroke or developed it afterward.
Eighty-one percent of patients had hypertension, 19.7% had diabetes, and 27.3% had ischemic heart disease; 35.3% had never smoked and smoking information was missing for 15.9%. Race/ethnicity information was not provided.
Patients were followed for an average of 2.9 years until 2022, and all were alive at least 30 days after discharge. During that time, 663 patients had a recurrent ischemic stroke (4.3%), of whom 80.4% were on OAC therapy. The percentage who had stroke at 2 years rose to 6.5%.
While the researchers thought the number of strokes was high, Dr. Gaist said, this isn’t a sign that the drugs aren’t working. “Oral anticoagulant use in secondary prevention in atrial fibrillation is guideline-supported as it has been proven to reduce the risk of stroke by roughly two thirds.”
Of study participants at baseline, 37.9% took oral anticoagulants, 23.5% took direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban), and 15.1% took vitamin K antagonists. In a nested case-control analysis of 663 cases (58.7% men, mean age 80.1) matched to 2,652 controls, at admission for ischemic stroke, 80.4% were on OAC therapy, and 8%-11% of patients stopped OAC therapy after their strokes, the researchers reported.
Patients who stopped OAC therapy had more severe strokes than those who didn’t at 7 days (median recurrent ischemic stroke Scandinavian Stroke Scale [SSS] score = 40.0 vs 46.0, respectively; aOR = 2.10; 95% CI, 1.31-3.36). Those who stopped OAC therapy also had higher mortality rates at 7 days (11.2% vs 3.9%, respectively) and 30 days (28.1% vs 10.9%, respectively).
It’s not clear why some patients discontinued OAC therapy. “We looked for evidence of serious bleeding or surgical procedures around the time of anticoagulant discontinuation but found this only to be the case in roughly 10% of these patients,” Dr. Gaist said.
He added that the study probably “underestimates the issue of anticoagulant discontinuation, particularly for DOACs, where a shorter half-life compared with warfarin means that even a short drug-break of a few days puts the patient at increased risk of stroke.”
The authors noted study limitations, including the lack of data on actual medication usage, alcohol usage, stroke etiology, lesion location, and socioeconomic status. And, they wrote, the study population is mostly of European origin.
No Surprises
Steven R. Messe, MD, professor of neurology at the Hospital of the University of Pennsylvania, Philadelphia, who didn’t take part in the study but is familiar with its findings, said in an interview that the study is a “well-done analysis.”
The findings are not surprising, he said. “The overall risk of stroke recurrence was 4.3% at 1 year while the mortality rate was higher at 15.4%. Given that the median CHA2DS2-VASc score was 4 and the average age was 79, the stroke recurrence rate and mortality rate are in line with prior studies.”
In regard to the power of OAC therapy to prevent recurrent strokes, Dr. Messe noted that patients may not be adhering to prescribed regimens. Also, “while DOACs are clearly safer that vitamin K–dependent anticoagulants, the medications are generally not dose adjusted. It is possible that adjusting the dose based on measured anti-Xa levels to insure therapeutic anticoagulant effects may reduce the stroke risk further.”
He added that “most of these patients with prior stroke and atrial fibrillation are vasculopathic and at risk of additional strokes due to other mechanisms such as small vessel or large vessel disease.”
In the big picture, the study “confirms again that anticoagulation should be prescribed to all patients with atrial fibrillation and prior stroke, unless there is a strong bleeding risk contraindication,” Dr. Messe said. These patients are clearly at high risk of stroke recurrence and mortality, and all risk factors should be aggressively managed.”
Researchers are exploring other options, he said. “For example, there are studies of factor XI inhibitors that could be added to a DOAC for additional reductions in ischemic stroke. In addition, in patients undergoing cardiac surgery, the randomized trial LAOS III demonstrated that surgical left atrial occlusion in addition to anticoagulation may provide additional stroke prevention.”
Dr. Gaist disclosed personal fees from Pfizer and Bristol Myers Squibb, and grants from Bayer. Several other authors reported various relationships with industry. Dr. Messe has no disclosures.
, a new Danish nationwide cohort study finds.
Among 8,119 patients aged 50 years and older (54.1% male, mean age 78.4), 4.3% had a recurrent stroke within 1 year following discharge for the initial stroke, reported David Gaist, PhD, of Odense University Hospital, Odense, Denmark, and colleagues in JAMA Neurology.
An adjusted analysis found that those who stopped therapy were more than twice as likely to experience another stroke over a mean 2.9 years (13.4% vs 6.8%, adjusted odds ratio [aOR] = 2.13; 95% confidence interval [CI], 1.57-2.89).
The findings highlight the preventive power of OAC therapy, Dr. Gaist said in an interview, and point to the importance of counseling patients about the benefits of the drugs. “Clinicians can provide balanced information on the pros and cons of discontinuing oral anticoagulants as well as lay out plans on when to restart the medication,” he said.
The researchers launched the study “to provide data on how often recurrent ischemic strokes occur in a large, unselected cohort of patients with atrial fibrillation who had a stroke and started or restarted oral anticoagulants, a situation mirroring what we see in our everyday lives as clinicians,” Dr. Gaist said. “We also wanted to see if patients with breakthrough strokes had particular characteristics compared with patients who did not have a recurrent stroke. Finally, we wanted to quantify a very simple cause of breakthrough stroke by answering the following question: How many of these patients had stopped taking their oral anticoagulant?”
A Large, Unselected Patient Cohort
Dr. Gaist and colleagues tracked 8,119 patients with ischemic stroke and atrial fibrillation who started or restarted OAC therapy within 30 days following their discharge between 2014 and 2021. Patients either had atrial fibrillation before their stroke or developed it afterward.
Eighty-one percent of patients had hypertension, 19.7% had diabetes, and 27.3% had ischemic heart disease; 35.3% had never smoked and smoking information was missing for 15.9%. Race/ethnicity information was not provided.
Patients were followed for an average of 2.9 years until 2022, and all were alive at least 30 days after discharge. During that time, 663 patients had a recurrent ischemic stroke (4.3%), of whom 80.4% were on OAC therapy. The percentage who had stroke at 2 years rose to 6.5%.
While the researchers thought the number of strokes was high, Dr. Gaist said, this isn’t a sign that the drugs aren’t working. “Oral anticoagulant use in secondary prevention in atrial fibrillation is guideline-supported as it has been proven to reduce the risk of stroke by roughly two thirds.”
Of study participants at baseline, 37.9% took oral anticoagulants, 23.5% took direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban), and 15.1% took vitamin K antagonists. In a nested case-control analysis of 663 cases (58.7% men, mean age 80.1) matched to 2,652 controls, at admission for ischemic stroke, 80.4% were on OAC therapy, and 8%-11% of patients stopped OAC therapy after their strokes, the researchers reported.
Patients who stopped OAC therapy had more severe strokes than those who didn’t at 7 days (median recurrent ischemic stroke Scandinavian Stroke Scale [SSS] score = 40.0 vs 46.0, respectively; aOR = 2.10; 95% CI, 1.31-3.36). Those who stopped OAC therapy also had higher mortality rates at 7 days (11.2% vs 3.9%, respectively) and 30 days (28.1% vs 10.9%, respectively).
It’s not clear why some patients discontinued OAC therapy. “We looked for evidence of serious bleeding or surgical procedures around the time of anticoagulant discontinuation but found this only to be the case in roughly 10% of these patients,” Dr. Gaist said.
He added that the study probably “underestimates the issue of anticoagulant discontinuation, particularly for DOACs, where a shorter half-life compared with warfarin means that even a short drug-break of a few days puts the patient at increased risk of stroke.”
The authors noted study limitations, including the lack of data on actual medication usage, alcohol usage, stroke etiology, lesion location, and socioeconomic status. And, they wrote, the study population is mostly of European origin.
No Surprises
Steven R. Messe, MD, professor of neurology at the Hospital of the University of Pennsylvania, Philadelphia, who didn’t take part in the study but is familiar with its findings, said in an interview that the study is a “well-done analysis.”
The findings are not surprising, he said. “The overall risk of stroke recurrence was 4.3% at 1 year while the mortality rate was higher at 15.4%. Given that the median CHA2DS2-VASc score was 4 and the average age was 79, the stroke recurrence rate and mortality rate are in line with prior studies.”
In regard to the power of OAC therapy to prevent recurrent strokes, Dr. Messe noted that patients may not be adhering to prescribed regimens. Also, “while DOACs are clearly safer that vitamin K–dependent anticoagulants, the medications are generally not dose adjusted. It is possible that adjusting the dose based on measured anti-Xa levels to insure therapeutic anticoagulant effects may reduce the stroke risk further.”
He added that “most of these patients with prior stroke and atrial fibrillation are vasculopathic and at risk of additional strokes due to other mechanisms such as small vessel or large vessel disease.”
In the big picture, the study “confirms again that anticoagulation should be prescribed to all patients with atrial fibrillation and prior stroke, unless there is a strong bleeding risk contraindication,” Dr. Messe said. These patients are clearly at high risk of stroke recurrence and mortality, and all risk factors should be aggressively managed.”
Researchers are exploring other options, he said. “For example, there are studies of factor XI inhibitors that could be added to a DOAC for additional reductions in ischemic stroke. In addition, in patients undergoing cardiac surgery, the randomized trial LAOS III demonstrated that surgical left atrial occlusion in addition to anticoagulation may provide additional stroke prevention.”
Dr. Gaist disclosed personal fees from Pfizer and Bristol Myers Squibb, and grants from Bayer. Several other authors reported various relationships with industry. Dr. Messe has no disclosures.
, a new Danish nationwide cohort study finds.
Among 8,119 patients aged 50 years and older (54.1% male, mean age 78.4), 4.3% had a recurrent stroke within 1 year following discharge for the initial stroke, reported David Gaist, PhD, of Odense University Hospital, Odense, Denmark, and colleagues in JAMA Neurology.
An adjusted analysis found that those who stopped therapy were more than twice as likely to experience another stroke over a mean 2.9 years (13.4% vs 6.8%, adjusted odds ratio [aOR] = 2.13; 95% confidence interval [CI], 1.57-2.89).
The findings highlight the preventive power of OAC therapy, Dr. Gaist said in an interview, and point to the importance of counseling patients about the benefits of the drugs. “Clinicians can provide balanced information on the pros and cons of discontinuing oral anticoagulants as well as lay out plans on when to restart the medication,” he said.
The researchers launched the study “to provide data on how often recurrent ischemic strokes occur in a large, unselected cohort of patients with atrial fibrillation who had a stroke and started or restarted oral anticoagulants, a situation mirroring what we see in our everyday lives as clinicians,” Dr. Gaist said. “We also wanted to see if patients with breakthrough strokes had particular characteristics compared with patients who did not have a recurrent stroke. Finally, we wanted to quantify a very simple cause of breakthrough stroke by answering the following question: How many of these patients had stopped taking their oral anticoagulant?”
A Large, Unselected Patient Cohort
Dr. Gaist and colleagues tracked 8,119 patients with ischemic stroke and atrial fibrillation who started or restarted OAC therapy within 30 days following their discharge between 2014 and 2021. Patients either had atrial fibrillation before their stroke or developed it afterward.
Eighty-one percent of patients had hypertension, 19.7% had diabetes, and 27.3% had ischemic heart disease; 35.3% had never smoked and smoking information was missing for 15.9%. Race/ethnicity information was not provided.
Patients were followed for an average of 2.9 years until 2022, and all were alive at least 30 days after discharge. During that time, 663 patients had a recurrent ischemic stroke (4.3%), of whom 80.4% were on OAC therapy. The percentage who had stroke at 2 years rose to 6.5%.
While the researchers thought the number of strokes was high, Dr. Gaist said, this isn’t a sign that the drugs aren’t working. “Oral anticoagulant use in secondary prevention in atrial fibrillation is guideline-supported as it has been proven to reduce the risk of stroke by roughly two thirds.”
Of study participants at baseline, 37.9% took oral anticoagulants, 23.5% took direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban), and 15.1% took vitamin K antagonists. In a nested case-control analysis of 663 cases (58.7% men, mean age 80.1) matched to 2,652 controls, at admission for ischemic stroke, 80.4% were on OAC therapy, and 8%-11% of patients stopped OAC therapy after their strokes, the researchers reported.
Patients who stopped OAC therapy had more severe strokes than those who didn’t at 7 days (median recurrent ischemic stroke Scandinavian Stroke Scale [SSS] score = 40.0 vs 46.0, respectively; aOR = 2.10; 95% CI, 1.31-3.36). Those who stopped OAC therapy also had higher mortality rates at 7 days (11.2% vs 3.9%, respectively) and 30 days (28.1% vs 10.9%, respectively).
It’s not clear why some patients discontinued OAC therapy. “We looked for evidence of serious bleeding or surgical procedures around the time of anticoagulant discontinuation but found this only to be the case in roughly 10% of these patients,” Dr. Gaist said.
He added that the study probably “underestimates the issue of anticoagulant discontinuation, particularly for DOACs, where a shorter half-life compared with warfarin means that even a short drug-break of a few days puts the patient at increased risk of stroke.”
The authors noted study limitations, including the lack of data on actual medication usage, alcohol usage, stroke etiology, lesion location, and socioeconomic status. And, they wrote, the study population is mostly of European origin.
No Surprises
Steven R. Messe, MD, professor of neurology at the Hospital of the University of Pennsylvania, Philadelphia, who didn’t take part in the study but is familiar with its findings, said in an interview that the study is a “well-done analysis.”
The findings are not surprising, he said. “The overall risk of stroke recurrence was 4.3% at 1 year while the mortality rate was higher at 15.4%. Given that the median CHA2DS2-VASc score was 4 and the average age was 79, the stroke recurrence rate and mortality rate are in line with prior studies.”
In regard to the power of OAC therapy to prevent recurrent strokes, Dr. Messe noted that patients may not be adhering to prescribed regimens. Also, “while DOACs are clearly safer that vitamin K–dependent anticoagulants, the medications are generally not dose adjusted. It is possible that adjusting the dose based on measured anti-Xa levels to insure therapeutic anticoagulant effects may reduce the stroke risk further.”
He added that “most of these patients with prior stroke and atrial fibrillation are vasculopathic and at risk of additional strokes due to other mechanisms such as small vessel or large vessel disease.”
In the big picture, the study “confirms again that anticoagulation should be prescribed to all patients with atrial fibrillation and prior stroke, unless there is a strong bleeding risk contraindication,” Dr. Messe said. These patients are clearly at high risk of stroke recurrence and mortality, and all risk factors should be aggressively managed.”
Researchers are exploring other options, he said. “For example, there are studies of factor XI inhibitors that could be added to a DOAC for additional reductions in ischemic stroke. In addition, in patients undergoing cardiac surgery, the randomized trial LAOS III demonstrated that surgical left atrial occlusion in addition to anticoagulation may provide additional stroke prevention.”
Dr. Gaist disclosed personal fees from Pfizer and Bristol Myers Squibb, and grants from Bayer. Several other authors reported various relationships with industry. Dr. Messe has no disclosures.
FROM JAMA NEUROLOGY
New Insight Into CVD, Stroke Risk in Migraine
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AHS 2024
Chronic Loneliness Tied to Increased Stroke Risk
Adults older than 50 years who report experiencing persistently high levels of loneliness have a 56% increased risk for stroke, a new study showed.
The increased stroke risk did not apply to individuals who reported experiencing situational loneliness, a finding that investigators believe bolsters the hypothesis that chronic loneliness is driving the association.
“Our findings suggest that individuals who experience chronic loneliness are at higher risk for incident stroke,” lead investigator Yenee Soh, ScD, research associate of social and behavioral sciences in the Harvard T.H. Chan School of Public Health, Boston, told this news organization. “It is important to routinely assess loneliness, as the consequences may be worse if unidentified and/or ignored.”
The findings were published online in eClinicalMedicine.
Significant, Chronic Health Consequences
Exacerbated by the COVID-19 pandemic, loneliness is at an all-time high. A 2023 Surgeon General’s report highlighted the fact that loneliness and social isolation are linked to significant and chronic health consequences.
Previous research has linked loneliness to cardiovascular disease, yet few studies have examined the association between loneliness and stroke risk. The current study is one of the first to examine the association between changes in loneliness and stroke risk over time.
Using data from the 2006-2018 Health and Retirement Study, researchers assessed the link between loneliness and incident stroke over time. Between 2006 and 2008, 12,161 study participants, who were all older than 50 years with no history of stroke, responded to questions from the Revised UCLA Loneliness Scale. From these responses, researchers created summary loneliness scores.
Four years later, from 2010 to 2012, the 8936 remaining study participants responded to the same 20 questions again. Based on loneliness scores across the two time points, participants were divided into four groups:
- Consistently low (those who scored low on the loneliness scale at both baseline and follow-up).
- Remitting (those who scored high at baseline and low at follow-up).
- Recent onset (those who scored low at baseline and high at follow-up).
- Consistently high (those who scored high at both baseline and follow-up).
Incident stroke was determined by participant report and medical record data.
Among participants whose loneliness was measured at baseline only, 1237 strokes occurred during the 2006-2018 follow-up period. Among those who provided two loneliness assessments over time, 601 strokes occurred during the follow-up period.
Even after adjusting for social isolation, depressive symptoms, physical activity, body mass index, and other health conditions, investigators found that participants who reported being lonely at baseline only had a 25% increased stroke risk, compared with those who did not report being lonely at baseline (hazard ratio [HR], 1.25; 95% confidence interval (CI), 1.06-1.47).
Participants who reported having consistently high loneliness across both time points had a 56% increased risk for incident stroke vs those who did not report loneliness at both time points after adjusting for social isolation and depression (HR, 1.56; 95% CI, 1.11-2.18).
The researchers did not investigate any of the underlying issues that may contribute to the association between loneliness and stroke risk, but speculated there may be physiological factors at play. These could include inflammation caused by increased hypothalamic pituitary-adrenocortical activity, behavioral factors such as poor medication adherence, smoking and/or alcohol use, and psychosocial issues.
Those who experience chronic loneliness may represent individuals that are unable to develop or maintain satisfying social relationships, which may result in longer-term interpersonal difficulties, Dr. Soh noted.
“Since loneliness is a highly subjective experience, seeking help to address and intervene to address a patient’s specific personal needs is important. It’s important to distinguish loneliness from social isolation,” said Dr. Soh.
She added that “by screening for loneliness and providing care or referring patients to relevant behavioral healthcare providers, clinicians can play a crucial role in addressing loneliness and its associated health risks early on to help reduce the population burden of loneliness.”
Progressive Research
Commenting on the findings for this news organization, Elaine Jones, MD, medical director of Access TeleCare, who was not involved in the research, applauded the investigators for “advancing the topic by looking at the chronicity aspect of loneliness.”
She said more research is needed to investigate loneliness as a stroke risk factor and noted that there may be something inherently different among respondents who reported loneliness at both study time points.
“Personality types may play a role here. We know people with positive attitudes and outlooks can do better in challenging health situations than people who are negative in their attitudes, regardless of depression. Perhaps those who feel lonely initially decided to do something about it and join groups, take up a hobby, or re-engage with family or friends. Perhaps the people who are chronically lonely don’t, or can’t, do this,” Dr. Jones said.
Chronic loneliness can cause stress, she added, “and we know that stress chemicals and hormones can be harmful to health over long durations of time.”
The study was funded by the National Institute on Aging. There were no conflicts of interest noted.
A version of this article first appeared on Medscape.com.
Adults older than 50 years who report experiencing persistently high levels of loneliness have a 56% increased risk for stroke, a new study showed.
The increased stroke risk did not apply to individuals who reported experiencing situational loneliness, a finding that investigators believe bolsters the hypothesis that chronic loneliness is driving the association.
“Our findings suggest that individuals who experience chronic loneliness are at higher risk for incident stroke,” lead investigator Yenee Soh, ScD, research associate of social and behavioral sciences in the Harvard T.H. Chan School of Public Health, Boston, told this news organization. “It is important to routinely assess loneliness, as the consequences may be worse if unidentified and/or ignored.”
The findings were published online in eClinicalMedicine.
Significant, Chronic Health Consequences
Exacerbated by the COVID-19 pandemic, loneliness is at an all-time high. A 2023 Surgeon General’s report highlighted the fact that loneliness and social isolation are linked to significant and chronic health consequences.
Previous research has linked loneliness to cardiovascular disease, yet few studies have examined the association between loneliness and stroke risk. The current study is one of the first to examine the association between changes in loneliness and stroke risk over time.
Using data from the 2006-2018 Health and Retirement Study, researchers assessed the link between loneliness and incident stroke over time. Between 2006 and 2008, 12,161 study participants, who were all older than 50 years with no history of stroke, responded to questions from the Revised UCLA Loneliness Scale. From these responses, researchers created summary loneliness scores.
Four years later, from 2010 to 2012, the 8936 remaining study participants responded to the same 20 questions again. Based on loneliness scores across the two time points, participants were divided into four groups:
- Consistently low (those who scored low on the loneliness scale at both baseline and follow-up).
- Remitting (those who scored high at baseline and low at follow-up).
- Recent onset (those who scored low at baseline and high at follow-up).
- Consistently high (those who scored high at both baseline and follow-up).
Incident stroke was determined by participant report and medical record data.
Among participants whose loneliness was measured at baseline only, 1237 strokes occurred during the 2006-2018 follow-up period. Among those who provided two loneliness assessments over time, 601 strokes occurred during the follow-up period.
Even after adjusting for social isolation, depressive symptoms, physical activity, body mass index, and other health conditions, investigators found that participants who reported being lonely at baseline only had a 25% increased stroke risk, compared with those who did not report being lonely at baseline (hazard ratio [HR], 1.25; 95% confidence interval (CI), 1.06-1.47).
Participants who reported having consistently high loneliness across both time points had a 56% increased risk for incident stroke vs those who did not report loneliness at both time points after adjusting for social isolation and depression (HR, 1.56; 95% CI, 1.11-2.18).
The researchers did not investigate any of the underlying issues that may contribute to the association between loneliness and stroke risk, but speculated there may be physiological factors at play. These could include inflammation caused by increased hypothalamic pituitary-adrenocortical activity, behavioral factors such as poor medication adherence, smoking and/or alcohol use, and psychosocial issues.
Those who experience chronic loneliness may represent individuals that are unable to develop or maintain satisfying social relationships, which may result in longer-term interpersonal difficulties, Dr. Soh noted.
“Since loneliness is a highly subjective experience, seeking help to address and intervene to address a patient’s specific personal needs is important. It’s important to distinguish loneliness from social isolation,” said Dr. Soh.
She added that “by screening for loneliness and providing care or referring patients to relevant behavioral healthcare providers, clinicians can play a crucial role in addressing loneliness and its associated health risks early on to help reduce the population burden of loneliness.”
Progressive Research
Commenting on the findings for this news organization, Elaine Jones, MD, medical director of Access TeleCare, who was not involved in the research, applauded the investigators for “advancing the topic by looking at the chronicity aspect of loneliness.”
She said more research is needed to investigate loneliness as a stroke risk factor and noted that there may be something inherently different among respondents who reported loneliness at both study time points.
“Personality types may play a role here. We know people with positive attitudes and outlooks can do better in challenging health situations than people who are negative in their attitudes, regardless of depression. Perhaps those who feel lonely initially decided to do something about it and join groups, take up a hobby, or re-engage with family or friends. Perhaps the people who are chronically lonely don’t, or can’t, do this,” Dr. Jones said.
Chronic loneliness can cause stress, she added, “and we know that stress chemicals and hormones can be harmful to health over long durations of time.”
The study was funded by the National Institute on Aging. There were no conflicts of interest noted.
A version of this article first appeared on Medscape.com.
Adults older than 50 years who report experiencing persistently high levels of loneliness have a 56% increased risk for stroke, a new study showed.
The increased stroke risk did not apply to individuals who reported experiencing situational loneliness, a finding that investigators believe bolsters the hypothesis that chronic loneliness is driving the association.
“Our findings suggest that individuals who experience chronic loneliness are at higher risk for incident stroke,” lead investigator Yenee Soh, ScD, research associate of social and behavioral sciences in the Harvard T.H. Chan School of Public Health, Boston, told this news organization. “It is important to routinely assess loneliness, as the consequences may be worse if unidentified and/or ignored.”
The findings were published online in eClinicalMedicine.
Significant, Chronic Health Consequences
Exacerbated by the COVID-19 pandemic, loneliness is at an all-time high. A 2023 Surgeon General’s report highlighted the fact that loneliness and social isolation are linked to significant and chronic health consequences.
Previous research has linked loneliness to cardiovascular disease, yet few studies have examined the association between loneliness and stroke risk. The current study is one of the first to examine the association between changes in loneliness and stroke risk over time.
Using data from the 2006-2018 Health and Retirement Study, researchers assessed the link between loneliness and incident stroke over time. Between 2006 and 2008, 12,161 study participants, who were all older than 50 years with no history of stroke, responded to questions from the Revised UCLA Loneliness Scale. From these responses, researchers created summary loneliness scores.
Four years later, from 2010 to 2012, the 8936 remaining study participants responded to the same 20 questions again. Based on loneliness scores across the two time points, participants were divided into four groups:
- Consistently low (those who scored low on the loneliness scale at both baseline and follow-up).
- Remitting (those who scored high at baseline and low at follow-up).
- Recent onset (those who scored low at baseline and high at follow-up).
- Consistently high (those who scored high at both baseline and follow-up).
Incident stroke was determined by participant report and medical record data.
Among participants whose loneliness was measured at baseline only, 1237 strokes occurred during the 2006-2018 follow-up period. Among those who provided two loneliness assessments over time, 601 strokes occurred during the follow-up period.
Even after adjusting for social isolation, depressive symptoms, physical activity, body mass index, and other health conditions, investigators found that participants who reported being lonely at baseline only had a 25% increased stroke risk, compared with those who did not report being lonely at baseline (hazard ratio [HR], 1.25; 95% confidence interval (CI), 1.06-1.47).
Participants who reported having consistently high loneliness across both time points had a 56% increased risk for incident stroke vs those who did not report loneliness at both time points after adjusting for social isolation and depression (HR, 1.56; 95% CI, 1.11-2.18).
The researchers did not investigate any of the underlying issues that may contribute to the association between loneliness and stroke risk, but speculated there may be physiological factors at play. These could include inflammation caused by increased hypothalamic pituitary-adrenocortical activity, behavioral factors such as poor medication adherence, smoking and/or alcohol use, and psychosocial issues.
Those who experience chronic loneliness may represent individuals that are unable to develop or maintain satisfying social relationships, which may result in longer-term interpersonal difficulties, Dr. Soh noted.
“Since loneliness is a highly subjective experience, seeking help to address and intervene to address a patient’s specific personal needs is important. It’s important to distinguish loneliness from social isolation,” said Dr. Soh.
She added that “by screening for loneliness and providing care or referring patients to relevant behavioral healthcare providers, clinicians can play a crucial role in addressing loneliness and its associated health risks early on to help reduce the population burden of loneliness.”
Progressive Research
Commenting on the findings for this news organization, Elaine Jones, MD, medical director of Access TeleCare, who was not involved in the research, applauded the investigators for “advancing the topic by looking at the chronicity aspect of loneliness.”
She said more research is needed to investigate loneliness as a stroke risk factor and noted that there may be something inherently different among respondents who reported loneliness at both study time points.
“Personality types may play a role here. We know people with positive attitudes and outlooks can do better in challenging health situations than people who are negative in their attitudes, regardless of depression. Perhaps those who feel lonely initially decided to do something about it and join groups, take up a hobby, or re-engage with family or friends. Perhaps the people who are chronically lonely don’t, or can’t, do this,” Dr. Jones said.
Chronic loneliness can cause stress, she added, “and we know that stress chemicals and hormones can be harmful to health over long durations of time.”
The study was funded by the National Institute on Aging. There were no conflicts of interest noted.
A version of this article first appeared on Medscape.com.
Study Finds Major CV Event Risk in Patients With AD Similar to Controls
The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.
To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.
Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
MACE Incidence, Relative Risk
The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).
In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).
MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
Unexpected Results
“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”
Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.
Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”
In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”
Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.
AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.
A version of this article appeared on Medscape.com.
The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.
To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.
Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
MACE Incidence, Relative Risk
The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).
In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).
MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
Unexpected Results
“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”
Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.
Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”
In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”
Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.
AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.
A version of this article appeared on Medscape.com.
The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.
To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.
Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
MACE Incidence, Relative Risk
The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).
In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).
MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
Unexpected Results
“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”
Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.
Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”
In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”
Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.
AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.
A version of this article appeared on Medscape.com.
Anticoagulation Shows No Benefit in Preventing Second Stroke
BOSTON — Patients who have had a stroke are thought to be at a higher risk for another one, but oral anticoagulation with edoxaban led to no discernible reduction in the risk for a second stroke, and the risk for major bleeding was more than quadruple the risk with no anticoagulation, a subanalysis of a major European trial has shown.
“There is no interaction between prior stroke or TIA [transient ischemic attack] and the treatment effect, and this is true for the primary outcome and the safety outcome,” Paulus Kirchoff, MD, director of cardiology at the University Heart and Vascular Center in Hamburg, Germany, said during his presentation of a subanalysis of the NOAH-AFNET 6 trial at the annual meeting of the Heart Rhythm Society (HRS) 2024. However, “there is a signal for more safety events in patients randomized to anticoagulation with a prior stroke.”
The subanalysis involved 253 patients who had had a stroke or TIA and who had device-detected atrial fibrillation (AF) from the overall NOAH-AFNET 6 population of 2536 patients, which enrolled patients 65 years and older with at least one additional CHA2DS-VASc risk factor and patients 75 years and older with device-detected subclinical AF episodes of at least 6 minutes. Patients were randomized to either edoxaban or no anticoagulation, but 53.9% of the no-anticoagulation group was taking aspirin at trial enrollment. Anticoagulation with edoxaban was shown to have no significant impact on stroke rates or other cardiovascular outcomes.
Subanalysis Results
In the subanalysis, a composite of stroke, systemic embolism, and cardiovascular death — the primary outcome — was similar in the edoxaban and no-anticoagulation groups (14/122 patients [11.5%] vs 16/131 patients [12.2%]; 5.7% vs 6.3% per patient-year).
The rate of recurrent stroke was also similar in the edoxaban and no-anticoagulation groups (4 of 122 patients [3.3%] vs 6 of 131 patients [4.6%]; 1.6% vs 2.3% per patient-year). And there were eight cardiovascular deaths in each group.
However, edoxaban patients had significantly higher rates of major bleeding.
“This is a subanalysis, so what we see in terms of the number of patients with events is not powered for a definitive answer, but we do see that there were 10 major bleeds in the group of patients with a prior stroke or TIA in NOAH,” Dr. Kirchoff reported. “Eight of those 10 major bleeds occurred in patients randomized to edoxaban.”
Results from the NOAH-AFNET 6 trial have been compared with those from the ARTESiA trial, which compared apixaban anticoagulation with aspirin in patients with subclinical AF and was also presented at HRS 2024. ARTESiA showed that apixaban significantly lowered the risk for stroke and systemic embolism.
“In ARTESiA, everyone was on aspirin when they were randomized to no anticoagulation; in NOAH, only about half were on aspirin,” Dr. Kirchoff said.
Both studies had similar outcomes for cardiovascular death in the anticoagulation and no-anticoagulation groups. “It’s not significant; it may be chance, but it’s definitely not the reduction in death that we have seen in the anticoagulant trials,” Dr. Kirchoff said. “When you look at the meta-analyses of the early anticoagulation trials, there’s a one third reduction in death, and here we’re talking about a smaller reduction.”
This research points to a need for a better way to evaluate stroke risk. “We need new markers,” Dr. Kirchoff said. “Some of them may be in the blood or imaging, genetics maybe, and one thing that really emerges from my perspective is that we now have the first evidence to suggest that patients with a very low atrial fibrillation burden have a low stroke rate.”
More research is needed to better understand AF characteristics and stroke risk, he said.
AF Care Enters a ‘Gray Zone’
The NOAH-AFNET 6 results, coupled with those from ARTESiA, are changing the paradigm for anticoagulation in patients with stroke, said Taya Glotzer, MD, an electrophysiologist at the Hackensack University Medical Center in Hackensack, New Jersey, who compiled her own analysis of the studies’ outcomes.
“In ARTESiA, the stroke reduction was only 0.44% a year, with a number needed to treat of 250,” she said. “In the NOAH-AFNET 6 main trial, the stroke reduction was 0.2%, with the number needed to treat of 500, and in the NOAH prior stroke patients, there was a 0.7% reduction, with a number needed to treat of 143.”
None of these trials would meet the standard for a class 1 recommendation for anticoagulation with a reduction of even 1%-2% per year, she noted, but they do show that the stroke rate “is very, very low” in prior patients with stroke.
“Prior to 2024, we knew what was black and white; we knew who to anticoagulate and who not to anticoagulate. And now we are in a gray zone, trying to balance the risk of stroke and bleeding. We have to individualize or hope for substudies, perhaps using the CHA2DS-VASc score or other information about the left atrium, to help us make decisions in these patients. It’s not just going to be black and white,” she said.
Dr. Kirchoff had no relevant financial relationships to disclose. Dr. Glotzer disclosed financial relationships with Medtronic, Abbott, Boston Scientific, and MediaSphere Medical.
A version of this article first appeared on Medscape.com.
BOSTON — Patients who have had a stroke are thought to be at a higher risk for another one, but oral anticoagulation with edoxaban led to no discernible reduction in the risk for a second stroke, and the risk for major bleeding was more than quadruple the risk with no anticoagulation, a subanalysis of a major European trial has shown.
“There is no interaction between prior stroke or TIA [transient ischemic attack] and the treatment effect, and this is true for the primary outcome and the safety outcome,” Paulus Kirchoff, MD, director of cardiology at the University Heart and Vascular Center in Hamburg, Germany, said during his presentation of a subanalysis of the NOAH-AFNET 6 trial at the annual meeting of the Heart Rhythm Society (HRS) 2024. However, “there is a signal for more safety events in patients randomized to anticoagulation with a prior stroke.”
The subanalysis involved 253 patients who had had a stroke or TIA and who had device-detected atrial fibrillation (AF) from the overall NOAH-AFNET 6 population of 2536 patients, which enrolled patients 65 years and older with at least one additional CHA2DS-VASc risk factor and patients 75 years and older with device-detected subclinical AF episodes of at least 6 minutes. Patients were randomized to either edoxaban or no anticoagulation, but 53.9% of the no-anticoagulation group was taking aspirin at trial enrollment. Anticoagulation with edoxaban was shown to have no significant impact on stroke rates or other cardiovascular outcomes.
Subanalysis Results
In the subanalysis, a composite of stroke, systemic embolism, and cardiovascular death — the primary outcome — was similar in the edoxaban and no-anticoagulation groups (14/122 patients [11.5%] vs 16/131 patients [12.2%]; 5.7% vs 6.3% per patient-year).
The rate of recurrent stroke was also similar in the edoxaban and no-anticoagulation groups (4 of 122 patients [3.3%] vs 6 of 131 patients [4.6%]; 1.6% vs 2.3% per patient-year). And there were eight cardiovascular deaths in each group.
However, edoxaban patients had significantly higher rates of major bleeding.
“This is a subanalysis, so what we see in terms of the number of patients with events is not powered for a definitive answer, but we do see that there were 10 major bleeds in the group of patients with a prior stroke or TIA in NOAH,” Dr. Kirchoff reported. “Eight of those 10 major bleeds occurred in patients randomized to edoxaban.”
Results from the NOAH-AFNET 6 trial have been compared with those from the ARTESiA trial, which compared apixaban anticoagulation with aspirin in patients with subclinical AF and was also presented at HRS 2024. ARTESiA showed that apixaban significantly lowered the risk for stroke and systemic embolism.
“In ARTESiA, everyone was on aspirin when they were randomized to no anticoagulation; in NOAH, only about half were on aspirin,” Dr. Kirchoff said.
Both studies had similar outcomes for cardiovascular death in the anticoagulation and no-anticoagulation groups. “It’s not significant; it may be chance, but it’s definitely not the reduction in death that we have seen in the anticoagulant trials,” Dr. Kirchoff said. “When you look at the meta-analyses of the early anticoagulation trials, there’s a one third reduction in death, and here we’re talking about a smaller reduction.”
This research points to a need for a better way to evaluate stroke risk. “We need new markers,” Dr. Kirchoff said. “Some of them may be in the blood or imaging, genetics maybe, and one thing that really emerges from my perspective is that we now have the first evidence to suggest that patients with a very low atrial fibrillation burden have a low stroke rate.”
More research is needed to better understand AF characteristics and stroke risk, he said.
AF Care Enters a ‘Gray Zone’
The NOAH-AFNET 6 results, coupled with those from ARTESiA, are changing the paradigm for anticoagulation in patients with stroke, said Taya Glotzer, MD, an electrophysiologist at the Hackensack University Medical Center in Hackensack, New Jersey, who compiled her own analysis of the studies’ outcomes.
“In ARTESiA, the stroke reduction was only 0.44% a year, with a number needed to treat of 250,” she said. “In the NOAH-AFNET 6 main trial, the stroke reduction was 0.2%, with the number needed to treat of 500, and in the NOAH prior stroke patients, there was a 0.7% reduction, with a number needed to treat of 143.”
None of these trials would meet the standard for a class 1 recommendation for anticoagulation with a reduction of even 1%-2% per year, she noted, but they do show that the stroke rate “is very, very low” in prior patients with stroke.
“Prior to 2024, we knew what was black and white; we knew who to anticoagulate and who not to anticoagulate. And now we are in a gray zone, trying to balance the risk of stroke and bleeding. We have to individualize or hope for substudies, perhaps using the CHA2DS-VASc score or other information about the left atrium, to help us make decisions in these patients. It’s not just going to be black and white,” she said.
Dr. Kirchoff had no relevant financial relationships to disclose. Dr. Glotzer disclosed financial relationships with Medtronic, Abbott, Boston Scientific, and MediaSphere Medical.
A version of this article first appeared on Medscape.com.
BOSTON — Patients who have had a stroke are thought to be at a higher risk for another one, but oral anticoagulation with edoxaban led to no discernible reduction in the risk for a second stroke, and the risk for major bleeding was more than quadruple the risk with no anticoagulation, a subanalysis of a major European trial has shown.
“There is no interaction between prior stroke or TIA [transient ischemic attack] and the treatment effect, and this is true for the primary outcome and the safety outcome,” Paulus Kirchoff, MD, director of cardiology at the University Heart and Vascular Center in Hamburg, Germany, said during his presentation of a subanalysis of the NOAH-AFNET 6 trial at the annual meeting of the Heart Rhythm Society (HRS) 2024. However, “there is a signal for more safety events in patients randomized to anticoagulation with a prior stroke.”
The subanalysis involved 253 patients who had had a stroke or TIA and who had device-detected atrial fibrillation (AF) from the overall NOAH-AFNET 6 population of 2536 patients, which enrolled patients 65 years and older with at least one additional CHA2DS-VASc risk factor and patients 75 years and older with device-detected subclinical AF episodes of at least 6 minutes. Patients were randomized to either edoxaban or no anticoagulation, but 53.9% of the no-anticoagulation group was taking aspirin at trial enrollment. Anticoagulation with edoxaban was shown to have no significant impact on stroke rates or other cardiovascular outcomes.
Subanalysis Results
In the subanalysis, a composite of stroke, systemic embolism, and cardiovascular death — the primary outcome — was similar in the edoxaban and no-anticoagulation groups (14/122 patients [11.5%] vs 16/131 patients [12.2%]; 5.7% vs 6.3% per patient-year).
The rate of recurrent stroke was also similar in the edoxaban and no-anticoagulation groups (4 of 122 patients [3.3%] vs 6 of 131 patients [4.6%]; 1.6% vs 2.3% per patient-year). And there were eight cardiovascular deaths in each group.
However, edoxaban patients had significantly higher rates of major bleeding.
“This is a subanalysis, so what we see in terms of the number of patients with events is not powered for a definitive answer, but we do see that there were 10 major bleeds in the group of patients with a prior stroke or TIA in NOAH,” Dr. Kirchoff reported. “Eight of those 10 major bleeds occurred in patients randomized to edoxaban.”
Results from the NOAH-AFNET 6 trial have been compared with those from the ARTESiA trial, which compared apixaban anticoagulation with aspirin in patients with subclinical AF and was also presented at HRS 2024. ARTESiA showed that apixaban significantly lowered the risk for stroke and systemic embolism.
“In ARTESiA, everyone was on aspirin when they were randomized to no anticoagulation; in NOAH, only about half were on aspirin,” Dr. Kirchoff said.
Both studies had similar outcomes for cardiovascular death in the anticoagulation and no-anticoagulation groups. “It’s not significant; it may be chance, but it’s definitely not the reduction in death that we have seen in the anticoagulant trials,” Dr. Kirchoff said. “When you look at the meta-analyses of the early anticoagulation trials, there’s a one third reduction in death, and here we’re talking about a smaller reduction.”
This research points to a need for a better way to evaluate stroke risk. “We need new markers,” Dr. Kirchoff said. “Some of them may be in the blood or imaging, genetics maybe, and one thing that really emerges from my perspective is that we now have the first evidence to suggest that patients with a very low atrial fibrillation burden have a low stroke rate.”
More research is needed to better understand AF characteristics and stroke risk, he said.
AF Care Enters a ‘Gray Zone’
The NOAH-AFNET 6 results, coupled with those from ARTESiA, are changing the paradigm for anticoagulation in patients with stroke, said Taya Glotzer, MD, an electrophysiologist at the Hackensack University Medical Center in Hackensack, New Jersey, who compiled her own analysis of the studies’ outcomes.
“In ARTESiA, the stroke reduction was only 0.44% a year, with a number needed to treat of 250,” she said. “In the NOAH-AFNET 6 main trial, the stroke reduction was 0.2%, with the number needed to treat of 500, and in the NOAH prior stroke patients, there was a 0.7% reduction, with a number needed to treat of 143.”
None of these trials would meet the standard for a class 1 recommendation for anticoagulation with a reduction of even 1%-2% per year, she noted, but they do show that the stroke rate “is very, very low” in prior patients with stroke.
“Prior to 2024, we knew what was black and white; we knew who to anticoagulate and who not to anticoagulate. And now we are in a gray zone, trying to balance the risk of stroke and bleeding. We have to individualize or hope for substudies, perhaps using the CHA2DS-VASc score or other information about the left atrium, to help us make decisions in these patients. It’s not just going to be black and white,” she said.
Dr. Kirchoff had no relevant financial relationships to disclose. Dr. Glotzer disclosed financial relationships with Medtronic, Abbott, Boston Scientific, and MediaSphere Medical.
A version of this article first appeared on Medscape.com.
FROM HRS 2024