Better data needed about anticoagulation resumption
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– Even when patients on an oral anticoagulant have the dreaded complication of an intracerebral hemorrhage, resumption of their oral anticoagulation regimen appears to produce the best midterm outcomes, based on a meta-analysis of data from more than 1,000 patients collected in three observational studies.

Resumption of oral anticoagulation therapy (OAT) is a “major dilemma” when managing patients who developed an intracerebral hemorrhage (ICH) while on OAT, said Alessandro Biffi, MD, explaining why he performed this meta-analysis that he presented at the International Stroke Conference sponsored by the American Heart Association.

Dr. Alessandro Biffi, a neurologist at Massachusetts General Hospital, Boston
Mitchel L. Zoler/Frontline Medical News
Dr. Alessandro Biffi
Although the results showed that patients who resumed OAT following an on-treatment ICH had their subsequent 1-year mortality cut by more than 70% and their 1-year stroke risk halved, compared with patients who did not resume OAT, Dr. Biffi acknowledged the strong limitations of these observational data and the need for a prospective, randomized trial to definitively address the issue. The suggestive findings from the analysis “strongly support” the need for a prospective trial to better assess the benefit and risk from OAT resumption following ICH, said Dr. Biffi, a neurologist at Massachusetts General Hospital in Boston.

He used individual patient data collected from a total of 1,027 patients enrolled in any of three different observational studies: the German-wide Multicenter Analysis of Oral Anticoagulation Associated Intracerebral Hemorrhage (RETRACE) study, the MGH longitudinal ICH study, or the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study. Overall 26% of the patients resumed OAT following their ICH, although the rate ranged from a low of 20% in one study to a high of 42% in another. The vast majority of patients received a vitamin K antagonist as their anticoagulant; very few received a new oral anticoagulant.

Using propensity score matching to compare similar patients who resumed or stayed off OAT, Dr. Biffi found that, during the year following the index ICH, mortality was 71%-74% lower among patients who resumed OAT. Recurrent all-cause stroke was 49%-55% lower with resumed OAT, and favorable functional outcomes (a score of 0-3 on the modified Rankin scale) were more than fourfold higher with OAT resumption, he reported.

Dr. Biffi calculated these relative rates, both for patients with a lumbar location of their ICH and for those with a nonlumbar location, and found that location had no influence on responsiveness to OAT. Patients with an index ICH in a lumbar location had a trend toward more recurrent ICH on OAT, a 26% higher rate relative to patients not resumed on OAT, but this difference fell short of statistical significance.

The only factor he found that linked with whether or not patients resumed OAT was the severity of their index ICH. The more severe their bleed, the less likely were patients to resume. Aside from that, “there is a lot of variation in practice,” he said. “We are gathering additional data” to try to further address this question.

Dr. Biffi had no disclosures.

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Resuming oral anticoagulation following an intracerebral hemorrhage is one of the most vexing problems today in vascular neurology. It’s a situation that often happens, and it will grow increasingly more common as the number of patients with atrial fibrillation escalates and even more people start oral anticoagulation.

Dr. Mark J. Alberts, chief of cardiology, Hartford (Conn.) Hospital
Mitchel L. Zoler/Frontline Medical News
Dr. Mark J. Alberts
Deciding when to resume oral anticoagulation must be individualized based on each patient’s risk for ischemic stroke and the size and cause of the ICH. Introduction of the new oral anticoagulants (NOACs) has been a huge game changer because of their reduced risk for causing ICH, compared with vitamin K antagonists. Most of the patients reviewed by Dr. Biffi received a vitamin K antagonist. If I was managing a patient like this and believed anticoagulant resumption was appropriate, I would prescribe a NOAC as long as it was financially feasible for the patient.

It’s also very important to remember that patients like these who need oral anticoagulation but now have a history of ICH must have all their other cardiovascular disease risk factors very well controlled: their blood pressure, their diabetes, their smoking, etc. Oral anticoagulation may be important for these patients, but tight risk factor control is even more important.

I agree with Dr. Biffi that a prospective, randomized trial is the best way to get more information to help guide resuming oral anticoagulation. Observational studies are significantly limited by ascertainment bias, and for these patients there are also many variables – at least a dozen – that can influence whether or not a patient resumes oral anticoagulation. Dr. Biffi’s findings are interesting, but the limitations of his data prevent the results from being truly compelling.

It would be very helpful to have data from a trial that randomized ICH patients who required anticoagulation to a full-dose NOAC, a reduced-dose NOAC, or aspirin and see which group had the best long-term outcome. Whatever the results, it would change practice. It’s intriguing to speculate that a reduced-dose NOAC might provide adequate ischemic protection with a reduced risk for more bleeding.

Mark J. Alberts, MD , is chief of neurology at Hartford (Conn.) Hospital. He had no disclosures. He made these comments in an interview and during a press conference.

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Resuming oral anticoagulation following an intracerebral hemorrhage is one of the most vexing problems today in vascular neurology. It’s a situation that often happens, and it will grow increasingly more common as the number of patients with atrial fibrillation escalates and even more people start oral anticoagulation.

Dr. Mark J. Alberts, chief of cardiology, Hartford (Conn.) Hospital
Mitchel L. Zoler/Frontline Medical News
Dr. Mark J. Alberts
Deciding when to resume oral anticoagulation must be individualized based on each patient’s risk for ischemic stroke and the size and cause of the ICH. Introduction of the new oral anticoagulants (NOACs) has been a huge game changer because of their reduced risk for causing ICH, compared with vitamin K antagonists. Most of the patients reviewed by Dr. Biffi received a vitamin K antagonist. If I was managing a patient like this and believed anticoagulant resumption was appropriate, I would prescribe a NOAC as long as it was financially feasible for the patient.

It’s also very important to remember that patients like these who need oral anticoagulation but now have a history of ICH must have all their other cardiovascular disease risk factors very well controlled: their blood pressure, their diabetes, their smoking, etc. Oral anticoagulation may be important for these patients, but tight risk factor control is even more important.

I agree with Dr. Biffi that a prospective, randomized trial is the best way to get more information to help guide resuming oral anticoagulation. Observational studies are significantly limited by ascertainment bias, and for these patients there are also many variables – at least a dozen – that can influence whether or not a patient resumes oral anticoagulation. Dr. Biffi’s findings are interesting, but the limitations of his data prevent the results from being truly compelling.

It would be very helpful to have data from a trial that randomized ICH patients who required anticoagulation to a full-dose NOAC, a reduced-dose NOAC, or aspirin and see which group had the best long-term outcome. Whatever the results, it would change practice. It’s intriguing to speculate that a reduced-dose NOAC might provide adequate ischemic protection with a reduced risk for more bleeding.

Mark J. Alberts, MD , is chief of neurology at Hartford (Conn.) Hospital. He had no disclosures. He made these comments in an interview and during a press conference.

Body

 

Resuming oral anticoagulation following an intracerebral hemorrhage is one of the most vexing problems today in vascular neurology. It’s a situation that often happens, and it will grow increasingly more common as the number of patients with atrial fibrillation escalates and even more people start oral anticoagulation.

Dr. Mark J. Alberts, chief of cardiology, Hartford (Conn.) Hospital
Mitchel L. Zoler/Frontline Medical News
Dr. Mark J. Alberts
Deciding when to resume oral anticoagulation must be individualized based on each patient’s risk for ischemic stroke and the size and cause of the ICH. Introduction of the new oral anticoagulants (NOACs) has been a huge game changer because of their reduced risk for causing ICH, compared with vitamin K antagonists. Most of the patients reviewed by Dr. Biffi received a vitamin K antagonist. If I was managing a patient like this and believed anticoagulant resumption was appropriate, I would prescribe a NOAC as long as it was financially feasible for the patient.

It’s also very important to remember that patients like these who need oral anticoagulation but now have a history of ICH must have all their other cardiovascular disease risk factors very well controlled: their blood pressure, their diabetes, their smoking, etc. Oral anticoagulation may be important for these patients, but tight risk factor control is even more important.

I agree with Dr. Biffi that a prospective, randomized trial is the best way to get more information to help guide resuming oral anticoagulation. Observational studies are significantly limited by ascertainment bias, and for these patients there are also many variables – at least a dozen – that can influence whether or not a patient resumes oral anticoagulation. Dr. Biffi’s findings are interesting, but the limitations of his data prevent the results from being truly compelling.

It would be very helpful to have data from a trial that randomized ICH patients who required anticoagulation to a full-dose NOAC, a reduced-dose NOAC, or aspirin and see which group had the best long-term outcome. Whatever the results, it would change practice. It’s intriguing to speculate that a reduced-dose NOAC might provide adequate ischemic protection with a reduced risk for more bleeding.

Mark J. Alberts, MD , is chief of neurology at Hartford (Conn.) Hospital. He had no disclosures. He made these comments in an interview and during a press conference.

Title
Better data needed about anticoagulation resumption
Better data needed about anticoagulation resumption

 

– Even when patients on an oral anticoagulant have the dreaded complication of an intracerebral hemorrhage, resumption of their oral anticoagulation regimen appears to produce the best midterm outcomes, based on a meta-analysis of data from more than 1,000 patients collected in three observational studies.

Resumption of oral anticoagulation therapy (OAT) is a “major dilemma” when managing patients who developed an intracerebral hemorrhage (ICH) while on OAT, said Alessandro Biffi, MD, explaining why he performed this meta-analysis that he presented at the International Stroke Conference sponsored by the American Heart Association.

Dr. Alessandro Biffi, a neurologist at Massachusetts General Hospital, Boston
Mitchel L. Zoler/Frontline Medical News
Dr. Alessandro Biffi
Although the results showed that patients who resumed OAT following an on-treatment ICH had their subsequent 1-year mortality cut by more than 70% and their 1-year stroke risk halved, compared with patients who did not resume OAT, Dr. Biffi acknowledged the strong limitations of these observational data and the need for a prospective, randomized trial to definitively address the issue. The suggestive findings from the analysis “strongly support” the need for a prospective trial to better assess the benefit and risk from OAT resumption following ICH, said Dr. Biffi, a neurologist at Massachusetts General Hospital in Boston.

He used individual patient data collected from a total of 1,027 patients enrolled in any of three different observational studies: the German-wide Multicenter Analysis of Oral Anticoagulation Associated Intracerebral Hemorrhage (RETRACE) study, the MGH longitudinal ICH study, or the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study. Overall 26% of the patients resumed OAT following their ICH, although the rate ranged from a low of 20% in one study to a high of 42% in another. The vast majority of patients received a vitamin K antagonist as their anticoagulant; very few received a new oral anticoagulant.

Using propensity score matching to compare similar patients who resumed or stayed off OAT, Dr. Biffi found that, during the year following the index ICH, mortality was 71%-74% lower among patients who resumed OAT. Recurrent all-cause stroke was 49%-55% lower with resumed OAT, and favorable functional outcomes (a score of 0-3 on the modified Rankin scale) were more than fourfold higher with OAT resumption, he reported.

Dr. Biffi calculated these relative rates, both for patients with a lumbar location of their ICH and for those with a nonlumbar location, and found that location had no influence on responsiveness to OAT. Patients with an index ICH in a lumbar location had a trend toward more recurrent ICH on OAT, a 26% higher rate relative to patients not resumed on OAT, but this difference fell short of statistical significance.

The only factor he found that linked with whether or not patients resumed OAT was the severity of their index ICH. The more severe their bleed, the less likely were patients to resume. Aside from that, “there is a lot of variation in practice,” he said. “We are gathering additional data” to try to further address this question.

Dr. Biffi had no disclosures.

 

– Even when patients on an oral anticoagulant have the dreaded complication of an intracerebral hemorrhage, resumption of their oral anticoagulation regimen appears to produce the best midterm outcomes, based on a meta-analysis of data from more than 1,000 patients collected in three observational studies.

Resumption of oral anticoagulation therapy (OAT) is a “major dilemma” when managing patients who developed an intracerebral hemorrhage (ICH) while on OAT, said Alessandro Biffi, MD, explaining why he performed this meta-analysis that he presented at the International Stroke Conference sponsored by the American Heart Association.

Dr. Alessandro Biffi, a neurologist at Massachusetts General Hospital, Boston
Mitchel L. Zoler/Frontline Medical News
Dr. Alessandro Biffi
Although the results showed that patients who resumed OAT following an on-treatment ICH had their subsequent 1-year mortality cut by more than 70% and their 1-year stroke risk halved, compared with patients who did not resume OAT, Dr. Biffi acknowledged the strong limitations of these observational data and the need for a prospective, randomized trial to definitively address the issue. The suggestive findings from the analysis “strongly support” the need for a prospective trial to better assess the benefit and risk from OAT resumption following ICH, said Dr. Biffi, a neurologist at Massachusetts General Hospital in Boston.

He used individual patient data collected from a total of 1,027 patients enrolled in any of three different observational studies: the German-wide Multicenter Analysis of Oral Anticoagulation Associated Intracerebral Hemorrhage (RETRACE) study, the MGH longitudinal ICH study, or the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study. Overall 26% of the patients resumed OAT following their ICH, although the rate ranged from a low of 20% in one study to a high of 42% in another. The vast majority of patients received a vitamin K antagonist as their anticoagulant; very few received a new oral anticoagulant.

Using propensity score matching to compare similar patients who resumed or stayed off OAT, Dr. Biffi found that, during the year following the index ICH, mortality was 71%-74% lower among patients who resumed OAT. Recurrent all-cause stroke was 49%-55% lower with resumed OAT, and favorable functional outcomes (a score of 0-3 on the modified Rankin scale) were more than fourfold higher with OAT resumption, he reported.

Dr. Biffi calculated these relative rates, both for patients with a lumbar location of their ICH and for those with a nonlumbar location, and found that location had no influence on responsiveness to OAT. Patients with an index ICH in a lumbar location had a trend toward more recurrent ICH on OAT, a 26% higher rate relative to patients not resumed on OAT, but this difference fell short of statistical significance.

The only factor he found that linked with whether or not patients resumed OAT was the severity of their index ICH. The more severe their bleed, the less likely were patients to resume. Aside from that, “there is a lot of variation in practice,” he said. “We are gathering additional data” to try to further address this question.

Dr. Biffi had no disclosures.

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Key clinical point: Resuming an oral anticoagulant following an on-treatment intracerebral hemorrhage led to better 1-year outcomes, compared with staying off oral anticoagulation.

Major finding: One-year mortality was 71%-74% lower among patients who resumed oral anticoagulation relative to those who did not.

Data source: Meta-analysis of data from 1,027 patients collected in three observational studies.

Disclosures: Dr. Biffi had no disclosures.