Edinburgh, Scotland—Patients with a history of brain hemorrhage might no longer need to avoid antiplatelet therapy, based on results of a new study.

A report in The Lancet said that questions had been raised about the safety of the medications, including aspirin, because of risks of recurrent brain bleeds.

The University of Edinburgh–led study suggests otherwise, however.

“Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial hemorrhage,” study authors write. “Patients surviving the commonest subtype of intracranial hemorrhage, intracerebral hemorrhage, are at risk of both hemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear.”

The study team sought to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral hemorrhage and whether that risk might exceed any reduction of occlusive vascular events.

To do that, it conducted the REstart or STop Antithrombotics Randomised Trial (RESTART), a prospective, randomized, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the U.K.

Recruited as participants were adults who were taking antithrombotic—antiplatelet or anticoagulant—therapy for the prevention of occlusive vascular disease when they developed intracerebral hemorrhage, discontinued antithrombotic therapy, and survived for 24 hours. Follow-up continued for 5 years.

Between May 22, 2013, and May 31, 2018, more than 530 participants were recruited a median of 76 days (IQR 29-146) after intracerebral hemorrhage onset. Of those, 268 were assigned to start and 269 to avoid antiplatelet therapy.

After a median follow-up of 2 years, 4% of participants allocated to antiplatelet therapy had recurrence of intracerebral hemorrhage versus 9% of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI, 0·25-1·03]; P = .060).

Researchers further report that 7% of participants allocated to antiplatelet therapy experienced major hemorrhagic events compared with 9% of participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; P = .27). Additionally, 15% of those on antiplatelet therapy had major occlusive vascular events versus 14% of patients not taking

“These results exclude all but a very modest increase in the risk of recurrent intracerebral hemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral hemorrhage,” study authors explain. “The risk of recurrent intracerebral hemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention.”

“The results of the RESTART trial are reassuring for survivors of brain hemorrhage who need to take antiplatelet medicines to prevent heart attacks and strokes,” said coauthor Rustam Salman, MA MB BChir PhD. “I am keen to investigate the possibility that these medicines might halve the risk of brain hemorrhage happening again.”

“Around a third of people who suffer a brain hemorrhage, also known as hemorrhagic stroke, do so when they are taking an antiplatelet medicine such as aspirin to reduce the risk of a heart attack or an ischemic stroke,” explained Metin Avrikan, MD, the associate medical director at the British Heart Foundation. “We now have a strong indication they can carry on taking these potentially life-saving medicines after the brain hemorrhage without increasing the risk of another one, which is crucial new information for both patients and doctors.”

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