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Antiplatelet therapy appears safe after stroke due to intracerebral hemorrhage
Antiplatelet therapy appears safe to use for secondary prevention in patients who had a stroke due to intracerebral hemorrhage, according to results of the RESTART trial presented at the European Stroke Organization Conference.
Rustam Al-Shahi Salman, MA, MB, BChir, PhD, FRCP Edin, FHEA, FESO, professor of clinical neurology at the Centre for Clinical Brain Sciences, University of Edinburgh, Scotland, United Kingdom, and colleagues analyzed the effects of antiplatelet therapy on recurrent intracerebral hemorrhage and whether its risks might outweigh the benefits of reducing occlusive vascular events. The results were simultaneously published in The Lancet.
The study included 537 patients who were taking antiplatelet or anticoagulant therapy for prevention of occlusive vascular disease but had a subsequent intracerebral hemorrhage. All patients discontinued antithrombotic therapy at the time of intracerebral hemorrhage and survived for at least 24 hours after the event.
Upon enrollment, patients were randomly assigned to start (mean age, 77 years; 35% women) or avoid (mean age, 76 years; 30% women) antiplatelet therapy, which consisted of one or more of aspirin, clopidogrel or dipyridamole. Regimen and dosages were at the discretion of the treating clinician.
The primary outcome was recurrent symptomatic intracerebral hemorrhage. Median follow-up was 2 years.
Intracerebral hemorrhage recurred in 4% of the antiplatelet group and 9% of the control group (adjusted HR = 0.51; 95% CI, 0.25-1.03), Salman and colleagues found.
Major hemorrhagic events occurred in 7% of the antiplatelet group and 9% of the control group (HR = 0.71; 95% CI, 0.39-1.3), whereas major occlusive vascular events occurred in 15% of the antiplatelet group and 14% of the control group (HR = 1.02; 95% CI, 0.65-1.6), according to the researchers.
“The risk of recurrent intracerebral hemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention,” Salman and colleagues wrote in The Lancet.
In a related editorial in The Lancet, Wendy C. Ziai, MD, associate professor of neurology and medical director of the neurovascular laboratory at Johns Hopkins Medicine, and Alexander Tsiskaridze, MD, PhD, DSc, professor of neurology and dean of the faculty of medicine at Ivane Javakhishvili Tbilisi State University, Tbilisi, Georgia, wrote: “Although similar treatment effect estimates for the primary outcome in the premedian and postmedian periods after intracerebral hemorrhage symptom onset do not suggest that the risk is higher in the first 2 months, optimal timing of starting antiplatelet therapy after intracerebral hemorrhage remains unclear. Future studies would benefit from earlier onset of antiplatelet on the basis of the results from RESTART because they suggest that the risk of intracerebral hemorrhage recurrence with antiplatelet therapy is potentially low.”
The RESTART investigators also conducted a subgroup analysis, published in The Lancet Neurology, of the effect of restarting antiplatelet therapy in patients from the cohort with cerebral microbleeds. They found no effect of restarting antiplatelet therapy on recurrent intracerebral hemorrhage according to 0 or 1 cerebral microbleeds vs. 2 or more (P for interaction = .41), to 0 or 1 vs. 2 to 4 vs. 5 or more (P for interaction = .75) or to strictly lobar microbleeds vs. other locations (P for interaction = .85). – by Erik Swain
References:
Salman RAS, et al. Official Welcome and Large Clinical Trials. Presented at: European Stroke Organization Conference; May 22-24, 2019; Milan.
RESTART Collaboration. Lancet. 2019;doi:10.1016/S0140-6736(19)30840-2.
Salman RAS, et al. Lancet Neurol. 2019;doi:10.1016/S1474-4422(19)30184-X.
Ziai WC, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31094-3.
Disclosures: Salman reports no relevant financial disclosures. Ziai reports she consults for C.R. Bard. Tsiskaridze reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Care of this population is individualized based on balancing the risk for ischemic events and the risk for recurrent hemorrhage. The rates of recurrent hemorrhage in this study, regardless of treatment group (approximately 2% to 4.5% per year), were somewhat lower than prior cohort studies (1.8% to 7.4% per year) and did not differ between the group that restarted vs. avoided antiplatelet drugs. There, however, was also no reduction between the groups in occlusive major vascular events. Although reassuring regarding safety, whether the balance of risk and benefit is maintained with longer treatment follow-up is not certain. We need studies with longer follow-up to answer this question.