Dabigatran not superior to aspirin for prevention of recurrent stroke
There was no significant difference between dabigatran and aspirin in preventing recurrent stroke in patients with an embolic stroke of undetermined source, according to findings published in The New England Journal of Medicine.
Hans-Christoph Diener, MD, PhD, and colleagues conducted the RE-SPECT ESUS trial to compare the efficacy and safety of dabigatran (Pradaxa, Boehringer Ingelheim) with aspirin as a means of recurrent stroke prevention.
“Guidelines for secondary prevention of stroke in patients who have had a cryptogenic stroke recommend administration of antiplatelet agents, and treatment may include aspirin, a combination of extended release dipyridamole and aspirin or clopidogrel and aspirin,” Diener, a professor of neurology and chairman of the department of neurology at the University Duisburg-Essen and University Hospital Essen, Germany, and colleagues wrote. “Oral anticoagulants, including dabigatran etexilate, have an established role in reducing the incidence of recurrent strokes among patients with high-risk cardioembolic factors, such as atrial fibrillation.”
The researchers conducted a multicenter, randomized, double-blind trial of dabigatran at a dose of 150 mg or 110 mg twice daily compared with aspirin at a dose of 100 mg once daily in patients who had an embolic stroke of undetermined source.
The primary outcome was recurrent stroke. The primary safety outcome was major bleeding. Median follow-up was 19 months.
The researchers randomly assigned 5,390 patients at 564 sites to dabigatran or aspirin.
During follow-up, 6.6% of patients in the dabigatran group had recurrent strokes compared with 7.7% in the aspirin group (HR = 0.85; 95% CI, 0.69-1.03), the researchers wrote. Ischemic strokes occurred at a rate of 4% per year in the dabigatran group compared with 4.7% per year in the aspirin group (HR = 0.84; 95% CI, 0.68-1.03).
Major bleeding occurred at a rate of 1.7% per year in the dabigatran group and 1.4% per year in the aspirin group (HR = 1.19; 95% CI, 0.85-1.66), Diener and colleagues wrote.
“The incidence of major bleeding was not greater in the dabigatran group than in the aspirin group, but there were more clinically relevant nonmajor bleeding events in the dabigatran group,” Diener and colleagues wrote. – by Earl Holland Jr.
Disclosures: The study was funded by Boehringer Ingelheim. Diener reports receiving honoraria from Abbott, Allergan, AstraZeneca, Bayer Vital, Boehringer Ingelheim, Bristol-Myers Squibb, Brainsgate, CoAxia, Corimmun, Covidien, Daiichi Sankyo, D-Pharm, EV3, Fresenius, GlaxoSmithKline, Janssen-Cilag, Knoll, Merck, Sharpe & Dohme, Lilly, Medtronic, Mind-Frame, Neurobiological Technologies, Novartis, Novo Nordisk, Paion, Parke-Davis, Pfizer, Sanofi Aventis, Schering-Plough, Servier, Solvay, Thrombogenics and Wyeth. Please the study for all other authors’ relevant financial disclosures.