HealthDay News – Dabigatran is not superior to aspirin for preventing recurrent stroke in patients with recent history of embolic stroke of undetermined source, according to a study published in the May 16 issue of the New England Journal of Medicine.
Hans-Christoph Diener, MD, PhD, from the University Duisburg-Essen in Germany, and colleagues conducted a multicenter, randomized, double-blind trial of dabigatran at 150mg or 110mg twice daily vs aspirin at 100mg once daily among patients with embolic stroke of undetermined source. Data were included for 5390 patients enrolled at 564 sites and randomly assigned to dabigatran (2695 patients) or aspirin (2695 patients).
The researchers found that recurrent strokes occurred in 6.6 and 7.7% of patients in the dabigatran and aspirin groups, respectively, during a median follow-up of 19 months (4.1 and 4.8% per year, respectively; hazard ratio, 0.85; 95% confidence interval, 0.69 to 1.03; P =.10). Ischemic strokes occurred at a rate of 4.0 and 4.7% per year, respectively (hazard ratio, 0.84; 95% confidence interval, 0.68 to 1.03). Major bleeding occurred at a rate of 1.7 and 1.4% per year, respectively (hazard ratio, 1.19; 95% confidence interval, 0.85 to 1.66).
“Post hoc analysis suggested that dabigatran may have had an effect on stroke recurrence after one year, but no inferences can be made because of the post hoc nature of the analysis,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Boehringer Ingelheim, which manufactures dabigatran and supported the study.