Rivaroxaban Not Superior to Aspirin for Patients with Embolic Stroke of Unknown Source

By Amy Orciari Herman

Edited by Lorenzo Di Francesco, MD, FACP, FHM

Among patients with embolic stroke of unknown source, rivaroxaban is not better than aspirin for preventing recurrent stroke — and does lead to more bleeding. Findings from the industry-funded, phase 3 trial were published on Wednesday in the New England Journal of Medicine and presented at the European Stroke Organisation Conference in Sweden.

Over 7200 adults aged 50 and older who'd recently had an ischemic stroke that was assumed to be caused by cerebral embolism — but without arterial stenosis, lacune, or a known cardioembolic source — were randomized to receive either rivaroxaban (15 mg daily) plus placebo or aspirin (100 mg daily) plus placebo.

During a median follow-up of 11 months, the annualized rate of recurrent stroke (any type) or systemic embolism did not differ significantly between the groups, at roughly 5%. However, major bleeding occurred more often with rivaroxaban than with aspirin (1.8% vs. 0.7%), as did life-threatening or fatal bleeding (1.0% vs. 0.4%). Accordingly, the trial was stopped early.