Oral anticoagulant drugs for stroke prevention in patients with atrial fibrillation added a new candidate, apixaban, which demonstrated positive results in an 18,000 patient trial. When matched against warfarin, atrial fibrillation (AF) patients treated with apixaban (Bristol-Myers Squibb, Pfizer) had significantly lower rates of stroke and systemic embolism, major bleeding complication, and overall mortality, compared with patients randomized to warfarin during a median follow-up of 1.8 years, Dr. Christopher B. Granger reported Aug. 28 at the annual congress of the European Society of Cardiology, and in a published article that concurrently appeared online (N. Engl. J. Med. 2011 Aug. 28 [10.1056/NEJMoa1107039]).
"Treatment with apixaban as compared with warfarin in patients with AF and at least one additional risk factor for stroke reduces stroke and systemic embolism by [a relative] 21%, reduces major bleeding by [a relative] 31%, and reduces mortality by [a relative] 11%," all statistically significant differences, reported Dr. Granger, director of the cardiac care unit at Duke University in Durham, N.C.
Apixaban’s accomplishment in significantly surpassing warfarin’s performance for the trio of stroke prevention, bleeding safety, and overall mortality in its pivotal trial, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study, appeared to vault it ahead of dabigatran (Pradaxa, Boehringer Ingelheim), which received Food and Drug Administration approval for stroke prevention in AF patients last October, and the still-investigational agent rivaroxaban (Xarelto, Janssen), which the FDA iscurrently reviewing for a similar AF indication.