Apixaban reduces stroke risk, embolism, bleeding, and mortality in patients with atrial fibrillation
MONDAY, Aug. 29 (HealthDay News) -- Apixaban is superior to warfarin in lowering the risk of stroke or systemic embolism, and reduces the rate of major bleeding and mortality in patients with atrial fibrillation, according to a study published online Aug. 28 in the New England Journal of Medicine to coincide with the European Society of Cardiology Congress 2011 held Aug. 27 to 31 in Paris, France.
Christopher B. Granger, M.D., from Duke University Medical Center in Durham, N.C., and colleagues compared apixaban (5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) for prevention of stroke in 18,201 patients with atrial fibrillation and at least one additional stroke risk factor. The study tested for noninferiority and superiority of the primary outcome (ischemic or hemorrhagic stroke or systemic embolism); secondary outcomes included rates of major bleeding and death from any cause during an average follow-up of 1.8 years.
The investigators found that the primary outcome rate in the apixaban and warfarin group was 1.27 and 1.60 percent per year, respectively (hazard ratio [HR] with apixaban, 0.79, significant for noninferiority and superiority). Rates of major bleeding in the apixaban and warfarin group was 2.13 and 3.09 percent per year, respectively (HR, 0.69), and rates for deaths from any cause were 3.52 and 3.94 percent per year, respectively (HR, 0.89). The rate of hemorrhagic stroke was significantly lower in the apixaban group (0.24 versus 0.47 percent per year for apixaban and warfarin, respectively; HR, 0.51), whereas rates of ischemic or uncertain types of stroke were 0.97 and 1.05 percent per year, respectively (HR, 0.92; P = 0.42).
"In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality," the authors write.
The study was funded by Bristol-Myers Squibb and Pfizer.
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