Apixaban versus Warfarin in Patients with Atrial Fibrillation

Apixaban versus Warfarin in Patients with Atrial Fibrillation
신동구C B.Granger[C B.Granger]John H. Alexander[John H. Alexander]John J. V. McMurray[John J. V. McMurray]Renato D.Lopes[Renato D.Lopes]Elaine M. Hylek[Elaine M. Hylek]Michael Hanna[Michael Hanna]Hussein R.Al-Khalidi[Hussein R.Al-Khalidi]Jack Ansell[Jack Ansell]Dan Atar[Dan Atar]Alvaro Avezum[Alvaro Avezum]M.Cecilia Bahit[M.Cecilia Bahit]Rafael Diaz[Rafael Diaz]J.Donald Easton[J.Donald Easton]Justin A. Ezekowitz[Justin A. Ezekowitz]Greg Flaker[Greg Flaker]David Garcia[David Garcia]Margarida Geraldes[Margarida Geraldes]Bernard J. Gersh[Bernard J. Gersh]Sergey Golitsyn[Sergey Golitsyn]Shinya Goto[Shinya Goto]Antonio G. Hermosill[Antonio G. Hermosill]Stefan H. Hohnloser[Stefan H. Hohnloser]John Horowitz[John Horowitz]Puneet Mohan[Puneet Mohan]Petr Jansky[Petr Jansky]Basil S. Lewis[Basil S. Lewis]J.L. Lopez-Sendon[J.L. Lopez-Sendon]Prem Pais[Prem Pais]A. Parkhomenko[A. Parkhomenko]Freek W. A. Verheugt[Freek W. A. Verheugt]Jun Zhu[Jun Zhu]Lars Wallentin[Lars Wallentin]
Issue Date
NEW ENGLAND JOURNAL OF MEDICINE, v.365, no.11, pp.981 - 992
Background Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. Methods In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. Results The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). Conclusions In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.govnumber, NCT00412984.)
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