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ARISTOTLE: Efficacy and safety of Apixaban compared to Warfarin for prevention of stroke and systemic embolism in 18,202 patients with atrial fibrillation: primary results of the ARISTOTLE trial

Atrial Fibrillation


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Christopher Granger Christopher B Granger (United States of America)

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Abstract:

Authors: Christopher B. Granger, John H. Alexander, John J.V. McMurray, Renato D. Lopes, Elaine M. Hylek, Michael Hanna, Hussein R. Al-Khalidi, Jack Ansell, Dan Atar, Alvaro Avezum, M. Cecilia Bahit, Rafael Diaz, J. Donald Easton, Justin A. Ezekowitz, Greg Flaker, David Garcia, Margarida Geraldes, Bernard J. Gersh, Sergey Golitsyn, Shinya Goto, Antonio G. Hermosillo, Stefan H. Hohnloser, John Horowitz, Puneet Mohan, Petr Jansky, Brasil S. Lewis, Jose Luis Lopez-Sendon, Prem Pais, Alexander Parkhomenko, Freek W.A. Verheugt, Jun Zhu, and Lars Wallentin, for the ARISTOTLE Committees and Investigators

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 = .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.

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Michael D Ezekowitz (United States of America)

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Report:

References


706007 - 706008

SessionTitle:

Hot Line I - Cardiovascular risk and complications

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.