Apixaban versus warfarin in patients with atrial fibrillation

Christopher Granger, John Alexander, John McMurray, Renato Lopes, Elaine Hylek, Michael Hanna, Hussein Al-Khalidi, Jack Ansell, Dan Atar, Alvaro Avezum, M Bahit, Rafael Diaz, Donald Easton, Justin Ezekowitz, Greg Flaker, David Garcia, Margarida Geraldes, Bernard Gersh, Sergey Golitsyn, Shinya GotoAntonio Hermosillo, Stefan Hohnloser, John Horowitz, Puneet Mohan, Petr Jansky, Basil Lewis, Jose Lopez-Sendon, Prem Pais, Alexander Parkhomenko, Freek Verheugt, Jun Zhu, Lars Wallentin, M Vico, I Mackinnon, D Vogel, A. Gabito, A Cassettari, C Zaidman, O Montana, A. Hrabar, H Jure, H Lastiri, C. Poy, A Caccavo, C Cuneo, H Colombo, F Rolandi, A Hershson, M Garrido, A Sanchez, M L Bruno, D Piskorz, J Cuadrado, E Hasbani, J Serra, L Cartasegna, P Schygiel, C Muratore, J Marino, M I Sosa Liprandi, R. A. Guerrero, H Ramos, D Mercado, L Guzmon, C Beneitez, J Estepo, R. Torrijos, E Retyk, N Vita, H Luciardi, M Casey, S Orlando, M B Labarta, D Santos, J Amerena, P Purnell, J Horowitz, H Salem, A Lui, L Zimmet, S Roger, Fred De Looze, R Lehman, B Jackson, D Ashby, W Heddle

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Abstract

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.

Original languageEnglish
Pages (from-to)981-992
Number of pages12
JournalNew England Journal of Medicine
Volume365
Issue number11
DOIs
Publication statusPublished - 15 Sep 2011

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  • Cite this

    Granger, C., Alexander, J., McMurray, J., Lopes, R., Hylek, E., Hanna, M., Al-Khalidi, H., Ansell, J., Atar, D., Avezum, A., Bahit, M., Diaz, R., Easton, D., Ezekowitz, J., Flaker, G., Garcia, D., Geraldes, M., Gersh, B., Golitsyn, S., ... Heddle, W. (2011). Apixaban versus warfarin in patients with atrial fibrillation. New England Journal of Medicine, 365(11), 981-992. https://doi.org/10.1056/NEJMoa1107039