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Apixaban versus warfarin in patients with atrial fibrillation.

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  • 1. Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA.
      Authors
    • Granger CB 1
    (1 author)

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The New England Journal of Medicine, 27 Aug 2011, 365(11):981-992
https://doi.org/10.1056/nejmoa1107039 PMID: 21870978 

A comment on this article appears in "More light at the end of the tunnel - apixaban in atrial fibrillation." Expert Opin Investig Drugs. 2012 Aug;21(8):1235-9. A comment on this article appears in "[Oral factor Xa inhibitors or warfarin for stroke prophylaxis. ROCKET AF and ARISTOTLE studies]." Internist (Berl). 2012 Jul;53(7):893-6. A comment on this article appears in "[Not Available]." Rev Clin Esp. 2012 Apr;212(4):208. Show all (10)

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. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).

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Read article at publisher's site: https://doi.org/10.1056/nejmoa1107039

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