Apixaban versus Warfarin in patients with atrial fibrillation

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dc.contributor.authorGranger, C.
dc.contributor.authorAlexander, J.
dc.contributor.authorMcMurray, J.
dc.contributor.authorLopes, R.
dc.contributor.authorHylek, E.
dc.contributor.authorHanna, M.
dc.contributor.authorAl-Khalidi, H.
dc.contributor.authorAnsell, J.
dc.contributor.authorAvezum, A.
dc.contributor.authorAtar, D.
dc.contributor.authorBahit, M.
dc.contributor.authorDiaz, R.
dc.contributor.authorEaston, J.
dc.contributor.authorEzekowitz, J.
dc.contributor.authorGarcia, D.
dc.contributor.authorGeraldes, M.
dc.contributor.authorGersh, B.
dc.contributor.authorGolitsyn, S.
dc.contributor.authorGoto, S.
dc.contributor.authorHermosillo, A.
dc.contributor.authoret al.
dc.date.issued2011
dc.description.abstract<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusions</h4>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.).
dc.description.statementofresponsibilityChristopher B. Granger... John Horowitz... et al. for the ARISTOTLE Committees and Investigators
dc.identifier.citationNew England Journal of Medicine, 2011; 365(11):981-992
dc.identifier.doi10.1056/NEJMoa1107039
dc.identifier.issn0028-4793
dc.identifier.issn1533-4406
dc.identifier.orcidHorowitz, J. [0000-0001-6883-0703]
dc.identifier.urihttp://hdl.handle.net/2440/66887
dc.language.isoen
dc.publisherMassachusetts Medical Soc
dc.relation.grantNCT00412984
dc.rightsCopyright © 2011 Massachusetts Medical Society
dc.source.urihttps://doi.org/10.1056/nejmoa1107039
dc.subjectARISTOTLE Committees and Investigators
dc.subjectHumans
dc.subjectAtrial Fibrillation
dc.subjectThromboembolism
dc.subjectHemorrhage
dc.subjectPyrazoles
dc.subjectPyridones
dc.subjectWarfarin
dc.subjectAnticoagulants
dc.subjectInternational Normalized Ratio
dc.subjectTreatment Outcome
dc.subjectFollow-Up Studies
dc.subjectDouble-Blind Method
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectStroke
dc.subjectKaplan-Meier Estimate
dc.subjectFactor Xa Inhibitors
dc.titleApixaban versus Warfarin in patients with atrial fibrillation
dc.typeJournal article
pubs.publication-statusPublished

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