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Cited by 8,943Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

The DOI matches its Crossref record; 15 of the 15 references it cites were found in a registry or an index.

Apixaban versus Warfarin in Patients with Atrial Fibrillation

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Granger, Christopher B., Alexander, John H., McMurray, John J.V., Lopes, Renato D., Hylek, Elaine M., Hanna, Michael, Al-Khalidi, Hussein R., Ansell, Jack, Atar, Dan, Avezum, Alvaro, Bahit, M. Cecilia, Diaz, Rafael, Easton, J. Donald, Ezekowitz, Justin A., Flaker, Greg, Garcia, David, Geraldes, Margarida, Gersh, Bernard J., Golitsyn, Sergey, Goto, Shinya, Hermosillo, Antonio G., Hohnloser, Stefan H., Horowitz, John, Mohan, Puneet, Jansky, Petr, Lewis, Basil S., Lopez-Sendon, Jose Luis, Pais, Prem, Parkhomenko, Alexander, Verheugt, Freek W.A., Zhu, Jun, Wallentin, Lars·2011·New England Journal of Medicine
DOI 10.1056/nejmoa1107039
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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. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).

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Authors
Granger, C. B., Alexander, J. H., McMurray, J. J. V., Lopes, R. D., Hylek, E. M., Hanna, M., Al-Khalidi, H. R., Ansell, J., Atar, D., Avezum, A., Bahit, M. C., Diaz, R., Easton, J. D., Ezekowitz, J. A., Flaker, G., Garcia, D., Geraldes, M., Gersh, B. J., Golitsyn, S., Goto, S., Hermosillo, A. G., Hohnloser, S. H., Horowitz, J., Mohan, P., Jansky, P., Lewis, B. S., Lopez-Sendon, J. L., Pais, P., Parkhomenko, A., Verheugt, F. W. A., Zhu, J., & Wallentin, L.
Affiliations
  • Duke Medical Center (US)
  • Boston University (US)
  • Bristol-Myers Squibb (United States) (US)
  • Lenox Hill Hospital (US)
  • Oslo University Hospital (NO)
  • Estudios Clínicos Latinoamérica (AR)
  • University of California, San Francisco (US)
  • University of Alberta (CA)
  • University of Missouri Health System (US)
  • University of New Mexico (US)
  • Mayo Clinic (US)
  • Tokai University (JP)
  • Instituto Nacional de Cardiología (MX)
  • Goethe University Frankfurt (DE)
  • The University of Adelaide (AU)
  • Carmel Medical Center (IL)
  • Hospital Universitario La Paz (ES)
  • St.John's Medical College Hospital (IN)
  • OLVG (NL)
  • Fu Wai Hospital (CN)
  • Uppsala University (SE)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2011-09-15
Volume
365
Issue
11
Pages
981-992
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1107039
OpenAlex
W2162508946
Cited by
8,943
References
15
Citations by year
2026: 274 · 2025: 391 · 2024: 464 · 2023: 518 · 2022: 545 · 2021: 663 · 2020: 695 · 2019: 619 · 2018: 696 · 2017: 679 · 2016: 726 · 2015: 696 · 2014: 659 · 2013: 687 · 2012: 523
FWCI
430.89
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Research Bank (Australian Catholic University) (submittedVersion)
  • Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
  • Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
  • Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
  • Radboud Repository (Radboud University) (submittedVersion)
Funders
Japan Society for the Promotion of Science (21390244, 21590911)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
  • Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
Keywords
apixaban, warfarin, atrial fibrillation, direct factor Xa inhibitors, oral anticoagulation, stroke prevention, systemic embolism, hemorrhagic stroke, ischemic stroke, major bleeding, non-inferiority, vitamin K antagonists, mortality, risk stratification, CHA2DS2-2V2 score, bleeding risk score
MeSH terms
Aged, Anticoagulants, Atrial Fibrillation, Double-Blind Method, Female, Follow-Up Studies, Hemorrhage, Humans, Male, Middle Aged, Pyrazoles, Pyridones, Thromboembolism, Warfarin, Treatment Outcome, International Normalized Ratio, Stroke, Kaplan-Meier Estimate, Factor Xa Inhibitors

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