Apixaban versus warfarin in patients with atrial fibrillation
Open accessAbstract
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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In the ARISTOTLE trial, apixaban reduced stroke or systemic embolism by 21% compared with warfarin, combined with a 31% reduction in major bleeding and an 11% reduction in all-cause mortality, all statistically significant.
“In the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, 319 apixaban reduced stroke or systemic embolism by 21% compared with warfarin, combined with a 31% reduction in major bleeding and an 11% reduction in all-cause mortality (all statistically significant).”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [319]
There are no randomized trials assessing oral anticoagulation in haemodialysis patients, and no controlled trials of NOACs in patients with severe CKD (CrCl < 25-30 mL/min).
“There are no randomized trials assessing OAC in haemodialysis patients, 418 and no controlled trials of NOACs in patients with severe CKD (CrCl < 25-30 mL/min).”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [319]
The risk of gastrointestinal bleeds was comparable to warfarin on dabigatran 110 mg twice daily and on apixaban 5 mg twice daily.
“The risk of gastrointestinal bleeds was comparable to warfarin on dabigatran 110 mg twice daily 490 and on apixaban 5 mg twice daily 319”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [319]
Apixaban has 25% renal clearance.
“Renal clearance”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [319]
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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
- Granger, Christopher B.
- Alexander, John H.
- McMurray, John J.V.
- Hylek, Elaine M.
- Ansell, Jack
- Atar, Dan
- Bahit, M. Cecilia
- Easton, J. Donald
- Ezekowitz, Justin A.
- Garcia, David
- Gersh, Bernard J.
- Goto, Shinya
- Hohnloser, Stefan H.
- Horowitz, John
- Lewis, Basil S.
- Lopez-Sendon, Jose Luis
- Parkhomenko, Alexander
- Verheugt, Freek W.A.
- Zhu, Jun
- Wallentin, Lars
- 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
- 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
- bronze
- doi.org
- 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 › Epidemiology › 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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