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Cited by 2,483Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

The DOI matches its Crossref record; 22 of the 23 references it cites were found in a registry or an index.

Apixaban in Patients with Atrial Fibrillation

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Connolly, Stuart J., Eikelboom, John, Joyner, Campbell, Diener, Hans-Christoph, Hart, Robert, Golitsyn, Sergey, Flaker, Greg, Avezum, Alvaro, Hohnloser, Stefan H., Diaz, Rafael, Talajic, Mario, Zhu, Jun, Pais, Prem, Budaj, Andrzej, Parkhomenko, Alexander, Jansky, Petr, Commerford, Patrick, Tan, Ru San, Sim, Kui-Hian, Lewis, Basil S., Van Mieghem, Walter, Lip, Gregory Y.H., Kim, Jae Hyung, Lanas-Zanetti, Fernando, Gonzalez-Hermosillo, Antonio, Dans, Antonio L., Munawar, Muhammad, O'Donnell, Martin, Lawrence, John, Lewis, Gayle, Afzal, Rizwan, Yusuf, Salim·2011·New England Journal of Medicine
DOI 10.1056/nejmoa1007432
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Abstract

BACKGROUND: Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients. METHODS: In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism. RESULTS: Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups. CONCLUSIONS: In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).

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Authors
Connolly, S. J., Eikelboom, J., Joyner, C., Diener, H.-C., Hart, R., Golitsyn, S., Flaker, G., Avezum, A., Hohnloser, S. H., Diaz, R., Talajic, M., Zhu, J., Pais, P., Budaj, A., Parkhomenko, A., Jansky, P., Commerford, P., Tan, R. S., Sim, K.-H., Lewis, B. S., Van Mieghem, W., Lip, G. Y. H., Kim, J. H., Lanas-Zanetti, F., Gonzalez-Hermosillo, A., Dans, A. L., Munawar, M., O'Donnell, M., Lawrence, J., Lewis, G., Afzal, R., & Yusuf, S.
Affiliations
Population Health Research Institute (CA)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2011-03-03
Volume
364
Issue
9
Pages
806-817
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1007432
OpenAlex
W2149388786
Cited by
2,483
References
23
Citations by year
2026: 45 · 2025: 54 · 2024: 99 · 2023: 70 · 2022: 71 · 2021: 111 · 2020: 111 · 2019: 119 · 2018: 139 · 2017: 172 · 2016: 215 · 2015: 239 · 2014: 249 · 2013: 310 · 2012: 303
FWCI
223.65
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • UWA Profiles and Research Repository (UWA) (submittedVersion)
  • Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
  • UnissResearch (Università degli Studi di Sassari) (submittedVersion)
  • Omeka S (Universidad de La Frontera) (submittedVersion)
Funders
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca
  • GlaxoSmithKline
  • Sanofi
  • Hamilton Health Sciences
  • McMaster University
  • Astellas Pharma
  • Servier
  • Institut de Cardiologie de Montréal
  • St. Jude Medical
  • Bayer Vital
  • Cilag
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, atrial fibrillation, factor Xa inhibitors, aspirin, stroke prevention, systemic embolism, vitamin K antagonists, major bleeding, intracranial hemorrhage, cardiovascular hospitalization, oral anticoagulation, early trial termination, cardiovascular mortality, cardiovascular risk stratification, subgroup analysis, bleeding risk stratification
MeSH terms
Aged, Aged, 80 and over, Aspirin, Atrial Fibrillation, Double-Blind Method, Embolism, Female, Fibrinolytic Agents, Hemorrhage, Humans, Male, Middle Aged, Pyrazoles, Pyridones, Risk Factors, Proportional Hazards Models, Stroke, Factor Xa Inhibitors

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