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Apixaban in Patients with Atrial Fibrillation
Open accessAbstract
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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“It is superior to no treatment or aspirin in patients with different profiles for stroke risk.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [354]
In the citing paper
“apixaban significantly reduced stroke or systemic embolism by 55% compared with aspirin, with no significant difference in rates of major bleeding or intracranial haemorrhage.354,403”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [354]
In the citing paper
“Antiplatelet therapy increases bleeding risk, especially dual antiplatelet therapy (2.0% vs. 1.3% with antiplatelet monotherapy; P < 0.001), 433 with bleeding rates that are similar to those on OAC.354,362,431,434”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [354]
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Metadata
- 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
- 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
- bronze
- doi.org
- 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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