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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Apixaban in patients with atrial fibrillation
New England Journal of Medicine, Volume 364, No. 9, Year 2011
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Description
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. Copyright © 2011 Massachusetts Medical Society.
Authors & Co-Authors
Connolly, Stuart J.
Unknown Affiliation
Eikelboom, John W.
Unknown Affiliation
Joyner, Campbell D.
Unknown Affiliation
Diener, Hans Christoph W.
Unknown Affiliation
Hart, Robert G.
Unknown Affiliation
Golitsyn, Sergey P.
Unknown Affiliation
Flaker, Greg C.
Unknown Affiliation
Avezum, Álvaro Jr
Unknown Affiliation
Hohnloser, Stefan Hans
Unknown Affiliation
Díaz, Rafaël J.
Unknown Affiliation
Talajic, Mario R.
Unknown Affiliation
Zhu, Jun
Unknown Affiliation
Pais, Prem S.
Unknown Affiliation
Budaj, Andrzej J.
Unknown Affiliation
Parkhomenko, Alexander N.
Unknown Affiliation
Janský, Petr
Unknown Affiliation
Commerford, Patrick Joseph
Unknown Affiliation
Tan, Ru San
Unknown Affiliation
Sim, Kui Hian
Unknown Affiliation
Lewis, Basil S.
Unknown Affiliation
van Mieghem, Walter
Unknown Affiliation
Lip, Gregory Y.H.
Unknown Affiliation
Kim, Jae-hyung
Unknown Affiliation
Lanas, Fernando T.
Unknown Affiliation
González-Hermosillo, Jesús Antonio
Unknown Affiliation
Dans, Antonio L.L.
Unknown Affiliation
Munawar, Muhammad Mohsin
Unknown Affiliation
O'Donnell, Martin J.
Unknown Affiliation
Lawrence, John
Unknown Affiliation
Lewis, Gayle
Unknown Affiliation
Afzal, Rizwan
Unknown Affiliation
Yusuf, Salim N.
Unknown Affiliation
Statistics
Citations: 2,091
Authors: 32
Affiliations: 29
Identifiers
Doi:
10.1056/NEJMoa1007432
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Disability
Environmental
Noncommunicable Diseases