Apixaban in patients with atrial fibrillation

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 and Yusuf, Salim (2011) Apixaban in patients with atrial fibrillation. New England Journal of Medicine, 364 9: 806-817. doi:10.1056/NEJMoa1007432

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Author 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
Title Apixaban in patients with atrial fibrillation
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2011-03-03
Year available 2011
Sub-type Article (original research)
DOI 10.1056/NEJMoa1007432
Open Access Status File (Publisher version)
Volume 364
Issue 9
Start page 806
End page 817
Total pages 12
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Formatted 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.

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. 
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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