Dabigatran versus warfarin in patients with atrial fibrillation.
Publication/Presentation Date
9-17-2009
Abstract
BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.
METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism.
RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P
CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)
Volume
361
Issue
12
First Page
1139
Last Page
1151
ISSN
1533-4406
Published In/Presented At
Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., Pogue, J., Reilly, P. A., Themeles, E., Varrone, J., Wang, S., Alings, M., Xavier, D., Zhu, J., Diaz, R., Lewis, B. S., Darius, H., Diener, H. C., Joyner, C. D., Wallentin, L., … RE-LY Steering Committee and Investigators (2009). Dabigatran versus warfarin in patients with atrial fibrillation. The New England journal of medicine, 361(12), 1139–1151. https://doi.org/10.1056/NEJMoa0905561
Disciplines
Medicine and Health Sciences
PubMedID
19717844
Department(s)
Department of Medicine, Cardiology Division
Document Type
Article