作者
Stuart J Connolly, Michael D Ezekowitz, Salim Yusuf, John Eikelboom, Jonas Oldgren, Amit Parekh, Janice Pogue, Paul A Reilly, Ellison Themeles, Jeanne Varrone, Susan Wang, Marco Alings, Denis Xavier, Jun Zhu, Rafael Diaz, Basil S Lewis, Harald Darius, Hans-Christoph Diener, Campbell D Joyner, Lars Wallentin, RE-LY Steering Committee and Investigators
发表日期
2009/9/17
期刊
New England Journal of Medicine
卷号
361
期号
12
页码范围
1139-1151
出版商
Massachusetts Medical Society
简介
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<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0 …
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