作者
Robert P Giugliano, Christian T Ruff, Eugene Braunwald, Sabina A Murphy, Stephen D Wiviott, Jonathan L Halperin, Albert L Waldo, Michael D Ezekowitz, Jeffrey I Weitz, Jindřich Špinar, Witold Ruzyllo, Mikhail Ruda, Yukihiro Koretsune, Joshua Betcher, Minggao Shi, Laura T Grip, Shirali P Patel, Indravadan Patel, James J Hanyok, Michele Mercuri, Elliott M Antman
发表日期
2013/11/28
期刊
New England Journal of Medicine
卷号
369
期号
22
页码范围
2093-2104
出版商
Massachusetts Medical Society
简介
Background
Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known.
Methods
We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding.
Results
The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for …
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RP Giugliano, CT Ruff, E Braunwald, SA Murphy… - New England Journal of Medicine, 2013