Dabigatran is a univalent low-molecular-weight direct thrombin inhibitor that has been developed as an alternative to vitamin K antagonists (VKAs). However, uncertainty remains regarding dabigatran's safety profile with respect to bleeding. Our objective was to compare the risk of bleeding and all-cause mortality of dabigatran with that of VKAs in a systematic review and meta-analysis of randomized controlled trials (RCTs). We systematically searched MEDLINE, Embase, and the Cochrane Library of clinical trials to identify RCTs comparing the bleeding risk of dabigatran (150 mg twice daily) with that of VKAs.
