Uchino and Hernandez performed a systematic review and meta-analysis of noninferiority randomized trials of dabigatran that reported acute coronary outcomes (myocardial infarction [MI] or acute coronary syndromes [ACS]) until May 2011. Seven trials were selected (n=30 514) including 2 studies of stroke prophylaxis in atrial fibrillation, 1 of acute venous thromboembolism, 1 of ACS, and 3 of short-term prophylaxis of deep venous thrombosis. Control arms included warfarin, enoxaparin, or placebo. Dabigatran was associated with a higher risk for MI or ACS than the control group (dabigatran, 237/20 000 [1.19%], vs control, 83/10 514 [0.79%], odds ratio (Mantel-Haenszel), 1.33; 95% CI 1.03-1.71; P = .03). Clinicians should consider the potential of serious harmful cardiovascular effects with the use of dabigatran.