The Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial391 randomized 18113 patients to dabi- gatran 150 mg or 110 mg twice daily or adjusted-dose war- farin (target INR, 2 to 3). The study enrolled patients with and without a history of prior stroke but with overall mod- erate to high risk of stroke (mean CHADS2 score, 2.1) and excluded patients who had stroke within 14 days (6 months for severe stroke), increased bleeding risk, creatinine clear- ance <30 mL/min, or active liver disease. The primary out- come of stroke or systemic embolism during the mean 2-year follow-up occurred at a rate of 1.7%/y in the warfarin (INR, 2 to 3) group compared with 1.11%/y in the 150 mg dabi- gatran group (RR=0.66 versus warfarin; 95% CI, 0.53 0.82; P<0.001 for superiority). Intracranial hemorrhage rates were strikingly lower with 150 mg dabigatran relative to adjusted- 0.27 0.60). However, the overall rates of major bleeding were not different between the groups (3.11%/y versus 3.36%/y; P=0.31), and gastrointestinal bleeding was more frequent 95% CI, 1.19 1.89). MI was also increased in the 150 mg although this difference was no longer sig- nificant when silent MIs or unstable angina, cardiac arrest, and cardiac death were included.391 Meta-analysis of 7 trials of dabigatran use for various indications has supported the possibility of a small but consistent increased risk of MI or acute coronary syndrome versus the risk observed in various control arms of these studies (OR, 1.33; 95% CI, 1.03 1.71; Finally, analyses of multiple patient subgroups, categorized by nationality,394 and the pres- ence or absence of prior TIA/stroke, have not found evidence for differences in the risk/benefit profile for dabigatran. 