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. In the subgroup of patients 75 years of age,396 mg was associated with increased gastrointestinal hemor- rhage relative to warfarin (OR, 1.79; 95% CI, 1.35 2.37) but reduced ICH (OR, 0.42; 95% CI, 0.25 0.70). The Rivaroxaban Versus Warfarin in Nonvalvular Atrial Fibrillation (ROCKETAF) Trial397 randomized 14264 patients with nonvalvular AF to rivaroxaban 20 mg/d or adjusted-dose warfarin (target INR, 2 to 3). A CHADS2 score of 2 was required, yielding a mean score for enrolled subjects of 3.5, which was higher than in the RE-LY and ARISTOTLE trials; more than half of the participants had a stroke, TIA, or sys- temic embolism before enrollment. Over a median follow-up of 707 days, the primary end point of ischemic and hemor- rhagic stroke and systemic embolism in patients as actually treated (the prespecified analysis plan for efficacy in this study) occurred in 1.7%/y in those receiving rivaroxaban and 2.2%/y in those on warfarin (HR, 0.79; 95% CI, 0.66 0.96; P<0.001 for noninferiority; analyzed by intention to treat, HR, for superiority). 