There was no evidence of a difference in major GI bleeding between apixaban and warfarin (hazard was lower with apixaban compared with warfarin (hazard ratio, 0.89; 95% CI, 0.80-0.998). In all three recently completed trials of novel anticoagulants vs warfarin (RE-LY, ROCKET-AF, and ARISTOTLE), the rate of intracranial hemorrhage (including both hemorrhagic stroke and other intracranial bleeds) was lower in patients assigned to the novel anticoag- ulant than in patients assigned to warfarin.84,85,87,88 2.1.7 General Approach to Recommendations About New Oral Anticoagulants in This Article: Our guideline panel elected to make recommendations only for those drugs that have received regulatory approval for use in AF (ie, dabigatran).89 Although based on the results of a single trial, there is evidence from RE-LY that dabigatran is no worse than VKA therapy with respect to nonfatal major extracranial bleeding and that it is similar or superior to warfarin with respect to nonfatal stroke, systemic embolism, and all-cause mortality in patients with nonvalvular AF (section 2.1.6). 