Additional Events in the RE-LY Trial

Abstract

To the Editor: Boehringer Ingelheim recently conducted a targeted review of the 1387 deaths that occurred during the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial,1 which evaluated the effects of two doses of dabigatran, as compared with warfarin, on rates of stroke or systemic embolism and major bleeding. Also included in this review were the deaths of 6 patients who did not undergo randomization and 10 deaths that occurred after the end of the study. This review was conducted to determine whether a concurrent event may have occurred with respect to each death, even though such an event was . . .