Response to Letters Regarding Article, “Periprocedural Bleeding and Thromboembolic Events With Dabigatran Compared With Warfarin: Results From the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Randomized Trial”

Abstract

RE-LY is the largest randomized experience reporting outcomes after interruption of anticoagulant therapy.1 There was no excess of bleeding in patients taking dabigatran, including those having major or urgent surgery.1 David and colleagues correctly state that the majority of procedures performed during the RE-LY trial were minor. Nonetheless, our analysis included 1482 major procedures that had a 6% to 8% rate of major bleeding,1 which was numerically lower among dabigatran-treated patients.1 Hjemdahl et al opine that the high rate of major bleeding in RE-LY patients assigned to dabigatran 150 mg twice daily who had interruption for >72 hours before surgery suggests accumulation of dabigatran in patients with renal impairment. However, data from RE-LY do not support this interpretation, because the same pattern …