Peri-Procedural Bleeding and Thromboembolic Events with Dabigatran Compared to Warfarin: Results from the RE-LY Randomized Trial

Circ.ahajournals.org: June 14, 2012.

Dabigatran reduces ischemic stroke compared to warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required.

Methods and Results—The current analysis was undertaken to compare the peri-procedural bleeding risk of patients in the RE-LY trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days prior until 30 days following invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least one invasive procedure: 24.7% of patients receiving dabigatran-110; 25.4% on dabigatran-150 and 25.9% on warfarin, p=0.34. Procedures included: pacemaker/ defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%) and joint replacement (6.2%). Among patients assigned to either dabigatran dose the last dose of study drug was given 49 (35-85) hours prior to the procedure; compared to 114 (87-144) hours in patients receiving warfarin, p<0.001. Read more