Sub-analysis of RE-LY trial shows Pradaxa (Boehringer) similar to warfarin in Atrial Fibrillation patients undergoing surgery

A new retrospective sub-analysis of the RE-LY trial for Pradaxa (dabigatran etexilate), from Boehringer, vs warfarin suggested similar rates of peri-procedural bleeding and thromboembolic complications, such as a Stroke or systemic embolism, in non-valvular Atrial Fibrillation (NVAF) patients undergoing a surgical or invasive procedure. A total of 4,591 out of 18,113 patients in the trial had anti-coagulant therapy interrupted at least once to have surgery or an invasive procedure with similar distribution across treatment arms. The sub-analysis suggests similar rates of peri-procedural major bleeding (5.1% Pradaxa vs. 4.6% warfarin). Additionally, patients treated with Pradaxa who discontinued treatment within 24 to 48 hours prior to surgery showed nearly three times lower rates of major bleeding compared to warfarin (3.3% vs. 9.0%). Results were published online: "Peri-Procedural Bleeding and Thromboembolic Events with Dabigatran Compared to Warfarin: Results from the RE-LY Randomized Trial." Jeff S. Healey et al. Circulation: Journal of the American Heart Association, June 2012 DOI: CIRCULATIONAHA.111.090464