The primary efficacy outcome was the combined rate of death from a cardiovascular cause, heart attack, stroke due to inadequate blood supply, blood clots or amputation due to cardiovascular disease.
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End-stage renal disease patients on dialysis with atrial fibrillation are at high risk for thrombotic complications.
The primary safety endpoint was defined as time to major bleeding events and clinically relevant non-major bleeding events when compared to triple therapy with warfarin.
Study patients were randomized to Pradaxa 150mg twice daily or warfarin (target INR 2-3) and remained on this treatment for the trial duration.
The data represents ~3,000 patients who had received the study drug in Phase 3 of GLORIA-AF with up to 2 years follow-up.
At ACC.13, the American College of Cardiology’s 62nd Annual Scientific Session, leading cardiologists presented that the use of dabigatran following ablation for atrial fibrillation resulted in no major post-procedural complications.