Clinical Medicine Reviews in Vascular Health

Vitamin K antagonists (VKAs) such as warfarin are the cornerstone therapy for stroke prevention in persons with atrial fibrillation. However, their inherent limitations make VKAs particularly challenging to manage safely and effectively. The resulting underutilization of this effective treatment has been well-documented. Several new oral anticoagulants are in development to address these limitations, the most advanced of which is dabigatran. The RE-LY study evaluated the safety and efficacy of 2 doses of dabigatran versus warfarin in a Phase III trial for the prevention of stroke and systemic embolism in persons with atrial fibrillation. The higher 150 mg dose demonstrated superior efficacy over warfarin, with a 34% relative risk reduction in the primary outcome (P , 0.001), and similar major bleeding rates. The lower 110 mg dose was similar to warfarin in efficacy but significantly reduced the risk of major bleeding. Both doses significantly reduced the risk of intracranial haemorrhage. These results provide strong evidence that dabigatran is a safe and effective alternative to warfarin with several advantages, including elimination of the requirement for routine anticoagulation monitoring.