Novel Oral Anticoagulants for Stroke Prevention in Nonvalvular Atrial Fibrillation
Dabigatran versus Warfarin in Patients with Atrial Fibrillation
Connolly SJ, Ezekowitz MD, Yusuf S, et al; RE-LY Steering Committee and Investigators. NEJM. 2009;361(12):1139-1151
BACKGROUND
AF is associated with an increased risk of ischemic stroke, and anticoagulant treatment is one of the most effective therapies for reducing this risk. However, vitamin K antagonists increase rates of hemorrhage and can be challenging to maintain within a desired international normalized ratio (INR) range. RE-LY was undertaken to compare an oral anticoagulant agent, the direct thrombin inhibitor dabigatran, with warfarin in patients with nonvalvular AF to determine if this medication had the potential to provide equivalent stroke prevention and decreased bleeding complications.
OBJECTIVES
To compare treatment outcomes with dabigatran and warfarin in patients with nonvalvular AF.
METHODS
Double-blind, randomized trial conducted at 951 clinical centers in 44 countries, with enrollment between 2005 and 2007.
Patients
18,113 patients with AF documented within 6 months were enrolled if they had at least one of the following characteristics: previous TIA or stroke, left ventricular ejection fraction <40%, New York Heart Association class II heart failure symptoms or more severe within 6 months, age > 74 or 65 to 74 years with diabetes, hypertension, or coronary artery disease. Notable exclusion criteria included cardiac valve disease or recent stroke.
Interventions
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