A Review of the Clinical Subgroup Analyses From the RE-LY Trial.
Dabigatran was the first direct-acting oral anticoagulant approved by the US Food and Drug Administration for prevention of stroke and systemic embolism in people with atrial fibrillation, based on data from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Over 18,000 patients with nonvalvular atrial fibrillation and a moderate-to-high risk of thromboembolic stroke were randomized to warfarin or dabigatran. With respect to the primary endpoints for efficacy and safety, dabigatran was superior to warfarin in the prevention of stroke and thromboembolism and noninferior with respect to major bleeding. Although unified by a common arrhythmia and a similar thromboembolic stroke risk, this large patient population is also significantly heterogeneous with respect to other demographics and comorbidities that raise important questions about the efficacy and safety of dabigatran in specific patient populations. Furthermore, there were significant differences between the warfarin and dabigatran groups with respect to several important secondary endpoints. Understanding the differences in outcomes between specific patient subgroups from the RE-LY trial can better inform the practicing clinician's ability to offer the best anticoagulation options to individual patients.
John H. Stroger, Jr. Hospital of Cook County, Department of Internal Medicine, Chicago, IL.
Rohit
R
Kumar
University of Pittsburgh Medical Center, Heart and Vascular Institute, and Pittsburgh Veterans Administration Medical Center, Department of Cardiology, Pittsburgh, PA.
Aref M
AM
Rahman
University of Pittsburgh Medical Center, Heart and Vascular Institute, and Pittsburgh Veterans Administration Medical Center, Department of Cardiology, Pittsburgh, PA.
Brian L
BL
Henry
D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D000069604:Dabigatran / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000517:prevention & control*; D013923:Thromboembolism / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage / Q000627:therapeutic use
D000925:Anticoagulants; D014859:Warfarin; D000069604:Dabigatran