RE-LY Trial

Dabigatran is an anticoagulant of the direct thrombin inhibitors class that offers an alternative to warfarin as the preferred orally administered anticoagulant, since it does not require blood tests for INR monitoring. It is approved by US Food and Drug Administration and indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) trial evaluated the efficacy and safety of two different doses of dabigatran relative to warfarin in 18,113 patients with nonvalvular atrial fibrillation randomized to one of three arms: adjusted-dose warfarin; dabigatran, 110 mg bid; or dabigatran, 150 mg bid. Dabigatran 110 mg was noninferior to warfarin for the primary efficacy endpoint of stroke or systemic embolization (HR .90 , P = NS), while dabigatran 150 mg was significantly more effective than warfarin (HR .65; P = .001) or dabigatran 110 mg (HR .72, P = .004). Major bleeding was significantly less with dabigatran 110 mg than warfarin (2.71% vs 3.36%); dabigatran 150 mg showed similar bleeding to warfarin (3.11% vs 3.36%) (Connolly et al. N Engl J Medicine. 2009;361[12]:1139). GI bleeding was slightly higher with 150 mg bid vs warfarin (1.6% vs 1.1%). Dose should be reduced if the creatinine clearance value is less than 30 mL/min. It is contraindicated in patients with active bleeding, history of hypersensitivity reaction, or concomitant use with P-glycoprotein inducers (eg, rifampin).

Dr. Krishnaswami Vijayaraghavan, FCCP
Steering Committee Member