Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis
Background—Dabigatran and warfarin have been compared for treatment of acute venous thromboembolism (VTE) in one previous trial. We undertook this study to extend those findings.
Methods and Results—In a randomized, double-blind, double-dummy trial of 2589 patients with acute VTE, treated with low molecular weight or unfractionated heparin for 5 to 11 days, we compared dabigatran, 150 mg twice daily, with warfarin. The primary outcome, recurrent symptomatic, objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients (2.3%), as compared with 28 of the 1289 warfarin patients (2.2%; hazard ratio 1.08; 95% confidence interval [CI], 0.64 to 1.80; absolute risk difference 0.2%; 95% CI, -1.0 to 1.3; P<0.001 for the prespecified noninferiority margin for both criteria). The safety endpoint, major bleeding, occurred in 15 patients receiving dabigatran (1.2%) and in 22 receiving warfarin (1.7%; hazard ratio 0.69; 95% CI, 0.36 to 1.32). Any bleeding occurred in 200 dabigatran (15.6%) and in 285 warfarin patients (22.1%; hazard ratio 0.67; 95% CI, 0.56 to 0.81). Deaths, adverse events, and acute coronary syndromes were similar in both groups. Pooled analysis of this study (RE-COVER II) and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 (95% CI, 0.76 to 1.57), major bleeding of 0.73 (95% CI, 0.48 to 1.11), and any bleeding of 0.70 (95% CI, 0.61 to 0.79).
Conclusions—Dabigatran has similar effect on VTE recurrence and a lower risk of bleeding compared to warfarin for the treatment of acute VTE.
- Received June 13, 2013.
- Revision received November 1, 2013.
- Accepted November 11, 2013.