Abstrakt
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 leeding 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. Clinical Trial Registration Information - clinicaltrials.gov.
Identifiers: NCT00680186 andNCT00291330.