Dabigatran vs. Warfarin for Acute VTE: Safety and Efficacy Analysis
This trial evaluates the safety and efficacy of dabigatran (150 mg twice daily) compared to warfarin for treating acute venous thromboembolism (VTE). Over a 6-month follow-up, the primary outcomes showed noninferiority with recurrent VTE or death rates of 2.4% for dabigatran and 2.1% for warfarin (p>0.05). Mortality rates were 1.6% vs. 1.7%, with major bleeding at 1.6% vs. 1.9% (p=0.38) and major plus clinically relevant bleeding significantly lower at 5.6% vs. 8.8% (p
Dabigatran vs. Warfarin for Acute VTE: Safety and Efficacy Analysis
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RE-COVER Primary outcome (recurrent VTE or death due to VTE): 2.4% vs. 2.1% Mortality: 1.6% vs. 1.7% (p > 0.05) Major bleeding: 1.6% vs. 1.9%; Major + clinically relevant bleeding: 5.6% vs. 8.8.% (p = 0.002) (p = 0.38) (p < 0.001*) Trial design:Evaluated the safety and efficacy of dabigatran 150 mg twice daily vs. warfarin for the treatment of acute VTE. Patients were followed for 6 months. Results * For noninferiority 5 5 4 4 3 3 % Conclusions 2.4 % 2.1 2 2 1.9 • Dabigatran 150 mg twice daily is noninferior to warfarin for the treatment of acute VTE, with a slightly better bleeding profile • Complements other studies showing safety and efficacy of dabigatran, as compared with warfarin in other settings, such as AF 1.6 1 1 0 0 Primary endpoint Major bleeding Dabigatran (n = 1,274) Warfarin (n = 1,265) Schulman S, et al. N Engl J Med 2009;361:2342-52
