6/29/23, 12:43 AM RE-COVER Pathway Feedback Search Clinical Topics Home Studies RE COVER RE COVER Disease Disease Deep vein thrombosis Pulmonary embolism Trial question Is dabigatran noninferior to warfarin for patients who have acute VTE? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.4% female N = 2564 58.6% male 2564 patients (1055 female, 1484 male) Inclusion criteria: patients who have acute VTE Key exclusion criteria: duration of symptoms > 14 days, PE with hemodynamic instability or requiring thrombolytic therapy, another indication for warfarin therapy, recent unstable CVD, a high risk of bleeding, liver disease, or a life expectancy < 6 months Interventions N=1274 dabigatran (150 mg BID) N=1265 warfarin (dose-adjusted, to achieve INR 2.0 to 3.0) Primary outcome Recurrent venous thromboembolism https://web.pathway.md/studies/reclyCcgaB7ao3PZI 1/2 6/29/23, 12:43 AM RE-COVER Pathway 2.4 % 2.4 2.1 1.8 % 1.2 % Difference not exceeding nonferiority margin 0.6 % 0.0 % Dabigatran Warfarin Difference not exceeding nonferiority margin in recurrent VTE (2.4% vs. 2.1%; HR 1.1, 95% CI 0.65 to 1.84) Secondary outcomes Significant decrease in symptomatic DVT (1.3% vs. 1.4%; HR 0.87, 95% CI 0.44 to 1.71) Significant increase in symptomatic nonfatal PE (1% vs. 0.6%; HR 1.85, 95% CI 0.74 to 4.64) Significant decrease in death related to VTE (0.1% vs. 0.2%; HR 0.33, 95% CI 0.03 to 3.15) Safety outcomes No significant differences in major bleeding (1.6% vs. 1.9%; HR 0.82, 95% CI 0.45-1.48) and any bleeding episodes (16.1% vs. 21.9%; HR 0.71, 95% CI 0.59-0.85). Significant differences in adverse events leading to drug discontinuation (9.0% vs. 6.8%, p = 0.05). Conclusion In patients who have acute VTE, dabigatran was noninferior to warfarin with respect to recurrent VTE. Reference Schulman S, Kearon C, Kakkar AK et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. Open reference URL https://web.pathway.md/studies/reclyCcgaB7ao3PZI 2/2