RE-COVER I

Dabigatran versus warfarin in the treatment of acute venous thromboembolism I (2009)

Condition

Treatment of acute VTE

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Objective

To compare the efficacy and safety of dabigatran vs. warfarin in the treatment of acute VTE

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Trial design

Randomized, double-blind phase III non-inferiority study
Active treatment: dabigatran 150 mg p.o. twice daily for 6 months plus warfarin placebo after an initial treatment with a parenteral anticoagulant (low molecular weight or unfractionated heparin) plus warfarin placebo (sham INR) for at least 5 days (n=1274)
Control treatment: dose-adjusted warfarin (INR 2.0–3.0) for 6 months, starting after randomization, plus dabigatran placebo, starting after at least 5 days parenteral anticoagulation (n=1265)

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Endpoints

Primary efficacy endpoint: 6-month incidence of recurrent symptomatic, objectively confirmed VTE and related deaths
Secondary efficacy endpoints: symptomatic VTE, symptomatic non-fatal PE, VTE-related death, all deaths
Safety endpoints: bleeding events, acute coronary syndromes, other adverse events, and liver function parameters

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Trial participants

2539 patients (mean age 55 years) with acute venous thromboembolism

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Results

Efficacy outcome: The primary endpoint (symptomatic VTE and VTE-related deaths) occurred in 30 of 1274 patients (2.4%) given 150 mg dabigatran twice daily and in 27 of 1265 patients (2.1%) given warfarin during the study period
Safety outcome: Major bleeding occurred in 20 of 1274 patients (1.6%) receiving 150 mg dabigatran twice daily and in 24 of 1265 patients (1.9%) receiving warfarin. A total of 71 patients in the dabigatran group (5.6%), as compared with 111 in the warfarin group (8.8%), had major or clinically relevant non-major bleeding (relative risk reduction 37%, p=0.002).The numbers of deaths, acute coronary syndromes, and abnormal liver-function tests were similar in both groups

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Summary

Efficacy: Dabigatran was non-inferior to warfarin in the the prevention of recurrent or fatal VTE in patients with acute VTE
Safety: In the dabigatran group, the rate of major or clinically relevant nonmajor bleeding events was significantly lower as in the warfarin group. The difference in major bleeding was not significant

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Reference

Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-2352

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Corresponding author

Sam Schulman, MD, Thrombosis Service, HHS-General Hospital, 237 Barton St. East, Hamilton, ON L8L 2X2, Canada, e-mail: schulms@mcmaster.ca

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