RE-COVER
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
42.0% female
58.0% male
N = 2539
2539 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=1273 dabigatran (150 mg BID).
N=1266 warfarin (dose-adjusted, to achieve INR 2.0 to 3.0).
Primary outcome
Recurrent venous thromboembolism
2.4%
2.1%
2.4 %
1.8 %
1.2 %
0.6 %
0.0 %
Dabigatran
Warfarin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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.
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