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RE-COVER II: Dabigatran met 6-month primary endpoint for treatment of DVT, PE
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New 6-month data from the phase 3 RE-COVER II study demonstrate that dabigatran met the primary endpoint of noninferiority to warfarin for recurrent, symptomatic, objectively confirmed deep vein thrombosis and/or pulmonary embolism and related deaths.
Researchers observed a low rate of venous thromboembolism in the RE-COVER trial that evaluated dabigatran (Pradaxa, Boehringer Ingelheim) for the treatment of DVT and PE, and launched RE-COVER II to confirm the results and pool data from both trials to perform subgroup analyses.
Sam Schulman, MD, PhD, and colleagues recruited 2,589 patients with acute VTE for the randomized, double blind, double dummy study. Approximately half were assigned fixed-dose dabigatran 150 mg twice daily and warfarin-like placebo; the rest were assigned active warfarin and dabigatran-like placebo. Most patients received a parenteral anticoagulant, usually unfractionated heparin or low-molecular-weight heparin, before randomization.
The primary efficacy endpoint of recurrent, symptomatic, objectively confirmed VTE and related deaths at 6 months occurred in 2.3% of patients assigned dabigatran vs. 2.2% assigned warfarin (HR=1.08; 95% CI, 0.64-1.8; absolute risk difference 0.2%; 95% CI, –1 to 1.3; P<.001 for prespecified noninferiority margin for both criteria).
The primary safety endpoint of major bleeding occurred in 1.2% of patients assigned dabigatran vs. 1.7% assigned warfarin (HR=0.69; 95% CI, 0.36-1.32). Any bleeding occurred in 15.6% of those assigned dabigatran vs. 22.1% assigned warfarin (HR=0.67; 95% CI, 0.56-0.81).
Schulman, of McMaster University and Henderson Research Center, Hamilton, Ontario, Canada, and colleagues found similar rates of death, adverse events and ACS between the groups.
When the researchers pooled data from RE-COVER and RE-COVER II, the HRs were as follows:
- Recurrent VTE: HR=1.09; 95% CI, 0.76-1.57.
- Major bleeding: HR=0.73; 95% CI, 0.48-1.11.
- Any bleeding: HR=0.7; 95% CI, 0.61-0.79.
“Subgroup analyses of the pooled data indicated no need for dose adjustment of dabigatran according to demographic characteristics or concomitant medication use,” the researchers wrote.
Disclosure: The study was funded by Boehringer Ingelheim. See the full study for a list of the researchers’ relevant financial disclosures.
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