• Sam Schulman, Ajay K Kakkar, Samuel Z Goldhaber, Sebastian Schellong, Henry Eriksson, Patrick Mismetti, Anita Vedel Christiansen, Jeffrey Friedman, Florence Le Maulf, Nuala Peter, Clive Kearon, and RE-COVER II Trial Investigators.
• Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, C.K.); Department of Hematology, Karolinska University Hospital, Stockholm, Sweden (S.S.); Thrombosis Research Institute and University College London, London, UK (A.K.K.); Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.Z.G.); Medical Division 2, Municipal Hospital Friedrichstadt, Dresden, Germany (S. Schellong); Department of Medicine, Sahlgrenska University Hospital-Östra, Gothenburg, Sweden (H.E.); Department of Vascular Pathology, Bellevue Hospital, Saint Etienne, France (P.M.); Clinical Research, Boehringer Ingelheim, Copenhagen, Denmark (A.V.C.); Boehringer Ingelheim, Ridgefield, CT (J.F.); Boehringer Ingelheim, Reims, France (F.L.M.); and Boehringer Ingelheim, Biberach and der Riss, BDM, Germany (N.P.).
• Circulation. 2014 Feb 18;129(7):764-72.

BackgroundDabigatran and warfarin have been compared for the treatment of acute venous thromboembolism (VTE) in a previous trial. We undertook this study to extend those findings.Methods And ResultsIn a randomized, double-blind, double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days, we compared dabigatran 150 mg twice daily with warfarin. The primary outcome, recurrent symptomatic, objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients (2.3%) compared with 28 of the 1289 warfarin patients (2.2%; hazard ratio, 1.08; 95% confidence interval [CI], 0.64-1.80; absolute risk difference, 0.2%; 95% CI, -1.0 to 1.3; P<0.001 for the prespecified noninferiority margin for both criteria). The safety end point, major bleeding, occurred in 15 patients receiving dabigatran (1.2%) and in 22 receiving warfarin (1.7%; hazard ratio, 0.69; 95% CI, 0.36-1.32). Any bleeding occurred in 200 dabigatran (15.6%) and 285 warfarin (22.1%; hazard ratio, 0.67; 95% CI, 0.56-0.81) patients. Deaths, adverse events, and acute coronary syndromes were similar in both groups. Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 (95% CI, 0.76-1.57), for major bleeding of 0.73 (95% CI, 0.48-1.11), and for any bleeding of 0.70 (95% CI, 0.61-0.79).ConclusionDabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE.Clinical Trial Registration Urlwww.clinicaltrials.gov. Unique identifiers: NCT00680186 and NCT00291330.

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