Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis

Study Questions:

What is the efficacy and safety of dabigatran versus warfarin for the treatment of acute venous thromboembolism (VTE) in a pooled analysis?


RE-COVER II was a randomized, double-blind, double-dummy trial of 2,589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5-11 days. The investigators compared dabigatran 150 mg twice daily with warfarin. The primary outcome was recurrent symptomatic, objectively confirmed VTE and related deaths during 6 months of treatment.


The primary outcome occurred in 30 of the 1,279 dabigatran patients (2.3%) compared with 28 of the 1,289 warfarin patients (2.2%; hazard ratio [HR], 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 endpoint, major bleeding, occurred in 15 patients receiving dabigatran (1.2%) and in 22 patients receiving warfarin (1.7%; HR, 0.69; 95% CI, 0.36-1.32). Any bleeding occurred in 200 dabigatran (15.6%) and 285 warfarin (22.1%; HR, 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 HRs 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).


The authors concluded that dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE.


This study, RE-COVER II, confirms the results of RE-COVER, with noninferiority of dabigatran to warfarin in the prevention of recurrent VTE, and with superiority of dabigatran for clinically relevant bleeding and for any bleeding. There is also a similar trend for fewer major bleedings with dabigatran. Future studies should compare efficacy and safety of dabigatran with the newer anticoagulants (i.e., apixaban, rivaroxaban, edoxaban) to define the optimum anticoagulation agent for acute VTE.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and ACS, Anticoagulation Management and Venothromboembolism, Novel Agents

Keywords: Acute Coronary Syndrome, beta-Alanine, Morpholines, Benzimidazoles, Warfarin, Heparin, Venous Thromboembolism, Thiazoles, Pyridines, Pyrazoles, Pyridones

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