Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.

Résumé

Auteurs » Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P -More

Catégorie » Primary study

Journal»Circulation

Year » 2014

Liens » Pubmed, DOI , circ.ahajournals.org

Cet article est inclus dans 33 Systematic reviews Systematic reviews (33 references) 2 Broad syntheses Broad syntheses (2 references)

This article is part of the following publication threads:

RE-COVER I [Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism] (15 documents)
RE-COVER II [Phase III Study Testing Efficacy and Safety of Oral Dabigatran Etexilate versus Warfarin for 6 Month Treatment for Acute Symptomatic Venous Thromboembolism (VTE)] (12 documents)

This article is part of the following matrixes of evidence:

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BACKGROUND:

Dabigatran 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 RESULTS:

In 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).