HAL will be down for maintenance from Friday, June 10 at 4pm through Monday, June 13 at 9am. More information
Skip to Main content Skip to Navigation
Journal articles

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

Abstract : 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). CONCLUSION: Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifiers: NCT00680186 and NCT00291330.
Document type :
Journal articles
Complete list of metadata

https://hal.univ-brest.fr/hal-01030866
Contributor : Ghislaine Calvez Connect in order to contact the contributor
Submitted on : Tuesday, July 22, 2014 - 3:56:20 PM
Last modification on : Thursday, November 21, 2019 - 2:19:20 AM

Links full text

Identifiers

Collections

Citation

Sam Schulman, Ajay K Kakkar, Samuel Z Goldhaber, Sebastian Schellong, Henry Eriksson, et al.. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.. Circulation, American Heart Association, 2014, 129 (7), pp.764-72. ⟨10.1161/CIRCULATIONAHA.113.004450⟩. ⟨hal-01030866⟩

Share

Metrics

Record views

117