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Treatment of AcuteVenousThromboembolism WithDabigatran orWarfarin and PooledAnalysis Sam SchulmanAjay K. KakkarSamuel Z. Goldhaber2013 год

Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis
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Аннотация: 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.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).Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE.www.clinicaltrials.gov. Unique identifiers: NCT00680186 and NCT00291330.
Год издания: 2013
Авторы: 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
Издательство: Lippincott Williams & Wilkins
Источник: Circulation
Ключевые слова: Venous Thromboembolism Diagnosis and Management, Atrial Fibrillation Management and Outcomes, Cardiac Arrhythmias and Treatments
Другие ссылки: Circulation (PDF)
Circulation (HTML)
HAL (Le Centre pour la Communication Scientifique Directe) (HTML)
PubMed (HTML)