Sam Schulman1, Ajay K Kakkar, Samuel Z Goldhaber, Sebastian Schellong, Henry Eriksson, Patrick Mismetti, Anita Vedel Christiansen, Jeffrey Friedman, Florence Le Maulf, Nuala Peter, Clive Kearon. 1. 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.).
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 orunfractionated 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.
RCT Entities:
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 dabigatranpatients (2.3%) compared with 28 of the 1289 warfarinpatients (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.
Authors: Akash Kataruka; Xiaowen Kong; Brian Haymart; Eva Kline-Rogers; Steve Almany; Jay Kozlowski; Gregory D Krol; Scott Kaatz; Michael W McNamara; James B Froehlich; Geoffrey D Barnes Journal: Vasc Med Date: 2017-02-01 Impact factor: 3.239
Authors: Hanno Riess; Cihan Ay; Rupert Bauersachs; Cecilia Becattini; Jan Beyer-Westendorf; Francis Cajfinger; Ian Chau; Alexander T Cohen; Alok A Khorana; Anthony Maraveyas; Marcos Renni; Annie M Young Journal: Oncologist Date: 2018-04-12
Authors: Mauro Molteni; Mario Bo; Giovanni Di Minno; Giuseppe Di Pasquale; Simonetta Genovesi; Danilo Toni; Paolo Verdecchia Journal: Intern Emerg Med Date: 2017-04-24 Impact factor: 3.397