Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin
Clinical Trials Thursday, October 10th, 2013CIRCULATIONAHA: September 30, 2013
Background—The aim of this study was to compare the management and prognosis of major bleeding in patients treated with dabigatran or warfarin.
Methods and Results—Two independent investigators reviewed bleeding reports from 1,034 individuals with 1,121 major bleeds enrolled in 5 phase III trials comparing dabigatran with warfarin in 27,419 patients treated for 6 to 36 months. Patients with major bleeds on dabigatran (n=627 of 16,755) were older, had lower creatinine clearance and more frequently used aspirin or non-steroid anti-inflammatory agents than those on warfarin (n=407 of 10,002). The 30-day mortality after the first major bleed tended to be lower in the dabigatran group (9.1%) than in the warfarin group (13.0%; pooled odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.46-1.01; p=0.057). Read more
