Dabigatran performed better than warfarin following major bleeds

ATLANTA — Patients treated with dabigatran had better prognosis after a major bleed than patients treated with warfarin, according to study results presented at the 2012 American Society of Hematology Meeting and Exposition.

Ammar Majeed, MD, of the Hematology Center at Karolinska University Hospital and Karolinska Institute in Stockholm, presented data on the management of major bleeds and prognosis in patients who bleed after treatment with dabigatran (Pradaxa, Boehringer Ingelheim) or warfarin (Coumadin, Bristol-Myers Squibb).

Majeed and colleagues analyzed data from the RE-LY trial. They also analyzed reports on 1,121 major bleeds from five phase 3 long-term trials of dabigatran in patients with atrial fibrillation, acute treatment and secondary prevention of venous thromboembolism. Those five trials involved 27,419 patients who were followed for 6 to 36 months.

Patients with major bleeds on dabigatran were older, had lower creatinine clearance, and more regularly used aspirin or non-steroid anti-inflammatory agents compared with patients on warfarin. Only 11 patients used factor concentrates (two, prothrombin complex concentrate; nine, recombinant Factor VIIa), and this was too few to determine the efficacy of these measures, according to the researchers.

Patients on warfarin required more plasma transfusions (30% vs. 20%; P<.0001) and vitamin K for bleeding management (27% vs. 9%; P<.0001) but were less frequently transfused with red blood cells (50% vs. 59%; P<.0013) compared with patients on dabigatran. More patients on warfarin had major bleeds that required an invasive procedure (14% vs. 9%; P=.09).

Thirty-day mortality favored dabigatran (9.1% vs. 13%; P=.044). The difference in mortality became stronger in logistic regression analysis (multivariate P=.007).

Patients who used dabigatran also experienced shorter stays in the intensive care unit than patients who used warfarin, researchers wrote.

For more information:

Majeed A. Abstract #19. Presented at: the 2012 ASH Annual Meeting and Exposition; Dec. 8-11, 2012; Atlanta.

Disclosure: The researchers report research funding from, as well as advisory board, speakers’ bureau, consulting or employment positions with, Bayer Healthcare, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Pfizer, Sanofi-Aventis and several other pharmaceutical companies.