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Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

Management and outcomes of major bleeding during treatment with dabigatran or warfarin.

Author information

1
Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden (A.M., S.S.); the Department of Medicine, Soonchunhyang University Gumi's Hospital, North Kyungsang Province, South Korea (H.-G-H.); McMaster University, Population Health Research Institute, Hamilton, ON, Canada (S.J.C., J.W.E., S.Y.); Lankenau Medical Center, Thomas Jefferson Medical College, Wynnewood, PA (M.D.E.); Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (L.W.); Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany (M.B., M.F.); Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany (M.B.); and the Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S.S.).

Abstract

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 1034 individuals with 1121 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, 0.68; 95% confidence interval, 0.46-1.01; P=0.057). After adjustment for sex, age, weight, renal function, and concomitant antithrombotic therapy, the pooled odds ratio for 30-day mortality with dabigatran versus warfarin was 0.66 (95% confidence interval, 0.44-1.00; P=0.051). Major bleeds in dabigatran patients were more frequently treated with blood transfusions (423/696, 61%) than bleeds in warfarin patients (175/425, 42%; P<0.001) but less frequently with plasma (dabigatran, 19.8%; warfarin, 30.2%; P<0.001). Patients who experienced a bleed had shorter stays in the intensive care unit if they had previously received dabigatran (mean 1.6 nights) compared with those who had received warfarin (mean 2.7 nights; P=0.01).

CONCLUSIONS:

Patients who experienced major bleeding on dabigatran required more red cell transfusions but received less plasma, required a shorter stay in intensive care, and had a trend to lower mortality compared with those who had major bleeding on warfarin.

CLINICAL TRIAL REGISTRATION URL:

http://www.ClinicalTrials.gov. Unique identifiers: NCT00262600, NCT00291330, NCT00680186, NCT00329238 and NCT00558259.

KEYWORDS:

anticoagulants; atrial fibrillation; hemorrhage; mortality; venous thrombosis

[Indexed for MEDLINE]

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