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Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin

Open access
Majeed, Ammar, Hwang, Hun-Gyu, Connolly, Stuart J., Eikelboom, John W., Ezekowitz, Michael D., Wallentin, Lars, Brueckmann, Martina, Fraessdorf, Mandy, Yusuf, Salim, Schulman, Sam·2013·Circulation

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.

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Metadata

Authors
Majeed, A., Hwang, H.-G., Connolly, S. J., Eikelboom, J. W., Ezekowitz, M. D., Wallentin, L., Brueckmann, M., Fraessdorf, M., Yusuf, S., & Schulman, S.
Venue
Circulation
Published
2013-11-19
Volume
128
Issue
21
Pages
2325-2332
ISSN
  • 0009-7322 (ISSN-L)
  • 1524-4539
OpenAlex
W2101863341
Cited by
277
References
7
FWCI
37.07
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin. https://app.cochat.ai/papers/10.1161/circulationaha.113.002332
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Majeed, A., Hwang, H.-G., Connolly, S. J., Eikelboom, J. W., Ezekowitz, M. D., Wallentin, L., Brueckmann, M., Fraessdorf, M., Yusuf, S., & Schulman, S. (2013). Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin. Circulation. https://doi.org/10.1161/circulationaha.113.002332

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