Dabigatran versus warfarin in patients with atrial fibrillation

Connolly, Stuart J., Ezekowitz, Michael D., Yusuf, Salim, Eikelboom, John, Oldgren, Jonas, Parekh, Amit, Pogue, Janice, Reilly, Paul A., Themeles, Ellison, Varrone, Jeanne, Wang, Susan, Alings, Marco, Xavier, Denis, Zhu, Jun, Diaz, Rafael, Lewis, Basil S., Darius, Harald, Diener, Hans-Christoph, Joyner, Campbell D., Wallentin, Lars, RE-LY Steering Committee and Investigators and Colquhoun, David (2009) Dabigatran versus warfarin in patients with atrial fibrillation. New England Journal of Medicine, 361 12: 1139-1151. doi:10.1056/NEJMoa0905561

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Author Connolly, Stuart J.
Ezekowitz, Michael D.
Yusuf, Salim
Eikelboom, John
Oldgren, Jonas
Parekh, Amit
Pogue, Janice
Reilly, Paul A.
Themeles, Ellison
Varrone, Jeanne
Wang, Susan
Alings, Marco
Xavier, Denis
Zhu, Jun
Diaz, Rafael
Lewis, Basil S.
Darius, Harald
Diener, Hans-Christoph
Joyner, Campbell D.
Wallentin, Lars
RE-LY Steering Committee and Investigators
Colquhoun, David
Title Dabigatran versus warfarin in patients with atrial fibrillation
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2009-09-17
Year available 2013
Sub-type Article (original research)
DOI 10.1056/NEJMoa0905561
Open Access Status File (Publisher version)
Volume 361
Issue 12
Start page 1139
End page 1151
Total pages 13
Place of publication Waltham, MA,United States
Publisher Massachusetts Medical Society
Language eng
Subject 2700 Medicine
Abstract BackgroundEdoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known.
Formatted abstract
BACKGROUND:
Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.

METHODS:
In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran - 110 mg or 150 mg twice daily - or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism.

RESULTS:
Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051).

CONCLUSIONS:
In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) 
Keyword Medicine, General & Internal
General & Internal Medicine
MEDICINE, GENERAL & INTERNAL
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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