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30 Aug 2009

RE-LY: A randomized trial of dabigatran, a oral direct thrombin inhibitor, compared to warfarin in 18,113 patients with atrial fibrillation at high risk of stroke 

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Topics: Atrial Fibrillation
Session number: 181-182
Session title: A randomized trial of dabigatran, a oral direct thrombin inhibitor, compared to warfarin in 18,113 patients with atrial fibrillation at high risk of stroke
Authors: Connolly, Stuart J - Camm, John


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Presenter | see Discussant report

Stuart J Connolly

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Stuart J Connolly, (Canada)

Abstract:

Background:
Warfarin reduces stroke in atrial fibrillation, but increases hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.

Methods:
In a non-inferiority trial, 18,113 patients with atrial fibrillation at risk of stroke were randomized to blinded fixed doses of dabigatran 110 mg or 150 mg twice daily versus unblinded adjusted warfarin. Median follow-up was 2.0 years. The primary outcome was stroke or systemic embolism.

Results:
Rates of the primary outcome were 1.69% per year on warfarin versus 1.53% per year on dabigatran 110 mg (relative risk 0.91, 95% confidence interval 0.74 to 1.11; p [non-inferiority]<0.001) and 1.11% per year on dabigatran 150 mg (relative risk 0.66, 95% confidence interval 0.53 to 0.82; p [superiority]<0.001. Rates of major hemorrhage were 3.36% per year on warfarin versus 2.71% per year on dabigatran 110 mg (p=0.003) and 3.36% per year on dabigatran 150 mg (p=0.31). Rates of hemorrhagic stroke were 0.38% per year on warfarin versus 0.12% per year on dabigatran 110 mg (p<0.001) and 0.10% per year on dabigatran 150 mg (p<0.001). Mortality rates were 4.13% per year on warfarin versus 3.74% per year on dabigatran 110 mg (p=0.13) and 3.64% per year on dabigatran 150 mg (p=0.05).

Conclusions:
In patients with atrial fibrillation, dabigatran 110 mg was associated with similar rates of stroke and systemic embolism to warfarin, and lower rates of major hemorrhage. Dabigatran 150 mg was associated with lower rates of stroke and systemic embolism than warfarin, and similar rates of major hemorrhage.



Discussant | see Presenter abstract

John Camm

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John Camm, FESC (United Kingdom)

 


Notes to editor
This congress report accompanies a presentation given at the ESC Congress 2009. Written by the author himself/herself, this report does not necessarily reflect the opinion of the European Society of Cardiology.

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.