American Society of Hirudotherapy

RE-LY Trial — Dabigatran vs Warfarin in Atrial Fibrillation

Landmark trial establishing the synthetic oral thrombin inhibitor dabigatran for stroke prevention

Last Updated: November 1, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Research reportDrug DevelopmentConnolly SJ et al. · New England Journal of Medicine, 2009

Summary

The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial compared dabigatran — a synthetic direct thrombin inhibitor that shares leech hirudin's target but is not derived from it — against warfarin for stroke prevention in atrial fibrillation. The trial (n=18,113) showed that dabigatran 110 mg twice daily was noninferior to warfarin for stroke or systemic embolism (1.53% vs 1.69% per year; relative risk 0.91, 95% CI 0.74-1.11) and that 150 mg twice daily was superior (1.11% per year; relative risk 0.66, 95% CI 0.53-0.82). Hemorrhagic stroke was lower with both doses (0.12% and 0.10% vs 0.38% per year); major bleeding was lower with 110 mg (2.71% vs 3.36% per year) and similar with 150 mg (3.11%).

Citation

Reference (Vancouver style)

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361(12):1139-1151. doi:10.1056/NEJMoa0905561. PMID: 19717844

Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.

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