Newly identified events in the RE-LY trial
Open accessAbstract
To the Editor: We wish to update our article about the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial (Sept. 17, 2009, issue).1 After the database was locked on August 15, 2009, we identified several additional primary efficacy and safety outcome events during routine clinical site closure visits. These events included two systemic embolic events and nine major hemorrhages. Subsequently, after discussions with the Food and Drug Administration, the primary and secondary efficacy and safety data were checked for consistency, and the study database was reevaluated for possible underreporting of events. To achieve this, all free text, outcomes, and adverse . . .
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There was a non-significant numerical increase in the rate of myocardial infarction with both dabigatran doses, which has not been replicated in large post-authorization analyses.
“There was a non-significant numerical increase in the rate of myocardial infarction with both dabigatran doses, 318,404 which has not been replicated in large post-authorization analyses.396”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [404]
Dabigatran 110 mg twice daily was non-inferior to warfarin for prevention of stroke and systemic embolism, with 20% fewer major bleeding events.
“Dabigatran 110 mg twice daily was non-inferior to warfarin for prevention of stroke and systemic embolism, with 20% fewer major bleeding events.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [404]
In the RE-LY study, dabigatran 150 mg twice daily reduced stroke and systemic embolism by 35% compared with warfarin without a significant difference in major bleeding events.
“In the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study, 318,404 dabigatran 150 mg twice daily reduced stroke and systemic embolism by 35% compared with warfarin without a significant difference in major bleeding events.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [404]
Both dabigatran doses significantly reduced haemorrhagic stroke and intracranial haemorrhage.
“Both dabigatran doses significantly reduced haemorrhagic stroke and intracranial haemorrhage.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [404]
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2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
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Dabigatran versus warfarin in patients with mechanical heart valves
Eikelboom, J. W., Connolly, S. J., Brueckmann, M., Granger, C. B., Kappetein, A. P., Mack, M. J., Blatchford, J., Devenny, K., Friedman, J., Guiver, K., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1300615 · Cited by 1,506 · see citing works
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
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Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism
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Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis
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A cost-effectiveness analysis of screening for silent atrial fibrillation after ischaemic stroke
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- Authors
- Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Reilly, P. A., & Wallentin, L.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-11-04
- Volume
- 363
- Issue
- 19
- Pages
- 1875-1876
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1982179895
- Cited by
- 688
- References
- 1
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 1 · 2023: 4 · 2022: 7 · 2021: 12 · 2020: 14 · 2019: 19 · 2018: 27 · 2017: 30 · 2016: 68 · 2015: 61 · 2014: 69 · 2013: 144 · 2012: 139
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- RE-LY trial, dabigatran, rivaroxaban, oral anticoagulation, direct oral anticoagulants, systemic embolism, major bleeding
- MeSH terms
- Dabigatran, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Cardiovascular Diseases, Embolism, Hemorrhage, Humans, Myocardial Infarction, Pyridines
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