The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index.
Dabigatran versus Warfarin in Patients with Atrial Fibrillation
Open accessAbstract
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.)
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“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 [318]
In the citing paper
“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 [318]
In the citing paper
“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 [318]
In the citing paper
“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 [318]
In the citing paper
“There are no randomized trials assessing OAC in haemodialysis patients, 418 and no controlled trials of NOACs in patients with severe CKD (CrCl < 25-30 mL/min).”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]
In the citing paper
“Renal clearance”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [318]
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Metadata
- Authors
- Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., Pogue, J., Reilly, P. A., Themeles, E., Varrone, J., Wang, S., Alings, M., Xavier, D., Zhu, J., Diaz, R., Lewis, B. S., Darius, H., Diener, H.-C., Joyner, C. D., & Wallentin, L.
- Affiliations
- Population Health Research Institute (CA)
- Lankenau Institute for Medical Research (US)
- Uppsala University (SE)
- Boehringer Ingelheim (United States) (US)
- Werkgroep Cardiologische centra Nederland (NL)
- St. John's National Academy of Health Sciences (IN)
- Fu Wai Hospital (CN)
- Carmel Medical Center (IL)
- Vivantes Klinikum (DE)
- Sunnybrook Health Science Centre (CA)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-09-17
- Volume
- 361
- Issue
- 12
- Pages
- 1139-1151
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2136489990
- Cited by
- 11,215
- References
- 18
- Citations by year
- 2026: 219 · 2025: 318 · 2024: 395 · 2023: 489 · 2022: 507 · 2021: 662 · 2020: 745 · 2019: 669 · 2018: 775 · 2017: 799 · 2016: 864 · 2015: 923 · 2014: 874 · 2013: 1000 · 2012: 915
- FWCI
- 419.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- UWA Profiles and Research Repository (UWA) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Minerva Access (University of Melbourne) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
- Figshare (submittedVersion)
- UnissResearch (Università degli Studi di Sassari) (submittedVersion)
- Open Repository and Bibliography (University of Liège) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Daiichi-Sankyo
- Eisai
- Servier
- Cilag
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
- Keywords
- dabigatran, warfarin, atrial fibrillation, direct thrombin inhibitors, oral anticoagulants, stroke prevention, systemic embolism, major bleeding, hemorrhagic stroke, non-inferiority, mortality, fixed-dose dosing, bleeding risk stratification, anticoagulation
- MeSH terms
- Dabigatran, Aged, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Double-Blind Method, Dyspepsia, Embolism, Female, Follow-Up Studies, Hemorrhage, Humans, Liver, Male, Middle Aged, Myocardial Infarction, Prodrugs, Pyridines, Warfarin, Chi-Square Distribution, Proportional Hazards Models, Stroke
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