Cited by 11,215Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

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Dabigatran versus Warfarin in Patients with Atrial Fibrillation

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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·2009·New England Journal of Medicine

DOI 10.1056/nejmoa0905561

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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.)

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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: Connolly, Stuart J.
Ezekowitz, Michael D.
Yusuf, Salim
Eikelboom, John
Oldgren, Jonas
Parekh, Amit
Alings, Marco
Xavier, Denis
Zhu, Jun
Lewis, Basil S.
Wallentin, Lars
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
DOI: 10.1056/nejmoa0905561
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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Dabigatran versus Warfarin in Patients with Atrial Fibrillation

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