Cited by 5,164Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

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Edoxaban versus Warfarin in Patients with Atrial Fibrillation

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Giugliano, Robert P., Ruff, Christian T., Braunwald, Eugene, Murphy, Sabina A., Wiviott, Stephen D., Halperin, Jonathan L., Waldo, Albert L., Ezekowitz, Michael D., Weitz, Jeffrey I., Špinar, Jindřich, Ruzyllo, Witold, Ruda, Mikhail, Koretsune, Yukihiro, Betcher, Joshua, Shi, Minggao, Grip, Laura T., Patel, Shirali P., Patel, Indravadan, Hanyok, James J., Mercuri, Michele, Antman, Elliott M.·2013·New England Journal of Medicine

DOI 10.1056/nejmoa1310907

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Abstract

BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.).

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Authors: Giugliano, R. P., Ruff, C. T., Braunwald, E., Murphy, S. A., Wiviott, S. D., Halperin, J. L., Waldo, A. L., Ezekowitz, M. D., Weitz, J. I., Špinar, J., Ruzyllo, W., Ruda, M., Koretsune, Y., Betcher, J., Shi, M., Grip, L. T., Patel, S. P., Patel, I., Hanyok, J. J., Mercuri, M., & Antman, E. M.
Affiliations: Brigham and Women's Hospital (US)
University Hospitals Cleveland Medical Center (US)
McMaster University (CA)
National Medical Research Center of Cardiology (RU)
Osaka National Hospital (JP)
IQVIA (United States) (US)
Daiichi Sankyo (United States) (US)
ORCID: Giugliano, Robert P.
Ruff, Christian T.
Wiviott, Stephen D.
Halperin, Jonathan L.
Weitz, Jeffrey I.
Špinar, Jindřich
Patel, Indravadan
Mercuri, Michele
Antman, Elliott M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2013-11-28
Volume: 369
Issue: 22
Pages: 2093-2104
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1310907
OpenAlex: W2096246254
Cited by: 5,164
References: 24
Citations by year: 2026: 201 · 2025: 280 · 2024: 344 · 2023: 419 · 2022: 405 · 2021: 469 · 2020: 505 · 2019: 443 · 2018: 487 · 2017: 454 · 2016: 494 · 2015: 378 · 2014: 266 · 2013: 12
FWCI: 260.36
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Discovery Research Portal (University of Dundee) (publishedVersion)
Pure Amsterdam UMC (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
Radboud Repository (Radboud University) (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
HAL (submittedVersion)
Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Figshare (submittedVersion, cc-by)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
Radboud Repository (Radboud University) (submittedVersion, other-oa)
Funders: Bristol-Myers Squibb
Eli Lilly and Company
Pfizer
AstraZeneca
Sanofi
Gilead Sciences
AtriCure
Boston Scientific Corporation
Medicines Company
Janssen Scientific Affairs
Bayer HealthCare
Eisai
St. Jude Medical
Biosense Webster
Janssen Pharmaceuticals
Daiichi Sankyo Europe
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: edoxaban, warfarin, atrial fibrillation, direct oral anticoagulants, factor Xa inhibitors, stroke and systemic embolism, major bleeding, non-inferiority, oral anticoagulation, time in therapeutic range, anticoagulant efficacy and safety, once-daily dosing
MeSH terms: Adult, Aged, Anticoagulants, Atrial Fibrillation, Cardiovascular Diseases, Double-Blind Method, Embolism, Female, Follow-Up Studies, Hemorrhage, Humans, Male, Middle Aged, Pyridines, Thiazoles, Warfarin, Stroke, Kaplan-Meier Estimate

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Edoxaban versus Warfarin in Patients with Atrial Fibrillation

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