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Edoxaban versus Warfarin in Patients with Atrial Fibrillation
Open accessAbstract
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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“Edoxaban 60 mg once daily was non-inferior to warfarin (primary outcome, HR 0.87; 97.5% CI 0.73-1.04;P = 0.08).”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [321]
In the citing paper
“while edoxaban 30 mg once daily was non-inferior to warfarin for prevention of stroke and systemic embolism but significantly reduced major bleeding events by 53%.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [321]
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“In an on-treatment analysis, edoxaban 60 mg once daily significantly reduced stroke or systemic embolism by 21% and significantly reduced major bleeding events by 20% compared with warfarin”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [321]
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“Renal clearance”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [321]
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Bassand, J., Virdone, S., Badoz, M., Verheugt, F. W. A., Camm, A. J., Cools, F. J. S., Fox, K. A. A., Goldhaber, S. Z., Goto, S., Haas, S. K., et al. (2021) · Blood Advances · doi:10.1182/bloodadvances.2020003560 · Cited by 72
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“Based on the vital trials of DOACs (Connolly et al., 2009; Granger et al., 2011; Patel et al., 2011; Giugliano et al., 2013), dose adjustment for each DOAC was approved by the National Food and Drug Administration according to patient characteristics (e.”
MethodSteinberg, B. A., Blanco, R. G., Ollis, D. M., Kim, S., Holmes, D. N., Kowey, P. R., Fonarow, G. C., Ansell, J., Gersh, B. J., Go, A. S., et al. (2014) · American Heart Journal · doi:10.1016/j.ahj.2014.04.005 · Cited by 71
How to choose appropriate direct oral anticoagulant for patient with nonvalvular atrial fibrillation
Schaefer, J. K., McBane, R. D., & Wysokiński, W. E. (2015) · Annals of Hematology · doi:10.1007/s00277-015-2566-x · Cited by 71
Amin, A., Keshishian, A. V., Trocio, J. N., Dina, O., Le, H., Rosenblatt, L. C., Liu, X., Mardekian, J., Zhang, Q., Başer, O., et al. (2017) · Current Medical Research and Opinion · doi:10.1080/03007995.2017.1345729 · Cited by 71
Intracranial Hemorrhage and Novel Anticoagulants for Atrial Fibrillation: What Have We Learned?
Hankey, G. J. (2014) · Current Cardiology Reports · doi:10.1007/s11886-014-0480-9 · Cited by 67
New oral anticoagulants: a practical guide for physicians
Hinojar, R., Jiménez-Natcher, J. J., Fernández‐Golfín, C., & Zamorano, J. L. (2015) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvv002 · Cited by 68
Alonso, Á., MacLehose, R. F., Chen, L. Y., Bengtson, L. G. S., Chamberlain, A. M., Norby, F. L., & Lutsey, P. L. (2017) · Heart · doi:10.1136/heartjnl-2016-310586 · Cited by 68
Xian, Y., Federspiel, J. J., Hernandez, A. F., Laskowitz, D. T., Schwamm, L. H., Bhatt, D. L., Smith, E. E., Fonarow, G. C., & Peterson, E. D. (2017) · Circulation · doi:10.1161/circulationaha.116.023940 · Cited by 69
Dissection of Cervical and Cerebral Arteries
Engelter, S. T., Traenka, C., & Lyrer, P. A. (2017) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-017-0769-3 · Cited by 71
Li, G., Lip, G. Y. H., Holbrook, A. M., Chang, Y., Larsen, T. B., Sun, X., Tang, J., Mbuagbaw, L. C. E., Witt, D. M., Crowther, M. A., et al. (2018) · European Journal of Epidemiology · doi:10.1007/s10654-018-0415-7 · Cited by 70
“The efficacy and safety of NOACs compared with warfarin have been presented in respective multicenter Phase III randomized controlled trials (RCTs) [8-11].”
BackgroundStroke Prevention in Nonvalvular Atrial Fibrillation
Alkhouli, M. A., Noseworthy, P. A., Rihal, C. S., & Holmes, D. R. (2018) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.04.013 · Cited by 70
“ENGAGE AF-TIMI 48, 2013 (31) RCT 21,105 Compared with warfarin, high-dose edoxaban led to: 21% Z in stroke/systemic embolization (95% CI: 1% to 37%) 20% Z in major bleeding (95% CI: 1% to 37%) 14% Z in CV death (95% CI: 3% to 23%)”
Ezekowitz, J. A., Lewis, B. S., Lópes, R. D., WOJDYLA, D. M., McMurray, J. J. V., Hanna, M., Atar, D., Bahit, M. C., Keltai, M., Lopez-Sendon, J. L., et al. (2015) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvu024 · Cited by 69
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Left Atrial Structure and Function and the Risk of Death or Heart Failure in Atrial Fibrillation
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The Italian START-Register on Anticoagulation with Focus on Atrial Fibrillation
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Organ-specific bleeding patterns of anticoagulant therapy: lessons from clinical trials
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Stroke Prevention in Atrial Fibrillation: Focus on Asian Patients
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New‐onset postoperative atrial fibrillation after heart surgery
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Practical management of bleeding in patients receiving non-vitamin K antagonist oral anticoagulants
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“5-fold the upper limit of normal.(10,11) The study design flowchart and patient enrollment are shown in Figure.”
BackgroundSTS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management.
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“Taking NOACs (n = 2207) Not taking anticoagulants (n = 160 831) Absolute standardized differencea National Institutes of Health Stroke Scale score, median (IQR)c 10 (5-17) 7 (4-14) 25.”
Methodon behalf of the APACHE-AF investigators, van Nieuwenhuizen, K. M., van der Worp, H. B., Algra, A., Kappelle, L. J., Rinkel, G. J. E., Gelder, I. C. V., Schutgens, R. E. G., & Klijn, C. J. M. (2015) · Trials · doi:10.1186/s13063-015-0898-4 · Cited by 68
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“No specific antidote is currently available for edoxaban in Europe, whereas andexanet alfa has recently been approved in the US for all FXa inhibitors.”
BackgroundInfluentialEpidemiology and Primary Prevention of Stroke
Furie, K. L. (2020) · CONTINUUM Lifelong Learning in Neurology · doi:10.1212/con.0000000000000831 · Cited by 72
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Thrombolysis In Myocardial Infarction (TIMI) Study Group
Sabatine, M. S., & Braunwald, E. (2021) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.01.060 · Cited by 70
Metadata
- 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
- 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
- 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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