Edoxaban versus warfarin in patients with atrial fibrillation

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.

doi:10.1056/nejmoa1310907

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

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. +13 more·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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In the ENGAGE AF-TIMI 48 trial, edoxaban 60 mg once daily was non-inferior to warfarin for the primary outcome (HR 0.87; 97.5% CI 0.73-1.04; P = 0.08).
“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]
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%.
“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]
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.
“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]
Edoxaban has 50% renal clearance.
“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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Grip LT, Ruff CT, Giugliano RP. New oral antithrombotic strategies: 2013 up- date on atrial fibrillation. Hot Topics Cardiol 2013;31:7-18.

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“On the other side of the spectrum, a possibly decreased efficacy of edoxaban 60 mg OD compared with warfarin was observed in patients with a CrCl of >95 mL/min.(31) Interestingly, as a result of these findings, further post hoc analyses revealed a similar effect also for Rivaroxaban(188) and Apixaban.”
BackgroundMethodResultInfluential
Definition of clinically relevant non‐major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non‐surgical patients: communication from the SSC of the ISTH
Kaatz, S., Ahmad, D., Spyropoulos, A. C., & Schulman, S. (2015) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.13140 · Cited by 1,436 · see citing works
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezw313 · Cited by 1,403 · see citing works
Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation
Lopes, R. D., Heizer, G., Aronson, R., Vora, A. N., Massaro, T., Mehran, R., Goodman, S. G., Windecker, S., Darius, H., Li, J., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1817083 · Cited by 1,228 · see citing works
Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation
Douketis, J. D., Spyropoulos, A. C., Kaatz, S., Becker, R. C., Caprini, J. A., Dunn, A. S., Garcia, D. A., Jacobson, A., Jaffer, A. K., Kong, D. F., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501035 · Cited by 1,184 · see citing works
2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation
Calkins, H. G., Hindricks, G., Cappato, R., Kim, Y., Saad, E., Aguinaga, L., Akar, J. G., Badhwar, V., Brugada, J., Camm, A. J., et al. (2017) · EP Europace · doi:10.1093/europace/eux274 · Cited by 1,191 · see citing works
“This recommendation is based on the following: (1) recurrences of AF are common both early and late following AF ablation; (2) asymptomatic AF is common, and is more common following AF ablation than prior to AF ablation; (3) AF ablation destroys a portion of the atria and the impact of this on stroke risk is uncertai…”
Background
2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation
Steffel, J., Collins, R., Antz, M., Cornu, P., Desteghe, L., Haeusler, K. G., Oldgren, J., Reinecke, H., Roldan-Schilling, V., Rowell, N., et al. (2021) · EP Europace · doi:10.1093/europace/euab065 · Cited by 1,132 · see citing works
Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation
Heidbüchel, H., Verhamme, P. B., Alings, M., Antz, M., Diener, H., Hacke, W., Oldgren, J., Sinnaeve, P., Camm, A. J., & Kirchhof, P. F. (2015) · EP Europace · doi:10.1093/europace/euv309 · Cited by 1,114 · see citing works
2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary
Otto, C. M., Nishimura, R. A., Bonow, R. O., Carabello, B. A., Erwin, J. P., Gentile, F., Jneid, H. M., Krieger, E. V., Mack, M. J., McLeod, C., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.11.035 · Cited by 1,104 · see citing works
Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity
Siegal, D. M., Curnutte, J. T., Connolly, S. J., Lu, G., Conley, P. B., Wiens, B. L., Mathur, V. S., Castillo, J., Bronson, M. D., Leeds, J. M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1510991 · Cited by 1,047 · see citing works
5-Year Outcomes After Left Atrial Appendage Closure
Reddy, V. Y., Doshi, S. K., Kar, S., Gibson, D. N., Price, M. J., Huber, K., Horton, R., Buchbinder, M., Neužil, P., Gordon, N. T., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.10.021 · Cited by 1,039 · see citing works
Antithrombotic Therapy for Atrial Fibrillation
Lip, G. Y. H., Banerjee, A., Boriani, G., Chiang, C. E., Fargo, R. A., Freedman, B., Lane, D. A., Ruff, C. T., Turakhia, M. P., Werring, D. J., et al. (2018) · CHEST Journal · doi:10.1016/j.chest.2018.07.040 · Cited by 952 · see citing works
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Heidenreich, P. A., Bozkurt, B., Aguilar, D. A., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Circulation · doi:10.1161/cir.0000000000001062 · Cited by 956 · see citing works
2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation
Joglar, J. A., Chung, M. K., Armbruster, A. L., Benjamin, E. J., Chyou, J. Y., Cronin, E. M., Deswal, A., Eckhardt, L. L., Goldberger, Z. D., Gopinathannair, R., et al. (2024) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.08.017 · Cited by 933 · see citing works
Management of severe perioperative bleeding
Kozek‐Langenecker, S. A., Afshari, A., Albaladejo, P., Aldecoa, C., ROBERTIS, E. D., Filipescu, D. C., Fries, D. R., Görlinger, K., Haas, T., Imberger, G. L., et al. (2013) · European Journal of Anaesthesiology · doi:10.1097/eja.0b013e32835f4d5b · Cited by 900 · see citing works
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.12.011 · Cited by 931 · see citing works
Ischemic Stroke
Feske, S. K. (2021) · The American Journal of Medicine · doi:10.1016/j.amjmed.2021.07.027 · Cited by 835 · see citing works
Management of severe perioperative bleeding
Kozek‐Langenecker, S. A., Ahmed, A. B., Afshari, A., Albaladejo, P., Aldecoa, C., Barauskas, G., ROBERTIS, E. D., Faraoni, D., Filipescu, D. C., Fries, D. R., et al. (2017) · European Journal of Anaesthesiology · doi:10.1097/eja.0000000000000630 · Cited by 801 · see citing works
2018 Chinese Guidelines for Prevention and Treatment of Hypertension-A report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension.
(2019) · PubMed Central · doi:10.11909/j.issn.1671-5411.2019.03.014 · Cited by 766 · see citing works
Guideline for Reversal of Antithrombotics in Intracranial Hemorrhage
Frontera, J. A., Lewin, J. J., Rabinstein, A. A., Aisiku, I. P., Alexandrov, A. W., Cook, A. M., del Zoppo, G. J., Kumar, M. A., Peerschke, E. I. B., Stiefel, M., et al. (2015) · Neurocritical Care · doi:10.1007/s12028-015-0222-x · Cited by 713 · see citing works
JCS 2017/JHFS 2017 Guideline on Diagnosis and Treatment of Acute and Chronic Heart Failure ― Digest Version ―
Tsutsui, H., Isobe, M., Ito, H., Ito, H., Okumura, K., Ōno, M., Kitakaze, M., Kinugawa, K., Kihara, Y., Goto, Y., et al. (2019) · Circulation Journal · doi:10.1253/circj.cj-19-0342 · Cited by 708 · see citing works
PACES/HRS Expert Consensus Statement on the Recognition and Management of Arrhythmias in Adult Congenital Heart Disease
Khairy, P., Van Hare, G. F., Balaji, S., Berul, C. I., Cecchin, F., Cohen, M. I., Daniels, C. J., Deal, B. J., Dearani, J. A., Groot, N. D., et al. (2014) · Heart Rhythm · doi:10.1016/j.hrthm.2014.05.009 · Cited by 709 · see citing works
Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial
Vranckx, P., Valgimigli, M., Eckardt, L., Tijssen, J. G. P., Lewalter, T., Gargiulo, G., Batushkin, V., Campo, G. C., Lysak, Z., Ip, V., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)31872-0 · Cited by 698 · see citing works
Direct Oral Anticoagulant Use: A Practical Guide to Common Clinical Challenges
Chen, A., Stecker, E. C., & Warden, B. A. (2020) · Journal of the American Heart Association · doi:10.1161/jaha.120.017559 · Cited by 679 · see citing works
The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients
Velleca, A., Shullo, M. A., Dhital, K. K., Azeka, E., Colvin, M. M., DePasquale, E. C., Farrero, M., Garcı́a-Guereta, L., Jamero, G., Khush, K. K., et al. (2022) · The Journal of Heart and Lung Transplantation · doi:10.1016/j.healun.2022.10.015 · Cited by 677 · see citing works
2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation
Tzeis, S. E., Gerstenfeld, E. P., Kalman, J. M., Saad, E., Shamloo, A. S., Andrade, J. G., Barbhaiya, C. R., Baykaner, T., Bovéda, S., Calkins, H. G., et al. (2024) · EP Europace · doi:10.1093/europace/euae043 · Cited by 692 · see citing works
Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation
Osmancik, P. P., Heřman, D., Neužil, P., Hála, P., Táborský, M., Kala, P., Poloczek, M., Šťásek, J., Haman, L., Branny, M., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.04.067 · Cited by 654 · see citing works
Stroke genetics informs drug discovery and risk prediction across ancestries
Mishra, A., Malik, R., Hachiya, T., Jürgenson, T., Namba, S., Posner, D. C., Kamanu, F., Koido, M., Grand, Q. L., Shi, M., et al. (2022) · Nature · doi:10.1038/s41586-022-05165-3 · Cited by 591 · see citing works
“…and who were of European ancestry from the ENGAGE AF-TIMI 48 (effective anticoagulation with factor Xa next generation in atrial fibrillation) 109 , SOLID-TIMI 52 (stabilization of plaques using darapladib) 110 , SAVOR-TIMI 53 (saxaglip-tin assessment of vascular outcomes recorded in…”
Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS)
Task Force Members, Lip, G. Y. H., Windecker, S., Huber, K., Kirchhof, P. F., Marín, F. R., ten Berg, J. M., Hæusler, K. G., Boriani, G., Capodanno, D., et al. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu298 · Cited by 567 · see citing works
The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation
Andrade, J. G., Aguilar, M., Atzema, C. L., Bell, A., Cairns, J. A., Cheung, C. C., Cox, J. L., Dorian, P., Gladstone, D. J., Healey, J. S., et al. (2020) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2020.09.001 · Cited by 568 · see citing works
2021 ESC Guidelines on cardiovascular disease prevention in clinical practice
Visseren, F. L. J., Mach, F., Smulders, Y. M., Carballo, D., Koskinas, K. C., Bäck, M., Bénétos, A., Biffi, A., Boavida, J.-M., Capodanno, D., et al. (2021) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwab154 · Cited by 565 · see citing works
Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation
Holmes, D. R., Doshi, S. K., Kar, S., Price, M. J., Sanchez, J. M., Sievert, H., Valderrabano, M., & Reddy, V. Y. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.04.025 · Cited by 543 · see citing works
Outcomes Associated With Apixaban Use in Patients With End-Stage Kidney Disease and Atrial Fibrillation in the United States
Siontis, K. C., Zhang, X., Eckard, A., Bhave, N. M., Schaubel, D. E., He, K., Tilea, A. M., Stack, A. G., Balkrishnan, R., Yao, X., et al. (2018) · Circulation · doi:10.1161/circulationaha.118.035418 · Cited by 496 · see citing works
Off-Label Dosing of Non-Vitamin K Antagonist Oral Anticoagulants and Adverse Outcomes
Steinberg, B. A., Shrader, P. J., Thomas, L. E., Ansell, J., Fonarow, G. C., Gersh, B. J., Kowey, P. R., Mahaffey, K. W., Naccarelli, G. V., Reiffel, J. A., et al. (2016) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2016.09.966 · Cited by 493 · see citing works
2014 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation
Verma, A., Cairns, J. A., Mitchell, L. B., Macle, L., Stiell, I. G., Gladstone, D. J., McMurtry, M. S., Connolly, S. J., Cox, J. L., Dorian, P., et al. (2014) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2014.08.001 · Cited by 475 · see citing works
Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies: The SEARCH-AF study
Lowres, N., Neubeck, L., Salkeld, G., Krass, I., McLachlan, A. J., Redfern, J., Bennett, A. A., Briffa, T., Bauman, A., Martinez, C., et al. (2014) · Thrombosis and Haemostasis · doi:10.1160/th14-03-0231 · Cited by 458 · see citing works
Non–Vitamin K Antagonist Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Renal Dysfunction
Yao, X., Shah, N. D., Sangaralingham, L. R., Gersh, B. J., & Noseworthy, P. A. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.03.600 · Cited by 469 · see citing works
XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation
Camm, A. J., Amarenco, P., Haas, S. K., Hess, S., Kirchhof, P. F., Kuhls, S., van Eickels, M., & Turpie, A. G. G. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv466 · Cited by 452 · see citing works
Effect of Adherence to Oral Anticoagulants on Risk of Stroke and Major Bleeding Among Patients With Atrial Fibrillation
Yao, X., Abraham, N. S., Alexander, G. C., Crown, W. H., Montori, V. M., Sangaralingham, L. R., Gersh, B. J., Shah, N. D., & Noseworthy, P. A. (2016) · Journal of the American Heart Association · doi:10.1161/jaha.115.003074 · Cited by 452 · see citing works
Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH
Martin, K. A., Beyer‐Westendorf, J., Davidson, B. L., Huisman, M. V., Sandset, P. M., & Moll, S. (2016) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.13323 · Cited by 446 · see citing works
2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
Ponikowski, P. P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., Falk, V., González‐Juanatey, J. R., Harjola, V., Jankowska, E. A., et al. (2016) · Kardiologia Polska · doi:10.5603/kp.2016.0141 · Cited by 450 · see citing works
2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation
Doherty, J. U., Gluckman, T. J., Hucker, W. J., Januzzi, J. L., Ortel, T. L., Saxonhouse, S. J., & Spinler, S. A. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2016.11.024 · Cited by 445 · see citing works
Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study
Larsen, T. B., Skjøth, F., Nielsen, P. B., Kjældgaard, J. N., & Lip, G. Y. H. (2016) · BMJ · doi:10.1136/bmj.i3189 · Cited by 440 · see citing works
Guidelines for Pharmacotherapy of Atrial Fibrillation (JCS 2013)
JCS Joint Working Group (2014) · Circulation Journal · doi:10.1253/circj.cj-66-0092 · Cited by 428 · see citing works
Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes
Kirchhof, P. F., Toennis, T., Goette, A., Camm, A. J., Diener, H., Becher, N., Bertaglia, E., Lundqvist, C. B., Borlich, M., Brandes, A., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2303062 · Cited by 442 · see citing works
Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation
Yao, X., Abraham, N. S., Sangaralingham, L. R., Bellolio, F., McBane, R. D., Shah, N. D., & Noseworthy, P. A. (2016) · Journal of the American Heart Association · doi:10.1161/jaha.116.003725 · Cited by 421 · see citing works
The NCDR Left Atrial Appendage Occlusion Registry
Freeman, J. V., Varosy, P. D., Price, M. J., Slotwiner, D. J., Kusumoto, F. M., Rammohan, C., Kavinsky, C. J., Turi, Z. G., Akar, J. G., Koutras, C., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.12.040 · Cited by 421 · see citing works
Use of PER977 to Reverse the Anticoagulant Effect of Edoxaban
Ansell, J., Bakhru, S., Laulicht, B., Steiner, S. S., GROSSO, M. A., Brown, K. S., Dishy, V., Noveck, R. J., & Costin, J. C. (2014) · New England Journal of Medicine · doi:10.1056/nejmc1411800 · Cited by 414 · see citing works
2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS
Valgimigli, M., Bueno, H., Byrne, R. A., Collet, J., Costa, F., Jeppsson, A., Jüni, P., Kastrati, A., Kolh, P. H., Mauri, L., et al. (2017) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezx334 · Cited by 416 · see citing works
Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial
Ruff, C. T., Giugliano, R. P., Braunwald, E., Morrow, D. A., Murphy, S. A., Kuder, J. F., Deenadayalu, N., Jarolim, P., Betcher, J., Shi, M., et al. (2015) · The Lancet · doi:10.1016/s0140-6736(14)61943-7 · Cited by 405 · see citing works
Self-citation
2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation
January, C. T., Wann, L. S., Calkins, H. G., Chen, L. Y., Cigarroa, J. E., Cleveland, J. C., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., Furie, K. L., et al. (2019) · Heart Rhythm · doi:10.1016/j.hrthm.2019.01.024 · Cited by 409 · see citing works
2017 EACTS Guidelines on perioperative medication in adult cardiac surgery
Sousa‐Uva, M., Head, S. J., Milojevic, M., Collet, J., Landoni, G., Castellà, M., Dunning, J., Guðbjartsson, T., Linker, N., Sandoval, E., et al. (2017) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezx314 · Cited by 402 · see citing works
2020 Clinical practice guidelines for Chronic heart failure
Russian Society of Cardiology (2020) · Russian Journal of Cardiology · doi:10.15829/1560-4071-2020-4083 · Cited by 529 · see citing works
The impact of atrial fibrillation type on the risk of thromboembolism, mortality, and bleeding: a systematic review and meta-analysis
Ganesan, A. N., Chew, D. P., Hartshorne, T., Selvanayagam, J. B., Aylward, P. E., Sanders, P., & McGavigan, A. D. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw007 · Cited by 394 · see citing works
International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants
Gosselin, R. C., Adcock, D. M., Bates, S. M., Douxfils, J., Favaloro, E. J., Gouin‐Thibault, I., Guillermo, C., Kawai, Y., Lindhoff‐Last, E., & Kitchen, S. (2018) · Thrombosis and Haemostasis · doi:10.1055/s-0038-1627480 · Cited by 395 · see citing works
Cortical superficial siderosis: detection and clinical significance in cerebral amyloid angiopathy and related conditions
Charidimou, A., Linn, J., Vernooij, M. W., Opherk, C., Akoudad, S., Baron, J.-C., Greenberg, S. M., Jäger, H. R., & Werring, D. J. (2015) · Brain · doi:10.1093/brain/awv162 · Cited by 385 · see citing works
Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: Patient-Level Network Meta-Analyses of Randomized Clinical Trials With Interaction Testing by Age and Sex
Carnicelli, A., Hong, H., Connolly, S. J., Eikelboom, J. W., Giugliano, R. P., Morrow, D. A., Patel, M. R., Wallentin, L. C., Alexander, J. H., Bahit, M. C., et al. (2022) · Circulation · doi:10.1161/circulationaha.121.056355 · Cited by 390 · see citing works
Fresh frozen plasma versus prothrombin complex concentrate in patients with intracranial haemorrhage related to vitamin K antagonists (INCH): a randomised trial
Steiner, T., Poli, S., Griebe, M., Hüsing, J., Hajda, J., Freiberger, A., Bendszus, M., Bösel, J., Christensen, H., Dohmen, C., et al. (2016) · The Lancet Neurology · doi:10.1016/s1474-4422(16)00110-1 · Cited by 379 · see citing works
Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation
Cappato, R., Ezekowitz, M. D., Klein, A. L., Camm, A. J., Ma, C., Heuzey, J. L., Talajic, M. R., Scanavacca, M., Vardas, P. E., Kirchhof, P. F., et al. (2014) · European Heart Journal · doi:10.1093/eurheartj/ehu367 · Cited by 371 · see citing works
JCS/JSCS/JATS/JSVS 2020 Guidelines on the Management of Valvular Heart Disease
Izumi, C., Eishi, K., Ashihara, K., Arita, T., Otsuji, Y., Kunihara, T., Komiya, T., Shibata, T., Seo, Y., Daimon, M., et al. (2020) · Circulation Journal · doi:10.1253/circj.cj-20-0135 · Cited by 371 · see citing works
EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update
Glikson, M., Wolff, R., Hindricks, G., Mandrola, J. M., Camm, A. J., Lip, G. Y. H., Fauchier, L., Betts, T. R., Lewalter, T., Saw, J., et al. (2020) · EuroIntervention · doi:10.4244/eijy19m08_01 · Cited by 366 · see citing works
Atrial fibrillation in heart failure: what should we do?
Kotecha, D., & Piccini, J. P. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv513 · Cited by 371 · see citing works
Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants
Bannow, B. S., Cuker, A. C., Siegal, D. M., Crowther, M. A., & Garcia, D. A. (2016) · CHEST Journal · doi:10.1016/j.chest.2016.08.1462 · Cited by 347 · see citing works
Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation
Okumura, K., Akao, M., Yoshida, T., Kawata, M., Okazaki, O., Akashi, S., Eshima, K., Tanizawa, K., Fukuzawa, M., Hayashi, T., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2012883 · Cited by 345 · see citing works
Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment
Burnett, A., Mahan, C. E., Vazquez, S. R., Oertel, L. B., Garcia, D. A., & Ansell, J. (2016) · Journal of Thrombosis and Thrombolysis · doi:10.1007/s11239-015-1310-7 · Cited by 338 · see citing works
EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion – an update
Glikson, M., Wolff, R., Hindricks, G., Mandrola, J. M., Camm, A. J., Lip, G. Y. H., Fauchier, L., Betts, T. R., Lewalter, T., Saw, J., et al. (2019) · EP Europace · doi:10.1093/europace/euz258 · Cited by 332 · see citing works
The impact of bleeding complications in patients receiving target-specific oral anticoagulants: a systematic review and meta-analysis
Chai‐Adisaksopha, C., Crowther, M. A., Isayama, T., & Lim, W. (2014) · Blood · doi:10.1182/blood-2014-07-590323 · Cited by 326 · see citing works
Gender differences in the effects of cardiovascular drugs
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Edoxaban was noninferior to warfarin for preventing stroke or systemic embolism in atrial fibrillation
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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 · 2012: 1
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 › Epidemiology › 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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