Edoxaban-based long-term antithrombotic therapy in patients with atrial fibrillation and stable coronary disease: Rationale and design of the randomized EPIC-CAD trial - 05/04/22

Doi : 10.1016/j.ahj.2022.01.014

Min Soo Cho, MD ^a,^{^{1
Two first authors (Drs MS Cho and DY Kang) contributed equally to the manuscript.}}, Do-Yoon Kang, MD ^a,^{^{1
Two first authors (Drs MS Cho and DY Kang) contributed equally to the manuscript.}}, Yong-Seog Oh, MD ^b, Chang Hoon Lee, MD ^c, Eue-Keun Choi, MD ^d, Ji Hyun Lee, MD ^e, Chang Hee Kwon, MD ^f, Gyung-Min Park, MD ^g, Hyun Woo Park, MD ^h, Kyoung-Ha Park, MD ⁱ, Kyoung-Min Park, MD ^j, Jongmin Hwang, MD ^k, Ki-Dong Yoo, MD ^l, Young-Rak Cho, MD ^m, Yoo Ri Kim, MD ⁿ, Ki Won Hwang, MD ^o, Eun Sun Jin, MD ^p, Pum-Joon Kim, MD ^q, Ki Hun Kim, MD ^r, Duk-Woo Park, MD ^a,^⁎ , Gi-Byoung Nam, MD ^a,^⁎
^a Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
^b Division of Cardiology, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
^c Division of Cardiology, Department of Internal Medicine, Veterans Health Service Medical Center, Seoul, South Korea
^d Department of Internal Medicine, College of Medicine, Seoul National University, Seoul, South Korea
^e Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea
^f Division of Cardiology, Department of Internal Medicine, Konkuk University Medical Center Konkuk University School of Medicine, Seoul, South Korea
^g Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine
^h Department of Cardiology, Soon Chun Hyang University Hospital Bucheon, Bucheon, South Korea
ⁱ Division of Cardiovascular Disease, Hallym University Medical Center, Anyang, South Korea
^j Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea
^k Department of Cariology, Keimyung University Dongsan Hospital, Daegu, South Korea
^l Division of Cardiology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon-si, Gyeonggi-do, South Korea
^m Department of Cardiology, Dong-A University Hospital, Busan, South Korea
ⁿ Division of Cardiology, Department of Internal Medicine, Dongguk University College of Medicine, Goyang, South Korea
^o Division of Cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University of Medicine, Yangsan, South Korea
^p Cardiovascular Center, Kyung Hee University Hospital at Gangdong, Seoul, South Korea
^q Department of Internal Medicine, College of Medicine, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea
^r Division of Cardiology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea

^⁎Reprint requests: Duk-Woo Park, MD and Gi-Byoung Nam, MD, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Poongnap-dong, Songpa-gu, Seoul 138-736, South Korea.Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine388-1 Poongnap-dongSongpa-guSeoul138-736South Korea

Abstract

Background

Anticoagulants are the standard therapy for patients with atrial fibrillation (AF) and antiplatelet therapy for those with coronary artery disease (CAD). However, compelling clinical evidence is still lacking regarding the long-term maintenance strategy with the combination of anticoagulant and antiplatelet drugs in patients with AF and stable CAD.

Design

The EPIC-CAD trial is an investigator-initiated, multicenter, open-label randomized trial comparing the safety and efficacy of 2 antithrombotic strategies in patients with high-risk AF (CHA₂DS₂-VASc score ≥ 2 points) and stable CAD (≥6 months after revascularization for stable angina or ≥12 months for acute coronary syndrome; or medical therapy alone). Patients (approximately N = 1,038) will be randomly assigned at a 1:1 ratio to (1) monotherapy with edoxaban (a non-vitamin K antagonist oral anticoagulant) or (2) combination therapy with edoxaban plus a single antiplatelet agent. The primary endpoint is the net composite outcome of death from any cause, stroke, systemic embolism, myocardial infarction, unplanned revascularization, and major or clinically relevant nonmajor bleeding at 1 year after randomization.

Results

As of December 2021, approximately 901 patients had been randomly enrolled over 2 years at 18 major cardiac centers across South Korea. The completed enrollment is expected at the mid-term of 2022, and the primary results will be available by 2023.

Conclusions

EPIC-CAD is a large-scale, multicenter, pragmatic design trial, which will provide valuable clinical insight into edoxaban-based long-term antithrombotic therapy in patients with high-risk AF and stable CAD.

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Methods

Trial design and objectives

Study population

Randomization and treatment groups

Study endpoints and follow-up

Statistical methods

Sample size and power calculation

Primary statistical analysis

Sources of funding and trial organization

Ethics and dissemination

Clinical trial registration: Edoxaban vs edoxaban with antiplatelet agent in patients with atrial fibrillation and chronic stable coronary artery disease (EPIC-CAD): NCT03718559.

Esportazione

Vol 247

P. 123-131 - maggio 2022 Ritorno al numero

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Edoxaban-based long-term antithrombotic therapy in patients with atrial fibrillation and stable coronary disease: Rationale and design of the randomized EPIC-CAD trial - 05/04/22

Abstract

Background

Design

Results

Conclusions

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