Joong Min Lee; Min Soo Cho; Do-Yoon Kang; Jung-Min Ahn; Yong-Seog Oh; Chang Hoon Lee; Eue-Keun Choi; Ji Hyun Lee; Chang Hee Kwon; Gyung-Min Park; Hyung Oh Choi; Kyoung-Ha Park; Kyoung-Min Park; Jongmin Hwang; Ki-Dong Yoo; Young-Rak Cho; Ji Hyun Kim; Ki Won Hwang; Eun-Sun Jin; Osung Kwon; Ki-Hun Kim; Seung-Jung Park; Gi-Byoung Nam; Duk-Woo Park

doi:10.4244/EIJ-D-25-01274

Impact of renal function on edoxaban antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease: a prespecified analysis of the EPIC-CAD trial

Joong Min Lee¹, MD; Min Soo Cho¹, MD, PhD; Do-Yoon Kang¹, MD, PhD; Jung-Min Ahn¹, MD, PhD; Yong-Seog Oh², MD, PhD; Chang Hoon Lee³, MD, PhD; Eue-Keun Choi⁴, MD, PhD; Ji Hyun Lee⁵, MD, PhD; Chang Hee Kwon⁶, MD, PhD; Gyung-Min Park⁷, MD, PhD; Hyung Oh Choi⁸, MD, PhD; Kyoung-Ha Park⁹, MD, PhD; Kyoung-Min Park¹⁰, MD, PhD; Jongmin Hwang¹¹, MD, PhD; Ki-Dong Yoo¹², MD, PhD; Young-Rak Cho¹³, MD, PhD; Ji Hyun Kim¹⁴, MD, PhD; Ki Won Hwang¹⁵, MD, PhD; Eun-Sun Jin¹⁶, MD, PhD; Osung Kwon¹⁷, MD, PhD; Ki-Hun Kim¹⁸, MD, PhD; Seung-Jung Park¹, MD, PhD; Gi-Byoung Nam¹, MD, PhD; Duk-Woo Park¹, MD, PhD

1. Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; 2. Seoul St. Mary’s Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea; 3. Department of Cardiology, Veterans Health Service Medical Center, Seoul, South Korea; 4. Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea; 5. Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, South Korea and National University College of Medicine, Seongnam, South Korea; 6. Division of Cardiology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, South Korea; 7. Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea; 8. Department of Cardiology, Soon Chun Hyang University Hospital Bucheon, Bucheon, South Korea; 9. Department of Cardiology, Hallym University Medical Center, Anyang, South Korea; 10. Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; 11. Department of Cardiology, Keimyung University Dongsan Hospital, Daegu, South Korea; 12. Department of Cardiology, St. Vincent’s Hospital, College of Medicine, Catholic University of Korea, Suwon, South Korea; 13. Department of Cardiology, Dong-A University Hospital, Dong-A University College of Medicine, Busan, South Korea; 14. Department of Cardiology, Dongguk University Ilsan Hospital, Goyang, South Korea; 15. Department of Cardiology, Pusan National University Yangsan Hospital, Pusan National University of Medicine, Yangsan, South Korea; 16. Department of Cardiology, Kyung Hee University Hospital at Gangdong, Kyung Hee University Medical College, Seoul, South Korea; 17. Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea; 18. Department of Cardiology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea

Abstract

Background: Renal function is a critical factor of ischaemic and bleeding risks in patients with atrial fibrillation (AF) receiving antithrombotic therapy.

Aims: This study aimed to evaluate the impact of renal dysfunction in patients with AF and stable coronary artery disease (CAD) undergoing antithrombotic therapy.

Methods: The Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD) trial randomised patients to edoxaban monotherapy or dual antithrombotic therapy (edoxaban plus a single antiplatelet agent). In this prespecified analysis, patients were stratified by creatinine clearance into low (<50 mL/min) or high (≥50 mL/min) groups according to edoxaban dose-reduction criteria. The primary endpoint was net adverse clinical events (NACE: death from any cause, myocardial infarction, stroke, systemic embolism, urgent revascularisation, or major/clinically relevant non-major bleeding) at 12 months.

Results: Of 1,040 randomised patients, 252 (24.2%) had low creatinine clearance; these patients were older and had more comorbidities compared with the 788 patients (75.8%) with high creatinine clearance. Patients with low creatinine clearance experienced higher risks of NACE (hazard ratio [HR] 1.72, 95% confidence interval [CI]: 1.19-2.49; p=0.004), ischaemic events (HR 2.70, 95% CI: 1.09-6.70; p=0.032), and bleeding (HR 1.54, 95% CI: 1.01-2.34; p=0.046). At 12 months, edoxaban monotherapy reduced NACE compared with dual therapy in both the low (12.1% vs 21.7%, HR 0.52, 95% CI: 0.28-0.98; p=0.042) and high creatinine clearance groups (5.2% vs 14.5%, HR 0.40, 95% CI: 0.25-0.65; p<0.001), with no interaction (p for interaction=0.53).

Conclusions: In patients with AF and stable CAD, edoxaban monotherapy led to a lower risk of primary NACE than dual antithrombotic therapy, regardless of renal function. (ClinicalTrials.gov: NCT03718559)

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