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.

IF 9.5 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Eurointervention Pub Date : 2026-04-20 DOI:10.4244/EIJ-D-25-01274

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

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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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肾功能对房颤和稳定型冠状动脉疾病患者依多沙班抗血栓治疗的影响：EPIC-CAD试验的预先指定分析

背景：肾功能是心房颤动（AF）患者接受抗栓治疗时发生缺血和出血风险的关键因素。目的：本研究旨在评估房颤合并稳定型冠心病（CAD）患者接受抗栓治疗后肾功能不全的影响。方法：心房颤动和慢性稳定型冠状动脉疾病（EPIC-CAD）患者的依多沙班与依多沙班联合抗血小板药物的对照试验将患者随机分组，接受依多沙班单药治疗或双重抗血栓治疗（依多沙班联合单一抗血小板药物）。在这个预先指定的分析中，患者按肌酐清除率分为低(结果：1040名随机分组患者中，252名（24.2%）肌酐清除率低；与788例高肌酐清除率患者（75.8%）相比，这些患者年龄较大，合并症较多。低肌酐清除率的患者发生NACE（风险比[HR] 1.72, 95%可信区间[CI]: 1.19-2.49; p=0.004）、缺血事件（HR 2.70, 95% CI: 1.09-6.70; p=0.032）和出血（HR 1.54, 95% CI: 1.01-2.34; p=0.046）的风险较高。在12个月时，与双重治疗相比，低（12.1% vs 21.7%, HR 0.52, 95% CI: 0.28-0.98; p=0.042）和高肌酐清除率组（5.2% vs 14.5%, HR 0.40, 95% CI: 0.25-0.65）， edo沙班单药治疗导致原发性NACE的风险低于双重抗血栓治疗，无论肾功能如何。(ClinicalTrials.gov: NCT03718559)。

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来源期刊

Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

4.80%

发文量

380

审稿时长

3-8 weeks

期刊介绍： EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.