Background. Current guidelines recommend an oral anticoagulant (OAC) monotherapy in patients with nonvalvular atrial fibrillation (NVAF) and stable coronary artery disease (CAD) 1 year postpercutaneous coronary intervention (PCI). It might be possible to shorten the time for de-escalation from a dual therapy to monotherapy, but data regarding de-escalation to an edoxaban monotherapy are lacking. This study aimed to assess the clinical safety of an edoxaban monotherapy in patients with NVAF and stable CAD. Methods. A multicenter, prospective, randomized, open-label, and parallel group study was established to investigate the safety of an edoxaban monotherapy in patients with NVAF and stable CAD including over 6 months postimplantation of a third-generation DES and 1 year postimplantation of other stents (PRAEDO AF study). Between March 2018 and June 2020, 147 patients from 8 institutions in Japan were randomized to receive either an edoxaban monotherapy (n = 74) or combination therapy (edoxaban plus clopidogrel, n = 73). The primary study endpoint was the composite incidence of major bleeding and clinically significant bleeding, defined according to the ISTH criteria. Results. Major or clinically significant bleeding occurred in 2 patients in the monotherapy group (1.67% per patient-year) and in 5 patients in the combination therapy group (4.28% per patient-year) (hazard ratio, 0.39; 95% confidence interval, 0.08–2.02). There was no incidence of a myocardial infarction, stent thrombosis, unstable angina requiring revascularization, ischemic stroke, systemic stroke, or hemorrhagic stroke in either of the groups. Conclusions. The edoxaban monotherapy was shown to have acceptable clinical safety in patients with NVAF and stable CAD. The study was registered with the Japan Registry of Clinical Trials (jRCTs031180119).

中文翻译：

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依多沙班单药治疗合并冠状动脉疾病的非瓣膜性心房颤动患者

背景。目前的指南建议对经皮冠状动脉介入治疗 (PCI) 后 1 年的非瓣膜性心房颤动 (NVAF) 和稳定性冠状动脉疾病 (CAD) 患者进行口服抗凝剂 (OAC) 单一疗法。有可能缩短从双联疗法降阶梯至单药疗法的时间，但缺乏关于降阶梯至依度沙班单药疗法的数据。本研究旨在评估依度沙班单药治疗 NVAF 和稳定性 CAD 患者的临床安全性。方法. 建立了一项多中心、前瞻性、随机、开放标签和平行组研究，以研究依度沙班单药治疗 NVAF 和稳定性 CAD 患者的安全性，包括第三代 DES 植入后 6 个月以上和其他支架植入后 1 年（PRAEDO 房颤研究）。2018 年 3 月至 2020 年 6 月，来自日本 8 家机构的 147 名患者被随机分配接受艾多沙班单药治疗（n  = 74）或联合治疗（艾多沙班加氯吡格雷，n  = 73）。主要研究终点是根据 ISTH 标准定义的大出血和临床显着出血的复合发生率。结果. 单药治疗组 2 例患者（每患者年 1.67%）和联合治疗组 5 例患者（每患者年 4.28%）发生大出血或有临床意义的出血（风险比，0.39；95% 置信区间，0.08 –2.02)。两组均未发生心肌梗死、支架内血栓形成、需要血运重建的不稳定型心绞痛、缺血性卒中、系统性卒中或出血性卒中。结论。依度沙班单一疗法在 NVAF 和稳定性 CAD 患者中显示出可接受的临床安全性。该研究已在日本临床试验注册中心 (jRCTs031180119) 注册。