Department of Cardiovascular Medicine and Cardiology, Nippon Medical School Tama Nagayama Hospital, 1-7-1 Nagayama, Tama-shi, Tokyo, 206-8512, Japan.
Saiseikai Toyama Hospital, Toyama, Japan.
Heart Vessels. 2024 Apr;39(4):330-339. doi: 10.1007/s00380-023-02343-9. Epub 2023 Dec 16.
Recently, a once-daily dose of edoxaban (15-mg) has been approved for stroke prevention in non-valvular atrial fibrillation (NVAF) patients aged ≥ 80 years, in whom standard oral anticoagulants are not recommended because of high bleeding risk (HBR), based on the ELDERCARE-AF trial. However, information regarding the characteristics and clinical outcomes among such patients is limited. Thus, this study aimed to clarify the characteristics and event rates in elderly patients with NVAF and HBR defined by the ELDERCARE-AF criteria. Of the 7406 NVAF outpatients included in the J-RHYTHM Registry, 60 patients with creatinine clearance (CrCl) < 15 mL/min were excluded. The remaining 7346 patients (age, 69.7 ± 9.9 years; men, 70.9%; warfarin use, 78.7%) were divided into three groups: Group 1, aged < 80 years (n = 6165); Group 2, aged ≥ 80 years without HBR (n = 584); and Group 3, aged ≥ 80 years with HBR (at least one of the followings; CrCl, 15-30 mL/min, history of bleeding, body weight ≤ 45 kg, and antiplatelet use) (n = 597, eligible for 15-mg edoxaban). Patients in Group 3 had a higher prevalence of comorbidities, and therefore, both higher thromboembolic and bleeding risk scores than in the other groups. During the 2-year follow-up period, the incidence rates (per 100 person-years) of thromboembolism in Groups 1, 2, and 3 were 0.7, 1.5, and 2.1 (P < 0.001), major hemorrhage, 0.8, 1.2, and 2.0 (P < 0.001), and all-cause death, 0.8, 2.6, and 4.6 (P < 0.001), respectively. Adjusted hazard ratios of Group 3 were 1.64 (95% confidence interval 0.89-3.04, P = 0.116) for thromboembolism, 1.53 (0.85-2.72, P = 0.154) for major hemorrhage, and 1.84 (1.19-2.85, P = 0.006) for all-cause death compared with Group 1. The NVAF Patients aged ≥ 80 years with HBR defined by the ELDERCARE-AF criteria were certainly at a higher adverse event risk, especially for all-cause death. Clinical trial registration: The J-RHYTHM Registry is registered in the University Hospital Medicine Information Network (UMIN) Clinical Trials Registry (unique identifier: UMIN000001569) http://www.umin.ac.jp/ctr/ .
最近，一项每日一次剂量的依度沙班（15 毫克）已被批准用于 80 岁及以上非瓣膜性心房颤动（NVAF）患者的卒中预防，因为 ELDERCARE-AF 试验表明这些患者因高出血风险（HBR）而不建议使用标准口服抗凝剂。然而，关于此类患者的特征和临床结局的信息有限。因此，本研究旨在阐明 ELDERCARE-AF 标准定义的高龄（≥80 岁）和 HBR 的 NVAF 患者的特征和事件发生率。在 J-RHYTHM 注册研究中，7406 名 NVAF 门诊患者中，排除了 60 名肌酐清除率（CrCl）<15ml/min 的患者。剩余的 7346 名患者（年龄 69.7±9.9 岁；男性 70.9%；华法林使用率 78.7%）分为三组：第 1 组，年龄<80 岁（n=6165）；第 2 组，年龄≥80 岁且无 HBR（n=584）；第 3 组，年龄≥80 岁且有 HBR（至少有以下之一；CrCl 为 15-30ml/min、出血史、体重≤45kg 和抗血小板治疗）（n=597，符合 15 毫克依度沙班治疗条件）。第 3 组患者合并症的患病率更高，因此，血栓栓塞和出血风险评分均高于其他两组。在 2 年随访期间，第 1、2 和 3 组的血栓栓塞发生率（每 100 人年）分别为 0.7、1.5 和 2.1（P<0.001），大出血发生率分别为 0.8、1.2 和 2.0（P<0.001），全因死亡率分别为 0.8、2.6 和 4.6（P<0.001）。第 3 组的调整后风险比为 1.64（95%置信区间 0.89-3.04，P=0.116）用于血栓栓塞，1.53（0.85-2.72，P=0.154）用于大出血，1.84（1.19-2.85，P=0.006）用于全因死亡，与第 1 组相比。ELDERCARE-AF 标准定义的年龄≥80 岁且有 HBR 的 NVAF 患者确实存在更高的不良事件风险，尤其是全因死亡。临床试验注册：J-RHYTHM 注册研究在大学医院医学信息网络（UMIN）临床试验注册处（独特标识符：UMIN000001569）http://www.umin.ac.jp/ctr/ 进行注册。
