Department of Emergency Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
Chang Gung University College of Medicine, Tao-Yuan, Taiwan.
J Thromb Thrombolysis. 2024 Jan;57(1):89-100. doi: 10.1007/s11239-023-02885-9. Epub 2023 Aug 21.
The role of direct oral anticoagulants (DOAC) in patients with atrial fibrillation (AF) and stage 4-5 chronic kidney disease (CKD) is controversial. Electronic medical records from 2012 to 2021 were retrieved for patients with AF and stage 4-5 CKD receiving oral anticoagulants. Patients were separated into those receiving DOACs (dabigatran, rivaroxaban, apixaban, or edoxaban) or vitamin K antagonists (VKA). Primary outcomes included ischemic stroke (IS), systemic thrombosis (SE), major bleeding, gastrointestinal bleeding, hemorrhagic stroke, acute myocardial infarction, cardiovascular death, and all-cause death. Renal outcomes included eGFR declines, creatinine doubling, progression to dialysis, and major adverse kidney events (MAKE). The primary analysis was until the end of follow up and the results at 1-year and 2-year of follow ups were also assessed. 2,382 patients (DOAC = 1,047, VKA = 1,335) between 2012 and 2021 with AF and stage 4-5 CKD were identified. The mean follow-up period was 2.3 ± 2.1 years in DOCAs and 2.6 ± 2.3 years in VKA respectively. At the end of follow up, the DOAC patients had significantly decreased SE (subdistribution hazard ratio [SHR] = 0.50, 95% confidence interval [CI] = 0.34-0.73), composite of IS/SE (SHR = 0.78, 95% CI = 0.62-0.98), major bleeding (HR = 0.77, 95% CI = 0.66-0.90), hemorrhagic stroke (HR = 0.52, 95% CI = 0.36-0.76), and composite of bleeding events (SHR = 0.80, 95% CI = 0.69-0.92) compared with VKA patients. The IS efficacy outcome revealed neutral between DOAC and VKA patients (HR = 1.05, 95% CI = 0.79-1.39). In addition, DOAC patients had significantly decreased rates of eGFR decline > 50% (SHR = 0.75, 95% CI = 0.64-0.87), creatinine doubling (SHR = 0.80, 95% CI = 0.67-0.95), and MAKE (SHR = 0.81, 95% CI = 0.71-0.93). In patients with AF and stage 4-5 CKD, use of DOAC was associated with decreased rates of a composite of ischemic stroke/systemic embolism, a composite of bleeding events, and renal events compared to VKA. Efficacy and safety benefits associated with apixaban at standard doses were consistent throughout follow-up.
在患有心房颤动 (AF) 和 4-5 期慢性肾脏病 (CKD) 的患者中，直接口服抗凝剂 (DOAC) 的作用存在争议。检索了 2012 年至 2021 年接受口服抗凝剂治疗的 AF 和 4-5 期 CKD 患者的电子病历。患者分为接受 DOAC（达比加群、利伐沙班、阿哌沙班或依度沙班）或维生素 K 拮抗剂 (VKA) 的患者。主要结局包括缺血性中风 (IS)、全身性血栓栓塞 (SE)、大出血、胃肠道出血、出血性中风、急性心肌梗死、心血管死亡和全因死亡。肾脏结局包括 eGFR 下降、肌酐翻倍、进展为透析和主要不良肾脏事件 (MAKE)。主要分析持续到随访结束，还评估了 1 年和 2 年随访的结果。2012 年至 2021 年间共确定了 2382 名患有 AF 和 4-5 期 CKD 的患者（DOAC=1047，VKA=1335）。DOAC 组和 VKA 组的平均随访时间分别为 2.3±2.1 年和 2.6±2.3 年。随访结束时，与 VKA 患者相比，DOAC 患者的 SE（亚分布风险比 [SHR]=0.50，95%置信区间 [CI]=0.34-0.73）、IS/SE 复合事件（SHR=0.78，95%CI=0.62-0.98）、大出血（HR=0.77，95%CI=0.66-0.90）、出血性中风（HR=0.52，95%CI=0.36-0.76）和出血事件复合事件（SHR=0.80，95%CI=0.69-0.92）显著降低。与 VKA 患者相比，DOAC 患者的 IS 疗效结果呈中性（HR=1.05，95%CI=0.79-1.39）。此外，与 VKA 患者相比，DOAC 患者的 eGFR 下降>50%（SHR=0.75，95%CI=0.64-0.87）、肌酐翻倍（SHR=0.80，95%CI=0.67-0.95）和 MAKE（SHR=0.81，95%CI=0.71-0.93）的发生率显著降低。在患有 AF 和 4-5 期 CKD 的患者中，与 VKA 相比，使用 DOAC 与降低缺血性中风/全身性栓塞复合事件、出血事件复合事件和肾脏事件的发生率相关。在整个随访期间，阿哌沙班标准剂量的疗效和安全性获益一致。
