Qutub Mohammed A, Algazzar Alaa S, Alassiri Abdullah K, Albukhari Saud A, Bokhary Abdallah H, Almarghany Alsayed Ali, Elsayed Ahmed AbdElmoez, Elbably Mohamed M
Department of Medicine, Cardiac Center of Excellence, King Abdulaziz University, Jeddah, Saudi Arabia.
Cardiology Department, Ahmed Maher Teaching Hospital, Cairo, Egypt.
Cardiology. 2025 Jun 14:1-13. doi: 10.1159/000546865.
The effectiveness and safety of oral anticoagulants (OACs) in patients with chronic kidney disease (CKD) and non-valvular atrial fibrillation (NVAF) in frail elderly patients have not been fully established. We aimed to evaluate the safety and effectiveness of OACs in frail elderly patients with atrial fibrillation (AF) and stage II-III CKD.
Frail elderly patients ≥65 years with AF and CKD who received OAC from January 2022 to June 2024 were retrospectively identified. Primary endpoints were composite of ischemic stroke and systemic embolism (IS/SE), and composite of intracranial hemorrhage (ICH) and/or gastrointestinal (GI) bleeding. Secondary endpoints included any bleeding.
The study enrolled 365 patients, of whom 141 (38.6%) initiated warfarin therapy and 224 (61.3%) initiated DOACs. CHA2DS2-VASc score was nonsignificant (2.6 ± 1.01 vs. 2.8 ± 0.89, p value 0.054), for GFR ≥60 and GFR <60 mL/min/1.73 m2 patients, respectively. HAS-BLED score (1.9 ± 0.67 vs. 2.3 ± 0.70, p value 0.071) for GFR ≥60 and GFR <60 mL/min/1.73 m2 patients respectively. While the observed incidence of ICH/GI bleeding was numerically higher in patients with GFR <60 mL/min/1.73 m2, Cox proportional hazards regression did not demonstrate a statistically significant difference in hazard between the groups. The incidence of composite IS/SE was 8.5% in GFR ≥60 mL/min/1.73 m2 versus 8.7% in GFR <60 mL/min/1.73 m2 (HR 1.02, 95% CI: 0.60-1.74, p = 0.24). Composite ICH/GI bleeding occurred in 7.1% versus 9.3% (HR 2.15, 95% CI: 0.91-4.56, p = 0.41).
In this study comparing frail elderly patients with NVAF and CKD stage II versus stage III receiving OACs, we observed no significant difference in the risk of IS/SE or ICH/GI bleeding between groups. These findings suggest that within moderate CKD (eGFR 30-89 mL/min), renal function stage may not independently influence OAC-related outcomes when anticoagulation is well managed. Our results may not generalize to less frail populations or those with advanced CKD. Further prospective studies with larger sample size are needed to provide clearer guidance on the optimal use of OACs in this challenging clinical scenario.
口服抗凝剂（OACs）在慢性肾脏病（CKD）合并非瓣膜性心房颤动（NVAF）的体弱老年患者中的有效性和安全性尚未完全确立。我们旨在评估OACs在患有心房颤动（AF）和II - III期CKD的体弱老年患者中的安全性和有效性。
回顾性纳入了2022年1月至2024年6月期间接受OAC治疗的≥65岁的患有AF和CKD的体弱老年患者。主要终点是缺血性卒中和系统性栓塞（IS/SE）的复合终点，以及颅内出血（ICH）和/或胃肠道（GI）出血的复合终点。次要终点包括任何出血。
该研究共纳入365例患者，其中141例（38.6%）开始使用华法林治疗，224例（61.3%）开始使用直接口服抗凝剂（DOACs）。对于估算肾小球滤过率（eGFR）≥60和eGFR<60 mL/min/1.73 m²的患者，CHA2DS2 - VASc评分无显著差异（分别为2.6±1.01和2.8±0.89，p值为0.054）。对于eGFR≥60和eGFR<60 mL/min/1.73 m²的患者，HAS - BLED评分分别为1.9±0.67和2.3±0.70（p值为0.071）。虽然在eGFR<60 mL/min/1.73 m²的患者中，观察到的ICH/GI出血发生率在数值上更高，但Cox比例风险回归未显示两组之间的风险有统计学显著差异。eGFR≥60 mL/min/1.73 m²组的复合IS/SE发生率为8.5%，而eGFR<60 mL/min/1.73 m²组为8.7%（风险比[HR]为1.02，95%置信区间[CI]：0.60 - 1.74，p = 0.24）。复合ICH/GI出血发生率分别为7.1%和9.3%（HR为2.15，95%CI：0.91 - 4.56，p = 0.41）。
在这项比较接受OAC治疗的患有NVAF和II期与III期CKD的体弱老年患者的研究中，我们观察到两组之间在IS/SE风险或ICH/GI出血风险方面无显著差异。这些发现表明，在中度CKD（eGFR 30 - 89 mL/min）范围内，当抗凝管理良好时，肾功能分期可能不会独立影响与OAC相关的结局。我们的结果可能不适用于身体状况较好的人群或患有晚期CKD的人群。需要进一步开展更大样本量的前瞻性研究，以在这一具有挑战性的临床场景中为OACs的最佳使用提供更清晰的指导。
