Department of Clinical Epidemiology, Hyogo Medical University, 1-1 Mukogawacho, Nishinomiya, Hyogo, 663-8501, Japan.
Department of Neurology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Am J Cardiovasc Drugs. 2023 Nov;23(6):721-733. doi: 10.1007/s40256-023-00611-7. Epub 2023 Oct 17.
We previously conducted a retrospective cohort study using chart review of oral anticoagulant-naïve Japanese patients with nonvalvular atrial fibrillation (NVAF) that assessed the risk of major bleeding and stroke/systemic embolism (SE) events of apixaban versus warfarin.
In this subgroup analysis, we compared the risk of major bleeding and stroke/SE events by stratifying patients into four subgroups matched 1:1 using propensity score matching (PSM) according to baseline creatinine clearance (CrCl; mL/min): ≥ 15 to < 30, ≥ 30 to < 50, ≥ 50 to < 80, and ≥ 80.
Of the 7074 patients in the apixaban group and 4998 in the warfarin group eligible for inclusion in the analysis, 4385 were included in each group after PSM. Incidence rates of major bleeding and stroke/SE events were generally lower with apixaban versus warfarin across the CrCl subgroups. When all patients with a CrCl change of < 0 mL/min per year during the study period (apixaban, n = 3871; warfarin, n = 2635) were stratified into four subgroups based on the magnitude of CrCl decline (median CrCl change [mL/min] per year: - 1.09, - 3.48, - 7.54, and - 36.92 for apixaban, and - 1.10, - 3.65, - 7.85, and - 40.40 for warfarin), the incidence rates of major bleeding and stroke/SE events generally increased with an increasing CrCl decline per year in both groups.
In Japanese patients with NVAF, the safety and effectiveness of apixaban and warfarin were consistent across different renal subgroups, including those with severe renal impairment. Our results highlight the importance of monitoring renal function variations over time in patients with NVAF.
NCT03765242.
我们之前进行了一项回顾性队列研究，通过对口服抗凝剂初治的日本非瓣膜性心房颤动（NVAF）患者的病历回顾，评估了阿哌沙班与华法林治疗 NVAF 的大出血和卒中/全身性栓塞（SE）事件风险。
在这项亚组分析中，我们根据基线肌酐清除率（CrCl；mL/min）将患者分为 4 个亚组，采用倾向评分匹配（PSM）进行 1:1 匹配，比较了大出血和卒中/SE 事件的风险：≥15 至 <30、≥30 至 <50、≥50 至 <80 和≥80。
在阿哌沙班组的 7074 例和华法林组的 4998 例符合纳入分析的患者中，PSM 后每组各纳入 4385 例。在 CrCl 亚组中，阿哌沙班与华法林相比，大出血和卒中/SE 事件的发生率通常较低。当研究期间所有 CrCl 变化<0 mL/min/年的患者（阿哌沙班，n=3871；华法林，n=2635）根据 CrCl 下降幅度分为 4 个亚组（每年中位数 CrCl 变化[mL/min]：阿哌沙班为-1.09、-3.48、-7.54 和-36.92，华法林为-1.10、-3.65、-7.85 和-40.40）时，两组大出血和卒中/SE 事件的发生率通常随每年 CrCl 下降而增加。
在日本 NVAF 患者中，阿哌沙班和华法林的安全性和有效性在不同的肾脏亚组中一致，包括严重肾功能损害的患者。我们的结果强调了在 NVAF 患者中监测肾功能随时间变化的重要性。
NCT03765242。
