He Xiao-Yi, He Chao, Chen Hui-Sheng
Dalian Medical University, Dalian, China.
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.
Front Neurol. 2025 Apr 30;16:1568711. doi: 10.3389/fneur.2025.1568711. eCollection 2025.
This secondary analysis of the ARAMIS trial evaluated renal function's modifying effects on therapeutic responses to dual antiplatelet therapy (DAPT) versus intravenous thrombolysis in acute minor ischemic stroke.
Based on the as-treated set, we stratified patients by admission estimated glomerular filtration rate into three groups: normal renal function (≥90 mL/min/1.73 m), mildly decreased renal function (eGFR 60 to 89 mL/min/1.73 m), and moderate to severe impairment renal function group (<60 mL/min/1.73 m). The primary endpoint was excellent functional outcome defined as a modified Rankin Scale score of 0-1 at 90 days.
Among 615 analyzed patients, 367 (59.7%) exhibited normal renal function, 209 (34.0%) exhibited mildly decreased renal function and 39 (6.3%) exhibited moderate to severe impairment renal function. A numerically higher rate of excellent functional outcome was found in normal renal function patients with DAPT vs. alteplase (94.4% vs. 90.4%; = 0.147), while no intergroup difference emerged in mildly decreased renal function patients (93.9% vs. 93.7%; = 0.958) and moderate to severe impairment renal function patients (93.8% vs. 95.7%; = 0.792). There was no significant interaction between treatment and renal function on the primary outcome (adjusted interaction = 0.337).
Among patients with normal renal function, DAPT was associated with a numerically higher, but not statistically significant, rate of excellent functional outcome in patients with minor nondisabling acute ischemic stroke presenting within 4.5 h of symptom onset compared with alteplase.
ClinicalTrials.gov, identifier NCT03661411.
ARAMIS试验的这项二次分析评估了肾功能对急性轻度缺血性卒中患者双联抗血小板治疗(DAPT)与静脉溶栓治疗反应的调节作用。
基于治疗意向集,我们根据入院时估计的肾小球滤过率将患者分为三组:肾功能正常(≥90 mL/min/1.73 m²)、肾功能轻度下降(eGFR 60至89 mL/min/1.73 m²)以及中重度肾功能损害组(<60 mL/min/1.73 m²)。主要终点是90天时改良Rankin量表评分为0 - 1分定义的良好功能结局。
在615例分析患者中,367例(59.7%)肾功能正常,209例(34.0%)肾功能轻度下降,39例(6.3%)中重度肾功能损害。DAPT治疗的肾功能正常患者良好功能结局发生率在数值上高于阿替普酶治疗患者(94.4%对90.4%;P = 0.147),而肾功能轻度下降患者(93.9%对93.7%;P = 0.958)和中重度肾功能损害患者(93.8%对95.7%;P = 0.792)组间未出现差异。治疗与肾功能对主要结局无显著交互作用(校正交互作用P = 0.337)。
在肾功能正常的患者中,对于症状出现4.5小时内就诊的轻度非致残性急性缺血性卒中患者,与阿替普酶相比,DAPT治疗的良好功能结局发生率在数值上更高,但无统计学意义。
ClinicalTrials.gov,标识符NCT03661411。