Department of Neurology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No.70, Heping road, Huancui District, Weihai City, 264200, Shandong Province, China.
Department of Neurology, Qingdao Central Hospital, Qingdao City, 266042, Shandong Province, China.
BMC Neurol. 2021 Nov 10;21(1):440. doi: 10.1186/s12883-021-02435-x.
Patients with acute non-lacunar single subcortical infarct (SSI) associated with mild intracranial atherosclerosis (ICAS) have a relatively high incidence of early neurological deterioration (END), resulting in unfavorable functional outcomes. Whether the early administration of argatroban and aspirin or clopidogrel within 6-12 h after symptom onset is effective and safe in these patients is unknown.
A review of the stroke database of Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University and Qingdao Center Hospital, Qingdao University Medical College in China was undertaken from May 2017 to January 2020 to identify all patients with non-lacunar SSI caused by ICAS within 6-12 h of symptom onset based on MRI screening. Patients were divided into two groups, one comprising those who received argatroban and mono antiplatelet therapy with aspirin or clopidogrel on admission (argatroban group), and the other those who received dual antiplatelet therapy (DAPT) with aspirin and clopidogrel during hospitalization (DAPT group). The primary outcome was recovery by 90 days after stroke based on a modified Rankin scale (mRS) score (0 to 1). The secondary outcome was END incidence within 120 h of admission. Safety outcomes were intracranial hemorrhage (ICH) and major extracranial bleeding. The probability of clinical benefit (mRS score 0-1 at 90 days) was estimated using multivariable logistic regression analysis.
A total of 304 acute non-lacunar SSI associated with mild ICAS patients were analyzed. At 90 days, 101 (74.2%) patients in the argatroban group and 80 (47.6%) in the DAPT group had an mRS score that improved from 0 to 1 (P < 0.001). The relative risk (95% credible interval) for an mRS score improving from 0 to 1 in the argatroban group was 1.50 (1.05-2.70). END occurred in 10 (7.3%) patients in the argatroban group compared with 37 (22.0%) in the DAPT group (P < 0.001). No patients experienced symptomatic hemorrhagic transformation.
Early combined administration of argatroban and an antiplatelet agent (aspirin or clopidogrel) may be beneficial for patients with non-lacunar SSI associated with mild ICAS identified by MRI screening and may attenuate progressive neurological deficits.
Our study is a retrospectively registered trial.
伴有轻度颅内动脉粥样硬化（ICAS）的急性非腔隙性单发皮质下梗死（SSI）患者早期神经功能恶化（END）发生率较高，导致功能预后不良。在这些患者中，症状发作后 6-12 小时内早期给予阿加曲班和阿司匹林或氯吡格雷治疗是否有效和安全尚不清楚。
回顾性分析 2017 年 5 月至 2020 年 1 月期间中国山东大学齐鲁医学院威海市立医院和青岛大学医学院附属医院的卒中数据库，根据 MRI 筛查确定所有症状发作后 6-12 小时内由 ICAS 引起的非腔隙性 SSI 患者。患者分为两组，一组为入院时接受阿加曲班和单种抗血小板治疗（阿司匹林或氯吡格雷）的患者（阿加曲班组），另一组为住院期间接受双联抗血小板治疗（阿司匹林和氯吡格雷）的患者（DAPT 组）。主要结局为卒中后 90 天根据改良 Rankin 量表（mRS）评分（0-1）的恢复情况。次要结局为入院后 120 小时内 END 的发生率。安全性结局为颅内出血（ICH）和主要外出血。使用多变量逻辑回归分析估计临床获益的概率（90 天 mRS 评分 0-1）。
共分析了 304 例伴有轻度 ICAS 的急性非腔隙性 SSI 患者。90 天时，阿加曲班组 101 例（74.2%）和 DAPT 组 80 例（47.6%）患者 mRS 评分改善至 0-1（P<0.001）。阿加曲班组 mRS 评分改善至 0-1 的相对风险（95%可信区间）为 1.50（1.05-2.70）。阿加曲班组发生 END 的患者有 10 例（7.3%），DAPT 组有 37 例（22.0%）（P<0.001）。无患者发生症状性出血性转化。
MRI 筛查确定的伴有轻度 ICAS 的非腔隙性 SSI 患者早期联合应用阿加曲班和抗血小板药物（阿司匹林或氯吡格雷）可能有益，并可减轻进行性神经功能缺损。
本研究为回顾性注册试验。
