Yan Jia, Yu Shuai, Feng Hongxuan, Zhao Huimin, Dong Xiaofeng, Xu Qinrong, Xu Guoli, Cheng Qingzhang, Tan Xin, Gui Qian, Wu Guanhui
Department of Neurology, The Affiliated Suzhou Hospital of Nanjing Medical University/Suzhou Municipal Hospital, Suzhou 215000, Jiangsu Province, PR China.
Department of Neurology, Suzhou Ninth People's Hospital, Suzhou 215000, Jiangsu Province, PR China.
J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108151. doi: 10.1016/j.jstrokecerebrovasdis.2024.108151. Epub 2024 Nov 27.
Patients with stroke due to large artery atherosclerosis are at risk of early progression and recurrence. The efficacy and safety of argatroban in stroke patients who did not receive reperfusion therapy, and which patients may benefit from it, are uncertain.
We conducted a cohort study to assess whether argatroban given within 72 hours of symptom onset, combined with antiplatelet therapy, improved neurological outcomes of patients with acute mild to moderate ischemic stroke in China. Patients were divided into the combined treatment group and the control group. Inverse probability of treatment weighting was used to balance baseline covariates. The primary efficacy outcome is the proportion of mRS score 0-2 at 90 days. The secondary efficacy outcomes included END proportion, change in NIHSS score from the baseline to day 7, recurrent cardiovascular events, and cardiovascular death. The safety outcomes were hemorrhagic transformation (HT) of infarction and organ hemorrhage at 7 days.
Compared with the control group, a higher proportion of mRS (0-2) at 90 days was found in patients in the combined treatment group (85.3% vs 74.5%, p=0.042). There was no significant difference in the safety outcomes between the two groups. Exploratory subgroup analysis showed positive associations with argatroban combined therapy and good prognosis in NIHSS score ≥5 and age ≥70 subgroups.
Our study suggested that argatroban can improve neurological outcomes for mild to moderate LAA patients but not increase the risk of bleeding.
大动脉粥样硬化所致卒中患者存在早期病情进展及复发风险。阿加曲班在未接受再灌注治疗的卒中患者中的疗效及安全性，以及哪些患者可能从中获益尚不确定。
我们进行了一项队列研究，以评估症状发作72小时内给予阿加曲班联合抗血小板治疗是否能改善中国急性轻至中度缺血性卒中患者的神经功能结局。患者被分为联合治疗组和对照组。采用治疗权重逆概率法平衡基线协变量。主要疗效结局为90天时改良Rankin量表（mRS）评分为0 - 2的比例。次要疗效结局包括早期神经功能恶化（END）比例、从基线到第7天美国国立卫生研究院卒中量表（NIHSS）评分的变化、心血管事件复发及心血管死亡。安全性结局为7天时梗死灶出血转化（HT）及器官出血。
与对照组相比，联合治疗组患者90天时mRS（0 - 2）比例更高（85.3%对74.5%，p = 0.042）。两组安全性结局无显著差异。探索性亚组分析显示，在NIHSS评分≥5及年龄≥70亚组中，阿加曲班联合治疗与良好预后呈正相关。
我们的研究表明，阿加曲班可改善轻至中度大动脉粥样硬化性卒中（LAA）患者的神经功能结局，但不增加出血风险。
