Yan Shenqiang, Zhou Ying, Lansberg Maarten G, Liebeskind David S, Yuan Changzheng, Yu Han, Chen Fujian, Chen Hongfang, Zhang Bing, Mao Lingqun, Zhang Xiaoling, Wang Xiaona, Zhang Xuting, Chen Yi, Zhou Huan, Zhong Wansi, He Yaode, Chen Kun, Wang Jianbing, Chen Hui, Huang Yuhui, Campbell Bruce C V, Lou Min
Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
Stanford Stroke Center, Department of Neurology and Neurological Sciences, Stanford University, Palo Alto, CA.
N Engl J Med. 2025 Apr 3;392(13):1288-1296. doi: 10.1056/NEJMoa2413344.
The effects and risks of the use of intravenous thrombolysis between 4.5 and 24 hours after the onset of a posterior circulation ischemic stroke are not well studied.
In a trial conducted in China, we randomly assigned patients with posterior circulation stroke, without extensive early hypodensity on computed tomography and with no planned thrombectomy, to receive alteplase (0.9 mg per kilogram of body weight; maximum dose, 90 mg) or standard medical treatment 4.5 to 24 hours after the onset of symptoms. The primary outcome was functional independence (defined as a score of 0 to 2 on the modified Rankin scale; scores range from 0 to 6, with higher scores indicating greater disability) at 90 days. The key safety outcomes were symptomatic intracranial hemorrhage and death.
A total of 234 patients were enrolled; 117 were assigned to the alteplase group and 117 to the standard-treatment group. The median score on the National Institutes of Health Stroke Scale was 3 (interquartile range, 2 to 6) (scores range from 0 to 42, with higher scores indicating greater neurologic deficit). A higher percentage of patients in the alteplase group than in the standard-treatment group had functional independence at 90 days (89.6% vs. 72.6%; adjusted risk ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.30; P = 0.01). The incidence of symptomatic intracranial hemorrhage within 36 hours was 1.7% in the alteplase group and 0.9% in the standard-treatment group. At 90 days, 5.2% of the patients in the alteplase group and 8.5% of those in the standard-treatment group had died.
Among Chinese patients with mainly mild posterior circulation stroke who did not receive thrombectomy, alteplase administered 4.5 to 24 hours after stroke onset resulted in a higher frequency of functional independence at 90 days than standard medical care. (Funded by the National Natural Science Foundation of China; EXPECTS ClinicalTrials.gov number, NCT05429476.).
后循环缺血性卒中发病4.5至24小时后使用静脉溶栓的效果和风险尚未得到充分研究。
在中国进行的一项试验中，我们将后循环卒中患者随机分组，这些患者在计算机断层扫描上无广泛早期低密度影且无计划进行血栓切除术，在症状发作后4.5至24小时接受阿替普酶治疗（0.9毫克/千克体重；最大剂量90毫克）或标准药物治疗。主要结局是90天时的功能独立（定义为改良Rankin量表评分为0至2分；评分范围为0至6分，分数越高表明残疾程度越重）。关键安全结局是症状性颅内出血和死亡。
共纳入234例患者；117例被分配至阿替普酶组，117例被分配至标准治疗组。美国国立卫生研究院卒中量表的中位数评分为3分（四分位间距，2至6分）（评分范围为0至42分，分数越高表明神经功能缺损越严重）。阿替普酶组在90天时功能独立的患者比例高于标准治疗组（89.6%对72.6%；调整后风险比，1.16；95%置信区间[CI]，1.03至1.30；P = 0.01）。阿替普酶组36小时内症状性颅内出血的发生率为1.7%，标准治疗组为0.9%。在90天时，阿替普酶组5.2%的患者死亡，标准治疗组为8.5%。
在未接受血栓切除术的主要为轻度后循环卒中的中国患者中，卒中发作后4.5至24小时给予阿替普酶治疗在90天时功能独立的频率高于标准药物治疗。（由中国国家自然科学基金资助；EXPECTS临床试验注册号，NCT05429476。）
