Department of Neurology, Beijing Tiantan Hospital, Affiliated Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
Stroke Vasc Neurol. 2020 Sep;5(3):285-290. doi: 10.1136/svn-2020-000337. Epub 2020 May 28.
Data on the efficacy and safety of alteplase for acute ischaemic stroke (AIS) administered 3-4.5 hours after the onset of stroke symptoms in Chinese patients is limited. We sought to determine whether AIS patients would benefit from thrombolysis with alteplase between 3 and 4.5 hours after the onset of stroke symptoms in a prospective, multicentre, single-arm trial in China.
Eligible AIS patients were given 0.9 mg/kg alteplase intravenously. The primary efficacy endpoint was a favourable outcome at 3 months, defined as a score of 0 or 1 on the modified Rankin Scale. Thresholds for the primary efficacy endpoint were determined to be 40% based on the literature review. The primary safety endpoint was symptomatic intracranial haemorrhage (sICH) according to the European Cooperative Acute Stroke Study III (ECASS III) trial definition. Post hoc analysis between this study and the ECASS III trial were compared using the propensity score matching (PSM) method.
A total of 120 eligible AIS patients from 11 sites in China received thrombolysis therapy in this study. The median time from onset of symptoms to needle was 3 hours 54 min. The percentage of patients with a favourable outcome was 63.3% (95% CI 54.4 to 71.4), significantly higher than the predefined threshold (p<0.0001). Three patients (2.5%, 95% CI 0.5 to 7.1) had sICH, including two fatal sICH. Six patients died within 3 months after treatment. The post hoc PSM analysis showed a numerically higher rate of the primary efficacy endpoint in this study (63.3%) than the matched placebo arm (56.7%) in the ECASS III trial.
Intravenous alteplase with a standard dose administered between 3 and 4.5 hours after onset of symptoms is effective and safe for Chinese AIS patients.
NCT02930837.
在中国开展的一项前瞻性、多中心、单臂试验中，我们旨在评估阿替普酶治疗中国急性缺血性脑卒中（AIS）患者在症状发作后 3-4.5 小时的有效性和安全性。数据显示，阿替普酶治疗 AIS 患者在症状发作后 3 至 4.5 小时内获益。
符合条件的 AIS 患者给予 0.9mg/kg 阿替普酶静脉溶栓治疗。主要疗效终点为 3 个月时的良好结局，定义为改良 Rankin 量表评分为 0 或 1。根据文献复习，主要疗效终点的阈值设定为 40%。主要安全性终点为根据欧洲急性卒中协作研究 III（ECASS III）试验定义的症状性颅内出血（sICH）。采用倾向评分匹配（PSM）法比较本研究与 ECASS III 试验的事后分析。
来自中国 11 个研究中心的 120 名符合条件的 AIS 患者接受了溶栓治疗。症状发作至溶栓开始的中位时间为 3 小时 54 分钟。良好结局的患者比例为 63.3%（95%CI：54.4%至 71.4%），显著高于预设阈值（p<0.0001）。3 例（2.5%，95%CI：0.5%至 7.1%）患者发生 sICH，包括 2 例致命性 sICH。治疗后 3 个月内 6 例患者死亡。事后 PSM 分析显示，本研究的主要疗效终点发生率（63.3%）高于 ECASS III 试验中匹配安慰剂组（56.7%），但差异无统计学意义。
在中国 AIS 患者中，阿替普酶标准剂量在症状发作后 3-4.5 小时内静脉溶栓治疗是有效且安全的。
NCT02930837。
