急性缺血性卒中静脉注射替奈普酶治疗时间相关的结局：TRACE-2随机对照临床试验的亚组分析
Outcomes associated to the time to treatment with intravenous tenecteplase for acute ischaemic stroke: subgroup analysis of the TRACE-2 randomised controlled clinical trial.
作者信息
Li Shuya, Wangqin Runqi, Pan Yuesong, Jin Aoming, Li Hao, Schwamm Lee H, Fisher Marc, Campbell Bruce C V, Parsons Mark W, Wang Ziran, Dai Hongguo, Li Deyang, Li Runhui, Wang Junhai, Wang David, Wang Yilong, Zhao Xingquan, Li Zixiao, Zheng Huaguang, Xiong Yunyun, Meng Xia, Wang Yongjun
机构信息
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
出版信息
Stroke Vasc Neurol. 2024 Dec 30;9(6):613-622. doi: 10.1136/svn-2023-002694.
BACKGROUND
The benefit of intravenous alteplase in acute ischaemic stroke (AIS) is time-dependent. Tenecteplase is non-inferior to alteplase among patients with AIS. We aimed to delineate the association of the stroke onset to treatment time (OTT) with tenecteplase compared with alteplase on therapeutic benefit and clinical risks.
METHODS
This is a post hoc analysis of the Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-2 an open-label, randomised, controlled, non-inferior trial. A total of 1430 AIS within 4.5 hours onset at 53 sites in China from 12 June 2021 to 29 May 2022 were randomly assigned (1:1) to receive either tenecteplase 0.25 mg/kg or alteplase 0.9 mg/kg. The primary efficacy outcome was the proportion of participants with a modified Rankin Scale score of 0-1 at 90 days. A post hoc subgroup analysis was conducted with the OTT divided into three intervals (0-90 min, 91-180 min and 181-270 min). The primary safety outcome was symptomatic intracranial haemorrhage within 36 hours post-thrombolytic treatment.
RESULTS
Treatment was initiated within 270 min of stroke onset in 1412 patients who were randomly allocated to either tenecteplase (n=707) or alteplase (n=705). The OR of primary efficacy outcome was similar as OTT increased (p=0.84). Adjusted odds of an excellent functional outcome were 0.99 (95% CI 0.37 to 2.67) for 0-90 min, 1.23 (95% CI 0.88 to 1.71) for 91-180 min and 1.21 (95% CI 0.88 to 1.65) for 181-270 min. All were in favour of the tenecteplase group. Meta-analysis of 2949 patients yielded a pooled risk difference of 5.54 (95% CI -0.18 to 11.26; p=0.82) in favour of tenecteplase for more than 180 min and 1.77 (95% CI -2.66 to 6.20; p=0.58) for 0-180 min.
CONCLUSIONS
In AIS patients who were treated with either tenecteplase or alteplase within 4.5 hours onset, there was no difference observed in the efficacy and safety between the two groups at the three different OTT time intervals.
背景
静脉注射阿替普酶治疗急性缺血性卒中（AIS）的获益具有时间依赖性。在AIS患者中，替奈普酶不劣于阿替普酶。我们旨在明确与阿替普酶相比，卒中发病至治疗时间（OTT）与替奈普酶治疗获益及临床风险之间的关联。
方法
这是一项对急性缺血性脑血管事件-2中替奈普酶再灌注治疗进行的事后分析，该试验为开放标签、随机、对照、非劣效性试验。2021年6月12日至2022年5月29日期间，在中国53个地点发病4.5小时内的1430例AIS患者被随机分配（1:1）接受0.25mg/kg替奈普酶或0.9mg/kg阿替普酶治疗。主要疗效结局为90天时改良Rankin量表评分为0 - 1分的参与者比例。进行了一项事后亚组分析，将OTT分为三个时间段（0 - 90分钟、91 - 180分钟和181 - 270分钟）。主要安全结局为溶栓治疗后36小时内的症状性颅内出血。
结果
1412例患者在卒中发病270分钟内开始治疗，这些患者被随机分配接受替奈普酶（n = 707）或阿替普酶（n = 705）治疗。随着OTT增加，主要疗效结局的比值比相似（p = 0.84）。0 - 90分钟时，良好功能结局的调整后比值比为0.99（95%CI 0.37至2.67），91 - 180分钟时为1.23（95%CI 0.88至1.71），181 - 270分钟时为1.21（95%CI 0.88至1.65）。所有结果均支持替奈普酶组。对2949例患者的荟萃分析显示，对于超过180分钟的情况，支持替奈普酶的合并风险差为5.54（95%CI -0.18至11.26；p = 0.82），对于0 - 180分钟的情况为1.77（95%CI -2.66至6.20；p = 0.58）。
结论
在发病4.5小时内接受替奈普酶或阿替普酶治疗的AIS患者中，在三个不同的OTT时间间隔内，两组在疗效和安全性方面均未观察到差异。
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