Tenecteplase versus alteplase for the treatment of acute ischemic stroke: a meta-analysis of randomized controlled trials.

Annals of medicine Pub Date : 2024-12-01 Epub Date: 2024-03-05 DOI:10.1080/07853890.2024.2320285
Jian Huang, Hui Zheng, Xianfeng Zhu, Kai Zhang, Xiaofeng Ping
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Abstract

Objectives: Tenecteplase, a modified variant of alteplase with greater fibrin specificity and longer plasma half-life, may have better efficacy and safety than alteplase in patients with acute ischemic stroke (AIS). We aimed to compare the benefits and risks of tenecteplase versus alteplase in the treatment of AIS.

Methods: Electronic databases were searched up to 10 February 2023 for randomized controlled trials evaluating the effect of tenecteplase versus alteplase in the treatment of AIS. The primary outcome was functional outcome at 90 days, and secondary outcomes including the symptomatic intracranial haemorrhage (SICH), and major neurological improvement. Subgroup analysis was performed based on the different dosage of tenecteplase.

Results: Ten studies with a total of 5123 patients were analysed in this meta-analysis. Overall, no significant difference between tenecteplase and alteplase was observed for functional outcome at 90 days (excellent: OR 1.08, 95%CI 0.93-1.26, I2 = 26%; good: OR 1.04, 95%CI 0.83-1.30, I2 = 56%; poor: OR 0.95, 95%CI 0.75-1.21, I2 = 31%), SICH (OR 1.12, 95%CI 0.79-1.59, I2 = 0%), and early major neurological improvement (OR 1.26, 95%CI 0.80-1.96, I2 = 65%). The subgroup analysis suggested that the 0.25 mg/kg dose of tenecteplase had potentially greater efficacy and lower symptomatic intracerebral haemorrhage risk compared with 0.25 mg/kg dose tenecteplase.

Conclusions: Among AIS patients, there was no significant difference on clinical outcomes between tenecteplase and alteplase. Subgroup analysis demonstrated that 0.25 mg/kg doses of tenecteplase were more beneficial than 0.4 mg/kg doses of tenecteplase. Further studies are required to identify the optimal dosage of tenecteplase.

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治疗急性缺血性脑卒中的替奈普酶与阿替普酶:随机对照试验荟萃分析。
目的:替奈普酶是阿替普酶的一种改良变体,具有更强的纤维蛋白特异性和更长的血浆半衰期,在急性缺血性卒中(AIS)患者中可能比阿替普酶具有更好的疗效和安全性。我们的目的是比较替奈普酶与阿替普酶治疗 AIS 的益处和风险:截至 2023 年 2 月 10 日,我们在电子数据库中检索了评估替奈普酶与阿替普酶治疗 AIS 效果的随机对照试验。主要结果是90天后的功能性结果,次要结果包括症状性颅内出血(SICH)和主要神经功能改善。根据替奈普酶的不同剂量进行了分组分析:本次荟萃分析共分析了 10 项研究,共计 5123 名患者。总体而言,替奈普酶和阿替普酶在90天后的功能预后方面无明显差异(优:OR 1.08,95%C:OR 1.08,95%C:OR 1.08):OR为1.08,95%CI为0.93-1.26,I2=26%;良好:良好:OR 1.04,95%CI 0.83-1.30,I2 = 56%;差:OR 0.95,95%CI 0.83-1.30,I2 = 56%:OR 0.95,95%CI 0.75-1.21,I2 = 31%)、SICH(OR 1.12,95%CI 0.79-1.59,I2 = 0%)和早期主要神经功能改善(OR 1.26,95%CI 0.80-1.96,I2 = 65%)。亚组分析表明,与0.25 mg/kg剂量的替奈普酶相比,0.25 mg/kg剂量的替奈普酶可能具有更高的疗效和更低的症状性脑出血风险:在AIS患者中,替奈普酶和阿替普酶的临床疗效无明显差异。亚组分析显示,0.25 毫克/千克剂量的替奈普酶比 0.4 毫克/千克剂量的替奈普酶更有益。要确定替奈普酶的最佳剂量,还需要进一步研究。
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