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Background <p>Tenecteplase (TNK) has been widely used in thrombolytic therapy for acute ischaemic stroke (AIS), but TNK-related intracranial haemorrhage(ICH) remains a severe complication. However, few data are available to guide the management of tenecteplase-related intracranial haemorrhage. The objective of this study was to evaluate the risk of intracranial haemorrhage associated with tenecteplase compared with alteplase in patients with acute ischaemic stroke.</p> Methods <p>A thorough literature search of Embase, PubMed, Cochrane Library, and Web of Science was conducted for randomized controlled trials (RCTs) published up to October 2024. Randomized controlled trials (RCTs) investigating the risk of intracranial haemorrhage between tenecteplase and alteplase (ALT) were eligible for inclusion. To reduce study bias, we uniformly adopted the random-effects model for the meta-analysis of all haemorrhagic outcomes.</p> Results <p>Eleven RCTs with a total of 7466 patients were analysed in this meta-analysis. No significant differences were observed between TNK-treated patients and ALT-treated patients in overall ICH (13.22% vs 12.72%; RR = 1.02, 95% CI = 0.8–1.24; p = 0.81), symptomatic ICH (3.09% vs. 2.49%; RR = 1.21, 95% CI = 0.92–1.59; p = 0.18), and asymptomatic ICH (8.68% vs. 9.03%; RR = 0.95, 95% CI = 0.78–1.16; p = 0.62). Subgroup analyses based on TNK dosage (0.25&#xa0;mg/kg vs. 0.4&#xa0;mg/kg) compared to ALT showed no significant differences in ICH incidences. The proportions of ICH in different locations, including intraventricular hemorrhage, subarachnoid hemorrhage, hemorrhagic infarction, parenchymal hematoma, and remote parenchymal hematoma, were also similar between the TNK and ALT groups (all P &gt; 0.05).</p> Conclusion <p>Our study provides the best evidence to date that TNK has a similar risk of ICH to ALT in AIS, with a very low incidence of symptomatic ICH, supporting that TNK has a good safety profile in terms of ICH.</p>

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Risk of intracerebral haemorrhage with tenecteplase versus alteplase in acute ischaemic stroke: a meta-analysis

  • 期刊论文

  • 发表日期：

    2025年4月10日

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  • Min Tao,
  • Xiao-han Zhang,
  • Ling-wan Yan,
  • Dun-chang Mo,
  • Rong-xin He,
  • Tian Wang,
  • Yi-nan Zeng,
  • Ri-lan Huang,
  • Hong-xia Liu,
  • Man Luo

摘要

Background

Tenecteplase (TNK) has been widely used in thrombolytic therapy for acute ischaemic stroke (AIS), but TNK-related intracranial haemorrhage(ICH) remains a severe complication. However, few data are available to guide the management of tenecteplase-related intracranial haemorrhage. The objective of this study was to evaluate the risk of intracranial haemorrhage associated with tenecteplase compared with alteplase in patients with acute ischaemic stroke.

Methods

A thorough literature search of Embase, PubMed, Cochrane Library, and Web of Science was conducted for randomized controlled trials (RCTs) published up to October 2024. Randomized controlled trials (RCTs) investigating the risk of intracranial haemorrhage between tenecteplase and alteplase (ALT) were eligible for inclusion. To reduce study bias, we uniformly adopted the random-effects model for the meta-analysis of all haemorrhagic outcomes.

Results

Eleven RCTs with a total of 7466 patients were analysed in this meta-analysis. No significant differences were observed between TNK-treated patients and ALT-treated patients in overall ICH (13.22% vs 12.72%; RR = 1.02, 95% CI = 0.8–1.24; p = 0.81), symptomatic ICH (3.09% vs. 2.49%; RR = 1.21, 95% CI = 0.92–1.59; p = 0.18), and asymptomatic ICH (8.68% vs. 9.03%; RR = 0.95, 95% CI = 0.78–1.16; p = 0.62). Subgroup analyses based on TNK dosage (0.25 mg/kg vs. 0.4 mg/kg) compared to ALT showed no significant differences in ICH incidences. The proportions of ICH in different locations, including intraventricular hemorrhage, subarachnoid hemorrhage, hemorrhagic infarction, parenchymal hematoma, and remote parenchymal hematoma, were also similar between the TNK and ALT groups (all P > 0.05).

Conclusion

Our study provides the best evidence to date that TNK has a similar risk of ICH to ALT in AIS, with a very low incidence of symptomatic ICH, supporting that TNK has a good safety profile in terms of ICH.