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Background <p>There is limited evidence regarding the safety and efficacy of tenecteplase 0.25&#xa0;mg/kg in patients with acute ischemic stroke in the extended time window, either with large vessel occlusion or not. Therefore, we aim to assess its safety and efficacy for these patients.</p> Methodology <p>We searched PubMed, Scopus, and Web of Science for randomized controlled trials that compared tenecteplase 0.25&#xa0;mg/kg with the best medical management. Our primary efficacy outcomes included favorable and excellent functional outcomes, measured via the modified Rankin score (mRS), and early neurological improvements. Primary safety outcomes were mortality and symptomatic intracranial hemorrhage rates. Subgroup analyses were performed based on mRs, and the inclusion of patients eligible for mechanical thrombectomy in addition to TNK.</p> Results <p>Our search found nine randomized controlled trials, of which 8 were included in the meta-analysis. A total of 3068 patients were included. Tenecteplase 0.25&#xa0;mg/kg did not differ from the control group in achieving excellent functional outcomes and favorable functional outcomes (<i>P</i> values: 0.15 and 0.69), while there was significant improvement in early neurological improvement (<i>P</i> value: 0.02). Symptomatic intracranial hemorrhage was statistically higher in the tenecteplase 0.25&#xa0;mg/kg group (<i>P</i> value 0.008). Subgroup analyses indicated that patients with mRS 0–1 who receive TNK 0.25&#xa0;mg/kg do better than those with mRS 0–2. Better results for TNK 0.25&#xa0;mg/kg were observed in studies that excluded patients eligible for mechanical thrombectomy in addition to TNK.</p> Conclusions <p>TNK 0.25&#xa0;mg/kg appears to significantly achieve early neurological improvement with no effect in achieving excellent or favorable functional outcomes; however, it showed a significant increase in symptomatic intracranial hemorrhage. Patients who performed endovascular thrombectomy after administering TNK 0.25&#xa0;mg/kg had statistically significantly higher rates of symptomatic intracranial hemorrhage; on the other hand, current evidence endorses the use of tenecteplase 0.25&#xa0;mg/kg in patients with ischemic strokes whose baseline mRs ranges from 0 to 1. Further RCTs are necessary to validate these findings. <i>Prospero registration number</i>: CRD42025636473.</p>

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Safety and efficacy of intravenous tenecteplase in patients with acute ischemic stroke in extended time window: systematic review and meta-analysis

  • 期刊论文

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  • 发表日期：

    2025年11月29日

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  • Abdelmonam M. Hagag,
  • Gannah S. El Labban,
  • Abdelrhman M. Asar,
  • Omar R. Ayad,
  • Salma Adel Ezzat,
  • Mostafa A. Fathi,
  • Mohamed Mohsen Helal

摘要

Background

There is limited evidence regarding the safety and efficacy of tenecteplase 0.25 mg/kg in patients with acute ischemic stroke in the extended time window, either with large vessel occlusion or not. Therefore, we aim to assess its safety and efficacy for these patients.

Methodology

We searched PubMed, Scopus, and Web of Science for randomized controlled trials that compared tenecteplase 0.25 mg/kg with the best medical management. Our primary efficacy outcomes included favorable and excellent functional outcomes, measured via the modified Rankin score (mRS), and early neurological improvements. Primary safety outcomes were mortality and symptomatic intracranial hemorrhage rates. Subgroup analyses were performed based on mRs, and the inclusion of patients eligible for mechanical thrombectomy in addition to TNK.

Results

Our search found nine randomized controlled trials, of which 8 were included in the meta-analysis. A total of 3068 patients were included. Tenecteplase 0.25 mg/kg did not differ from the control group in achieving excellent functional outcomes and favorable functional outcomes (P values: 0.15 and 0.69), while there was significant improvement in early neurological improvement (P value: 0.02). Symptomatic intracranial hemorrhage was statistically higher in the tenecteplase 0.25 mg/kg group (P value 0.008). Subgroup analyses indicated that patients with mRS 0–1 who receive TNK 0.25 mg/kg do better than those with mRS 0–2. Better results for TNK 0.25 mg/kg were observed in studies that excluded patients eligible for mechanical thrombectomy in addition to TNK.

Conclusions

TNK 0.25 mg/kg appears to significantly achieve early neurological improvement with no effect in achieving excellent or favorable functional outcomes; however, it showed a significant increase in symptomatic intracranial hemorrhage. Patients who performed endovascular thrombectomy after administering TNK 0.25 mg/kg had statistically significantly higher rates of symptomatic intracranial hemorrhage; on the other hand, current evidence endorses the use of tenecteplase 0.25 mg/kg in patients with ischemic strokes whose baseline mRs ranges from 0 to 1. Further RCTs are necessary to validate these findings. Prospero registration number: CRD42025636473.