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Background <p>We performed an updated systematic review and meta-analysis to evaluate tenecteplase 0.25&#xa0;mg/kg in the extended time window.</p> Methods <p>MEDLINE was searched via PubMed, Scopus, and Web of Science from inception to February 2026, with trial registries also screened. Eligible trials were RCTs of adults treated beyond 4.5&#xa0;h from last known well or with wake-up stroke, comparing IV tenecteplase 0.25&#xa0;mg/kg with placebo or standard care. Primary efficacy outcomes were 90-day mRS 0–1 and mRS 0–2, and primary safety outcomes were symptomatic intracranial hemorrhage and death. RoB 2 and GRADE were used to assess risk of bias and certainty. Risk ratios were pooled using a random effects model.</p> Results <p>Nine RCTs, including 4,000 participants, met eligibility criteria. Tenecteplase was associated with a modest increase in excellent functional outcome (9 studies, 4000 patients, RR 1.12, 95% CI 1.027 to 1.22, <i>p</i> = 0.01, I<sup>2</sup>: 14.9%) and favorable functional outcome (9 studies, 4000 patients, RR 1.06, 95% CI 1.01 to 1.11, <i>p</i> = 0.0091, I<sup>2</sup>: 10.6%). Tenecteplase showed a significantly higher risk of sICH (9 studies, 4000 patients, RR 1.86, 95% CI 1.065 to 3.24, <i>p</i> = 0.029, I<sup>2</sup>: 21.8%), while no difference was found in death (9 studies, 4000 patients, RR 1.006, 95% CI 0.85 to 1.19, <i>p</i> = 0.95, I<sup>2</sup>: 35.5%). GRADE certainty was high for favorable outcome and death, and moderate for excellent outcome, sICH, reperfusion, and parenchymal hematoma type 2.</p> Conclusions <p>In extended window acute ischemic stroke, tenecteplase 0.25&#xa0;mg/kg improved 90-day functional outcomes and increased reperfusion, but it increased intracranial hemorrhage, including sICH. These findings support careful use in imaging selected patients, with attention to bleeding risk.</p>

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Safety and efficacy of intravenous tenecteplase in patients with acute ischemic stroke in the extended time window: an updated meta-analysis

  • 期刊论文

  • 发表日期：

    2026年5月26日

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  • Mokhtar Rejili,
  • Yumna Khan,
  • Anurag Rawat,
  • Faouzi Haouala,
  • Lala Hasanli,
  • Azra Shaheen,
  • Abdelmonam M Hagag,
  • Zebiniso Alimova

摘要

Background

We performed an updated systematic review and meta-analysis to evaluate tenecteplase 0.25 mg/kg in the extended time window.

Methods

MEDLINE was searched via PubMed, Scopus, and Web of Science from inception to February 2026, with trial registries also screened. Eligible trials were RCTs of adults treated beyond 4.5 h from last known well or with wake-up stroke, comparing IV tenecteplase 0.25 mg/kg with placebo or standard care. Primary efficacy outcomes were 90-day mRS 0–1 and mRS 0–2, and primary safety outcomes were symptomatic intracranial hemorrhage and death. RoB 2 and GRADE were used to assess risk of bias and certainty. Risk ratios were pooled using a random effects model.

Results

Nine RCTs, including 4,000 participants, met eligibility criteria. Tenecteplase was associated with a modest increase in excellent functional outcome (9 studies, 4000 patients, RR 1.12, 95% CI 1.027 to 1.22, p = 0.01, I2: 14.9%) and favorable functional outcome (9 studies, 4000 patients, RR 1.06, 95% CI 1.01 to 1.11, p = 0.0091, I2: 10.6%). Tenecteplase showed a significantly higher risk of sICH (9 studies, 4000 patients, RR 1.86, 95% CI 1.065 to 3.24, p = 0.029, I2: 21.8%), while no difference was found in death (9 studies, 4000 patients, RR 1.006, 95% CI 0.85 to 1.19, p = 0.95, I2: 35.5%). GRADE certainty was high for favorable outcome and death, and moderate for excellent outcome, sICH, reperfusion, and parenchymal hematoma type 2.

Conclusions

In extended window acute ischemic stroke, tenecteplase 0.25 mg/kg improved 90-day functional outcomes and increased reperfusion, but it increased intracranial hemorrhage, including sICH. These findings support careful use in imaging selected patients, with attention to bleeding risk.