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<p>Thrombolysis beyond the 4.5-h window improves functional outcomes in ischemic stroke. However, no randomized controlled trials (RCTs) have directly compared alteplase and tenecteplase in this extended time frame. To compare the efficacy and safety of alteplase versus tenecteplase administered beyond 4.5&#xa0;h through a network meta-analysis. PubMed, EMBASE, Web of Science, and the Cochrane Library were searched on June 24, 2025. Randomized clinical trials that enrolled adults with acute ischemic stroke treated with alteplase or tenecteplase beyond 4.5&#xa0;h and reporting at least one primary outcome. PRISMA guidelines for network meta-analyses were applied. Two reviewers independently extracted data and appraised risk of bias. Relative risks (RR) with 95% confidence intervals (CI) were calculated in R Studio (version 2024.12.1 + 563). The primary endpoints were good outcome (modified Rankin Scale [mRS] ≤ 2), and death. Secondary outcome was excellent outcome (mRS 0–1) and any intracranial hemorrhage. A total of 1060 citations were screened; 11 randomized clinical trials were included (n, 2926; age, 69.18 ± 12.63&#xa0;years; men, 61.65%). Follow-up ranged 90–180&#xa0;days, with median baseline NIHSS 3–12 and ASPECTS 9–10. No significant differences were found between alteplase and tenecteplase in good outcome (RR, 0.95; 95% CI, 0.84–1.09; P = .41), death (RR, 0.99; 95% CI, 0.60–1.63; P = .95), excellent outcome (RR, 0.95; 95% CI, 0.80–1.12; P = .52), or any intracranial hemorrhage (RR, 0.66; 95% CI, 0.20–2.19; P = .50). In this first network meta-analysis comparing alteplase and tenecteplase beyond 4.5&#xa0;h, no significant differences in efficacy or safety were observed. Our findings suggest both thrombolytics may be equally viable in late-window stroke, supporting the need for direct RCT comparisons to confirm these results.</p> Graphical Abstract <p></p>

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Tenecteplase vs. alteplase for ischemic stroke beyond 4.5 hours: a network meta-analysis of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2026年4月7日

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  • Davi Chaves Rocha de Souza,
  • Marcos Paulo Rodrigues de Oliveira,
  • Pedro Henrique Ferreira Sandes,
  • Gabriel Teles de Oliveira Piñeiro,
  • Geane Vasconcellos de Vasconcelos,
  • Gabriel Souza Medrado-Nunes,
  • Felipe Asaf Borges Millard,
  • Caio Fontes do Nascimento,
  • Victor Ogando-Santana,
  • Pedro Antonio Pereira de Jesus

摘要

Thrombolysis beyond the 4.5-h window improves functional outcomes in ischemic stroke. However, no randomized controlled trials (RCTs) have directly compared alteplase and tenecteplase in this extended time frame. To compare the efficacy and safety of alteplase versus tenecteplase administered beyond 4.5 h through a network meta-analysis. PubMed, EMBASE, Web of Science, and the Cochrane Library were searched on June 24, 2025. Randomized clinical trials that enrolled adults with acute ischemic stroke treated with alteplase or tenecteplase beyond 4.5 h and reporting at least one primary outcome. PRISMA guidelines for network meta-analyses were applied. Two reviewers independently extracted data and appraised risk of bias. Relative risks (RR) with 95% confidence intervals (CI) were calculated in R Studio (version 2024.12.1 + 563). The primary endpoints were good outcome (modified Rankin Scale [mRS] ≤ 2), and death. Secondary outcome was excellent outcome (mRS 0–1) and any intracranial hemorrhage. A total of 1060 citations were screened; 11 randomized clinical trials were included (n, 2926; age, 69.18 ± 12.63 years; men, 61.65%). Follow-up ranged 90–180 days, with median baseline NIHSS 3–12 and ASPECTS 9–10. No significant differences were found between alteplase and tenecteplase in good outcome (RR, 0.95; 95% CI, 0.84–1.09; P = .41), death (RR, 0.99; 95% CI, 0.60–1.63; P = .95), excellent outcome (RR, 0.95; 95% CI, 0.80–1.12; P = .52), or any intracranial hemorrhage (RR, 0.66; 95% CI, 0.20–2.19; P = .50). In this first network meta-analysis comparing alteplase and tenecteplase beyond 4.5 h, no significant differences in efficacy or safety were observed. Our findings suggest both thrombolytics may be equally viable in late-window stroke, supporting the need for direct RCT comparisons to confirm these results.

Graphical Abstract