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Background <p>Acute ischemic stroke (AIS), a leading cause of death, requires timely management. Standard treatment with alteplase has limitations, including symptomatic intracranial hemorrhage (sICH) risk. Tenecteplase, with improved efficacy and safety, is a promising alternative. This meta-analysis compares their safety profiles, focusing on sICH and other outcomes.</p> Methods <p>Randomized controlled trials (RCTs) and non-randomized studies comparing tenecteplase and alteplase in acute AIS were identified through systematic searches of Medline (PubMed), Embase, and Google Scholar. Inclusion criteria encompassed studies reporting complications in AIS patients treated within 4.5&#xa0;h of symptom onset. Exclusion criteria included case reports, reviews, and non-comparator studies.</p> Results <p>Forty studies (14 RCTs, 26 cohort studies) involving 371,800 participants (tenecteplase: 72,705; alteplase: 299,095) were included. Tenecteplase and alteplase were comparable for sICH (RR: 1.05, 95% CI: 0.90–1.22, I²=32%), parenchymal hematoma (RR: 1.04, 95% CI: 0.81–1.34, I²=22%), and 3-month functional independence (mRS 0–2; RR: 1.02, 95% CI: 0.99–1.05, I²=0%). A slight increase in overall mortality was observed with tenecteplase (RR: 1.10, 95% CI: 1.02–1.19, I²=47%), but not at 90 days (RR: 1.03, 95% CI: 0.89–1.18, I²=53%). Secondary outcomes, including angioedema (RR: 0.93, 95% CI: 0.49–1.78, I²=16%) and major neurological improvement at 24&#xa0;h (RR: 1.22, 95% CI: 0.97–1.54, I²=48%), showed no significant differences.</p> Conclusion <p>Tenecteplase’s safety profile is comparable to alteplase for most AIS outcomes.</p>

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Symptomatic Intracranial Hemorrhage and Other Complications with Tenecteplase Versus Alteplase in Acute Ischemic Stroke: A Systematic Review and Meta-analysis

  • 期刊论文

  • 发表日期：

    2026年7月17日

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  • Syeda Takreem Fatima,
  • Muhammad Hamza Shoaib,
  • Sophia Ahmed,
  • Mahrukh Iqbal,
  • Muhammad Muaaz Sajid,
  • Dawood Javed,
  • Abdul Raheem Malik,
  • Rana Ali Mustafa,
  • Sheza Irfan,
  • Mishaal Noor,
  • Syeda Duaa Uzair,
  • Muhammad Asfandyar Nadir,
  • Eeshal Fatima

摘要

Background

Acute ischemic stroke (AIS), a leading cause of death, requires timely management. Standard treatment with alteplase has limitations, including symptomatic intracranial hemorrhage (sICH) risk. Tenecteplase, with improved efficacy and safety, is a promising alternative. This meta-analysis compares their safety profiles, focusing on sICH and other outcomes.

Methods

Randomized controlled trials (RCTs) and non-randomized studies comparing tenecteplase and alteplase in acute AIS were identified through systematic searches of Medline (PubMed), Embase, and Google Scholar. Inclusion criteria encompassed studies reporting complications in AIS patients treated within 4.5 h of symptom onset. Exclusion criteria included case reports, reviews, and non-comparator studies.

Results

Forty studies (14 RCTs, 26 cohort studies) involving 371,800 participants (tenecteplase: 72,705; alteplase: 299,095) were included. Tenecteplase and alteplase were comparable for sICH (RR: 1.05, 95% CI: 0.90–1.22, I²=32%), parenchymal hematoma (RR: 1.04, 95% CI: 0.81–1.34, I²=22%), and 3-month functional independence (mRS 0–2; RR: 1.02, 95% CI: 0.99–1.05, I²=0%). A slight increase in overall mortality was observed with tenecteplase (RR: 1.10, 95% CI: 1.02–1.19, I²=47%), but not at 90 days (RR: 1.03, 95% CI: 0.89–1.18, I²=53%). Secondary outcomes, including angioedema (RR: 0.93, 95% CI: 0.49–1.78, I²=16%) and major neurological improvement at 24 h (RR: 1.22, 95% CI: 0.97–1.54, I²=48%), showed no significant differences.

Conclusion

Tenecteplase’s safety profile is comparable to alteplase for most AIS outcomes.