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The New England Journal of MedicineTenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy

Tenecteplase Shows Promise for Reducing Disability in Ischemic Stroke Beyond the Conventional 4.5-Hour Window

This study evaluates the efficacy and safety of tenecteplase administered within 4.5 to 24 hours after ischemic stroke onset in patients with large-vessel occlusion who were not eligible for endovascular thrombectomy. Conducted in China, the trial compares tenecteplase with standard medical treatment in achieving favorable outcomes as measured by disability scores and survival rates at 90 days.

Study Design:

  • Participants: 516 patients with large-vessel occlusion of the middle cerebral artery or internal carotid artery and salvageable brain tissue as identified on perfusion imaging.
  • Randomization: 264 patients received tenecteplase (0.25 mg/kg, max 25 mg); 252 received standard medical treatment.
  • Inclusion Criteria: Patients treated within 4.5 to 24 hours after the last known well time, including those with stroke on awakening or unwitnessed stroke.
  • Primary Outcome: Absence of disability (modified Rankin scale score of 0 or 1) at 90 days.
  • Key Safety Outcomes: Symptomatic intracranial hemorrhage and mortality.

Key Findings:

  • Disability Reduction: Tenecteplase group had a higher percentage of patients with a modified Rankin scale score of 0 or 1 at 90 days compared to the standard treatment group (33.0% vs. 24.2%; relative rate, 1.37; 95% CI, 1.04 to 1.81; P=0.03).
  • Mortality: Similar rates between tenecteplase and standard treatment (13.3% vs. 13.1%).
  • Symptomatic Intracranial Hemorrhage: Higher incidence in the tenecteplase group (3.0% vs. 0.8%).

HCN Medical Memo
The use of tenecteplase beyond the traditional 4.5-hour window shows potential in reducing disability for ischemic stroke patients, although it comes with an increased risk of intracranial hemorrhage. Clinicians should weigh these benefits and risks when considering treatment options for patients presenting outside the typical therapeutic window.

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