The New England Journal of MedicineTenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection

Exploring the Boundaries of Stroke Treatment Timing

This multicenter, double-blind, randomized, placebo-controlled trial investigated the efficacy of tenecteplase, a thrombolytic agent, when administered between 4.5 to 24 hours after the onset of stroke symptoms. The study aimed to determine if late administration of tenecteplase could improve clinical outcomes in patients with ischemic stroke due to occlusion of the middle cerebral artery or internal carotid artery and who had salvageable brain tissue on perfusion imaging.

Study Design:

• Participants: 458 patients with ischemic stroke, randomized to receive tenecteplase (0.25 mg/kg, up to 25 mg) or placebo 4.5 to 24 hours after being last known well.
• Methodology: Double-blind, randomized, placebo-controlled trial across multiple centers.
• Imaging: Required evidence of occlusion of the middle cerebral artery or internal carotid artery and salvageable tissue on perfusion imaging.
• Thrombectomy: 77.3% of participants underwent thrombectomy.

Key Findings:

• Primary Outcome: No significant difference in the median score on the modified Rankin scale at 90 days (score of 3 in both groups).
• Odds Ratio: Adjusted common odds ratio for the distribution of scores on the modified Rankin scale was 1.13 (95% CI, 0.82 to 1.57; P=0.45), indicating no significant benefit of tenecteplase over placebo.
• Safety Outcomes: Similar mortality rates at 90 days (19.7% in tenecteplase group vs. 18.2% in placebo) and incidence of symptomatic intracranial hemorrhage (3.2% vs. 2.3%).

HCN Medical Memo
Tenecteplase administered 4.5 to 24 hours post-stroke did not improve clinical outcomes compared to placebo, with similar rates of symptomatic intracerebral hemorrhage in both groups.

More on Stroke