The following is a summary of “Tenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection,” published in the February 2024 issue of Neurology by Albers, et al.

Researchers started a retrospective study to investigate if tenecteplase provides benefits beyond the 4.5-hour window typically used for thrombolytic treatment in stroke cases.

They conducted a trial on patients with ischemic stroke, comparing tenecteplase (0.25 mg/kg body weight, up to 25 mg) with a placebo given 4.5 to 24 hours after the patient’s last known healthy time. Patients had occlusion of the middle cerebral artery or internal carotid artery and salvageable tissue on perfusion imaging. The primary outcome was the modified Rankin scale score (0-6; higher scores indicate greater disability, and 6 means death) at day 90. Safety outcomes included death and symptomatic intracranial hemorrhage. The trial was multicenter, double-blind, randomized, and placebo-controlled.

The results showed 458 patients, 77.3% undergoing thrombectomy, 228 patients receiving tenecteplase, and 230 receiving placebo. The median time from last known well to randomization was around 12 hours for tenecteplase and about 13 hours for placebo. The median modified Rankin scale score at 90 days was 3 in both groups. The adjusted common OR for modified Rankin scale scores at 90 days was 1.13 (95% CI, 0.82 to 1.57; P=0.45) for tenecteplase vs placebo. In terms of safety, mortality at 90 days was 19.7% with tenecteplase and 18.2% with placebo, while symptomatic intracranial hemorrhage rates were 3.2% and 2.3%, respectively.

Investigators concluded that initiating tenecteplase 4.5-24 hours after stroke with middle cerebral artery or internal carotid artery occlusion did not improve outcomes compared to placebo, with similar bleeding rates in both groups.

Source: nejm.org/doi/full/10.1056/NEJMoa2310392