Study supports thrombolysis with tenecteplase in patients with ischemic stroke

The results, published in JAMA Neurology, support the safety of tenecteplase for stroke thrombolysis in real-world clinical practice.

Symptomatic intracranial haemorrhage is a severe complication of stroke thrombolytic therapy. Many stroke centres have adopted 0.25-mg/kg tenecteplase over alteplase for stroke thrombolysis based on evidence from randomized comparisons to alteplase and its practical advantages. No significant differences in sICH were reported from randomized clinical trials or published case series for the 0.25-mg/Kg dose.

Against the above background, Steven J. Warach, University of Texas at Austin, Austin, and colleagues aimed to evaluate sICH risk following ischemic stroke in patients treated with tenecteplase compared to those treated with alteplase in a retrospective observational study. They hypothesized that tenecteplase thrombolysis would be associated with a reduced sICH risk.

For this purpose, the authors used data from the extensive multicenter international CERTAIN collaboration containing de-identified data on ischemic stroke patients treated with IV thrombolysis. The analysis included data from more than 100 US, Australian, and New Zealand hospitals that used tenecteplase or alteplase for patients treated between 2018 and 2021. The retrospective analysis included all 9238 patients (median age was 71 years, and 48% were female) who received thrombolysis. Patients with acute ischemic stroke who were considered eligible and received thrombolysis were included.

Symptomatic intracranial haemorrhage was defined as clinical worsening of at least 4 points on the NIHSS (National Institutes of Health Stroke Scale), attributed to a subarachnoid, hematoma, or intraventricular haemorrhage. Differences between alteplase and tenecteplase in the sICH risk were assessed after adjusting for sex, age, thrombectomy, and NIHSS score.

The study led to the following findings:

• Tenecteplase was administered to 1925 patients. The tenecteplase group was older (median, 73 years versus 70 years), more likely to be male (54% versus 51%), had higher NIHSS scores (median nine versus 7), and more frequently underwent endovascular thrombectomy (38% vs 20%).
• The proportion of patients with sICH was 1.8% for tenecteplase and 3.6% for alteplase, with an adjusted odds ratio (aOR) of 0.42.
• Similar results were observed in both thrombectomy and non-thrombectomy subgroups.

"In this large study, ischemic stroke treatment with 0.25-mg/kg tenecteplase was LINKED with lower odds of sICH than alteplase treatment," the researchers wrote. "The results support the safety of tenecteplase for stroke thrombolysis in real-world clinical practice."

Reference:

Warach SJ, Ranta A, Kim J, et al. Symptomatic Intracranial Hemorrhage With Tenecteplase vs Alteplase in Patients With Acute Ischemic Stroke: The Comparative Effectiveness of Routine Tenecteplase vs Alteplase in Acute Ischemic Stroke (CERTAIN) Collaboration. JAMA Neurol. Published online May 30, 2023. doi:10.1001/jamaneurol.2023.1449