Tenecteplase noninferior to alteplase for treatment of acute ischemic stroke
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Tenecteplase was noninferior to alteplase for acute ischemic stroke when given within 4.5 hours of symptom onset in patients not eligible for endovascular thrombectomy, according to research presented at International Stroke Conference.
“There is increasing interest in replacing alteplase with tenecteplase as the preferred thrombolytic treatment for acute ischemic stroke,” Yongjun Wang, MD, professor and director of neurology at Beijing Tiantan Hospital, and colleagues wrote.
Seeking to determine the safety and efficacy of IV tenecteplase compared with alteplase for patients with acute ischemic stroke not eligible for endovascular thrombectomy, researchers conducted a phase 3 prospective, randomized, open-label, blinded endpoint-controlled trial in 53 locations in China from 2021 to 2022.
They enrolled 1,430 individuals with a NIH Stroke Scale (NIHSS) score between 5 and 25 within 4.5 hours of stroke symptom onset. Participants were randomized 1:1 to receive IV tenecteplase (n = 716; 0.25 mg/kg; maximum dose, 25 mg) or IV alteplase (n = 714; 0.9 mg/kg; maximum dose, 90 mg).
Researchers measured efficacy by the proportion of patients with a 90-day modified Rankin Scale (mRS) score of 0 to 1, with a noninferiority margin of 3.74% for absolute risk difference, and safety by symptomatic intracranial hemorrhage within 36 hours of symptom onset.
According to results, the primary outcome occurred in 62.3% of the tenecteplase group compared with 58.2% of the alteplase group (risk ratio = 1.09; 95% CI, 1-1.18).
In addition, researchers reported symptomatic intracranial hemorrhage within 36 hours of disease onset in 2.1% and 1.8% of the tenecteplase and alteplase groups, respectively, (RR = 1.15; 95% CI, 0.55-2.4).
Forty-six participants died within 90 days in the tenecteplase group vs. 35 in the alteplase group (RR = 1.27; 95% CI, 0.82-1.97).
“Tenecteplase was noninferior to alteplase with respect to the primary efficacy outcome in patients with ischemic stroke treated within 4.5 hours of symptom onset who were not eligible or refused for EVT,” Wang and colleagues wrote.