Prehospital treatment with tenecteplase superior to alteplase for ischemic stroke

Treatment with tenecteplase in an Australian mobile stroke unit was safe and resulted in improved outcomes compared with alteplase, according to a study published in The Lancet Neurology.

“Several clinical trials have suggested benefit of tenecteplase vs. alteplase, but none of these trials were performed in the prehospital setting,” Andrew Bivard, PhD, of the Melbourne Brain Centre at the University of Melbourne Royal Melbourne Hospital in Australia, and colleagues wrote.

Bivard and fellow researchers sought to test the hypothesis that tenecteplase, given to ischemic stroke patients in a mobile stroke unit before transport to a hospital, would result in superior restoration of blood flow compared with alteplase by hospital arrival.

Researchers conducted a randomized, open-label, phase 2 trial at the Melbourne mobile stroke unit and five tertiary hospitals throughout the city. Between June 20, 2019, and Nov. 16, 2021, 104 patients (median age, 73 years) were enrolled and randomly assigned within 4 to 5 hours of stroke symptom onset to receive 0.25 mg/kg tenecteplase as an IV bolus over 10 seconds (n = 55) or standard-of-care alteplase (0.9 mg/kg IV with 10% as a bolus over 1 minute and 90% as an IV bolus over 1 hour; n = 49) before transport to a hospital.

The primary outcome was volume of the perfusion lesion on hospital arrival, assessed via CT-perfusion imaging. Secondary safety outcomes included modified Rankin Scale (mRS) score of 5 or 6 at 90 days, symptomatic intracerebral hemorrhage and any hemorrhage within 36 hours, as well as death at 90 days.

Results showed that perfusion lesion volume at hospital arrival was significantly smaller with tenecteplase compared with alteplase (adjusted incidence rate ratio = 0.55; 95% CI, 0.37-0.81). At 90 days, an mRS of 5 or 6 was reported in 15% of patients who received tenecteplase and 20% of patients who received alteplase (adjusted OR = 0.7; 95% CI, 0.23-2.16).

In addition, 9% of tenecteplase patients and 10% of alteplase patients died from any cause at 90 days (aOR = 1.12; 95% CI, 0.26-4.9). There were no cases of symptomatic intracerebral hemorrhage reported in either treatment group within 36 hours of administration.

Researchers noted 13 serious adverse events throughout the course of the trial, five of which were observed in tenecteplase patients and eight alteplase patients.

“This trial provides evidence to support the use of tenecteplase and [mobile stroke units] in an optimal model of stroke care,” Bivard and colleagues wrote.