Up to 24 Hours After Stroke Onset, Alteplase Benefits Patients With Salvageable Brain Tissue
Compared with standard care, intravenous alteplase given between 4.5 and 24 hours after acute ischemic stroke onset provided functional benefit in patients with imaging-confirmed salvageable brain tissue who did not initially receive thrombectomy, according to study results published in JAMA.
“There was an increase in symptomatic intracranial hemorrhage, but no significant difference in mortality,” wrote corresponding author Min Lou, MD, of the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China, and study coauthors.
The standard therapeutic window for intravenous thrombolysis (IVT) is within 4.5 hours of symptom onset, researchers explained. However, most patients with stroke present after that time has passed. Extending the window to within 24 hours of symptom onset in appropriate patients could increase IVT eligibility.
The randomized, open-label, blinded end-point trial included 372 patients at 26 stroke centers across China. All patients had acute ischemic stroke onset 4.5 to 24 hours before presentation, salvageable brain tissue identified by perfusion imaging, and no initial plan for thrombectomy. Among the patients, half received intravenous alteplase and half received standard medical treatment.
The study’s primary efficacy outcome was a modified Rankin Scale score of 0 to 1 at 90 days, indicating the patient regained functional independence. According to the findings, the outcome was achieved by 75 of 186 patients (40%) in the alteplase group and 49 of 186 (26%) in the control group. Researchers reported an adjusted risk ratio of 1.52 for achieving functional independence with alteplase compared with standard care. The unadjusted risk difference was 13.98%.
Safety analyses showed a higher incidence of symptomatic intracranial hemorrhage within 36 hours with alteplase (3.8%) compared with standard treatment (0.51%). The adjusted risk ratio was 7.34, and the unadjusted risk difference was 3.23%.
The rate of all-cause mortality within 90 days was 11% in both groups.
“These findings support extending the therapeutic window for IVT in appropriately selected patients when endovascular thrombectomy is not initially planned or indicated,” researchers wrote.
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