ABSTRACT NUMBER: ESOC2026LB147 EFFECT OF TIME TO TREATMENT WITH INTRAVENOUS TENECTEPLASE ON CLINICAL OUTCOMES IN ACUTE ISCHEMIC STROKE: A SECONDARY ANALYSIS OF THE TRACE-III TRIAL

Abstract Background and aims We aimed to assess the effect of time to treatment on clinical outcomes in patients who received intravenous tenecteplase versus standard medical treatment between 4.5 and 24 hours after last known well (LKW). Methods This secondary analysis of the Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III (TRACE-III) trial explored the association of LKW-to treatment time, analyzed as both categorical (4.5-9, 9-16, and 16-24 hours) and continuous variables, with 90-day functional outcomes and safety outcomes including symptomatic intracranial hemorrhage and mortality. Results Among 516 patients, 134 were treated within 4.5-9 hours, 232 within 9-16 hours, and 150 within 16-24 hours after LKW. The primary outcome (mRS 0-1) occurred in 31.9% versus 23.1% of patients receiving tenecteplase and standard medical treatment within 4.5-9 hours (adjusted odds ratio [aOR], 1.37; 95% confidence interval [CI], 0.59 to 3.17; adjusted P=0.470); 30.6% versus 21.3% within 9-16 hours (aOR, 1.69; 95%CI, 0.88 to 3.25; adjusted P=0.115); and 38.0% versus 29.1% within 16-24 hours (aOR, 1.98; 95%CI, 0.92 to 4.29; adjusted P=0.081). There was no statistically significant association between each 1-hour treatment delay and efficacy outcomes or symptomatic intracranial hemorrhage in either treatment arm, whereas mortality exhibited an inverse trend, with lower rates observed with longer treatment delays. Overall, no significant interaction between LKW-to-treatment time and treatment assignments was discovered (all p for interaction >0.1). Conclusions Collectively, these findings support the use of tenecteplase in TRACE-III-qualified patients throughout the entire 4.5-24-hour window and highlight the potential for extending the therapeutic window beyond 24 hours. Conflict of interest