ABSTRACT NUMBER: ESOC2026A309 SEX DIFFERENCES IN OUTCOMES OF LATE-WINDOW TENECTEPLASE THROMBOLYSIS——A SECONDARY ANALYSIS OF THE TRACE-III RANDOMIZED TRIAL

Abstract Background and aims Whether sex influence thrombolysis outcomes beyond 4.5 hours remains unclear. We aimed to investigate potential sex-based disparities in outcomes of late-window tenecteplase thrombolysis. Methods The Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events–III (TRACE-III) trial is a phase 3, multicenter, prospective, open-label, randomized, blinded-outcome-assessment trial, including patients with large-vessel occlusion at 4.5 to 24 hours without thrombectomy who were enrolled at 58 centers in China and randomly assigned to receive 0.25mg/kg tenecteplase or standard medical treatment. In this secondary analysis, we compared outcomes after tenecteplase versus control, stratified by sex. We also compared outcomes in female versus male patients treated with tenecteplase. The primary outcome was modified Rankin scale (mRS) 0-1 at 90 days. Sex-related effect modification was examined. Results Women accounted for 166 (32.2%) of 516 patients enrolled in the TRACE-III trial. Eighty-one (48.8%) of 166 women and 183 (52.3%) of 350 men received tenecteplase thrombolysis. Among male participants, the tenecteplase group achieved significantly higher rates of mRS 0-1 at 90 days compared with control (36.6% tenecteplase, 25.7% control, OR 1.67 [95% CI, 1.05–2.64]). Among female participants, the primary outcome was similar between groups (24.7% tenecteplase, 21.2% control, OR 1.22 [95% CI, 0.59–2.52]). No significant sex-based differences were observed for the primary outcome (P for interaction= 0.48) and other efficacy or safety outcomes. Conclusions Tenecteplase treatment benefit was maintained in both women and men without increasing safety concerns. Thrombolysis should be equally considered for patients of both sex meeting eligibility criteria in late-time windows. Conflict of interest All authors have nothing to disclose.