ABSTRACT NUMBER: ESOC2026LB104 EFFECTS OF FIBRINOGEN ON TENECTEPLASE TREATMENT IN ACUTE ISCHEMIC STROKE AFTER 4.5 HOURS OF SYMPTOM ONSET: A POST HOC ANALYSIS OF THE TRACE-III TRIAL

Abstract Background and aims The efficacy and safety of tenecteplase at different fibrinogen levels remains uncertain. Methods We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III (TRACE-III) Trial. Patients with anterior large vessel occlusion, salvageable brain tissue, and no access to endovascular thrombectomy were randomized (1:1) to receive either 0.25 mg/kg tenecteplase or standard medical treatment. We categorized patients into groups with non-elevated fibrinogen (≤4.0 g/L) and elevated fibrinogen levels (>4.0 g/L). The primary outcome was the absence of disability, which was defined as a score of 0 to 1 on the modified Rankin scale (mRS) at 90 days. The safety outcomes were symptomatic intracranial hemorrhage (sICH) within 36 hours and all-cause mortality within 90 days. Results We included 498 of the 516 patients in the TRACE-III trial who had baseline fibrinogen data. Among them, 426 (85.5%) had non-elevated fibrinogen, and 72 (14.5%) had elevated fibrinogen. Compared with standard medical treatment, tenecteplase significantly increased the proportion of mRS scores of 0 to 1 at 90 days among patients with non-elevated fibrinogen (35.0% vs. 25.7%; relative rate [RR], 1.55; 95% confidence interval [CI], 1.03-2.37; P =0.04). No significant difference was observed in those with elevated fibrinogen (16.7% vs. 11.1%; RR, 1.60; 95% CI, 0.42-6.78; P =0.50). Safety outcomes were similar between the two treatment groups across fibrinogen categories. Conclusions Patients with non-elevated fibrinogen levels may receive greater benefit from tenecteplase in reducing disability risk without increasing the incidence of sICH, compared to those with elevated fibrinogen levels. Conflict of interest