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Abstract: BACKGROUND: Although intravenous tenecteplase (TNK) at 0.25 mg/kg is guideline-endorsed for stroke, the ideal dosage for maximizing efficacy while minimizing risk has not been definitively established. This investigation aimed to identify the optimal TNK dose through a prospective, multicenter registry in a Chinese cohort. METHODS: Consecutive stroke patients receiving intravenous TNK, with or without endovascular therapy, were enrolled. TNK was administered as either a fixed 16 mg bolus or a weight-adjusted dose of 0.25 mg/kg (maximum 16 mg), per physician judgment. Utilizing restricted cubic spline analysis of the mg/kg dose, participants were stratified into six dose categories. Efficacy endpoint was an excellent functional outcome (90-day modified Rankin Scale scoring 0–1), and safety endpoint was symptomatic intracranial hemorrhage (sICH). RESULTS: The final analysis comprised 993 of 1,000 initially enrolled patients. Rates of excellent functional outcome were: 59.9% (≤ 0.20 mg/kg), 65.7% (0.21–0.22 mg/kg), 63.9% (0.23–0.24 mg/kg), 60.0% (0.26–0.27 mg/kg), and 53.5% (≥ 0.28 mg/kg). No statistically significant differences were observed relative to the 0.25 mg/kg reference group (61.0%). The incidence of sICH was 1.4% in the reference group, with other groups ranging from 1.0% to 2.9%. CONCLUSIONS: This real-world analysis suggests that a TNK dose range of 0.21–0.24 mg/kg may be associated with a nonsignificant trend toward better 90-day outcomes and a favorable safety profile compared to the standard 0.25 mg/kg dose in Chinese stroke patients, warranting further validation. TRIAL REGISTRATION: http://www.clinicaltrials.gov (identifier: NCT04588337).
Cui et al. (Wed,) studied this question.