Safety and efficacy of tenecteplase versus alteplase for acute ischemic stroke in a real-world patient population.

PURPOSE: We compared safety and efficacy of tenecteplase (TNK) and alteplase for acute ischemic stroke (AIS) in a real-world setting. METHODS: Retrospective, observational, study of adult AIS patients who received TNK or alteplase within 4.5 h of symptom onset from May 2020-June 2024. Primary outcome was symptomatic intracranial hemorrhage (sICH) occurrence. Secondary outcomes were major and minor bleeding occurrence, National Institutes of Health Stroke Scale (NIHSS) score changes, angioedema occurrence, modified Rankin Scale changes, length of stay, and mortality. Univariate and stratified analyses were conducted to assess bleeding differences and specifically in subpopulations often underrepresented in the literature (advanced age, minor strokes [NIHSS, < 5], and poor pre-stroke functional status). RESULTS: 478 patients were included; 255 (53.2%) TNK and 223 (46.7%) alteplase (median age 72 years [IQR 61-83], 33% minor strokes [33%]). There were numerically more sICH and other major bleeding events in the TNK group; 3.9%, vs. 3.1%, p = 0.65 and 20.4% vs. 15.7%, p = 0.18, respectively, although not statistically significant. There were no differences in secondary outcomes. Age < 80 years and NIHSS ≥5 at presentation were associated with a bleeding event on stratified analysis, however not maintained in the logistic regression model. CONCLUSIONS: There were no statistically significant differences in safety or efficacy between TNK and alteplase for AIS. These results provide real-world experience especially in a large, older patient population, with relatively minor stroke. Type II error may limit findings. Research is needed to identify patient, stroke, or fibrinolytic agent related factors that may increase bleeding occurrence.