Adjunctive Shuxuetong following thrombolysis in patients with acute ischemic stroke: A multicenter target trial emulation study

BACKGROUND: Nearly half of patients with acute ischemic stroke (AIS) fail to achieve excellent functional outcomes after intravenous thrombolysis (IVT), highlighting the need for credible evidence on adjunctive therapies to address this clinical gap. We evaluated whether adjunctive Shuxuetong (SXT) could improve 90-day excellent functional outcomes in patients with AIS receiving IVT. METHODS: Leveraging data from a multicenter, nationwide registry, this study emulated a target trial identifying adult patients with AIS who received intravenous alteplase or tenecteplase within 4.5 h of symptom onset and had a baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 3 from September 2023 to September 2025. All patients were followed up for 90 days. SXT administration was defined as 6 ml daily within 48 h after thrombolysis. The primary outcome was the percentage of patients with excellent functional status at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 1. Logistic and linear regression with inverse probability of censoring weighting were used to estimate the effects. RESULTS: Among 1429 eligible patients with AIS receiving IVT, the median age was 67 years (IQR, 58-74 years), 33.3% were women, and the median pre-IVT NIHSS score was 5 (IQR, 4-8). After adjusting for confounders, IVT plus SXT was associated with a significantly higher proportion of patients achieving an excellent functional outcome at 90 days (mRS 0-1, 79.7% vs 72.2%, adjusted odds ratio [aOR], 1.48; 95% CI, 1.23 to 1.78) and a significantly lower incidence of death (aOR, 0.30; 95% CI, 0.16 to 0.54) and symptomatic intracranial hemorrhage (sICH) (aOR, 0.31; 95% CI, 0.14 to 0.68) compared with IVT alone. CONCLUSIONS: In patients with AIS receiving IVT within 4.5 h of onset, IVT plus SXT was associated with higher observed rates of 90-day excellent functional outcomes and lower observed rates of death and sICH compared with IVT alone.