Abstract
BACKGROUND: Edaravone dexborneol, a novel neuroprotective agent with combined antioxidant and anti-inflammatory properties, has demonstrated significant improvement in 90-day functional outcomes for patients with acute ischemic stroke. This study aimed to evaluate the outcomes of edaravone dexborneol in patients with acute ischemic stroke with large infarct core. METHODS: This prospective, multicenter, parallel-group, real-world cohort study was conducted between December 2022 and October 2023 across 72 centers in China. Participants were categorized into an exposed group (receiving edaravone dexborneol 37.5 mg/dose every 12 hours for 14 days) and an unexposed group (not receiving edaravone dexborneol). Propensity score matching (1:1) was used to balance baseline characteristics, and clinical outcomes were compared between the groups. The primary efficacy outcome was the proportion of patients achieving a modified Rankin Scale score of ≤2 at 90 days. RESULTS: After matching, the 90-day modified Rankin Scale ordinal shift was significantly better in the edaravone dexborneol group compared with the unexposed group (median: 2 [interquartile range, 1-4.5] versus 3 [interquartile range, 1-5]; unadjusted odds ratio [OR], 1.90 [95% CI, 1.04-3.46]; P=0.04). Patients in the edaravone dexborneol group had a higher rate of functional independence (58.8% versus 36.8%; unadjusted OR, 2.46 [95% CI, 1.23-4.90]; P=0.01) and a lower 90-day mortality rate (11.8% versus 19.1%; unadjusted OR, 0.56 [95% CI, 0.22-1.46]; P=0.24). CONCLUSIONS: In patients with acute ischemic stroke with large infarct core, edaravone dexborneol improved the likelihood of achieving favorable functional outcomes at 90 days. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT05644223.