Edaravone dexborneol in acute ischemic stroke: a systematic review and meta-analysis of randomized trials with clinical and thrombectomy-specific subgroup analyses.

Edaravone dexborneol (ED), a combination of edaravone and ( +)-borneol, offers antioxidant and anti-inflammatory neuroprotection in acute ischemic stroke (AIS). Prior meta-analyses were limited by small sample sizes, inclusion of observational studies, and lack of subgroup evaluations. To assess the efficacy and safety of ED in AIS, including patients undergoing endovascular thrombectomy (EVT). We systematically reviewed randomized controlled trials (RCTs) up to February 2026 using PubMed, Embase, Scopus, Cochrane Library, and ClinicalTrials.gov. The primary outcome was excellent functional recovery (mRS 0-1 at 90 days). Secondary outcomes included mRS 0-2 and 3-6, NIHSS changes, mortality, hemorrhagic complications, cognitive and functional measures, and adverse events. Risk of bias and certainty of evidence were evaluated using RoB 2 and GRADE. Eight RCTs (n = 4,197) were included. ED significantly improved mRS 0-1 (RR = 1.14; 95% CI: 1.07-1.20) and mRS 0-2 (RR = 1.06; 95% CI: 1.02-1.11), reduced poor outcomes (mRS 3-6; RR = 0.87; 95% CI: 0.79-0.94) and hemorrhagic transformation (RR = 0.55; 95% CI: 0.38-0.81), without increasing adverse events or mortality. Subgroup analyses suggested benefits across most demographics, although effects on mRS 0-1 were less pronounced in EVT-only patients. ED appears to improve functional outcomes and reduce hemorrhagic complications in AIS, with a favorable safety profile. However, findings should be interpreted cautiously due to population and trial limitations, and further multicentre studies are needed to confirm efficacy, particularly in EVT and high-risk subgroups.