Meta-analysis finds no benefit of IV thrombolysis for minor ischemic stroke

BackgroundThe efficacy and safety of intravenous thrombolysis (IVT) compared to standard medical management (SMM) remain unclear in patients with minor ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] ≤ 5). This meta-analysis of randomized controlled trials (RCTs) aimed to synthesize evidence from a direct comparison of these treatments.MethodsWe systematically searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception to June 30th, 2025. The primary efficacy outcome was an excellent functional outcome (modified Rankin Scale [mRS] score 0–1) at 90 days. The secondary efficacy outcome was functional independence (mRS score 0–2) at 90 days. Key safety outcomes included symptomatic intracranial hemorrhage (sICH) and 90-day all-cause mortality. Data were analyzed using a random-effects model. This study was registered with PROSPERO (CRD420251089799).ResultsFive RCTs involving 4,361 patients were included. The meta-analysis revealed no significant difference between IVT and SMM in efficacy, both for the primary efficacy outcome (90-day mRS 0–1: OR 0.85, 95% CI 0.72–1.00) or the secondary efficacy outcome (90-day mRS 0–2: OR 0.85, 95% CI 0.63–1.13). Regarding safety, the risk of sICH was significantly higher in the IVT group (OR 4.70, 95% CI 1.76–12.52), whereas no significant difference was found in 90-day all-cause mortality (OR 1.62, 95% CI 0.69–3.79).ConclusionIn patients with minor ischemic stroke, IVT offers no superior benefit in functional outcomes over SMM but significantly increases sICH risk. Therefore, routine use of IVT should be approached with caution. Future research should identify specific subgroups who might benefit.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251089799.