Key result
IVT reduces functional independence and increases mortality ~142% vs antiplatelets in mild ischemic stroke, driven by sICH.
Why the study?
The safety and efficacy of intravenous thrombolysis compared with standard antiplatelet therapy in patients with mild acute ischemic stroke needed evaluation.
Does intravenous thrombolysis improve functional independence or reduce mortality in patients with mild acute ischemic stroke compared to standard antiplatelet therapy?
Meta-Analysis (n=3,405)
Yes
Does intravenous thrombolysis improve functional independence or reduce mortality in patients with mild acute ischemic stroke compared to standard antiplatelet therapy?
Effect estimate: RR 0.97 (95% CI 0.94–1.00)
p-value: p=0.04
In patients with mild acute ischemic stroke, intravenous thrombolysis provides no functional benefit and significantly increases the risk of mortality and symptomatic intracranial hemorrhage compared to standard antiplatelet therapy.
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Avoid IVT in mild AIS due to net harm; challenges consensus favoring thrombolysis in minor stroke.
Objectives To evaluate the safety and efficacy of intravenous thrombolysis (IVT) versus standard antiplatelet therapy in patients with minor acute ischemic stroke (AIS). Methods A systematic review and meta-analysis of databases, including PubMed, Embase, Web of Science, and Cochrane Library, up to 27 June 2025. Inclusion criteria were randomized clinical trials comparing IVT with standard antiplatelet care in patients with mild acute ischemic stroke. Exclusions included non-randomized studies, observational studies, non-interventional trials, meeting abstracts, duplicates, studies with overlapping data, and non-English language studies. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Fixed-effects or random-effects model meta-analysis were used to analyze the pooled data. Main outcomes and measures: Rates of functional independence (modified Rankin Scale score ≤ 1 or ≤ 2), 90-day mortality, sICH. Results Four randomized clinical trials, involving 3,405 initially enrolled patients, were included in the analysis. A lower rate of functional independence was observed in the IVT group (mRS ≤ 1, relative risk [RR], 0.97 [95% CI, 0.94–1.00]; mRS ≤ 2, RR, 0.97 [95% CI, 0.95–0.99]). Higher 90-day mortality rates (RR, 2.42 [95% CI, 1.39–4.20]) and sICH rates (RR, 4.90 [95% CI, 1.67–14.40]) were observed in the IVT group. All outcomes reported in this analysis had low heterogeneity. Conclusion and relevance Our findings suggest that intravenous thrombolysis for mild acute ischemic stroke yields no benefit and may pose additional risks compared to antiplatelets standard care. More large clinical randomized controlled trials are still needed in the future to validate our results. Systematic review registration [ https://www.crd.york.ac.uk/prospero/ ], identifier [CRD42025643646].
Zhou et al. (2026) conducted a meta-analysis in mild acute ischemic stroke (n=3,405). Intravenous thrombolysis (IVT) vs. Antiplatelet standard care was evaluated on Functional independence (mRS score ≤ 1 or ≤ 2) (RR 0.97, 95% CI 0.94–1.00, p=0.04). Intravenous thrombolysis decreased the incidence of functional independence and increased 90-day mortality (RR 2.42) and sICH (RR 4.90) compared to antiplatelet standard therapy in patients with mild acute ischemic stroke.
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