What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: mild acute ischemic stroke (n=3405). Intervention: Intravenous thrombolysis (IVT) vs. Antiplatelet standard care. Primary outcome: Functional independence (mRS score ≤ 1 or ≤ 2) (RR 0.97, 95% CI 0.94–1.00, p=0.04).

What does this research mean for the field?

Intravenous thrombolysis for mild acute ischemic stroke yields no benefit and may pose additional risks compared to standard antiplatelet therapy. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

To assess the safety and efficacy of intravenous thrombolysis compared to standard antiplatelet therapy in mild acute ischemic stroke patients.

March 14, 2026Open Access

Intravenous thrombolysis versus antiplatelet standard care for patients with mild acute ischemic stroke: a systematic review and meta-analysis

Key Result

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.

Key Points

To assess the safety and efficacy of intravenous thrombolysis compared to standard antiplatelet therapy in mild acute ischemic stroke patients.
Conducted a systematic review and meta-analysis of relevant databases up to June 2025.
Included randomized clinical trials comparing IVT and antiplatelet therapy.
Exclusions involved non-randomized and observational studies, among others.
Analyzed pooled data using fixed-effects or random-effects models.
Included four randomized clinical trials with 3,405 patients.
The IVT group showed lower functional independence rates (RR 0.97 for mRS ≤ 1 and RR 0.97 for mRS ≤ 2).
Higher 90-day mortality observed in the IVT group (RR 2.42).
Significantly increased rates of sICH in the IVT group (RR 4.90).

Study Design

Type

Meta-Analysis (n=3,405)

Multicenter

Yes

Structured PICO

Does intravenous thrombolysis improve functional independence or reduce mortality in patients with mild acute ischemic stroke compared to standard antiplatelet therapy?

Population

3,405 patients with mild acute ischemic stroke (AIS) pooled from 4 RCTs. Multinational (US, China, Australia, Austria, Brazil, Canada, Finland, Ireland, New Zealand, Singapore, Spain, UK).

Intervention

Intravenous thrombolysis (IVT) including alteplase, tenecteplase, or prourokinase

Comparator

Standard antiplatelet therapy (aspirin monotherapy, dual antiplatelet therapy with clopidogrel and aspirin, or investigator's choice)

Outcome

Rates of functional independence (modified Rankin Scale score ≤ 1 or ≤ 2) at 90 dayshard clinical

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.

Main Result

Effect estimate: RR 0.97 (95% CI 0.94–1.00)

p-value: p=0.04

Limitations

Inclusion of three pharmacologically distinct thrombolytic agents may influence outcomes.
Standard treatment for antiplatelet therapy not uniform across studies.
Not all trials reported TOAST classification data, limiting subgroup analysis opportunities.
Inability to perform subgroup analyses comparing disabling vs non-disabling mild stroke patients due to incomplete reporting.

Abstract

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.

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