Key result
IV alteplase provides no functional benefit in minor ischemic stroke while increasing symptomatic ICH.
Why the study?
The benefit-risk profile of intravenous alteplase in patients with minor ischemic stroke remained uncertain.
Does intravenous alteplase improve functional outcomes and increase hemorrhagic risk compared to non-thrombolytic treatment in adults with minor ischemic stroke?
Meta-Analysis (n=9,680)
Yes
Does intravenous alteplase improve functional outcomes and increase hemorrhagic risk compared to non-thrombolytic treatment in adults with minor ischemic stroke?
Intravenous alteplase does not significantly improve overall functional outcomes in unselected patients with minor ischemic stroke (NIHSS <= 5) while significantly increasing the risk of symptomatic and any intracranial hemorrhage.
Answers are grounded in this paper and cite their sources.
Avoid alteplase in minor ischemic stroke due to no benefit and higher ICH risk; reinforces evidence against routine use.
Background The benefit–risk profile of intravenous alteplase in patients with minor ischemic stroke remains uncertain. This study aimed to evaluate the efficacy and safety of alteplase in this population. Methods We systematically searched MEDLINE, Embase, and the Cochrane Library from inception to April 2026. Randomized controlled trials (RCTs), subgroup analyses of RCTs, and prospective comparative studies were eligible if they included adults with minor ischemic stroke, defined mainly as a National Institutes of Health Stroke Scale ≤ 5, and compared intravenous alteplase with non-thrombolytic treatment. Random-effects meta-analyses were performed, and effect estimates were expressed as odds ratios (ORs) with 95% confidence intervals (CIs). Results Sixteen reports representing 11 studies were included, involving 9,680 patients, of whom 3,664 received alteplase and 6,016 received control treatment. Alteplase was not associated with significant improvement in excellent functional outcome, defined as modified Rankin Scale score 0–1 (OR 1.05, 95% CI 0.83–1.33; I2 = 20%), or good functional outcome, defined as modified Rankin Scale score 0–2 (OR 0.96, 95% CI 0.60–1.53; I2 = 3%). However, alteplase significantly increased the risks of symptomatic intracranial hemorrhage (OR 6.01, 95% CI 2.60–13.89; I2 = 0%) and any intracranial hemorrhage (OR 1.86, 95% CI 1.17–2.95; I2 = 17%). No significant differences were observed in mortality, early neurological deterioration, or recurrent stroke. Subgroup analyses suggested a possible functional benefit in mixed or higher-risk minor stroke populations. Sensitivity analysis confirmed the robustness of the main findings. Conclusion Current evidence does not support a clear overall functional benefit of alteplase in unselected patients with minor ischemic stroke, while showing increased hemorrhagic risk. Individualized treatment may be more appropriate for selected higher-risk patients. Systematic review registration https://www.crd.york.ac.uk/PROSPERO , Identifier CRD420261394338.
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Zhang et al. (2026) conducted a meta-analysis in Minor acute ischemic stroke (n=9,680). Intravenous alteplase vs. Non-thrombolytic treatment (aspirin, dual antiplatelet therapy, placebo, best medical therapy, or standard care) was evaluated on Excellent functional outcome, defined as modified Rankin Scale (mRS) score 0-1 at 90 days or 3 months (OR 1.05, 95% CI 0.83-1.33, p=0.67). Intravenous alteplase did not improve excellent functional outcome (mRS 0-1: OR 1.05, 95% CI 0.83-1.33) in minor ischemic stroke, while increasing symptomatic ICH (OR 6.01, 95% CI 2.60-13.89).
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