Endovascular therapy showed no benefit over medical care alone for mild-to-moderate medium or distal vessel occlusion stroke patients in this randomized trial
This randomized trial investigated the efficacy of endovascular treatment combined with best medical treatment versus best medical treatment alone in adults with acute ischaemic stroke. The study population consisted of 553 enrolled patients, with 543 included in the final analysis, across 55 hospitals in Europe and the Middle East. Participants were adults aged 18 years or older who presented from home within six hours of their last known well time, or between six and 24 hours if neuroimaging showed potentially salvageable tissue. The primary condition involved medium or distal vessel occlusion.
The primary outcome measured disability at 12 months using the ordinal modified Rankin Scale, where scores of 5 and 6 were combined to indicate severe disability or death. The results demonstrated no difference between the groups regarding disability. The median mRS score was 2 with an interquartile range of 1 to 4 in both the intervention and comparator groups. The adjusted common odds ratio was 0.81, with a 95% confidence interval ranging from 0.59 to 1.12 and a p-value of 0.20. This indicates no statistically significant reduction of disability with the addition of endovascular treatment.
Secondary outcomes assessed overall survival between the two groups. The hazard ratio was 1.46, with a 95% confidence interval from 0.93 to 2.30 and a p-value of 0.10. Similar survival rates were observed between groups, reinforcing the finding that endovascular treatment did not provide a survival advantage over medical management alone in this specific patient population. Absolute numbers for survival were not reported in the main results summary.
Safety data regarding adverse events, serious adverse events, discontinuations, and tolerability were not reported in the provided text. The study design was open-label, which is listed as a limitation. Funding sources included the Swiss National Science Foundation, Gottfried und Julia Bangerter-Rhyner-Foundation, and various medical device companies including Medtronic, Stryker Neurovascular, Phenox, Rapid Medical, and Penumbra.
The practice relevance of these findings is significant for clinical decision-making. Routine endovascular treatment is therefore not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke. Clinicians must weigh the risks and costs of invasive procedures against the lack of demonstrated benefit for this specific subgroup. The certainty of the evidence and causality notes were not reported, but the open-label nature of the trial warrants careful interpretation of the results.
In conclusion, this trial challenges the assumption that all ischaemic strokes benefit from endovascular intervention regardless of vessel location or severity. The data supports a more selective approach to endovascular therapy, reserving it for cases where clear benefit is anticipated. Healthcare providers should consider these findings when developing stroke protocols, ensuring resources are allocated to interventions with proven efficacy.
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Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke
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