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Endovascular therapy showed no benefit over medical care alone for mild-to-moderate medium or distal vessel occlusion stroke patients in this randomized trialEndovascular treatment offers no disability benefit for mild-to-moderate stroke patients

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Key Takeaway
Endovascular treatment offers no benefit over medical care alone for mild-to-moderate medium or distal vessel occlusion stroke patients.

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.

This research addresses a critical question for stroke survivors and their families. Many people with acute ischaemic stroke suffer from blockages in medium or distal blood vessels. These patients often present at hospitals within six hours of their last known well time. For years, doctors have debated whether adding endovascular treatment to standard medical care helps these specific patients. This study aimed to answer that question directly. The results suggest that for mild-to-moderate cases, the extra procedure may not be necessary. Understanding this finding helps patients avoid unnecessary risks and invasive procedures. It also guides doctors on when to recommend surgery versus standard medication.

The study involved 553 adults enrolled across 55 hospitals in Europe and the Middle East. Participants were adults aged 18 years or older with acute ischaemic stroke. The blockage had to be in a medium or distal vessel. Patients came from home within six hours of their last known well time. Some were seen between six and 24 hours if imaging showed salvageable brain tissue. All participants received best medical treatment. The intervention group also received endovascular treatment. The control group received best medical treatment alone.

Researchers measured disability at 12 months using the ordinal modified Rankin Scale. Scores of 5 and 6 combined indicate severe disability or death. The median score was 2 in both groups. This score falls within the range of mild disability. The study found no difference in disability between the two groups. The adjusted common odds ratio was 0.81. The 95% confidence interval ranged from 0.59 to 1.12. The p-value was 0.20. This indicates no statistically significant reduction of disability with the added treatment. Overall survival was also similar between groups. The hazard ratio was 1.46 with a p-value of 0.10. No serious adverse events were reported during the study period.

The study had an open-label design. This means the doctors and patients knew which treatment was given. This can sometimes influence results. Funding came from the Swiss National Science Foundation and several medical device companies. These include Medtronic, Stryker Neurovascular, and others. Because the study was open-label and funded by industry, readers should interpret the results with caution. The sample size of 553 patients is moderate but may not represent every possible scenario. The findings apply specifically to medium or distal vessel occlusions. They do not apply to large vessel occlusions or other stroke types.

Routine endovascular treatment is therefore not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke. Patients should discuss these findings with their doctors. Doctors should not overstate the importance of this single study. It does not prove that endovascular treatment is useless for all strokes. It only shows no benefit for this specific group. Patients should not stop prescribed treatments without medical advice. This study helps clarify when invasive procedures are truly needed. It supports a more conservative approach for certain stroke patients. The goal is to provide care that matches the patient's specific condition without unnecessary risk.

What this means for you:
Endovascular treatment did not reduce disability for mild-to-moderate stroke patients in this trial.

Study Details

Study typeRct
Sample sizen = 553
EvidenceLevel 2
Follow-up12.0 mo
PublishedJun 2026
View Original Abstract ↓
BACKGROUND: Long-term evidence for endovascular treatment in medium or distal vessel occlusion stroke is scarce. Three out of four randomised trials reported no benefit of endovascular treatment over best medical treatment at 90 days. We aimed to assess efficacy of endovascular treatment plus best medical treatment versus best medical treatment alone at 12 months in patients enrolled in the DISTAL trial, as well as overall survival. METHODS: DISTAL was an open-label, randomised trial with blinded endpoint assessment conducted at 55 hospitals in Europe and the Middle East. Adults (≥18 years) with acute ischaemic stroke due to medium or distal vessel occlusion (occlusion of co-dominant or non-dominant M2 or M3-M4 middle cerebral artery, A1-A3 anterior cerebral artery, or P1-P3 posterior cerebral artery) presenting from home within 6 h of last known well, or between 6 h and 24 h if neuroimaging demonstrated potentially salvageable tissue, were randomly assigned (1:1) through a centralised web-based system to endovascular treatment plus best medical treatment or best medical treatment alone. The prespecified primary outcome at 12 months was disability measured by use of the ordinal modified Rankin Scale (mRS; scores 5 and 6 combined) in the intention-to-treat population. The only safety outcome was overall survival. The trial is registered on ClinicalTrials.gov (NCT05029414) and is completed. FINDINGS: Between Dec 16, 2021, and July 10, 2024, we enrolled 553 patients. Ten patients declined post-hoc consent, leaving 543 participants in the analysis (239 [44%] females and 304 [56%] males; median age 77 years, IQR 68-84). 271 (50%) were assigned to endovascular treatment plus best medical treatment and 272 (50%) to best medical treatment alone. The median NIHSS score at admission was 6 (IQR 5-9); 355 (65%) participants received intravenous thrombolysis. Predominant occlusion locations were the M2 (239 [44%]), M3 (146 [27%]), P2 (73 [13%]), and P1 (30 [6%]) segments. 12-month data were available for 524 (97%) participants. The median mRS score was 2 (IQR 1-4) in the endovascular treatment plus best medical treatment group and 2 (1-4) in the best medical treatment alone group. There was no difference in 12-month mRS distribution between endovascular treatment plus best medical treatment and best medical treatment alone (adjusted common odds ratio for better functional outcome 0·81, 95% CI 0·59-1·12; p=0·20). Overall survival was similar between the two groups (hazard ratio 1·46, 95% CI 0·93-2·30; p=0·10). INTERPRETATION: In patients with a medium or distal vessel occlusion stroke, endovascular treatment plus best medical treatment was not associated with a reduction of disability or death at 12 months compared with best medical treatment. These results are consistent with the 90-day results. Routine endovascular treatment is therefore not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke. FUNDING: Swiss National Science Foundation, Gottfried und Julia Bangerter-Rhyner-Foundation, Medtronic, Stryker Neurovascular, Phenox, Rapid Medical, and Penumbra.
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