DISTAL
(2026)Objective
To assess whether endovascular treatment plus best medical treatment reduces disability or death at 12 months compared with best medical treatment alone in patients with acute ischaemic stroke due to medium or distal vessel occlusion.
Study Summary
• Overall survival was similar between groups (HR 1.46, 95% CI 0.93–2.30; p=0.10), with no statistically significant mortality difference.
• Quality-of-life scores did not favour EVT + BMT over BMT alone.
• 12-month results are consistent with the neutral 90-day findings, reaffirming that routine endovascular treatment is not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke.
Intervention
Endovascular treatment (stent retrievers, aspiration catheters, or both) plus best medical treatment versus best medical treatment alone
Inclusion Criteria
Adults ≥18 years with acute ischaemic stroke due to non-dominant or co-dominant M2, M3–M4 MCA; A1–A3 ACA; or P1–P3 PCA occlusion on CT/MR angiography; NIHSS ≥4 or clearly disabling symptoms; not bedridden; living in own household before stroke; presenting within 6h of last known well, or 6–24h with evidence of salvageable tissue on neuroimaging
Study Design
Arms: EVT + Best Medical Treatment (n=271) vs Best Medical Treatment alone (n=272)
Patients per Arm: 271 vs 272
Outcome
• Safety (overall survival): HR 1.46 (95% CI 0.93–2.30; p=0.10) — no significant difference.
• Quality-of-life scores did not favour EVT + BMT over BMT alone.
Bottom Line
Endovascular treatment added to best medical treatment does not reduce disability or mortality at 12 months in patients with mild-to-moderate acute ischaemic stroke from medium or distal vessel occlusion; these findings reinforce the 90-day results and do not support routine thrombectomy in this population.
Major Points
- At 12 months, EVT + BMT did not significantly reduce disability compared to BMT alone: adjusted common OR 0.81 (95% CI 0.59–1.12; p=0.20).
- Median 12-month mRS was 2 (IQR 1–4) in both the EVT + BMT and BMT-alone groups — identical functional outcomes.
- Overall survival was similar between groups (HR 1.46, 95% CI 0.93–2.30; p=0.10); no statistically significant difference in mortality.
- Quality-of-life scores did not favour EVT + BMT over BMT alone at 12 months.
- 12-month results are fully consistent with the neutral 90-day primary findings.
- DISTAL is the first randomised trial to report 12-month outcomes in medium or distal vessel occlusion stroke.
- The ORIENTAL-MeVO trial (China) showed 90-day benefit, but those patients had higher stroke severity (median NIHSS 10 vs 6) and lower IV thrombolysis use (~36% vs 65%), limiting cross-trial comparability.
- Across all available evidence, routine endovascular treatment should not be offered for mild-to-moderate medium or distal vessel occlusion stroke.
Study Design
- Study Type
- Investigator-initiated, international, multicentre, open-label, randomised, two-arm trial with blinded endpoint assessment
- Randomization
- Yes
- Blinding
- Open-label (treatment); assessor-blinded endpoint evaluation
- Sample Size
- 553
- Follow-up
- 12 months
- Centers
- 55
- Countries
- Switzerland, Germany, Spain, Belgium, Netherlands, Finland, Italy, Sweden, United Kingdom, Portugal, Israel
Primary Outcome
Definition: Disability measured by ordinal modified Rankin Scale (mRS; scores 5 and 6 combined) at 12 months in the intention-to-treat population
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| Median mRS 2 (IQR 1–4) | Median mRS 2 (IQR 1–4) | 0.81 (0.59–1.12) | 0.20 |
Limitations & Criticisms
- Open-label treatment assignment introduces potential performance bias despite blinded outcome assessment.
- Heterogeneous occlusion locations (M2 through P3, including both dominant and non-dominant M2) may obscure subgroup-specific treatment effects.
- Device selection, anaesthesia, and procedural technique were left to operator discretion, introducing variability in EVT quality across 55 centres.
- The ORIENTAL-MeVO trial showed 90-day benefit in a Chinese cohort, raising the possibility that EVT may benefit a more severely affected subgroup (higher NIHSS, lower thrombolysis eligibility) not well represented in DISTAL.
- The study was powered for the 90-day primary endpoint; the 12-month analysis was prespecified but the trial may not have been adequately powered for detecting smaller long-term differences.
- Outcome assessment at 12 months was performed by telephone rather than in-person visit, which may introduce measurement variability for mRS.
Citation
Fischer U, Brehm A, Ribo M, et al. Endovascular treatment for medium or distal vessel occlusion stroke (DISTAL): 12-month outcomes of a multicentre, open-label, randomised trial. Lancet Neurol. 2026. https://doi.org/10.1016/S1474-4422(26)00169-9