DISTAL
Endovascular treatment for medium or distal vessel occlusion stroke (DISTAL): 12-month outcomes of a multicentre, open-label, randomised trial
Clinical Question
Does adding endovascular treatment to best medical treatment reduce disability or death at 12 months in patients with medium or distal vessel occlusion stroke?
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.
Design
Study Type: Investigator-initiated, international, multicentre, open-label, randomised, two-arm trial with blinded endpoint assessment
Randomization: 1
Blinding: Open-label (treatment); assessor-blinded endpoint evaluation
Allocation: 1:1 via centralised web-based minimisation algorithm incorporating current treatment-group balance
Enrollment Period: December 16, 2021 – July 10, 2024
Follow-up Duration: 12 months
Centers: 55
Countries: Switzerland, Germany, Spain, Belgium, Netherlands, Finland, Italy, Sweden, United Kingdom, Portugal, Israel
Sample Size: 553
Analyzed: 543
Analysis: Intention-to-treat
Registration: NCT05029414
Inclusion Criteria
- Age ≥18 years
- Acute ischaemic stroke due to occlusion of the non-dominant or co-dominant M2 MCA, M3 or M4 MCA, A1/A2/A3 ACA, or P1/P2/P3 PCA confirmed on CT or MR angiography
- NIHSS score ≥4 or clearly disabling symptoms
- Living in own household before the index event (not institutionalised)
- Not bedridden prior to stroke
- Presenting within 6h of last known well, OR between 6–24h if neuroimaging demonstrated potentially salvageable tissue
Exclusion Criteria
- Full exclusion criteria are published with the 90-day primary results and trial protocol (NCT05029414); not fully reproduced in this 12-month report
Arms
| Field | EVT + Best Medical Treatment | Control |
|---|---|---|
| N | 271 | 272 |
| Intervention | Endovascular treatment using stent retrievers, aspiration catheters, or a combination of both, with or without balloon guiding catheters; device selection, technique, anaesthesia, and procedural management at treating physician discretion; plus best medical treatment per European Stroke Organisation and AHA/ASA guidelines | Best medical treatment according to local standards based on European Stroke Organisation and AHA/ASA guidelines, including intravenous thrombolysis where indicated |
| Duration | Acute intervention; follow-up to 12 months | Follow-up to 12 months |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Disability measured by ordinal modified Rankin Scale (mRS; scores 5 and 6 combined) at 12 months in the intention-to-treat population | Primary | Median mRS 2 (IQR 1–4) | Median mRS 2 (IQR 1–4) | 0.81 | 0.20 |
| Self-reported quality of life at 12 months | Secondary | Quality-of-life scores did not favour EVT + BMT over BMT alone; specific scale values not reported in this excerpt | |||
| Overall survival (only prespecified safety outcome) | Safety | 1.46 | 0.10 | ||
Subgroup Analysis
Not reported in this excerpt
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.
Funding
Swiss National Science Foundation, Gottfried und Julia Bangerter-Rhyner-Foundation, Medtronic, Stryker Neurovascular, Phenox, Rapid Medical, and Penumbra
Based on: DISTAL (Lancet Neurology, 2026)
Authors: Urs Fischer, Alex Brehm, Marc Ribo, ..., on behalf of the DISTAL investigators
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
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