DISTAL
Endovascular treatment for medium or distal vessel occlusion stroke (DISTAL): 12-month outcomes of a multicentre, open-label, randomised trial
Clinical Question
Does endovascular treatment plus best medical treatment improve 12-month functional outcomes and survival compared with best medical treatment alone in patients with medium or distal vessel occlusion stroke?
Study Overview
Objective
To assess efficacy of endovascular treatment plus best medical treatment versus best medical treatment alone at 12 months in patients with acute ischaemic stroke due to medium or distal vessel occlusion, as well as overall survival.
Study Summary
- No difference in 12-month mRS distribution between EVT + BMT vs BMT alone (adjusted common OR 0.81, 95% CI 0.59–1.12; p=0.20)
- Median mRS score was 2 (IQR 1–4) in both groups at 12 months
- Overall survival was similar between groups (HR 1.46, 95% CI 0.93–2.30; p=0.10)
- Quality of life scores did not favour EVT + BMT over BMT alone
- Results consistent with 90-day findings — routine EVT not supported for mild-to-moderate MeVO/DVO stroke
Intervention
Endovascular treatment (stent retrievers, aspiration catheters, or combination) plus best medical treatment vs best medical treatment alone
Patients per Arm
271 vs 272
Bottom Line
In patients with medium or distal vessel occlusion stroke, endovascular treatment plus best medical treatment was not associated with reduced disability or death at 12 months compared with best medical treatment alone. Routine endovascular treatment is not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke.
Major Points
- First trial to report long-term (12-month) outcomes for medium or distal vessel occlusion stroke
- No difference in ordinal mRS distribution at 12 months (adjusted common OR 0.81, 95% CI 0.59–1.12; p=0.20)
- Overall survival similar between groups (HR 1.46, 95% CI 0.93–2.30; p=0.10)
- Quality of life scores did not favour endovascular treatment
- Results consistent with 90-day primary results, reinforcing that routine EVT should not be offered for MeVO/DVO stroke in moderately affected patients
Design
Study Type: Investigator-initiated, international, multicentre, open-label, randomised trial with blinded endpoint assessment (two-arm, assessor-blinded)
Randomization: 1
Blinding: Open-label with blinded outcome assessment (assessors masked to treatment allocation; core imaging lab also masked)
Allocation: 1:1 via centralised web-based system with treatment-group balance algorithm and random component
Enrollment Period: Dec 16, 2021 to July 10, 2024
Follow-up Duration: 12 months (±30 days for 12-month visit)
Centers: 55
Countries: Switzerland, Germany, Spain, Belgium, Netherlands, Finland, Italy, Sweden, UK, Portugal, Israel
Sample Size: 553
Analyzed: 543
Analysis: Intention-to-treat; 12-month data available for 524 (97%) of 543 analyzed participants
Registration: NCT05029414
Inclusion Criteria
- Age ≥18 years
- Acute ischaemic stroke due to occlusion of non-dominant or co-dominant M2 segment of MCA
- Or occlusion of M3 or M4 segment of MCA
- Or occlusion of A1, A2, or A3 segment of ACA
- Or occlusion of P1, P2, or P3 segment of PCA (P3 added Sept 22, 2024)
- Occlusion assessed on non-invasive imaging (CT or MR angiography)
- NIHSS score ≥4 or clearly disabling symptoms
- Living in own household before stroke
- Presentation within 6 h of last known well from home, or between 6–24 h with neuroimaging showing potentially salvageable tissue
Arms
| Field | Endovascular treatment + best medical treatment | Control |
|---|---|---|
| N | 271 | 272 |
| Intervention | Endovascular treatment using stent retrievers, aspiration catheters, or a combination (with or without balloon guiding catheters); device selection, anaesthesia, and periprocedural care at operator discretion; plus best medical treatment per ESO and AHA/ASA guidelines | Best medical treatment per European Stroke Organisation and AHA/ASA guidelines, including intravenous thrombolysis when eligible |
| Duration | Single procedure with 12-month follow-up | 12-month follow-up |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Disability measured by ordinal modified Rankin Scale (mRS; scores 5 and 6 combined) in the intention-to-treat population | Primary | Median mRS 2 (IQR 1–4) | Median mRS 2 (IQR 1–4) | 0.81 | 0.20 |
| Overall survival at 12 months | Secondary | 1.46 | 0.10 | ||
| Self-reported quality of life at 12 months | Secondary | Did not favour endovascular treatment plus best medical treatment over best medical treatment alone | |||
| Overall survival (the only prespecified safety outcome) | Safety | 1.46 | 0.10 | ||
Criticisms
- Open-label design (though endpoint assessment was blinded)
- Success of assessor masking was not formally evaluated
- Predominantly moderately-affected patients (median NIHSS 6) — results may not generalize to more severely affected patients (contrast with ORIENTAL-MeVO median NIHSS 10, which showed benefit)
- 12-month assessments primarily by telephone, limiting granularity vs in-person 90-day visits
- P3 segment added mid-trial (Sept 22, 2024)
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: Fischer U, Brehm A, Ribo M, ..., on behalf of the DISTAL investigators
Citation: Lancet Neurol 2026; 25: 571–80
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