DISTAL 12 MONTHS
(2026)Objective
To assess the 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.
Study Summary
• Median mRS score was 2 (IQR 1–4) in both groups
• 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 prior 90-day outcomes — routine EVT not supported in mild-to-moderate medium/distal vessel occlusion stroke
Intervention
Endovascular treatment (stent retrievers, aspiration catheters, or combination) plus best medical treatment versus best medical treatment alone.
Inclusion Criteria
Adults ≥18 years with acute ischaemic stroke due to medium or distal vessel occlusion (non-dominant or co-dominant M2, M3–M4 MCA, A1–A3 ACA, or P1–P3 PCA), NIHSS ≥4 or clearly disabling symptoms, living independently before stroke, presenting within 6 h of last known well or 6–24 h with salvageable tissue on imaging.
Study Design
Arms: Endovascular treatment + best medical treatment (n=271) vs Best medical treatment alone (n=272)
Patients per Arm: 271 vs 272
Outcome
• Median mRS 2 (IQR 1–4) in both arms
• Overall survival: HR 1.46, 95% CI 0.93–2.30, p=0.10 — no significant difference
• 12-month data available for 524/543 (97%) participants
• Quality of life did not favour EVT
Bottom Line
In patients with medium or distal vessel occlusion stroke, endovascular treatment plus best medical treatment did not reduce 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 randomised trial to report 12-month outcomes after endovascular treatment for medium or distal vessel occlusion stroke
- No difference in 12-month mRS distribution between EVT + BMT and BMT alone (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) — point estimate trends toward worse survival with EVT but not statistically significant
- Quality of life scores did not favour EVT plus BMT
- Results consistent with previously reported 90-day outcomes
- Findings reaffirm that endovascular treatment should not be routinely offered to patients with medium or distal vessel occlusion stroke
Study Design
- Study Type
- Multicentre, international, investigator-initiated, two-arm, open-label, randomised trial with blinded endpoint assessment
- Randomization
- Yes
- Blinding
- Open-label treatment with blinded outcome assessment (assessor-masked); each site designated a dedicated outcome assessor not part of the treatment team
- 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
| 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 design (only outcome assessment was blinded), success of masking not formally evaluated
- Median NIHSS of 6 reflects mild-to-moderate strokes; results may not generalise to more severely affected patients (as suggested by ORIENTAL-MeVO with median NIHSS 10)
- Heterogeneous occlusion sites (M2, M3, M4, A1–A3, P1–P3) — limited subgroup-level conclusions per occlusion location
- Outcome assessment at 12 months largely by telephone, which may differ from in-person assessment
- Higher rate of intravenous thrombolysis (65%) compared with some other trials may have limited the additive benefit of EVT
Citation
Lancet Neurol 2026; 25: 571–80