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DISTAL

Endovascular Treatment for Stroke Due to Occlusion of Medium or Distal Vessels

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Year of Publication: 2025

Authors: Marios Psychogios, Alex Brehm, Marc Ribo, ..., for the DISTAL Investigators

Journal: New England Journal of Medicine

Citation: N Engl J Med 2025; DOI: 10.1056/NEJMoa2408954

Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2408954

Clinical Question

Does endovascular therapy (EVT) improve disability outcomes in patients with medium or distal vessel occlusion stroke compared to best medical treatment alone?

Bottom Line

EVT did not improve disability or mortality outcomes at 90 days for patients with medium or distal vessel occlusion stroke compared to best medical treatment alone.

Major Points

  • Multicenter RCT of 543 patients with medium/distal occlusions (M2–M4, A1–A3, P1–P3) randomized to EVT + best medical treatment vs. best medical treatment alone.
  • No difference in 90-day mRS outcomes: median mRS 2.0 in both groups; common OR 0.90, p=0.50.
  • Symptomatic ICH was more frequent with EVT (5.9% vs. 2.6%), but mortality was similar (15.5% vs. 14%).
  • Successful reperfusion (TICI 2b–3) achieved in 71.7% of EVT patients.
  • No subgroups showed statistically significant benefit from EVT, including those with higher NIHSS.

Design

Study Type: Randomized, assessor-blinded, multicenter, controlled trial

Randomization: 1

Blinding: Blinded outcome assessors and imaging core lab

Enrollment Period: December 2021 – July 2024

Follow-up Duration: 90 days

Centers: 55

Countries: Switzerland, Germany, Belgium, Spain, Italy, Netherlands, Finland, France, Portugal, Israel, Greece

Sample Size: 543

Analysis: Mixed-effects ordinal regression (primary), intention-to-treat, adjusted logistic models for safety

Inclusion Criteria

  • Age ≥18 years
  • Lived at home pre-stroke
  • Acute ischemic stroke due to occlusion of nondominant or codominant M2, M3–M4 MCA, A1–A3 ACA, or P1–P3 PCA
  • Confirmed by CTA or MRA
  • NIHSS ≥4 (or disabling symptoms if <4)
  • Imaging showing salvageable tissue if randomized >6 hours from last seen well

Exclusion Criteria

  • Dominant M2 occlusion
  • Large core infarct
  • Other concurrent indications for surgery
  • Unconfirmed occlusion or alternative diagnosis on imaging

Arms

FieldEVT + Best Medical TreatmentControl
InterventionEndovascular thrombectomy using any device + guideline-based stroke careGuideline-based medical therapy (± thrombolysis)
DurationSingle EVT procedure within 24h of last seen wellStandard care without EVT

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Shift in 90-day modified Rankin Scale (mRS 0–6)PrimaryMedian mRS 2.0 (IQR 1.0–3.0)Median mRS 2.0 (IQR 1.0–4.0)0.50
Excellent functional outcome (mRS 0–1)Secondary37.5%34.7%NS
Change in NIHSS at 24hSecondary0.30.4NS
90-day mortalitySecondary14.0%15.5%NS
Symptomatic ICHAdverse2.6%5.9%NS
Serious Adverse EventsAdverse88114NS
Device-related Events (EVT group only)AdverseEmbolization 6.3%, Arterial perforation 3.0%, Access-site hematoma 3.7%

Subgroup Analysis

No subgroup (age, sex, NIHSS >5, occlusion site, thrombolysis use) showed statistically significant benefit with EVT.

Criticisms

  • Lower-than-expected reperfusion rates (TICI ≥2b in 71.7%) may explain neutral results.
  • Delays between imaging and arterial puncture (median 70 minutes).
  • Variable EVT techniques and operator experience.
  • Trial may be underpowered for some subgroups.
  • Results may not generalize to dominant M2 occlusions (excluded).

Funding

Swiss National Science Foundation; Medtronic; Stryker Neurovascular; Phenox; Rapid Medical; Penumbra

Based on: DISTAL (New England Journal of Medicine, 2025)

Authors: Marios Psychogios, Alex Brehm, Marc Ribo, ..., for the DISTAL Investigators

Citation: N Engl J Med 2025; DOI: 10.1056/NEJMoa2408954

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