ESCAPE-MeVO
Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion
Clinical Question
Does endovascular thrombectomy improve outcomes in patients with acute ischemic stroke due to medium-vessel occlusion within 12 hours?
Study Overview
Objective
To evaluate whether EVT plus usual care improves functional outcomes compared to usual care alone in patients with acute ischemic stroke due to medium-vessel occlusion presenting within 12 hours.
Study Summary
- EVT did not improve 90-day excellent outcome (mRS 0–1: 41.6% vs 43.1%; adjusted rate ratio 0.95, 95% CI 0.79–1.15; P=0.61) or functional independence (mRS 0–2: 54.1% vs 58.8%; adjusted rate ratio 0.92, 95% CI 0.80–1.05) compared to usual care in MeVO stroke.
- Mortality was higher in the EVT group (13.3% vs 8.4%; adjusted HR 1.82, 95% CI 1.06–3.12), and sICH was numerically higher (5.4% vs 2.2%).
- Possible explanations include long onset-to-recanalization times (median 359 min), suboptimal reperfusion rates (75.1%), high general anesthesia use (43.1%), and 15% spontaneous recanalization before EVT.
Intervention
EVT (Solitaire X first-line) + usual care vs. usual care alone (including IVT when eligible)
Patients per Arm
530 enrolled (EVT: 255, Usual care: 275); ITT 529 (EVT: 255, Usual care: 274 after 1 withdrawal)
Bottom Line
EVT did not improve functional outcomes in medium-vessel occlusion (MeVO) stroke: mRS 0-1 at 90 days 41.6% vs 43.1% (adjusted rate ratio 0.95; 95% CI 0.79-1.15; P=0.61). Mortality was significantly higher with EVT (13.3% vs 8.4%; adjusted HR 1.82; 95% CI 1.06-3.12). SAEs higher with EVT (33.9% vs 25.7%), including more sICH (5.4% vs 2.2%). First RCT of EVT for MeVO. 530 patients enrolled (529 ITT), 58 sites, 5 countries.
Major Points
- EVT did NOT improve outcomes in MeVO: mRS 0-1 41.6% vs 43.1% (adjusted rate ratio 0.95; 95% CI 0.79-1.15; P=0.61).
- EVT associated with HIGHER mortality: 13.3% vs 8.4% (adjusted HR 1.82; 95% CI 1.06-3.12).
- More SAEs with EVT: 33.9% vs 25.7% — including sICH 5.4% vs 2.2%, pneumonia 7.0% vs 3.3%.
- Reperfusion achieved in 75.1% (MeVO-eTICI 2b/2c/3) — but didn't translate to benefit.
- Longer workflow than LVO trials: onset-to-recanalization 359 min (vs 241 min in ESCAPE-LVO).
- 15% of EVT patients had spontaneous recanalization before angiography (82% had IV tPA).
- MeVO defined: M2/M3, A2/A3, P2/P3 segments. MCA branch occlusion in 84.7%.
- Contradicts prior observational data suggesting EVT benefit for MeVO — selection bias likely.
- Does not support routine EVT for MeVO at current workflow speeds.
- 530 patients enrolled (255 EVT, 275 UC; 274 UC in ITT after 1 immediate withdrawal), 58 sites, 5 countries (Canada, US, Germany, Hungary, Japan). PROBE design.
Design
Study Type: Multicenter, open-label, randomized controlled trial with blinded outcome assessment
Randomization: 1
Blinding: Open-label with blinded outcome adjudication
Enrollment Period: April 2022 – June 2024
Follow-up Duration: 90 days
Centers: 58
Countries: 5
Sample Size: 530
Analysis: Modified intention-to-treat; adjusted analyses with generalized linear models and Cox regression
Inclusion Criteria
- Age ≥18 years
- Acute ischemic stroke with medium-vessel occlusion (M2/M3 segment of MCA, A2/A3 of ACA, or P2/P3 of PCA)
- Last known well within 12 hours; NIHSS >5 or 3–5 with disabling deficit
- Favorable baseline imaging — lack of extensive ischemic changes on noncontrast CT/MRI, at least moderate collaterals on CTA/MRA, or core–penumbra mismatch on perfusion imaging
Exclusion Criteria
- Large-vessel occlusion (ICA or M1)
- Severe disability (pre-stroke mRS >2)
- Large core infarct or extensive early ischemic changes
- Contraindications to thrombectomy or usual care
Arms
| Field | EVT + Usual Care | Control |
|---|---|---|
| Intervention | Endovascular thrombectomy with Solitaire X first-line device plus guideline-based usual care (including IV thrombolysis when eligible) | Standard medical therapy (including IV thrombolysis when indicated) |
| Duration | Single intervention; follow-up at 90 days | Follow-up at 90 days |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Proportion of patients with modified Rankin Scale score 0 or 1 at 90 days | Primary | 43.1% (118/274) | 41.6% (106/255) | 0.61 | |
| Modified Rankin Scale 0–2 at 90 days | Secondary | 58.8% (161/274) | 54.1% (138/255) | ||
| Barthel Index ≥95 at 90 days | Secondary | 64.7% (167/258) | 53.5% (130/243) | ||
| Death at 90 days | Secondary | 8.4% (23/274) | 13.3% (34/255) | 1.82 | |
| EQ-5D-5L Index at 90 days | Secondary | 0.69 ± 0.02 | 0.64 ± 0.02 | ||
| EQ VAS score at 90 days | Secondary | 63.4 | 61.8 | ||
| Infarct volume at 18–54 hr (mean, ml) | Secondary | 29.1 | 31.9 | ||
| Any Serious Adverse Event | Adverse | 25.7% (70/272) | 33.9% (87/257) | ||
| Symptomatic ICH | Adverse | 2.2% (6/272) | 5.4% (14/257) | ||
| Pneumonia | Adverse | 3.3% (9/272) | 7.0% (18/257) | ||
| Recurrent Stroke | Adverse | 3.7% (10/272) | 5.4% (14/257) | ||
| Stroke Progression | Adverse | 1.8% (5/272) | 5.4% (14/257) |
Subgroup Analysis
Prespecified subgroup analysis suggested possible heterogeneity of the treatment effect according to time from onset to randomization (Fig. S5); no other clear subgroup heterogeneity observed.
Criticisms
- Open-label design may introduce performance bias
- Study may be underpowered to detect small treatment effects
- Baseline core volumes and vessel segment distributions not stratified
- Unclear generalizability to lower-resource settings or different imaging protocols
- Long workflow times (onset-to-recanalization 359 min) and high general anesthesia use (43.1%) may have biased result toward the null
- Mandated first-line Solitaire X device — other technical approaches may be more effective
Funding
Canadian Institutes of Health Research, Medtronic
Based on: ESCAPE-MeVO (New England Journal of Medicine, 2025)
Authors: M. Goyal, J. M. Ospel, A. Ganesh, ..., M.A. Möhlenbruch
Citation: N Engl J Med 2025; DOI:10.1056/NEJMoa2411668
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