PDF: REVASCAT
(2015)Objective
To assess the safety and efficacy of stent retriever thrombectomy within 8 hours after stroke onset in patients with anterior circulation LVO.
Study Summary
Intervention
Solitaire FR thrombectomy device plus standard medical therapy (including alteplase when eligible) vs. standard medical therapy alone. Patients were randomized up to 8 hours from onset.
Inclusion Criteria
Age 18–85, proximal anterior circulation occlusion (ICA or M1), NIHSS ≥6, mRS ≤1 pre-stroke, ASPECTS ≥7, and treatment within 8 hours of onset.
Study Design
Arms: Thrombectomy + Medical Therapy vs. Medical Therapy Alone
Patients per Arm: Thrombectomy: 103, Medical Therapy: 103
Outcome
Bottom Line
Among patients with anterior circulation large-vessel occlusion stroke treatable within 8 hours, endovascular thrombectomy with the Solitaire stent retriever significantly reduced the severity of post-stroke disability and increased the rate of functional independence at 90 days compared with medical therapy alone.
Major Points
- One of five landmark thrombectomy RCTs published in 2015 (MR CLEAN, ESCAPE, EXTEND-IA, SWIFT PRIME, REVASCAT) that collectively established mechanical thrombectomy as standard of care for LVO stroke.
- Conducted at 4 comprehensive stroke centers in Catalonia, Spain — the most geographically concentrated of the 2015 trials.
- Stopped early at 206 patients (target 690) due to loss of equipoise after MR CLEAN, ESCAPE, and EXTEND-IA published positive results.
- Unique 8-hour treatment window — the longest among the 2015 trials (MR CLEAN 6h, ESCAPE 12h, EXTEND-IA 6h, SWIFT PRIME 6h) — providing early evidence for extended time windows.
- Primary outcome: ordinal shift in mRS at 90 days favored thrombectomy (adjusted OR 1.7, 95% CI 1.05–2.8). Functional independence (mRS 0–2): 43.7% vs 28.2%.
- Dramatic early neurologic improvement at 24h (NIHSS drop ≥8 or score 0–2): 59% vs 20% (adjusted OR 5.8, 95% CI 3.0–11.1) — the most striking 24-hour outcome among the 2015 trials.
- Occlusion sites: ICA ~35%, M1 ~65%. Solitaire stent retriever was the exclusive first-line device.
- High IV tPA co-treatment rate: 68–78% received alteplase before randomization.
- No significant difference in sICH (1.9% each group) or 90-day mortality (18.4% vs 15.5%).
- Notably included older patients (age cap initially 80, later amended to 85) and required ASPECTS >6 on CT or >5 on DWI — stricter imaging criteria than MR CLEAN.
Study Design
- Study Type
- Multicenter, prospective, randomized, open-label phase 3 study with blinded evaluation of outcomes.
- Randomization
- Yes
- Blinding
- Open-label for treatment assignment; outcome assessors for the modified Rankin Scale were blinded.
- Sample Size
- 206
- Follow-up
- 90 days.
- Centers
- 4
- Countries
- Spain
Primary Outcome
Definition: The severity of global disability at 90 days, assessed by the distribution of scores on the modified Rankin scale (analyzed as an ordinal shift).
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | - | 1.7 (1.05 to 2.8) | - |
Limitations & Criticisms
- Stopped early at 206/690 patients (30%) — markedly underpowered for subgroup analyses and rare event detection.
- Conducted at only 4 highly experienced centers in Catalonia, Spain — among the most geographically restricted of the 2015 thrombectomy trials, limiting generalizability.
- Protocol mandated vessel occlusion confirmation 30 minutes after alteplase administration, potentially delaying thrombectomy in bridging therapy patients.
- Discrepancies between site and core lab ASPECTS readings — some patients had ASPECTS ≤6 on core lab review but were enrolled based on site interpretation.
- Used ASPECTS on NCCT/DWI rather than advanced perfusion imaging (unlike EXTEND-IA and SWIFT PRIME), potentially including patients with larger established infarcts.
- Open-label treatment assignment with potential for bias in post-stroke care intensity, partially mitigated by blinded outcome assessment.
- Solitaire was mandated as first-line device — results may not generalize to other stent retriever or aspiration-first approaches.
- Higher mortality in thrombectomy group (18.4% vs 15.5%), though not significant — raises questions about safety in this extended-window population.
Citation
N Engl J Med 2015;372:2296-306.