Details of the study
- Compares Artemis Neuro Evacuation Device (minimally invasive surgery) vs medical management for spontaneous supratentorial ICH in adults aged 18-80 with 20-80 mL hemorrhage, NIHSS ≥6, GCS 5-15.
Study design
- Class Of Evidence
- Randomized controlled trial
- Randomisation
- 2:1 ratio (minimally invasive surgery: medical management)
- Number Of Patients
- 236 participants (ITT population)
- Length Of Follow Up
- 180 days (primary outcome)
- Number Of Centres
- 32 global sites
- Stratification
- Hemphill score and hemorrhage location (deep vs lobar)
- Outcome Measures
- Primary efficacy: 180-day ordinal mRS; Primary safety: 30-day mortality
Results
- Primary efficacy: OR 1.03 (96% CI 0.62-1.72; P=.45) for 180-day mRS.
- 30-day mortality: 7.2% (MIS) vs 9.8% (medical management; difference -2.5%).
- Technical success: 80.7% median ICH volume reduction post-surgery.
Conclusion
- Minimally invasive surgery within 72 hours did not significantly reduce 30-day mortality or improve 180-day disability compared to medical management alone.
Critique
- Early stopping reduced statistical power to detect differences.
- Excellent technical performance achieved (80.7% volume reduction).