- Compared with standard medical care, minimally invasive catheter evacuation followed by thrombolytic irrigation did not improve functional outcome among patients with spontaneous supratentorial intracerebral hemorrhage (ICH).
Why this matters
- Lack of benefit of open craniotomy hematoma evacuation in large randomized trials.
- Among intention-to-treat population, 1-year rate of good functional outcome: 45% with intervention vs 41% with standard medical care (adjusted risk difference, 4%; P=.33).
- In exploratory analysis among as-treated population (intervention achieved goal of clot size ≤15 mL), 1-year rate of good functional outcome favored intervention (adjusted risk difference, 10.5%; P=.03).
- Intervention yielded lower mortality:
- At 7 days (1% vs 4%; P=.018).
- At 30 days (9% vs 15%; P=.0066).
- Groups similar:
- Symptomatic bleeding (2% vs 1%; P=.325).
- Brain bacterial infections (1% vs 0%; P=.160).
- 30-day serious adverse events:
- Patients affected: 30% vs 33%.
- Number of events: 126 vs 142 (P=.012).
- In a comment, Rustam Al-Shahi Salman, PhD, FRCP(Edin), and colleagues write, "These results suggest that minimally invasive surgery (via a catheter with repeated instillation of alteplase) cannot be recommended for intracerebral haemorrhage in standard practice. MISTIE III highlights the importance of good trial design, large sample size, high adherence to the intervention, and focused hypothesis-testing, which are factors that should be considered in ongoing randomised trials of minimally invasive surgery… and decompressive hemicraniectomy."
- Multinational phase 3 randomized controlled MISTIE III trial: adults with spontaneous supratentorial intracerebral hemorrhage ≥30 mL.
- Randomization: open-label image-guided minimally invasive catheter evacuation followed by thrombolysis (alteplase [Activase]) vs standard medical care.
- Main outcome: 1-year good functional outcome (modified Rankin Scale score, 0-3).
- Funding: National Institute of Neurological Disorders and Stroke; Genentech.
- Open-label design.
- Differences in care across sites.
- Patients with poor prognosis excluded.