Details of the study
- Patients with symptomatic subacute or chronic subdural hematoma requiring surgical evacuation randomized to middle meningeal artery embolization plus surgery versus surgery alone.
Study design
- Class Of Evidence
- Randomized controlled trial
- Randomisation
- 1:1 ratio with permuted-block randomization and stratification
- Number Of Patients
- 400 total (197 treatment, 203 control)
- Length Of Follow Up
- 90 days for primary outcome
- Number Of Centres
- 39 centers in the United States
Stratification
- Hematoma thickness, Markwalder Grading Scale, surgery type, antithrombotic use
Outcome Measures
- Primary: reoperation for recurrence/progression within 90 days; secondary: neurologic function (modified Rankin scale) at 90 days
Results
- Primary end point: 4.1% (8/197) treatment vs 11.3% (23/203) control (RR 0.36, P=0.008).
- Functional deterioration: 11.9% vs 9.8% (risk difference 2.1%, 95% CI -4.8 to 8.9).
- Mortality at 90 days: 5.1% (treatment) vs 3.0% (control).
- Serious adverse events related to embolization by 30 days: 2.0% (4/197) in treatment, including disabling stroke in 2.
Conclusion
- Middle meningeal artery embolization plus surgery was associated with lower risk of hematoma recurrence requiring reoperation than surgery alone, with further safety study needed.
Critique
- Open-label design prone to bias due to surgeon judgment for primary outcome.
- Substantial loss to follow-up (13.2%) due to older population and pandemic.
- Trial not powered for safety outcomes (e.g., stroke, neurologic death).
- Lippa 2025: MMAE cannot yet be considered standard treatment for CS-DH due to insufficient evidence
- Unequal distribution of prerandomization surgeries (28.6% vs 39.6%)
- Study not powered to detect differences in stroke rates or neurologic deaths
- Industry sponsorship and high industry involvement disclosures raise bias concerns
- Exclusion of very high-risk patients limits applicability to common frail populations