EMBOLISE
Trial question
What is the role of adjunctive middle meningeal artery embolization in patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 400
400 patients (108 female, 292 male).
Inclusion criteria: patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation.
Key exclusion criteria: life expectancy < 1 year; score on the mRS of 4-6 before the hematoma developed; Markwalder Grading Scale score ≥ 3.
Interventions
N=197 MMA embolization plus surgery (middle meningeal artery embolization with the use of biplane digital subtraction angiography plus surgery).
N=203 surgery alone (use of either burr holes or craniotomy according to surgeon's discretion).
Primary outcome
Rate of hematoma recurrence or progression leading to repeat surgery within 90 days after index treatment
4.1%
11.3%
11.3 %
8.5 %
5.7 %
2.8 %
0.0 %
MMA embolization plus
surgery
Surgery
alone
Significant
decrease ▼
NNT = 13
Significant decrease in the rate of hematoma recurrence or progression leading to repeat surgery within 90 days after index treatment (4.1% vs. 11.3%; RR 0.36, 95% CI 0.11 to 0.8).
Secondary outcomes
No significant difference in deterioration of neurologic function at day 90 (11.9% vs. 9.8%; AD 2.1%, 95% CI -4.8 to 8.9).
No significant difference in death at day 90 (5.1% vs. 3%; RR 1.72, 95% CI 0.62 to 5.54).
Safety outcomes
No significant differences in neurologic death, stroke, serious adverse events by day 30.
Conclusion
In patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation, MMA embolization plus surgery was superior to surgery alone with respect to the rate of hematoma recurrence or progression leading to repeat surgery within 90 days after index treatment.
Reference
Jason M Davies, Jared Knopman, Maxim Mokin et al. Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1890-1900.
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