EMPROTECT
Trial question
What is the effect of middle meningeal artery embolization in patients who underwent an operation for chronic subdural hematoma recurrence or a first chronic subdural hematoma episode at high risk recurrence?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 342
342 patients (68 female, 274 male).
Inclusion criteria: adult patients who underwent an operation for chronic subdural hematoma recurrence or a first chronic subdural hematoma episode at high risk recurrence.
Key exclusion criteria: chronic subdural hematoma evacuation performed by craniotomy or twist drill craniostomy; index surgery beyond 7 days; functionally dependent with a mRS score ≥ 4 before chronic subdural hematoma; life expectancy < 6 months; allergy to an iodinated contrast agent; embolization procedure deemed unachievable under local anesthesia.
Interventions
N=171 MMA embolization (middle meningeal artery embolization within 7 days of surgery).
N=171 standard treatment (standard medical management).
Primary outcome
Chronic subdural hematoma recurrence rate at 6 months
14.8%
21%
21.0 %
15.8 %
10.5 %
5.3 %
0.0 %
MMA
embolization
Standard
treatment
No significant
difference ↔
No significant difference in chronic subdural hematoma recurrence rate at 6 months (14.8% vs. 21%; OR 0.64, 95% CI 0.36 to 1.14).
Secondary outcomes
No significant difference in repeat surgery for homolateral chronic subdural hematoma recurrence (4.3% vs. 8.3%; ARD -4, 95% CI -9.4 to 1.4).
No significant difference in disability and dependency rate at 1 month, mRS score ≥ 4 (9.6% vs. 5.8%; AD 3.8%, 95% CI -2.3 to 9.9).
No significant difference in death at 6 months (5.5% vs. 7.9%; ARD -2.4, 95% CI -7.9 to 2.9).
Safety outcomes
No significant difference in major and minor complications.
Conclusion
In adult patients who underwent an operation for chronic subdural hematoma recurrence or a first chronic subdural hematoma episode at high risk recurrence, MMA embolization was not superior to standard treatment with respect to chronic subdural hematoma recurrence rate at 6 months.
Reference
Eimad Shotar, Bertrand Mathon, Henri Salle et al. Meningeal Embolization for Preventing Chronic Subdural Hematoma Recurrence After Surgery: The EMPROTECT Randomized Clinical Trial. JAMA. 2025 Jun 5:e257583. Online ahead of print.
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