Meta-analysis of four phase III, Multicenter, randomized trials assessing the efficacy and safety of middle meningeal artery embolization for subdural hematoma.

Abstract

Objective: There is currently no clear consensus on the use of middle meningeal artery embolization (MMAE) for the treatment of chronic subdural hematoma. This study aimed to elucidate the efficacy and safety of the MMAE for chronic subdural hematoma.

Methods: We performed a pooled analysis of four recently conducted phase III multicenter randomized controlled trials (EMBOLISE, EMPROTECT, MAGIC-MT, and STEM), encompassing a total of 1,774 patients with subacute or chronic subdural hematoma. MMAE was compared with conventional treatment in terms of treatment failure (primary efficacy outcomes) and serious adverse events (primary safety outcomes). Subgroup analyses were conducted on the basis of surgical combination status, haematoma type, embolic material used, and follow-up duration.

Results: Compared with the control, MMAE was associated with a lower risk of treatment failure (risk ratio [RR] = 0.55, 95% confidence interval [CI]: 0.41-0.74, P < 0.001) in chronic subdural hematoma patients, without increasing the incidence of serious adverse events (RR = 0.91, 95% CI: 0.71-1.16, P = 0.45). The benefits were consistent across most subgroups, although they were attenuated in high-risk patients treated with particulate agents. The secondary outcomes, including changes in hematoma volume and thickness, midline shift, and mortality, were not significantly different.

Conclusion: MMAE was associated with a lower risk of treatment failure in chronic subdural hematoma patients. Our findings cautiously support its potential role in clinical management. However, further research remains necessary to optimize embolization strategies and refine patient selection criteria.