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This multicentre randomized trial conducted in China evaluated middle meningeal artery embolization using a liquid embolic agent in patients with symptomatic nonacute subdural hematoma and mass effect. Patients were assigned to embolization plus usual care or usual care alone after the treating surgeon had determined whether surgical or nonsurgical management was appropriate. The primary endpoint was symptomatic hematoma recurrence or progression within 90 days. Among 722 randomized patients, symptomatic recurrence or progression occurred in 24 of 360 patients (6.7%) assigned to embolization and 36 of 362 (9.9%) assigned to usual care, corresponding to an absolute between-group difference of −3.3 percentage points (95% CI, −7.4 to 0.8; P=0.10). Symptomatic recurrence occurred in 17 patients (4.7%) versus 19 (5.2%), while symptomatic progression occurred in 7 (1.9%) versus 17 (4.7%), respectively. Repeat or rescue surgery was performed within 90 days in 11 patients (3.1%) in the embolization group compared with 23 (6.4%) in the usual-care group. The primary endpoint did not differ significantly between groups, despite numerically fewer symptomatic events and rescue procedures with embolization. These results contrast with the significant treatment-failure reduction reported in STEM and illustrate how differences in endpoint definitions, patient selection, and background management influence interpretation of MMAE trials
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This multicentre randomized trial conducted in China evaluated middle meningeal artery embolization using a liquid embolic agent in patients with symptomatic nonacute subdural hematoma and mass effect. Patients were assigned to embolization plus usual care or usual care alone after the treating surgeon had determined whether surgical or nonsurgical management was appropriate. The primary endpoint was symptomatic hematoma recurrence or progression within 90 days. Among 722 randomized patients, symptomatic recurrence or progression occurred in 24 of 360 patients (6.7%) assigned to embolization and 36 of 362 (9.9%) assigned to usual care, corresponding to an absolute between-group difference of −3.3 percentage points (95% CI, −7.4 to 0.8; P=0.10). Symptomatic recurrence occurred in 17 patients (4.7%) versus 19 (5.2%), while symptomatic progression occurred in 7 (1.9%) versus 17 (4.7%), respectively. Repeat or rescue surgery was performed within 90 days in 11 patients (3.1%) in the embolization group compared with 23 (6.4%) in the usual-care group. The primary endpoint did not differ significantly between groups, despite numerically fewer symptomatic events and rescue procedures with embolization. These results contrast with the significant treatment-failure reduction reported in STEM and illustrate how differences in endpoint definitions, patient selection, and background management influence interpretation of MMAE trials
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