Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial.

The effect of adjunctive embolization of the middle meningeal artery (EMMA) on recurrence risk remains unclear.

辅助栓塞中脑膜动脉（EMMA）对复发风险的影响尚不明确。

Background

To evaluate whether EMMA as an adjunct to surgical drainage reduces chronic subdural hematoma recurrence compared with surgery alone.

评估EMMA作为手术引流辅助治疗是否能降低慢性硬膜下血肿复发率，与单独手术治疗相比。

DESIGN, SETTING, AND PARTICIPANTS: This trial was a randomized, open-label, blinded-end point trial involving adults with unilateral, symptomatic chronic subdural hematoma (≥10 mm) undergoing surgical drainage across 9 tertiary care centers in Canada between August 2021 and April 2025.

设计、环境和参与者：这项试验是一项随机、开放标签、终点盲法试验，涉及在2021年8月至2025年4月期间，于加拿大9个三级护理中心接受单侧、有症状的慢性硬膜下血肿（≥10毫米）手术引流的成人患者。

intervention

EMMA using a liquid embolic agent (Onyx-18) within 72 hours after surgical drainage vs a control group that did not receive EMMA after surgical drainage.

在手术引流后72小时内使用液态栓塞剂（Onyx-18）的EMMA组与手术引流后未接受EMMA的对照组进行比较。

main_outcomes_and_measures

Primary outcome was symptomatic recurrence of chronic subdural hematoma detected on computed tomographic (CT) scan at 90 days (range, 60 to 120 days).

主要结果是在90天（范围，60至120天）时通过计算机断层扫描（CT）检测到的慢性硬膜下血肿的有症状复发。

Secondary outcomes included radiographic recurrence of chronic subdural hematoma, 90-day mortality, and serious adverse events.

次要结果包括慢性硬膜下血肿的影像学复发、90天死亡率和严重不良事件。

The last date of follow-up was July 27, 2025.

最后的随访日期是2025年7月27日。

Results

Of 192 randomized participants, 186 (mean age, 71.8 years; 136 male [73%]) completed the trial (93 per group).

在192名随机参与者中，有186人（平均年龄71.8岁；136名男性[73%]）完成了试验（每组93人）。

The primary outcome of symptomatic recurrence of chronic subdural hematoma detected on CT scan occurred in 4 participants (4.3%) in the EMMA group vs 26 patients (28%) in the control group (risk difference, -23.7; 95% CI, -34.1 to -13.9; P < .001).

在CT扫描上检测到的慢性硬膜下血肿症状性复发的主要结果，在EMMA组的4名参与者（4.3%）中发生，而在对照组的26名患者（28%）中发生（风险差异，-23.7；95%置信区间，-34.1至-13.9；P < .001）。

Radiographic recurrence occurred in 13 participants (14%) in the EMMA group vs 46 patients (49.5%) in the control group.

在EMMA组中有13名参与者（14%）发生了放射学复发，而在对照组中有46名患者（49.5%）发生了放射学复发。

Mortality was 4.3% vs 1.1%; serious adverse events occurred in 8.6% vs 5.4%, respectively.

死亡率为4.3%对1.1%；严重不良事件的发生率分别为8.6%对5.4%。

conclusions_and_relevance

Adjunctive EMMA after surgical drainage significantly reduced symptomatic recurrence on CT scan of unilateral chronic subdural hematoma at 90 days compared with surgery alone.

在单侧慢性硬膜下血肿患者中，与单独手术治疗相比，手术引流后辅助使用EMMA显著降低了90天时CT扫描显示的症状性复发。

trial_registration

ClinicalTrials.gov Identifier: NCT04750200.

ClinicalTrials.gov注册号：NCT04750200。