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

IF 55 Q1 Medicine

Journal of the American Medical Association Pub Date : 2026-04-30 DOI:10.1001/jama.2026.4910

Jai Jai Shiva Shankar, Susan Alcock, Nima Kashani, Tim Darsaut, Bill Hao Wang, Marlise P Dos Santos, Geneviève Milot, Cian O'Kelly, Michael E Kelly, Daniela Iancu, Adela Cora, Tom Marotta, Brian van Adel, Kislay Kishore, Brian Drake, Howard Lesiuk, Sylvine Carrondo-Cottin, Jeremy Rempel, Uzair Ahmed, Chiraz Chaalala, Joseph Silvaggio, Zul Kaderali, James McEachern, Mohammed Suheel Abdul Salam, Namita Sinha, Roman Marin, Yan Sin Leung, Robert Balshaw, Ian Fleetwood, Depeng Jiang, Bijoy K Menon, Nishita Singh, Frederick A Zeiler

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引用次数: 0

Abstract

Importance: Chronic subdural hematomas commonly recur after surgical drainage. The effect of adjunctive embolization of the middle meningeal artery (EMMA) on recurrence risk remains unclear.

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

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.

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.

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). Secondary outcomes included radiographic recurrence of chronic subdural hematoma, 90-day mortality, and serious adverse events. The last date of follow-up was July 27, 2025.

Results: Of 192 randomized participants, 186 (mean age, 71.8 years; 136 male [73%]) completed the trial (93 per group). 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). Radiographic recurrence occurred in 13 participants (14%) in the EMMA group vs 46 patients (49.5%) in the control group. Mortality was 4.3% vs 1.1%; serious adverse events occurred in 8.6% vs 5.4%, respectively.

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.

Trial registration: ClinicalTrials.gov Identifier: NCT04750200.

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辅助脑膜中动脉栓塞治疗慢性硬膜下血肿：EMMA-Can随机临床试验。

重要性：慢性硬膜下血肿常在手术引流后复发。辅助栓塞脑膜中动脉（EMMA）对复发风险的影响尚不清楚。目的：评价与单纯手术相比，EMMA辅助手术引流是否能减少慢性硬膜下血肿复发。设计、环境和参与者：该试验是一项随机、开放标签、盲终点试验，在2021年8月至2025年4月期间，在加拿大9个三级医疗中心进行手术引流的单侧、症状性慢性硬膜下血肿（≥10mm）成人患者。干预：在手术引流后72小时内使用液体栓塞剂（Onyx-18）进行EMMA，对照组在手术引流后不接受EMMA。主要结局和测量方法：主要结局是在90天（范围60 ~ 120天）CT扫描发现慢性硬膜下血肿的症状性复发。次要结局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。最后一次随访日期为2025年7月27日。结果：192名随机参与者中，186名（平均年龄71.8岁，136名男性[73%]）完成了试验（每组93名）。在CT扫描中发现慢性硬膜下血肿症状复发的主要结局中，EMMA组有4名参与者（4.3%），对照组有26名患者（28%）(风险差，-23.7;95% CI, -34.1至-13.9；P结论及相关性：与单纯手术相比，手术引流后辅助EMMA可显著减少单侧慢性硬膜下血肿90天CT扫描的症状复发。试验注册：ClinicalTrials.gov标识符：NCT04750200。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the American Medical Association Medicine-Medicine (all)

CiteScore

45.40

自引率

0.00%

发文量

期刊介绍： JAMA, published continuously since 1883, is an international peer-reviewed general medical journal. JAMA is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.