Middle Meningeal Artery Embolization With n-Butyl Cyanoacrylate in Patients With Chronic Subdural HematomaA Randomized Clinical Trial

Christopher P. Kellner, MD1; Ansaar T. Rai, MD2; Hazem Shoirah, MD1 et alet al

2026년 6월 15일

JAMA Published Online: June 15, 2026

DOI: 10.1001/jama.2026.1542

Abstract

Importance  Middle meningeal artery embolization (MMAE) is a minimally invasive adjunctive treatment for chronic subdural hematoma (cSDH). The TRUFILL n-butyl cyanoacrylate (n-BCA) liquid embolic system is indicated for embolization of cerebral arteriovenous malformations for presurgical devascularization and may be appropriate for MMAE in patients with cSDH.

Objectives    To evaluate safety and effectiveness of the study device for MMAE plus standard of care vs standard of care alone in patients with cSDH.

Design, Setting, and Participants   The Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL n-BCA (MEMBRANE) trial was a prospective, multicenter, open-label, randomized clinical trial conducted from May 27, 2021, to February 6, 2024, at 30 hospitals (28 in the United States and 2 in China). Participants aged 18 to 90 years with symptomatic cSDH and a modified Rankin Scale score of 3 or less were enrolled.

Interventions Site physicians determined whether each patient required surgical or nonsurgical management. Participants in the surgical and nonsurgical cohorts were then randomized 1:1 to receive MMAE plus standard of care or standard of care alone.

Main Outcomes and Measures   The primary effectiveness end point was residual or re-accumulation of hematoma (>10 mm; assessed by an independent core laboratory) at 6 months or requiring a surgical procedure on the cSDH within 6 months (conducted as an intention-to-treat analysis). The primary safety end point was incidence of adverse events through 6 months (conducted as an as-treated analysis).

Results   A total of 376 participants (188 in MMAE plus standard of care and 188 in standard of care alone) were included. In the MMAE plus standard of care and standard of care alone groups, the mean (SD) age was 70.9 (10.6) and 70.3 (12.1) years, and 45 (23.9%) and 49 (26.1%) were female, respectively. Primary effectiveness end point events occurred in 17 of 146 participants receiving MMAE plus standard of care (11.6%) and 29 of 131 receiving standard of care alone (22.1%) (final estimate of common odds ratio: 0.53 [90% CI, 0.31-0.91]; P = .04), indicating statistically significant benefit for MMAE plus standard of care vs standard of care alone. Adverse events occurred in 130 of 181 participants in the MMAE plus standard of care group (71.8%) and 124 of 190 in the standard of care alone group (65.3%) through 6 months. MMAE plus standard of care treatment was noninferior to standard of care alone based on analysis of good functional outcome at 3 months, as assessed by the modified Rankin Scale

Conclusions and Relevance    In this randomized clinical trial, MMAE plus standard of care significantly reduced rates of recurrence and reoperation vs standard of care alone, without a significant increase in adverse events.

Key Points

Question   Is middle meningeal artery embolization (MMAE) with n-butyl cyanoacrylate (n-BCA) plus standard of care (SOC) safe and effective for the treatment of patients with chronic subdural hematoma (cSDH) compared with SOC alone?

Findings   In this randomized clinical trial with 376 participants, MMAE using the study device plus SOC reduced the rate of recurrence and re-accumulation of hematoma and need for surgery over 6 months (11.6% with MMAE plus SOC vs 22.1% with SOC alone; 47% risk reduction).

Meaning   These findings suggest that adjunctive treatment of cSDH using MMAE with n-BCA resulted in reduced rates of recurrence or re-accumulation and need for surgery.

Middle Meningeal Artery Embolization With n-Butyl Cyanoacrylate in Patients With Chronic Subdural Hematoma

요약

·         중요성 중간수막동맥 색전술(Middle meningeal artery embolization, MMAE)은 만성 경막하혈종(chronic subdural hematoma, cSDH)에 시행할 수 있는 최소 침습적  보조 치료법이다.

TRUFILL n-butyl cyanoacrylate(n-BCA) 액상 색전 시스템은 뇌동정맥기형(cerebral arteriovenous malformation)의 수술 전 혈류 차단(presurgical devascularization)을 위한 색전술에 사용하도록 허가되어 있으며, cSDH 환자에서 MMAE를 시행하는 데에도 적합할 수 있다.

·         목적 cSDH 환자에서 시험 의료기기를 이용한 MMAE를 표준치료에 추가하는 것이 표준치료 단독에 비해 안전하고 효과적인지를 평가하는 것이다

·         연구 설계, 장소, 대상자  

• 전향적, 다기관, 공개형(open-label), 무작위배정 임상시험​으로

• 2021년 5월 27일- 2024년 2월 6일, 미국 28개 + 중국 2개, 총 30개 병원

• 증상이 있는 만성 경막하혈종(cSDH) 환자

• 18세 이상 90세 이하​

• modified Rankin Scale(mRS) ≤3

·         중재 

• 담당 의사가 먼저 수술적 치료 vs 비수술적 치료 여부 결정

• 각 cohort 내에서 1:1로 무작위 배정

  -MMAE + 표준치료

  -표준치료 단독

  
  

·      주요 결과 및 측정치 

• 총 376명 (MMAE +표준치료 188명 vs 표준치료 단독 188명) 

• 평균 연령: 70.9세 vs 70.3세로 두 군이 유사 

• Primary effectiveness endpoint

  -MMAE + 표준치료: 11.6% (17/146)

  -표준치료 단독: 22.1% (29/131)

  -OR 0.53 (90% CI 0.31–0.91), P=.04

  -MMAE 추가 시 재발·재축적 또는 추가 수술이 필요한 치료 실패가 유의하게 감소 

  -절대위험감소(ARR) 10.5%p, 상대위험감소 약 47%, NNT 약 10명 

• 6개월 이상반응(AE): 71.8% vs 65.3%로 MMAE군에서 수치상 높았음

• 3개월 good functional outcome (mRS): MMAE + 표준치료가 표준치료 단독에 대해 비열등(noninferior)

·         결론 및 임상적 의의 이 임상시험에서 중간수막동맥 색전술(MMAE)과 표준치료를 병행한 경우, 표준치료 단독에 비해 ​만성 경막하혈종의 재발률과 재수술률이 유의하게 감소하였으며, 이상반응은 유의하게 증가하지 않았다.