Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery The EMMA-Can Randomized Clinical Trial
- 3일 전
- 3분 분량
2026년04월30일
JAMA Neurol. Published online: April 30, 2026.
DOI:10.1001/jamaneurol.2026.4910
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.
Key Points
Question Does adjunctive embolization of the middle meningeal artery (EMMA) after surgical drainage reduce recurrence of chronic subdural hematoma compared with surgery alone?
Findings In this randomized clinical trial of 186 participants with unilateral symptomatic chronic subdural hematoma, adjunctive EMMA after surgery significantly reduced symptomatic recurrence detected on computed tomographic scan (4% vs 28%) at 90 days compared with surgery alone.
Meaning Adjunctive EMMA performed after surgical drainage lowered chronic subdural hematoma recurrence, supporting its role as an effective addition to surgical management of chronic subdural hematoma.
요약
· 중요성 : 만성 경막하혈종(chronic subdural hematoma, cSDH)은 수술적 배액 후 흔히 재발한다.수술 후 중경막동맥 색전술(embolization of the middle meningeal artery, EMMA)을 추가하는 것이 재발 위험을 줄이는지에 대해서는 아직 명확하지 않았다.
· 목적 : 수술적 배액 후 보조적으로 시행한 EMMA가, 수술 단독 치료와 비교하여 만성 경막하 혈종의 재발을 감소시키는지를 평가하고자 하였다.
· 설계, 환경 및 참가자 :
-연구 유형: 무작위 배정(randomized), 공개(open-label), 평가자 눈가림(blinded end-point)
-연구 기간: 2021년 8월~2025년 4월
-참여 센터: 캐다다 9개 상급 의료기관
-대상자: 수술적 배액이 예정된 일측성(unilateral), 증상이 있는(symptomatic), 두께 10 mm 이상의 만성 경막하혈종 성인 환자
· 중재 :
-실험군: 수술적 배액 후 72시간 이내에 액체 색전 물질(Onyx-18)을 이용한 EMMA 시행
-대조군: 수술적 배액 후 추가적인 EMMA를 시행하지 않음
· 주요 평가 변수 및 측정
-1차 평가변수:
90일 시점(범위: 60~120일)에 CT에서 확인된 증상성 만성 경막하혈종 재발
-2차 평가변수
영상학적 재발(radiographic recurrence)
90일 사망률
중대한 이상반응(serious adverse events)
-최종 추적관찰 날짜는 2025년 7월 27일이었다.
결과 : 무작위 배정된 192명 중 186명(평균 연령 71.8세, 남성 136명[73%])이 연구를 완료하였다. 각 군은 93명이었다.
-CT에서 확인된 증상성 재발:
EMMA군: 4명(4.3%)
대조군: 26명(28%)
위험 차이(risk difference)는 −23.7(95% 신뢰구간 −34.1 ~ −13.9, P < .001),이는 통계적으로 유의
-영상학적 재발:
EMMA군: 13명(14%)
대조군: 46명(49.5%)
-사망률:
EMMA군: 4.3%
대조군: 1.1%
-중대한 이상반응:
EMMA군: 8.6%
대조군: 5.4%
· 결론 및 의의 : 수술적 배액 후 보조적으로 시행한 EMMA는, 수술 단독 치료와 비교하여 90일 시점의 CT에서 확인된 일측성 만성 경막하혈종의 증상성 재발을 유의하게 감소시켰다.
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