Embolization of the Middle Meningeal Artery for Chronic Subdural Hematoma

David Fiorella, M.D., Ph.D. et al.

2024년 11월 20일

N Engl J Med 2025;392:855-864

DOI: 10.1056/NEJMoa2409845

Abstract

Background

Patients receiving standard treatment for chronic subdural hematoma have a high risk of treatment failure. The effect of adjunctive middle meningeal artery embolization on the risk of treatment failure in this population remains unknown.

Methods

We randomly assigned patients with symptomatic chronic subdural hematoma to undergo middle meningeal artery embolization as an adjunct to standard treatment (embolization group) or to receive standard treatment alone (control group). Either surgical or nonsurgical standard treatment had been chosen for each patient before randomization. The primary efficacy outcome was a composite of the following events: recurrent or residual chronic subdural hematoma (measuring >10 mm) at 180 days; reoperation or surgical rescue within 180 days; or major disabling stroke, myocardial infarction, or death from neurologic causes within 180 days. The primary safety outcome was a composite of major disabling stroke or death from any cause within 30 days.

Results

Among 310 enrolled patients, 149 were randomly assigned to the embolization group and 161 to the control group; 189 patients were to receive surgical standard treatment and 121 nonsurgical standard treatment. The mean age of the patients was 73 years, and 70% were men. In the primary efficacy analysis, a primary-outcome event occurred in 19 of 120 patients (16%) in the embolization group, as compared with 47 of 129 patients (36%) in the control group (odds ratio, 0.36; 95% confidence interval, 0.20 to 0.66; P=0.001). In the primary safety analysis, 4 of 144 patients (3%) in the embolization group and 5 of 166 patients (3%) in the control group either had a major disabling stroke or died within 30 days. Through 180 days, 12 patients (8%) in the embolization group and 9 patients (5%) in the control group had died, with death from neurologic causes occurring in 1 patient (1%) in the embolization group and in 3 patients (2%) in the control group.

Conclusions

Among patients with symptomatic chronic subdural hematoma, adjunctive middle meningeal artery embolization resulted in a lower risk of treatment failure than standard treatment alone, without resulting in an increased incidence of disabling stroke or death in the short term. Further study of longer-term safety outcomes is warranted. (Funded by Balt USA; STEM ClinicalTrials.gov number, NCT04410146.)

요약

·         소개 : 만성 경막하혈종(chronic subdural hematoma)에 대해 표준 치료를 받는 환자들은 치료 실패 위험이 높다. 이 환자군에서 보조적 중경막동맥 색전술(adjunctive middle meningeal artery embolization)이 치료 실패 위험에 미치는 영향은 아직 알려져 있지 않다.

·         방법:  증상이 있는 만성 경막하혈종 환자들을 무작위로 배정하여, 표준 치료에 보조적으로 중경막동맥 색전술을 시행한 군(색전술군)과 표준 치료만 시행한 군(대조군)으로 나누었다.

수술적 치료 또는 비수술적 치료 중 어떤 표준 치료를 시행할지는 각 환자에서 무작위 배정 전에 이미 결정되었다.

주요 유효성 평가 변수(primary efficacy outcome)는 다음 사건들의 복합 지표(composite outcome)였다:

• 180일 시점에서 재발하거나 잔존하는 만성 경막하혈종(두께 >10 mm)

• 180일 이내 재수술 또는 구제 수술(surgical rescue)

• 180일 이내 발생한 중증 장애성 뇌졸중(major disabling stroke), 심근경색(myocardial infarction), 또는 신경학적 원인에 의한 사망 

주요 안전성 평가 변수(primary safety outcome)는

• 30일 이내 발생한 중증 장애성 뇌졸중 또는 모든 원인에 의한 사망

·         결과 : 등록된 310명의 환자 중149명은 색전술군(embolization group), 161명은 대조군(control group)에 무작위 배정되었다.

이 중:

• 189명은 수술적 표준 치료(surgical standard treatment)

• 121명은 비수술적 표준 치료(nonsurgical standard treatment)

를 받도록 계획되었다.

환자들의 평균 연령은 73세였으며, 70%가 남성이었다.

주요 유효성 평가(primary efficacy analysis)에, 1차 결과 사건(primary-outcome event)은

• 색전술군에서는 120명 중 19명(16%)

• 대조군에서는 129명 중 47명(36%)

에서 발생하였다.

오즈비(odds ratio)는 0.36이었고, 95% 신뢰구간은 0.20–0.66, P값은 0.001이었다.

즉, 중경막동맥 색전술을 추가한 군에서 치료 실패 위험이 유의하게 감소하였다.

·         결론 : 증상이 있는 만성 경막하혈종 환자에서, 보조적 중경막동맥 색전술(adjunctive middle meningeal artery embolization)을 시행한 경우는 표준 치료만 시행한 경우보다 치료 실패 위험이 더 낮았다. 또한 단기적으로 장애를 남기는 뇌졸중(disabling stroke) 사망의 발생률 증가 없이 이러한 효과를 보였다. 다만 장기적인 안전성(longer-term safety outcomes)에 대해서는 추가 연구가 필요하다.

(본 연구는 Balt USA의 지원을 받았으며, STEM 임상시험 등록번호는 NCT04410146이다.)