Mortezaei Ali, Al-Saidi Nadir, Ghorbi Leila, Taghlabi Khaled M, Hajikarimloo Bardia, Habibi Mohammad Amin, Mohammadzadeh Ibrahim, Rahmani Redi, Srinivasan Visish M, Burkhardt Jan-Karl, Faraji Amir H
Gonabad University of Medical Sciences, Gonābād, Islamic Republic of Iran.
Houston Methodist, Houston, USA.
Neuroradiology. 2025 May 20. doi: 10.1007/s00234-025-03651-9.
Selection of an embolic agent for middle meningeal artery embolization (MMAE) in a chronic subdural hematoma (cSDH) is a subject of debate and is limited to observational data. We report the first meta-analysis that exclusively assessed randomized controlled trials (RCTs) to address this gap.
A systematic review and meta-analysis was conducted, incorporating all available RCTs that compared MMAE plus standard of care (SOC) versus SOC alone for cSDH usingeither Onyx, n-BCA, and Squid as embolic agent for embolization. Primary outcomes were the rate of hematoma recurrence/progression and the need for reoperation. Secondary outcomes included serious adverse events (SAE), all-cause mortality, functional independence (defined as a Modified Rankin Scale (mRS) score of 0-2), and the rate of successful embolization. To assess heterogeneity, a fixed-effect or random-effects model was applied, depending on statistical significance (I²>50%, P < 0.1).
Four RCTs, with 894 patients in the MMAE plus SOC group and 914 patients in the SOC alone group, were identified and met our standard for analysis. Results revealed significant superiority of n-BCA compared to Onyx and Squid in lower all-cause mortality at last follow-up. There was no significant difference in using Onyx, Squid, and n-BCA in recurrence at the last follow-up (P = 0.36), reoperation at the last follow-up (P = 0.55), and successful embolization (P = 0.52), and 90-day functional independence (P = 0.076) between trials. Additionally, further analysis on safety outcomes showed no significant difference between embolic agents in SAE at last follow-up (P = 0.78), embolization-related complications (P = 0.087), new onset ischemic stroke (P = 0.98), and deep venous thrombosis (P = 0.94).
This meta-analysis of RCTs suggests that while n-BCA is associated with lower all-cause mortality compared to Onyx and Squid in MMAE for cSDH, all three embolic agents demonstrate comparable efficacy and safety.
慢性硬膜下血肿（cSDH）患者中，选择何种栓塞剂用于脑膜中动脉栓塞术（MMAE）存在争议，且相关研究仅限于观察性数据。我们开展了首个荟萃分析，专门评估随机对照试验（RCT）以填补这一空白。
进行了一项系统评价和荟萃分析，纳入了所有比较MMAE联合标准治疗（SOC）与单纯SOC治疗cSDH的RCT，栓塞剂使用Onyx、n-丁基氰基丙烯酸酯（n-BCA）和Squid。主要结局为血肿复发/进展率和再次手术需求。次要结局包括严重不良事件（SAE）、全因死亡率、功能独立性（定义为改良Rankin量表（mRS）评分为0-2）和栓塞成功率。为评估异质性，根据统计学显著性（I²>50%，P < 0.1）应用固定效应或随机效应模型。
共纳入4项RCT，MMAE联合SOC组894例患者，单纯SOC组914例患者，均符合分析标准。结果显示，在末次随访时，n-BCA的全因死亡率低于Onyx和Squid。在末次随访时的复发率（P = 0.36）、再次手术率（P = 0.55）、栓塞成功率（P = 0.52）以及90天功能独立性（P = 0.076）方面，使用Onyx、Squid和n-BCA的试验之间无显著差异。此外，对安全性结局的进一步分析显示，在末次随访时，SAE（P = 0.78）、栓塞相关并发症（P = 0.087）、新发缺血性卒中（P = 0.98）和深静脉血栓形成（P = 0.94）方面，栓塞剂之间无显著差异。
这项RCT的荟萃分析表明，在cSDH的MMAE中，与Onyx和Squid相比，n-BCA全因死亡率较低，但三种栓塞剂疗效和安全性相当。
