Generalizability of the EMBOLISE, MAGIC-MT, STEM, EMPROTECT, and MEMBRANE trials of middle meningeal artery embolization for chronic subdural hematoma: A single-center cohort analysis

IF 1.9 4区医学 Q3 CLINICAL NEUROLOGY

Clinical Neurology and Neurosurgery Pub Date : 2027-01-01 Epub Date: 2026-10-14 DOI:10.1016/j.clineuro.2026.109671

Naveen Arunachalam Sakthiyendran, Jimena Gonzalez-Salido, Alejandro Enriquez-Marulanda, Niels Pacheco-Barrios, Justin H. Granstein, Philipp Taussky, Christopher S. Ogilvy

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Abstract

Objective

The pivotal EMBOLISE, MAGIC-MT, and STEM randomized trials (RCTs) established middle meningeal artery embolization (MMAE) for chronic subdural hematoma (cSDH) but used differing criteria of uncertain real-world representativeness, and two further RCTs (EMPROTECT, MEMBRANE) have since reported. We quantified how many recipients met each trial's criteria, which criteria drove ineligibility, and whether outcomes differed between eligible and ineligible patients.

Methods

We retrospectively analyzed 214 consecutive single-center MMAE patients, classifying each as eligible or ineligible for all five trials by published criteria (bilateral hematomas judged by worst side). Outcomes were recurrence, rescue surgery, complications, radiologic resolution, and functional outcome (modified Rankin Scale, mRS); eligible-versus-ineligible outcomes were compared directly with Fisher exact tests (Benjamini-Hochberg/Holm correction), favorable outcome was modeled with multivariable logistic regression, and agreement used Cohen's kappa.

Results

Among 214 patients (mean age 73.4 years; 29.0% bilateral; 25.7% anticoagulated; 69.2% standalone MMAE), eligibility was 13.5% for EMBOLISE, 24.7% for MAGIC-MT, 17.7% for STEM, 6.1% for EMPROTECT, and 78.9% for MEMBRANE; the two newer trials bracketed rather than resolved the generalizability gap, EMPROTECT being the most restrictive and MEMBRANE the most permissive. Across the three original trials, 142 (66.4%) met none; across all five, 60 (28.0%) met none and only 1 met all five. Pairwise agreement was minimal except MAGIC-MT-versus-STEM (kappa 0.57). Recurrence (16.8%), rescue surgery (16.8%), complications (5.6%), and radiologic resolution did not differ by eligibility for any trial, and no eligible-versus-ineligible difference survived multiple-comparison correction. Favorable functional outcome (mRS 0–2; available in 95.8%) was nominally higher among eligible patients for MAGIC-MT, STEM, and MEMBRANE, but this advantage vanished after adjustment for pre-morbid mRS and age (all adjusted odds ratios non-significant); pre-morbid mRS and age—not trial eligibility—were the only independent predictors of functional outcome, and no baseline characteristic independently predicted recurrence, rescue surgery, or resolution.

Conclusions

Across five pivotal RCTs, a majority of real-world recipients fell outside any single trial population, and the two newest trials widened rather than closed this gap. Comparable outcomes across every eligibility stratum suggest MMAE effectiveness may extend beyond trial-defined populations, pending confirmation in dedicated trials.

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栓塞、MAGIC-MT、STEM、EMPROTECT和膜试验治疗慢性硬膜下血肿的普遍性：一项单中心队列分析。

目的：关键的EMBOLISE， MAGIC-MT和STEM随机试验（rct）建立了脑膜中动脉栓塞（MMAE）治疗慢性硬膜下血肿（cSDH），但使用了不同的标准，不确定现实世界的代表性，另外两项rct （EMPROTECT， MEMBRANE）已经报道。我们量化了有多少接受者符合每个试验的标准，哪些标准导致不合格，以及符合条件和不符合条件的患者之间的结果是否不同。方法：我们回顾性分析了214例连续的单中心MMAE患者，根据公布的标准（双侧血肿以最坏一侧判断）将每个患者分为符合条件或不符合条件的5个试验。结果包括复发、抢救手术、并发症、放射学缓解和功能结果（改良Rankin量表，mRS）；采用Fisher精确检验（Benjamini-Hochberg/Holm校正）直接比较符合条件和不符合条件的结果，采用多变量logistic回归对符合条件的结果进行建模，采用Cohen’s kappa对符合条件的结果进行建模。结果：在214例患者中（平均年龄73.4岁，29.0%双侧，25.7%抗凝，69.2%独立MMAE），栓塞治疗的适格率为13.5%,MAGIC-MT 24.7%, STEM 17.7%, EMPROTECT 6.1%, MEMBRANE 78.9%；这两个较新的试验并没有解决普遍性的差距，EMPROTECT是最严格的，而MEMBRANE是最宽松的。在三个原始试验中，142个（66.4%）不符合；在这五个人中，60人（28.0%）没有满足任何要求，只有1人满足所有要求。除magic - mt与stem （kappa 0.57）外，两两一致性最小。复发率（16.8%）、抢救手术率（16.8%）、并发症率（5.6%）和放射学分辨率没有因任何试验的合格性而不同，在多次比较校正后没有合格与不合格的差异。在MAGIC-MT、STEM和MEMBRANE的符合条件的患者中，良好的功能结局（mRS 0-2, 95.8%）名义上更高，但在调整发病前mRS和年龄后，这种优势消失了（所有调整后的优势比均不显著）；发病前mRS和年龄（非试验资格）是功能结局的唯一独立预测因素，没有基线特征独立预测复发、抢救手术或缓解。结论：在五项关键的随机对照试验中，大多数现实世界的接受者不在任何单一试验人群中，而两项最新的试验扩大了而不是缩小了这一差距。每个适格阶层的可比结果表明，MMAE的有效性可能超出试验定义的人群，有待专门试验的证实。

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

Clinical Neurology and Neurosurgery 医学-临床神经学

CiteScore

3.70

自引率

5.30%

发文量

358

审稿时长

46 days

期刊介绍： Clinical Neurology and Neurosurgery is devoted to publishing papers and reports on the clinical aspects of neurology and neurosurgery. It is an international forum for papers of high scientific standard that are of interest to Neurologists and Neurosurgeons world-wide.