TY - JOUR
T1 - Middle Meningeal Artery Embolization for Subdural Hematoma
T2 - CT/MRI End Points of the EMBOLISE Trial
AU - EMBOLISE Investigators
AU - Kniep, Helge
AU - Gellissen, Susanne
AU - Bechstein, Matthias
AU - Meyer, Lukas
AU - Broocks, Gabriel
AU - Heitkamp, Christian
AU - Winkelmeier, Laurens
AU - Flottmann, Fabian
AU - Geest, Vincent
AU - Hanning, Uta
AU - Thaler, Christian
AU - Bester, Maxim
AU - Davies, Jason M.
AU - Knopman, Jared
AU - Mokin, Maxim
AU - Hassan, Ameer E.
AU - Harbaugh, Robert E.
AU - Khalessi, Alexander
AU - Siddiqui, Adnan H.
AU - Gross, Bradley A.
AU - Grandhi, Ramesh
AU - Tarpley, Jason
AU - Sivakumar, Walavan
AU - Bain, Mark
AU - Crowley, R. Webster
AU - Link, Thomas W.
AU - Fraser, Justin F.
AU - Levitt, Michael R.
AU - Chen, Peng Roc
AU - Hanel, Ricardo A.
AU - Bernard, Joe D.
AU - Jumaa, Mouhammad
AU - Youssef, Patrick
AU - Cress, Marshall C.
AU - Chaudry, Mohammad Imran
AU - Shakir, Hakeem J.
AU - Lesley, Walter S.
AU - Billingsley, Joshua
AU - Jones, Jesse
AU - Koch, Matthew J.
AU - Paul, Alexandra R.
AU - Mack, William J.
AU - Osbun, Joshua W.
AU - Dlouhy, Kathleen
AU - Grossberg, Jonathan A.
AU - Kellner, Christopher P.
AU - Sahlein, Daniel H.
AU - Santarelli, Justin
AU - Schirmer, Clemens M.
AU - Singer, Justin
PY - 2026/1/1
Y1 - 2026/1/1
N2 - Background Chronic subdural hematomas (cSDHs) are associated with high recurrence risks following surgical evacuation. The EMBOLISE trial demonstrated that, compared with surgery alone, adjunctive middle meningeal artery embolization (MMAE) significantly reduced reoperation rates. However, given the limitations of the clinical end points of the trial, which may be subject to interrater variability and certain biases, the quantitative imaging metrics need to be evaluated. Purpose To evaluate the prespecified imaging end points of the EMBOLISE trial and assess the long-term resolution of cSDH through quantitative imaging analyses. Materials and Methods EMBOLISE was a multicenter, randomized, interventional trial conducted across 39 U.S. sites between December 2020 and August 2023. Prespecified secondary imaging end points included changes in hematoma volume and thickness and midline shifts from 24 hours to 90 days after the procedure at CT and MRI. The post hoc analyses performed herein extended the assessment to 180 days and included absolute hematoma metrics. Mixed-effects modeling was employed to adjust for confounders. Results Four hundred patients were enrolled in the EMBOLISE study, among whom 352 were included (mean age, 72 years ± 10.4 [SD]; 256 men). The mean cSDH volume was 126 mL at screening, with no intergroup differences. At 90 and 180 days, the MMAE plus surgery group had lower cSDH volumes (20.6 mL vs 28.9 mL [P = .03] and 19.4 mL vs 31.5 mL [P = .04], respectively). Mixed-effects models revealed a 6.9 mL (95% CI: -13.5, -0.40; approximately 25%) greater volume reduction and an 8.4 mL (95% CI: -15.2, -1.6; approximately 30%) lower absolute volume at 90 days in the MMAE group There was no evidence of a difference in the prespecified secondary imaging end points between the groups. Conclusion While the prespecified secondary imaging end points did not significantly differ, the absolute 90- and 180-day hematoma volumes were significantly lower in patients who received MMAE and surgery. Confounder-adjusted mixed-effects analysis indicated a greater reduction in hematoma volume with adjunctive MMAE. ClinicalTrials.gov identifier NCT04402632
AB - Background Chronic subdural hematomas (cSDHs) are associated with high recurrence risks following surgical evacuation. The EMBOLISE trial demonstrated that, compared with surgery alone, adjunctive middle meningeal artery embolization (MMAE) significantly reduced reoperation rates. However, given the limitations of the clinical end points of the trial, which may be subject to interrater variability and certain biases, the quantitative imaging metrics need to be evaluated. Purpose To evaluate the prespecified imaging end points of the EMBOLISE trial and assess the long-term resolution of cSDH through quantitative imaging analyses. Materials and Methods EMBOLISE was a multicenter, randomized, interventional trial conducted across 39 U.S. sites between December 2020 and August 2023. Prespecified secondary imaging end points included changes in hematoma volume and thickness and midline shifts from 24 hours to 90 days after the procedure at CT and MRI. The post hoc analyses performed herein extended the assessment to 180 days and included absolute hematoma metrics. Mixed-effects modeling was employed to adjust for confounders. Results Four hundred patients were enrolled in the EMBOLISE study, among whom 352 were included (mean age, 72 years ± 10.4 [SD]; 256 men). The mean cSDH volume was 126 mL at screening, with no intergroup differences. At 90 and 180 days, the MMAE plus surgery group had lower cSDH volumes (20.6 mL vs 28.9 mL [P = .03] and 19.4 mL vs 31.5 mL [P = .04], respectively). Mixed-effects models revealed a 6.9 mL (95% CI: -13.5, -0.40; approximately 25%) greater volume reduction and an 8.4 mL (95% CI: -15.2, -1.6; approximately 30%) lower absolute volume at 90 days in the MMAE group There was no evidence of a difference in the prespecified secondary imaging end points between the groups. Conclusion While the prespecified secondary imaging end points did not significantly differ, the absolute 90- and 180-day hematoma volumes were significantly lower in patients who received MMAE and surgery. Confounder-adjusted mixed-effects analysis indicated a greater reduction in hematoma volume with adjunctive MMAE. ClinicalTrials.gov identifier NCT04402632
UR - https://www.scopus.com/pages/publications/105028739249
U2 - 10.1148/radiol.251746
DO - 10.1148/radiol.251746
M3 - Article
C2 - 41591252
AN - SCOPUS:105028739249
SN - 0033-8419
VL - 318
SP - e251746
JO - Radiology
JF - Radiology
IS - 1
ER -