| Title: |
Meningeal Embolization for Preventing Chronic Subdural Hematoma Recurrence After Surgery: The EMPROTECT Randomized Clinical Trial. |
| Authors: |
Shotar, Eimad; Mathon, Bertrand; Salle, Henri; Rouchaud, Aymeric; Mounayer, Charbel; Bricout, Nicolas; Lejeune, Jean-Paul; Janot, Kevin; Amelot, Aymeric; Naggara, Olivier; Roux, Alexandre; Goutagny, Stéphane; Guédon, Alexis; Houdart, Emmanuel; Brunel, Hervé; Hak, Jean-François; Troude, Lucas; Dufour, Henry; Bernat, Anne-Laure; Tuilier, Titien; Bresson, Damien; Apra, Caroline; Fouet, Mathilde; Escalard, Simon; Chauvet, Dorian; Premat, Kevin; Lebbah, Said; Dechartres, Agnès; Clarencon, Frédéric; EMPROTECT Investigators; Delvoye, François |
| Source: |
JAMA: Journal of the American Medical Association, 334 (2), 127 - 135 (2025-07-08) |
| Publisher Information: |
American Medical Association |
| Publication Year: |
2025 |
| Collection: |
University of Liège: ORBi (Open Repository and Bibliography) |
| Subject Terms: |
Aged; 80 and over; Female; Humans; Male; Recurrence; Reoperation/statistics & numerical data; Treatment Outcome; Embolization; Therapeutic/adverse effects; Therapeutic/methods; Therapeutic/statistics & numerical data; Hematoma; Subdural; Chronic/prevention & control; Chronic/surgery; Chronic/therapy; Meningeal Arteries; Secondary Prevention/methods; Therapeutic; Chronic; Middle Aged; Reoperation; Secondary Prevention; Medicine (all); Human health sciences; Neurology; Sciences de la santé humaine; Neurologie |
| Description: |
peer reviewed ; [en] IMPORTANCE: Middle meningeal artery (MMA) embolization has been proposed as a potential treatment for chronic subdural hematoma (CSDH). OBJECTIVE: To assess the efficacy of MMA embolization in reducing the risk of CSDH recurrence at 6 months compared with standard care in patients who underwent an operation and were at high risk of CSDH recurrence. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized clinical trial with blinded end point assessment. Patients who underwent an operation for CSDH recurrence or a first CSDH episode at high risk of recurrence were recruited from July 2020 to March 2023 in 12 French neurosurgical or comprehensive neurosurgical and interventional neuroradiology centers. Last follow-up took place on November 2, 2023. INTERVENTION: Participants were randomized 1:1 to undergo MMA embolization with microparticles within 7 days of surgery (171 patients, intervention group) or standard medical care alone (171 patients, control group). MAIN OUTCOMES AND MEASURES: The primary end point was the rate of CSDH recurrence at 6 months assessed by an independent, blinded adjudication committee. There were 5 secondary end points, including rates of repeat surgery for homolateral CSDH recurrence during the 6-month follow-up period and embolization procedure-related complications. RESULTS: Among 342 randomized patients (median [IQR] age, 77 [68-83] years; 274 [80.1%] male), 308 (90.1%) completed the trial. The primary end point was observed in 24 of 162 (14.8%) and 33 of 157 (21.0%) patients in the intervention and control groups, respectively (after imputation: odds ratio, 0.64 [95% CI, 0.36-1.14]; adjusted absolute difference, -6% [95% CI, -14% to 2%]; P = .13). The groups did not significantly differ in any of the secondary end points. Repeat surgery was performed in 7 of 162 (4.3%) and 13 of 157 (8.3%) patients in the intervention and control groups (P = .14), respectively. Minor and major embolization procedure-related complications occurred in 3 of 171 (1.8%) ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0098-7484; 1538-3598 |
| Relation: |
https://jamanetwork.com/journals/jama/articlepdf/2834971/jama_shotar_2025_oi_250033_1749157018.19131.pdf; urn:issn:0098-7484; urn:issn:1538-3598; https://orbi.uliege.be/handle/2268/343147; info:hdl:2268/343147; https://orbi.uliege.be/bitstream/2268/343147/1/jama_shotar_2025_oi_250033_1750956987.75881.pdf; info:pmid:40471557 |
| DOI: |
10.1001/jama.2025.7583 |
| Availability: |
https://orbi.uliege.be/handle/2268/343147; https://orbi.uliege.be/bitstream/2268/343147/1/jama_shotar_2025_oi_250033_1750956987.75881.pdf; https://doi.org/10.1001/jama.2025.7583 |
| Rights: |
open access ; http://purl.org/coar/access_right/c_abf2 ; info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.3AE69797 |
| Database: |
BASE |