| Autor: |
Shotar, Eimad, Mathon, Bertrand, Rouchaud, Aymeric, Mounayer, Charbel, Salle, Henri, Bricout, Nicolas, Lejeune, Jean-Paul, Janot, Kevin, Zemmoura, Ilyess, Naggara, Olivier, Roux, Alexandre, Goutagny, Stéphane, Guedon, Alexis, Brunel, Herve, Troude, Lucas, Dufour, Henry, Bernat, Anne-Laure, Tuilier, Titien, Bresson, Damien, Apra, Caroline, Fouet, Mathilde, Escalard, Simon, Chauvet, Dorian, Baptiste, Amandine, Lebbah, Said, Dechartres, Agnès, Clarencon, Frédéric |
| Zdroj: |
Journal of Neurointerventional Surgery; 2025, Vol. 17 Issue: 1 pe172-e177, 6p |
| Abstrakt: |
BackgroundMiddle meningeal artery (MMA) embolization has been proposed as a treatment of chronic subdural hematoma (CSDH). The benefit of the procedure has yet to be demonstrated in a randomized controlled trial. We aim to assess the efficacy of MMA embolization in reducing the risk of CSDH recurrence 6 months after burr-hole surgery compared with standard medical treatment in patients at high risk of postoperative recurrence.MethodsThe EMPROTECT trial is a multicenter open label randomized controlled trial (RCT) involving 12 French centers. Adult patients (≥18 years) operated for CSDH recurrence or for a first episode with a predefined recurrence risk factor are randomized 1:1 to receive either MMA embolization within 7 days of the burr-hole surgery (experimental group) or standard medical care (control group). The number of patients to be included is 342.ResultsThe primary outcome is the rate of CSDH recurrence at 6 months. Secondary outcomes include the rate of repeated surgery for a homolateral CSDH recurrence during the 6-month follow-up period, the rate of disability and dependency at 1 and 6 months, defined by a modified Rankin Scale (mRS) score ≥4, mortality at 1 and 6 months, total cumulative duration of hospital stay during the 6-month follow-up period, directly or indirectly related to the CSDH and embolization procedure-related complication rates.ConclusionsThe EMPROTECT trial is the first RCT evaluating the benefit of MMA embolization as a surgical adjunct for the prevention of CSDH recurrence. If positive, this trial will have a significant impact on patient care.Trial registration numberNCT04372147. |
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