Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma (PREMMA); A multi-center, blinded assessor, superiority, 12-month, parallel-group, randomized controlled trial to compare the reoperation rate between embolization of the middle meningeal artery versus surgical evacuation in chronic subdural hematoma

Abstract Background: Chronic subdural hematoma (cSDH) is a collection of fluid and blood breakdown products that evolves over weeks to months in the subdural space. It is more common among people older than 65 and has been associated with increased use of antithrombotic therapy among this population. The current standard of care is surgical evacuation (SE), which has been associated with recurrence rates between 10-30%. In recent years, embolization of the middle meningeal artery (eMMA) has been shown to decrease the recurrence of chronic subdural hematoma and the need for revision burr hole or craniotomy with rates from 4-10%. Many randomized controlled trials are ongoing, most of them comparing the eMMA as an adjunctive therapy to SE. The present trial aims to compare the eMMA as a stand-alone treatment for cSDH vs the standard of care. Methods: PREMMA is an investigator-initiated multicentric trial comparing 1:1 eMMA vs. SE. Patients presented to the emergency room (ER) with cSDH symptoms and radiologic confirmation will be invited to participate. The primary objective of the study is to determineif the reoperation rate of cSDH at 12 months is lower after stand-alone embolization of the middle meningeal artery than after surgical evacuation. Discussion: Following retrospective data review, eMMA has demonstrated efficacy as a stand-alone treatment for cSDH with lower recurrence rates than SE. Randomized controlled trials are necessary to support the data, which may represent vital information for changing the standard of care that will positively impact the vulnerable population. Trial registration: The PREMMA trial was registered and approved by the UPR-RCM-IRB Number: 2305109135. The PREMMA trial was registered on Clinicaltrials.gov with the NCT number: NCT06466733