Johnson & Johnson (J&J) recently announced the publication of the primary results from the MEMBRANE randomised controlled trial (RCT) in JAMA Neurology. The study showed that adding middle meningeal artery embolisation (MMAe) with the company’s Trufill n-butyl cyanoacrylate (n-BCA) to standard of care was associated with reduced chronic subdural haematoma (cSDH) recurrence and reintervention versus standard of care alone.
“CSDH remains a challenging condition with meaningful risk of recurrence, particularly in elderly and medically complex patients,” said MEMBRANE study co-principal investigator Christopher Kellner (Mount Sinai Health System, New York, USA). “The MEMBRANE data provide important evidence that MMAe with Trufill n-BCA can reduce recurrence and the need for additional intervention while demonstrating an encouraging safety profile.”
MEMBRANE is a prospective, multicentre, open-label RCT that randomised 376 patients across 30 sites in the USA and China, evaluating MMAe within both surgical and non-surgical cSDH treatment pathways.
Participants treated with standard of care plus MMAe with Trufill n-BCA were significantly less likely to meet the prespecified composite primary endpoint of residual or re-accumulated cSDH >10mm, or the need for surgical reintervention within six months, than those treated with standard of care alone. This corresponded to a 47% reduction in odds, as noted in a J&J press release.
Additional findings from the MEMBRANE study include the embolisation group having a numerically lower all-cause mortality rate at six months (3.3% vs 8.4%); 85.3% vs 77% achieving good functional outcomes at three months, with MMAe meeting the trial’s non-inferiority threshold; and high procedural success, with successful embolisation achieved in 98.9% of cases.
“These results reinforce the growing clinical evidence supporting MMAe as an important treatment strategy for cSDH,” commented Christian Cuzick, worldwide president of neurovascular at J&J MedTech. “The MEMBRANE study adds meaningful randomised evidence demonstrating that embolisation with Trufill n-BCA can help reduce recurrence and reintervention while supporting positive patient outcomes.”
According to J&J, publication of the MEMBRANE results in JAMA Neurology ultimately adds to the growing body of randomised clinical evidence supporting MMAe as part of comprehensive cSDH management.
