Object: The Onyx liquid embolic system (Onyx) was approved in the European Union in 1999 for embolization of lesions in the intracranial and peripheral vasculature, including brain arteriovenous malformations (AVMs) and hypervascular tumors. In 2001 a prospective, equivalence, multicenter, randomized controlled trial was initiated to support a submission for FDA approval. The objective of this study was to verify the safety and efficacy of Onyx compared with N-butyl cyanoacrylate (NBCA) for the presurgical treatment of brain AVMs.
Methods: One hundred seventeen patients with brain AVMs were treated with either Onyx (54 patients) or NBCA (63 patients) for presurgical endovascular embolization between May 2001 and April 2003. The primary end point was technical success in achieving ≥ 50% reduction in AVM volume. Secondary end points were operative blood loss and resection time. All adverse events (AEs) were reported and assigned a relationship to the Onyx or NBCA system, treatment, disease, surgery, or other/unknown. The Data Safety Monitoring Board adjudicated AEs, and a blinded, independent core lab assessed volume measurements. Patients were monitored through discharge after the final surgery or through a 3- and/or 12-month follow-up if resection had not been performed or was incomplete.
Results: The use of Onyx led to ≥ 50% AVM volume reduction in 96% of cases versus 85% for NBCA (p = not significant). The secondary end points of resection time and blood loss were similar. Serious AEs were also similar between the 2 treatment groups.
Conclusions: Onyx is equivalent to NBCA in safety and efficacy as a preoperative embolic agent in reducing brain AVM volume by at least 50%.