The ADVANCE II Study: A Prospective, Randomized, Multi‐center Study to Assess the Safety and Efficacy of a Bioabsorbable Steroid‐Eluting Sinus Implant

Abstract

Objective: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) may be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent intervention. To address this issue, we investigated the safety and effectiveness of controlled delivery of mometasone furoate to the sinus mucosa via bioabsorbable implants deployed at the time of ESS. Method: A prospective, multicenter, randomized, double-blind trial was performed on 105 patients with CRS under-going ESS, comparing the effect of drug-eluting to non-drug-eluting stents. Postoperative interventions, polyposis, and adhesions were assessed postoperatively. Efficacy was determined through independent analysis of randomized video-endoscopies by 3 blinded sinus surgeons. Safety assessments included ocular exams. Results: Implants were successfully deployed in all 210 sinuses. Compared with control sinuses, the drug-eluting stent provided a 29% relative reduction in postoperative interventions ( P = .0280), a 52% ( P = .0053) decrease in lysis of adhesions, and a 29% ( P = .0881) decrease in oral steroid prescriptions. The relative reduction in frank polyposis was 45% ( P = .0023). Similar reductions were observed in real-time grading performed by the clinical investigators. No clinically significant changes from baseline in intraocular pressure or cataracts were observed. Conclusion: Continual postoperative application of topical corticosteroids applied via drug-eluting stent deployed at surgery was studied to assess its impact upon ESS outcomes. This study strongly suggests that steroid-eluting implants are effective at improving surgical outcomes by reducing the need for postoperative interventions, with negligible ocular safety risk.