Luong A, et al. - This study was planned to assess the safety and efficacy of the hourglass-shaped, bioabsorbable, steroid-releasing sinus implant in improving postoperative outcomes when placed in the frontal sinus ostia (FSO) following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). Findings revealed that compared with surgery alone, the hourglass-shaped steroid-releasing sinus implant was safe and more effective in terms of maintaining FSO patency and improving surgical outcomes in the setting where no other immediate postoperative corticosteroids were administered.

Methods

• Eighty adult patients, with a mean (SD) age of 49.5 (13.4) years were enrolled in a prospective, multicenter, randomized clinical trial using an intrapatient control design (ESS followed by implant placement within 1 FSO vs ESS alone on the contralateral side).
• The patients consisted of 53 (66%) men and 27 (34%) women.
• Patients underwent bilateral frontal sinusotomies with 1 frontal sinus randomized to receive a steroid-releasing implant.
• From July 2015 to March 2016, this study was carried out in 12 US centers.
• Interventions included a bioabsorbable steroid-releasing implant with hourglass shape containing 370 μg of mometasone furoate.
• Standardized postoperative care was provided to all the patients.

Results

• In all 80 randomized treatment sinuses, implants were successfully placed.
• At day 30, steroid-releasing implants resulted in marked reduction in the need for postoperative interventions to 11.5% compared with 32.8% by surgery alone (mean difference, -21.3%; 95% CI, -35.1% to -7.6%), as assessed by the independent reviewer.
• At day 30, real-time endoscopic assessment by clinical investigators showed marked reduction in need for postoperative intervention (mean difference, -17.3%; 95% CI, -27.9% to -6.7%), significant reduction in inflammation score (mean difference, -12.3 mm; 95% CI, -18.3 to -6.4 mm), and significant reduction in rate of frontal restenosis or occlusion (mean difference, -22.7%; 95% CI, -33.5% to -11.9%) on treated compared with control sides.
• Through day 90, the results favoring the treatment sides were sustained: reduced need for postoperative interventions (mean difference, -11.7%; 95% CI, -21.0% to -2.4%) and reduction in restenosis and/or occlusion of the frontal ostium (mean difference, -17.4%; 95% CI, -28.6% to -6.1%).
• Researchers observed no implant-related adverse events.