Ethmoidal drug-eluting stent therapy is not superior to nasal corticosteroid spray in the prevention of endoscopic sinus surgery: Results from a randomised, clinical trial.

ABSTRACT

OBJECTIVES: To evaluate whether an ethmoidal drug-eluting stent (DES) (the Relieva Stratus™ MicroFlow Spacer) could better prevent endoscopic sinus surgery (ESS) than standard non-invasive therapy using corticosteroid nasal spray in patients suffering from chronic rhinosinusitis (CRS). DESIGN: Prospective, randomised clinical trial. SETTING: Tertiary referral centre. PARTICIPANTS: Sixty-three adult patients with ethmoidal involvement in cone beam computerised tomography (CBCT) whose first-line medical treatment with topical corticosteroids had failed and who were candidates for ESS were randomised either to a DES group, which received triamcinolone acetonide stents (n = 34), or to a topical intranasal corticosteroid group (n = 29) that used optimally dosed triamcinolone acetonide nasal spray. OUTCOME MEASURES: Patients were followed up prospectively for 6 months and at 36 months. Freedom from ESS was the primary endpoint. Further, we identified those factors predicting ESS. RESULTS: At 6 months, ESS could be prevented in almost half of the patients in both groups (DES 13/28, 46.4%, nasal spray 14/29, 48.3%). At 36 months, 20/28 (71.4%) patients in the DES group and 18/29 (62.1%) in the nasal spray group had been operated. The differences were not statistically significant at either timepoint. Patients who smoked (14/19, 73.7% vs 16/38, 42.1%) were more likely to be operated at 6 months. CONCLUSION: Endoscopic sinus surgery can be prevented using both therapies in the medium term in almost half of cases with neither therapy being statistically superior. This effect was somewhat diminished in the long term with a trend towards more patients being operated in the DES group. Considering the additional costs, the need for general anaesthesia and the potential side effects associated with DES, its potential clinical role appears to be limited. Smoking was significantly associated with ESS.