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
| Autor: | Jura Numminen, Rami Taulu, Niko Sillanpää, Markus Rautiainen |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Triamcinolone acetonide medicine.drug_class medicine.medical_treatment Triamcinolone Acetonide 03 medical and health sciences 0302 clinical medicine Ethmoid Sinus medicine Clinical endpoint Humans Prospective Studies Sinusitis 030223 otorhinolaryngology Glucocorticoids Administration Intranasal Rhinitis business.industry Stent Drug-Eluting Stents Endoscopy Nasal Sprays Middle Aged Surgery Clinical trial Treatment Outcome Otorhinolaryngology Nasal spray Drug-eluting stent 030220 oncology & carcinogenesis Chronic Disease Corticosteroid Nasal administration Female business medicine.drug |
| Zdroj: | Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-LaryngologyCervico-Facial SurgeryREFERENCES. 45(3) |
| ISSN: | 1749-4486 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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