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- Title
RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study.
- Authors
Forwith, Keith D.; Han, Joseph K.; Stolovitzky, J. Pablo; Yen, David M.; Chandra, Rakesh K.; Karanfilov, Boris; Matheny, Keith E.; Stambaugh, James W.; Gawlicka, Anna K.
- Abstract
Background Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer-term outcomes. Methods A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in-office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six-month follow-up included endoscopic grading and patient-reported outcomes. Results At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score ( p = 0.021) and >2-fold improvement in mean nasal obstruction/congestion score (−1.06 ± 1.4 vs −0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction ( p < 0.001) and bilateral polyp grade ( p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction ( p = 0.010) and 2-fold improvement in bilateral polyp grade ( p = 0.099), which reached statistical significance ( p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients. Conclusion The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.
- Subjects
SURGICAL complications; NASAL surgery; ARTIFICIAL implants; SINUSITIS treatment; RANDOMIZED controlled trials
- Publication
International Forum of Allergy & Rhinology, 2016, Vol 6, Issue 6, p573
- ISSN
2042-6976
- Publication type
Article
- DOI
10.1002/alr.21741