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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
Author(s) -
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.
Publication year - 2016
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.21741
Subject(s) - medicine , mometasone furoate , surgery , randomized controlled trial , nasal polyps , nasal congestion , implant , sinus (botany) , sinusitis , ethmoid sinus , chronic rhinosinusitis , nose , corticosteroid , biology , botany , genus
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.