RESOLVE: A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis

Joseph K. Han, Keith D. Forwith, Timothy L. Smith, Robert C. Kern, William J. Brown, Steven K. Miller, Randall A. Ow, David M. Poetker, Boris Karanfilov, Keith E. Matheny, James Stambaugh, Anna K. Gawlicka

Research output: Contribution to journalArticle

29 Scopus citations

Abstract

Background: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. Methods: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes. Results: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation. Conclusion: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.

Original languageEnglish (US)
Pages (from-to)861-870
Number of pages10
JournalInternational Forum of Allergy and Rhinology
Volume4
Issue number11
DOIs
StatePublished - Nov 1 2014

Keywords

  • CRSwNP
  • Corticosteroid
  • Drug-eluting
  • Efficacy
  • Endoscopic sinus surgery
  • Mometasone furoate
  • Nasal polyps
  • Refractory
  • Safety
  • Sinusitis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Otorhinolaryngology

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    Han, J. K., Forwith, K. D., Smith, T. L., Kern, R. C., Brown, W. J., Miller, S. K., Ow, R. A., Poetker, D. M., Karanfilov, B., Matheny, K. E., Stambaugh, J., & Gawlicka, A. K. (2014). RESOLVE: A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. International Forum of Allergy and Rhinology, 4(11), 861-870. https://doi.org/10.1002/alr.21426