2018 Section 5 - Rhinology and Allergic Disorders

Reprinted by permission of Int Forum Allergy Rhinol. 2016; 6(6):573-581.

OR I G I NAL ART I CLE

RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis a er sinus surgery: 6-month outcomes from a randomized, controlled, blinded study Keith D. Forwith, PhD, MD 1 , Joseph K. Han, MD 2 , J. Pablo Stolovitzky, MD 3 , David M. Yen, MD 4 , Rakesh K. Chandra, MD 5 , Boris Karanfilov, MD 6 , Keith E. Matheny, MD 7 , James W. Stambaugh, BS 8 and Anna K. Gawlicka, PhD, MBA 8

Background: Patients with recurrent sinonasal polyposis a er endoscopic sinus surgery (ESS) have limited treat- ment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometa- sone 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 consid- ered 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 indepen- dent 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 signifi- cant improvement in Nasal Obstruction Symptom Evalua- tion (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 pa- tients experienced significant reduction in ethmoid si- nus obstruction ( p < 0.001) and bilateral polyp grade ( p = 0.018) compared to controls. Panel review con- firmed 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 improve- ments observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP a er 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. C 2016 ARS-AAOA, LLC. Key Words: chronic sinusitis; CRSwNP; corticosteroid; bioabsorbable; revision ESS; inflammation; nasal polyps; stent; implant; refractory How to Cite this Article : Forwith KD, Han JK, Stolovitzky JP, et al. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis a er si- nus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol . 2016;6:573–581. Funding sources for the study: Intersect ENT. Potential conflict of interest: K.D.F.: consultant to Intersect ENT; J.K.H.: consultant to Intersect ENT; J.P.S.: consultant to Intersect ENT; D.M.Y.: consultant to Intersect ENT; B.K.: consultant to Intersect ENT; K.E.M.: consultant to Intersect ENT; J.W.S. and A.K.G.: Intersect ENT employees. Presented at the Annual ARS Meeting on September 25, 2015, in Dallas, TX. Public clinical trial registration: http://clinicaltrials.gov/show/NCT01732536. A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction. Received: 27 August 2015; Revised: 9 December 2015; Accepted: 5 January 2016 DOI: 10.1002/alr.21741 View this article online at wileyonlinelibrary.com.

1 Advanced ENT and Allergy, Louisville, KY; 2 Divisions of Rhinology and Endoscopic Sinus-Skull Base Surgery and Allergy, Eastern Virginia Medical School, Norfolk, VA; 3 ENT of Georgia, Atlanta, GA; 4 Bethlehem Ear, Nose and Throat Associates, Bethlehem, PA; 5 Rhinology, Sinus and Skull Base Surgery, Department of Otolaryngology, Vanderbilt University, Nashville, TN; 6 Department of Otolaryngology, Ohio State University, Ohio Sinus Institute, Dublin, OH; 7 Collin County Ear Nose and Throat, Frisco, TX; 8 Clinical Affairs, Intersect ENT, Menlo Park, CA Correspondence to: Keith D. Forwith, PhD, MD, Advanced ENT and Allergy, 4004 Dupont Circle, Suite 220, Louisville, KY 40207; e-mail: kforwith@advancedentandallergy.com

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