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 language | English (US) |
|---|---|
| Pages (from-to) | 861-870 |
| Number of pages | 10 |
| Journal | International Forum of Allergy and Rhinology |
| Volume | 4 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 1 2014 |
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Keywords
- Corticosteroid
- CRSwNP
- Drug-eluting
- Efficacy
- Endoscopic sinus surgery
- Mometasone furoate
- Nasal polyps
- Refractory
- Safety
- Sinusitis
ASJC Scopus subject areas
- Immunology and Allergy
- Otorhinolaryngology
- Medicine(all)
Cite this
RESOLVE : A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. / Han, Joseph K.; Forwith, Keith D.; Smith, Timothy; Kern, Robert C.; Brown, William J.; Miller, Steven K.; Ow, Randall A.; Poetker, David M.; Karanfilov, Boris; Matheny, Keith E.; Stambaugh, James; Gawlicka, Anna K.
In: International Forum of Allergy and Rhinology, Vol. 4, No. 11, 01.11.2014, p. 861-870.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - RESOLVE
T2 - A randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis
AU - Han, Joseph K.
AU - Forwith, Keith D.
AU - Smith, Timothy
AU - Kern, Robert C.
AU - Brown, William J.
AU - Miller, Steven K.
AU - Ow, Randall A.
AU - Poetker, David M.
AU - Karanfilov, Boris
AU - Matheny, Keith E.
AU - Stambaugh, James
AU - Gawlicka, Anna K.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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.
AB - 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.
KW - Corticosteroid
KW - CRSwNP
KW - Drug-eluting
KW - Efficacy
KW - Endoscopic sinus surgery
KW - Mometasone furoate
KW - Nasal polyps
KW - Refractory
KW - Safety
KW - Sinusitis
UR - http://www.scopus.com/inward/record.url?scp=84933522459&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84933522459&partnerID=8YFLogxK
U2 - 10.1002/alr.21426
DO - 10.1002/alr.21426
M3 - Article
C2 - 25266981
AN - SCOPUS:84933522459
VL - 4
SP - 861
EP - 870
JO - International Forum of Allergy and Rhinology
JF - International Forum of Allergy and Rhinology
SN - 2042-6976
IS - 11
ER -