title: Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent.
abstract: BACKGROUND
  Inflammation/polyp recurrence, adhesions, and middle turbinate lateralization are causes of suboptimal outcomes following sinus surgery and lead to increased rates of revision. A bioabsorbable, drug-eluting stent was evaluated for its ability to preserve sinus patency by providing controlled steroid delivery to the sinus mucosa. The study objective was to assess safety and efficacy of a steroid-eluting sinus stent when used following functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis (CRS).
  
  
  METHODS
  Prospective, multicenter, randomized, double-blind clinical trial, enrolling 43 patients in 2 groups. One group (n = 38) used an intrapatient control design comparing drug-eluting to non-drug-eluting stents. The other group (n = 5) received bilateral drug-eluting stents to assess systemic safety. Endoscopic follow-up was performed for 60 days. Efficacy endpoints included assessment of inflammation, polyp formation, adhesions, and middle turbinate position.
  
  
  RESULTS
  Stents were successfully deployed in all 86 sinuses. Compared to the control stent, the drug-eluting stent provided statistically significant reduction in inflammation at days 21 to 45 (p < 0.003), frequency of polyp formation (p = 0.0391), and frequency of significant adhesion (p = 0.0313). Reduced frequency of middle turbinate lateralization was also apparent though not statistically significant. No device-related adverse events occurred. Eluted steroid was unquantifiable systemically and there was no evidence of adrenal cortical suppression.
  
  
  CONCLUSIONS
  This study demonstrates the safety and efficacy of a novel bioabsorbable, steroid-eluting stent for use in CRS patients. The steroid-eluting stent is effective in improving wound healing by preserving sinus patency, reducing inflammation, and minimizing adhesions via controlled local steroid delivery without measurable systemic exposure.
authors.affiliation: University of California, San Francisco School of Medicine, San Francisco, CA, USA. ahmurr@ohns.ucsf.edu
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Murr
authors.forename: Timothy L
authors.initials: TL
authors.lastname: Smith
authors.forename: Peter H
authors.initials: PH
authors.lastname: Hwang
authors.forename: Neil
authors.initials: N
authors.lastname: Bhattacharyya
authors.forename: Brent J
authors.initials: BJ
authors.lastname: Lanier
authors.forename: James W
authors.initials: JW
authors.lastname: Stambaugh
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Mugglin
mesh_terms: D020341:Absorbable Implants; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D004724:Endoscopy / Q000379:methods*; D004867:Equipment Design; D005005:Ethmoid Sinus / Q000601:surgery; D015521:Ethmoid Sinusitis / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009298:Nasal Polyps / Q000188:drug therapy; D011183:Postoperative Complications / Q000188:drug therapy; D011244:Pregnadienediols / Q000008:administration & dosage*; D011446:Prospective Studies; D012220:Rhinitis / Q000601:surgery*; D013256:Steroids / Q000008:administration & dosage; D000267:Tissue Adhesions / Q000517:prevention & control; D016896:Treatment Outcome; D014420:Turbinates / Q000601:surgery; D014945:Wound Healing / Q000187:drug effects
chemical_list: D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D013256:Steroids; D000068656:Mometasone Furoate