The pilot study enrolled 43 patients; 38 were randomized to receive a drug-eluting stent on one side and a non-drug-eluting stent on the other. The remaining five patients received bilateral sinus stents. No device-related adverse effects were noted during the six-week trial period, and post-operative inflammation, polyposis and adhesion were significantly less common in sinuses with drug-eluting stents than in the sinuses with non-drug-eluting stents The adhesion rate in sinuses without drug-eluting stents was 21.1 percent, compared with 5.3 percent in the sinuses with a drug-eluting stent. The pilot study also demonstrated the safety of the bioabsorbable stent. By day 30, an average of less than 10 percent of the stent material remained; by the end of the study, the stent material was completely absorbed (Int Forum Allergy Rhinol. 2011;1(1):23-32).
Explore This IssueDecember 2011
As Dr. Marple explained during his AAO-HNS presentation, the ADVANCE trial studied the device in 50 patients; ADVANCE II enrolled 105 patients with CRS refractory to medical management. All patients underwent FESS prior to deployment of the stent. As in the pilot study, patients were randomized to receive a non-drug-eluting stent on one side and the drug-eluting stent on the other. An independent panel of three sinus surgeons reviewed and graded endoscopic views of the treated sinuses at post-op day 30. Compared with the control sinuses, the drug-eluting stent provided a 29 percent (p=0.0280) relative reduction in post-operative interventions, a 52 percent (p=0.0053) decrease in lysis of adhesions and a 29 percent decrease (p=0.0023) in oral steroid prescriptions. No clinically significant ocular effects were noted; two device-related adverse events were coded as sinusitis and relieved without difficulty.
While the pilot and ADVANCE II research studies did not specifically examine patients’ quality-of-life pre- and post-stenting, the ADVANCE study assessed patients’ symptoms for six months using Sino-Nasal Outcome Test and RSDI quality of life instruments. Significant improvements in patient outcomes were reported during the six-month period, Dr. Han, who participated in the research and conducted the meta-analysis, said in an interview after the AAO-HNS meeting. A number of his patients also reported less pain on one side than the other, though neither the patient nor the clinician knew with certainty which side contained the drug-eluting stent and which contained a plain version of the stent.
Patients in the clinical research studies had a “relatively significant” disease burden, Dr. Marple said in an interview after the AAO-HNS meeting. All had a minimum Lund-MacKay stage of six; the average was 12.4. Patients with insulin-dependent diabetes, acute or invasive fungal sinusitis, an oral-steroid dependent condition and a history of immunodeficiency, glaucoma or ocular hypertension were excluded from the studies.