Airway Stents for Excessive Central Airway Collapse: A Randomized Controlled Open-label Trial.

ABSTRACT

BACKGROUND: Short-term airway stent placement (stent evaluation) has been employed to evaluate whether patients with excessive central airway collapse (ECAC) will benefit from tracheobronchoplasty. Although retrospective studies have explored the impact of stent placement on ECAC, prospective randomized controlled trials are absent. METHODS: This was a randomized open-label trial comparing patients receiving airway stent placement and standard medical treatment (intervention group) versus standard medical treatment alone (control group) for ECAC. At baseline, patients' respiratory symptoms, self-reported measures, and functional capabilities were assessed. Follow-up evaluations occurred 7 to 14 days postintervention, with an option for the control group to crossover to stent placement. Follow-up evaluations were repeated in the crossover patients. RESULTS: The study enrolled 17 patients in the control group [medical management (MM)] and 14 patients in the intervention group. At follow-up, 15 patients in the MM crossed over to the stent group, resulting in a total of 29 patients in the combined stent group (CSG). Subjectively (shortness of breath and cough), 45% of the CSG exhibited improvement with the intervention compared with just 12% in the MM. The modified St. George Respiratory Questionnaire score in the CSG improved significantly from 61.2 at baseline to 52.5 after stent placement (-8.7, P = 0.04). With intervention, the 6-minute walk test in CSG improved significantly from 364 meters to 398 meters (34 m, P < 0.01). The MM did not show a significant change in the St. George Respiratory Questionnaire score or 6-minute walk test distance. CONCLUSION: Short-term airway stent placement in patients with ECAC significantly improves respiratory symptoms, quality of life, and exercise capacity.