Abstract Rationale Benign airway stenosis (BAS) causes significant morbidity due to dyspnea and impaired quality of life. BAS management remains challenging and often requires recurrent procedures. This study evaluated the safety and efficacy of a semicompliant paclitaxel coated balloon (DCB) to prevent recurrence in the treatment of BAS. Methods This is a first-in-human study conducted as a prospective, multicenter, single-arm, open-label study. Participants were treated with the Airiver Pulmonary DCB and evaluated preprocedure, at discharge, and at 1-, 3-, and 6-months posttreatment. The primary safety endpoint was freedom from major adverse events (MAE) through 1 month. The primary efficacy endpoint was freedom from symptom-driven target lesion reintervention though 6 months. Seventeen participants were included in a pharmacokinetic cohort. Results Fifty participants were enrolled at 4 sites in Georgia, Paraguay, and Panama. One participant discontinued the study early due to an unrelated medical issue, leaving 49 participants included in the 6-month analysis. The most common etiology of BAS was trauma (80%). Most patients had lesions in the trachea (83.0%) vs the bronchi (17.0%). Three participants (6%) had 2 lesions treated; all others had 1 lesion treated. Freedom from MAE at 30 days was 100%. There were no device-related SAE and 3 procedure-related SAEs. Freedom from symptom-driven reintervention through 6 months was 95.8% (45/47; 95% CI, 84.3%-98.9%). The incidence of any target lesion reintervention at 6 months was 10.4% (5/48; 95% CI 3.5%-22.7%). Myer-Cotton scores were improved from a mean of 2.7±0.6 at baseline to 1.3±0.6 at 6 months (P.0001). Mean modified Medical Research Council scores were improved from 2.1±1.2 at baseline to 0.7±1.0 at 6 months. All spirometry measures evaluated were significantly improved over baseline at 6 months (P0.05), except % predicted FVC. SF-12 physical and mental component scores were improved by 11.5±11.7 (P.0001) and 6.5±12.6 (P=.0013), respectively. The mean maximum plasma drug concentration (Cmax) was 0.06 ng/mL and was undetectable 48 hours postprocedure. Conclusion Results of this feasibility study show that at 6 months post dilation with the Airiver DCB, participants with BAS experienced low rates of symptom-driven reintervention, improvements in patency, and no device-related SAEs. Low PK levels of paclitaxel show no increased systemic risk. Symptom relief was observed through improved mean mMRC scores, mean spirometry values and improved measures of general well-being (SF-12). The DCB’s local antiproliferative effects show promise in preventing recurrence and improving patients’ symptoms, lung function, and quality of life, warranting additional investigations. This abstract is funded by: Airiver
Tchkonia et al. (Fri,) studied this question.