The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema.
Publication/Presentation Date
10-1-2014
Abstract
BACKGROUND: Lung volume reduction surgery improves quality of life, exercise capacity, and survival in selected patients but is accompanied by significant morbidity. Bronchoscopic approaches may provide similar benefits with less morbidity.
METHODS: In a randomized, sham procedure controlled, double-blind trial, 277 subjects were enrolled at 36 centers. Patients had emphysema, airflow obstruction, hyperinflation, and severe dyspnea. The primary effectiveness measure was a significant improvement in disease-related quality of life (St. George's Respiratory Questionnaire) and changes in lobar lung volumes. The primary safety measure was a comparison of serious adverse events.
RESULTS: There were 6/121 (5.0%) responders in the treatment group at 6 months, significantly >1/134 (0.7%) in the control group [Bayesian credible intervals (BCI), 0.05%, 9.21%]. Lobar volume changes were significantly different with an average decrease in the treated lobes of -224 mL compared with -17 mL for the control group (BCI, -272, -143). The proportion of responders in St. George's Respiratory Questionnaire was not greater in the treatment group. There were significantly more subjects with a serious adverse event in the treatment group (n=20 or 14.1%) compared with the control group (n=5 or 3.7%) (BCI, 4.0, 17.1), but most were neither procedure nor device related.
CONCLUSIONS: This trial had technical and statistical success but partial-bilateral endobronchial valve occlusion did not obtain clinically meaningful results. Safety results were acceptable and compare favorably to lung volume reduction surgery and other bronchial valve studies. Further studies need to focus on improved patient selection and a different treatment algorithm.
TRIAL REGISTRY: ClinicalTrials.gov NCT00475007.
Volume
21
Issue
4
First Page
288
Last Page
297
ISSN
1948-8270
Published In/Presented At
Wood, D. E., Nader, D. A., Springmeyer, S. C., Elstad, M. R., Coxson, H. O., Chan, A., Rai, N. S., Mularski, R. A., Cooper, C. B., Wise, R. A., Jones, P. W., Mehta, A. C., Gonzalez, X., Sterman, D. H., & IBV Valve Trial Research Team (2014). The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. Journal of bronchology & interventional pulmonology, 21(4), 288–297. https://doi.org/10.1097/LBR.0000000000000110
Disciplines
Medicine and Health Sciences
PubMedID
25321447
Department(s)
Department of Medicine
Document Type
Article