A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Criner, G. J., Sue, R., Wright, S., Dransfield, M., Rivas-Perez, H., Wiese, T., Sciurba, F. C., Shah, P. L., Wahidi, M. M., de Oliveira, H., Morrissey, B., Cardoso, P. G., Hays, S., Majid, A., Pastis, N., Kopas, L., Vollenweider, M., McFadden, P., Machuzak, M., Hsia, D. W., Sung, A., Jarad, N., Kornaszewska, M., Hazelrigg, S., Krishna, G., Armstrong, B., Shargill, N. S., Slebos, D., LIBERATE Study Grp
2018; 198 (9): 1151?64
Abstract
This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilation out to 12 months.To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation in the treated lobe.Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites. Primary outcome at 12 months was the ?EBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of greater than or equal to 15%. Secondary endpoints included absolute changes in post-bronchodilator FEV1, 6-minute-walk distance, and St. George's Respiratory Questionnaire scores.A total of 190 subjects (128 EBV and 62 SoC) were randomized. At 12 months, 47.7% EBV and 16.8% SoC subjects had a ?FEV1 greater than or equal to 15% (P?
View details for PubMedID 29787288
Abstract
Bronchoscopy is frequently used for the evaluation of suspicious pulmonary lesions found on computed tomography, but its sensitivity for detecting lung cancer is limited. Recently, a bronchial genomic classifier was validated to improve the sensitivity of bronchoscopy for lung cancer detection, demonstrating a high sensitivity and negative predictive value among patients at intermediate risk (10-60 %) for lung cancer with an inconclusive bronchoscopy. Our objective for this study was to determine if a negative genomic classifier result that down-classifies a patient from intermediate risk to low risk (<10 %) for lung cancer would reduce the rate that physicians recommend more invasive testing among patients with an inconclusive bronchoscopy.We conducted a randomized, prospective, decision impact survey study assessing pulmonologist recommendations in patients undergoing workup for lung cancer who had an inconclusive bronchoscopy. Cases with an intermediate pretest risk for lung cancer were selected from the AEGIS trials and presented in a randomized fashion to pulmonologists either with or without the patient's bronchial genomic classifier result to determine how the classifier results impacted physician decisions.Two hundred two physicians provided 1523 case evaluations on 36 patients. Invasive procedure recommendations were reduced from 57 % without the classifier result to 18 % with a negative (low risk) classifier result (p?
View details for DOI 10.1186/s12890-016-0217-1
View details for Web of Science ID 000375958900001
View details for PubMedID 27184093
View details for PubMedCentralID PMC4869188
