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A multicenter RCT of Zephyr® Endobronchial Valve treatment in heterogeneous emphysema (LIBERATE)

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Title: A multicenter RCT of Zephyr® Endobronchial Valve treatment in heterogeneous emphysema (LIBERATE)
Authors: Criner, GJ
Sue, R
Wright, S
Dransfield, M
Rivas-Perez, H
Wiese, T
Sciurba, FC
Shah, PL
Wahidi, MM
De Oliveira, HG
Morrissey, B
Cardoso, PFG
Hays, S
Majid, A
Pastis, N
Kopas, L
Vollenweider, M
McFadden, PM
Machuzak, M
Hsia, DW
Sung, A
Jarad, N
Kornaszewska, M
Hazelrigg, S
Krishna, G
Armstrong, B
Shargill, NS
Slebos, D-J
LIBERATE Study Group
Item Type: Journal Article
Abstract: RATIONALE: This is the first multicenter RCT to evaluate effectiveness and safety of Zephyr® Endobronchial Valve EBV® out to 12-months. OBJECTIVES: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation (CV) in the treated lobe. METHODS: Subjects were enrolled with a 2:1 randomization (EBV: Standard-of-Care (SoC)) at 24 sites. Primary outcome at 12-months was the ΔEBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of ≥15%. Secondary endpoints included absolute changes in post-BD FEV1, Six-Minute Walk Distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ) scores. RESULTS: 190 subjects, 128 EBV and 62 SoC were randomized. At 12-months, 47.7% EBV and 16.8% SoC subjects had a ΔFEV1 ≥15% (p<0.001). ΔEBV-SoC at 12-months was statistically and clinically significant: for FEV1 (L), 0.106L (p<0.001); 6MWD, +39.31m (p=0.002); and SGRQ, -7.05 points (p=0.004). Significant ΔEBV-SoC were also observed in hyperinflation (RV, -522ml; p<0.001), mMRC, -0.8 points (p<0.001), and the BODE Index (-1.2 points). Pneumothorax was the most common serious adverse event in the Treatment Period (procedure to 45 days), in 34/128 (26.6%) of EBV subjects. Four deaths occurred in the EBV group during this phase, and one each in the EBV and SoC groups between 46 days and 12-months. CONCLUSIONS: Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea and quality of life out to at least 12-months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01796392.
Issue Date: 1-Nov-2018
Date of Acceptance: 22-May-2018
URI: http://hdl.handle.net/10044/1/61452
DOI: https://dx.doi.org/10.1164/rccm.201803-0590OC
ISSN: 1073-449X
Publisher: American Thoracic Society
Start Page: 1151
End Page: 1164
Journal / Book Title: American Journal of Respiratory and Critical Care Medicine
Volume: 198
Issue: 9
Copyright Statement: © 2018 American Thoracic Society, All Rights Reserved.
Keywords: Science & Technology
Life Sciences & Biomedicine
Critical Care Medicine
Respiratory System
General & Internal Medicine
chronic obstructive pulmonary disease
emphysema
lung reduction
LUNG-VOLUME-REDUCTION
OBSTRUCTIVE PULMONARY-DISEASE
NATIONAL EMPHYSEMA
IMPORTANT DIFFERENCE
OPERATIVE MORTALITY
CLINICAL-OUTCOMES
MEDICAL THERAPY
SURGERY
TESTS
COPD
chronic obstructive pulmonary disease
emphysema
lung reduction
LIBERATE Study Group
COPD
Emphysema
Lung reduction
11 Medical and Health Sciences
Respiratory System
Publication Status: Published
Conference Place: United States
Online Publication Date: 2018-05-22
Appears in Collections:National Heart and Lung Institute
Airway Disease
Faculty of Medicine



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