1. A multicenter RCT of Zephyr® Endobronchial Valve treatment in heterogeneous emphysema (LIBERATE)
- Author
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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, and LIBERATE Study Group
- Subjects
LIBERATE Study Group ,Emphysema ,CLINICAL-OUTCOMES ,Science & Technology ,IMPORTANT DIFFERENCE ,SURGERY ,lung reduction ,Respiratory System ,OPERATIVE MORTALITY ,NATIONAL EMPHYSEMA ,OBSTRUCTIVE PULMONARY-DISEASE ,chronic obstructive pulmonary disease ,MEDICAL THERAPY ,Critical Care Medicine ,General & Internal Medicine ,TESTS ,COPD ,LUNG-VOLUME-REDUCTION ,Life Sciences & Biomedicine ,11 Medical and Health Sciences - 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
- Published
- 2018