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2018 Nov 1 - A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)

Gerard J. Criner 1, Richard Sue 2, Shawn Wright 2, Mark Dransfield 3, Hiram Rivas-Perez 4, Tanya Wiese 4, Frank C. Sciurba 5, Pallav L. Shah 6, Momen M. Wahidi 7, Hugo Goulart de Oliveira 8, Brian Morrissey 9, Paulo F. G. Cardoso 10, Steven Hays 11, Adnan Majid 12, Nicholas Pastis Jr.13, Lisa Kopas 14, Mark Vollenweider 15, P. Michael McFadden 16, Michael Machuzak 17, David W. Hsia 18, Arthur Sung 19, Nabil Jarad 20, Malgorzata Kornaszewska 21, Stephen Hazelrigg 22, Ganesh Krishna 23, Brian Armstrong 24, Narinder S. Shargill 25, and Dirk-Jan Slebos 26; for the LIBERATE Study Group

Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164

Rationale: 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.

Objectives: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation 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 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.

Measurements and Main Results: 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 ΔFEV1 greater than or equal to 15% (P < 0.001). ΔEBV–SoC at 12 months was statistically and clinically significant: for FEV1, 0.106 L (P < 0.001); 6-minute-walk distance, +39.31 m (P = 0.002); and St. George’s Respiratory Questionnaire, −7.05 points (P = 0.004). Significant ΔEBV–SoC were also observed in hyperinflation (residual volume, −522 ml; P < 0.001), modified Medical Research Council Dyspnea Scale (−0.8 points; P < 0.001), and the BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index (−1.2 points). Pneumothorax was the most common serious adverse event in the treatment period (procedure to 45 d), 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.

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