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

2018; American Thoracic Society; Volume: 198; Issue: 9 Linguagem: Inglês

10.1164/rccm.201803-0590oc

1535-4970

Gerard J. Criner, Richard Sue, Shawn E. Wright, Mark T. Dransfield, Hiram Rivas-Perez, Tanya Wiese, Frank C. Sciurba, Pallav L. Shah, Momen M. Wahidi, Hugo Goulart de Oliveira, Brian Morrissey, Paulo Francisco Guerreiro Cardoso, Steven R. Hays, Adnan Majid, Nicholas J. Pastis, Lisa Kopas, Mark Vollenweider, P. Michael McFadden, Michael Machuzak, David W. Hsia, Arthur Sung, Nabil Jarad, Malgorzata Kornaszewska, Stephen R. Hazelrigg, Ganesh Krishna, Brian Armstrong, Narinder S. Shargill, Dirk‐Jan Slebos, Gerard J. Criner, Francis Cordova, Parag Desai, Nathaniel Marchetti, Victor Kim, Kartik Shenoy, John M. Travaline, Jiji Thomas, Lii-Yoong H. Criner, Richard Sue, Shawn E. Wright, Aaron Thornburg, Terry Thomas, Mark T. Dransfield, Surya P. Bhatt, J. Michael Wells, Necole Seabron-Harris, Hiram Rivas-Perez, Umair Gauhar, Tanya Wiese, Crissie Despirito, Frank C. Sciurba, Jessica Bon Field, Divay Chandra, Joseph K. Leader, Roy Semaan, Christina M. Ledezma, Pallav L. Shah, Samuel V. Kemp, Justin Garner, Arafa Aboelhassan, Karthi Srikanthan, Eric Daniel Tenda, A.M López Abraham, Cai Sim, Momen M. Wahidi, Kamran Mahmood, Scott Shofer, Kathleen Coles, Hugo Goulart de Oliveira, Guilherme A. P. de Oliveira, Betina Machado, Igor Gorski Benedetto, Fábio Munhoz Svartman, Amarilio de Macedo Neto, Leonardo Schreiner, Taiane Alves Vieira, Brian Morrissey, Ken Y. Yoneda, Tristan Tham, Daniel Tompkins, Paulo Francisco Guerreiro Cardoso, Rodrigo Abensur Athanazio, Felipe Nominando, Samia Zahi Rached, Luciana Cassimiro, Steven R. Hays, Eric J. Seeley, Pavan Shrestha, Gabriela R. Dincheva, Adnan Majid, Daniel Alape, Mihir Parikh, Alichia Paton, A. Agnew, Nicholas J. Pastis, Charlie Strange, Tatsiana Beiko, Danielle Woodford, Mary Blanton, Lisa Kopas, Timothy M. Connolly, Jose F. Santacruz, Bhavin Shah, Mark Vollenweider, Luís Herrera, Rumi Ahmed Khan, Kristine Sernulka, P. Michael McFadden, Richard G. Barbers, Michelle L. Hernandez, Michael Machuzak, Francisco A. Almeida, Joseph Cicenia, Thomas R. Gildea, Atul C. Mehta, Sonali Sethi, Yvonne Meli, David W. Hsia, Richard Casaburi, William Stringer, Leticia M. Diaz, Arthur Sung, Meghan Ramsey, Ryan Van Wert, Karen Morris, Nabil Jarad, Tim Batchelor, Iara Sequeiros, Katy Tucker, Malgorzata Kornaszweska, Hazem Fallouh, Ramsey Sabit, Hatam Naase, Joseph George, Azin Salimian, Helen M. Dyer, Stephen R. Hazelrigg, Kristal Adams, Karen Bade, Ganesh Krishna, Bryan S. Benn, Michelle Canfield, Sharmila Vetri Villalan, Travis J. Stewart, Dirk‐Jan Slebos, Nick H.T. ten Hacken, Karin Klooster, Jorine E. Hartman, Sonja W.S. Augustijn,

Pleural and Pulmonary Diseases

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.Clinical trial registered with www.clinicaltrials.gov (NCT 01796392).