--- title: "RCT Zephyr Endobronchial Valve tx emphysema LIBERATE | Sutter Health" description: "Zephyr Endobronchial Valve provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea and quality of life out to at least 12-months." url: "https://www.sutterhealth.org/research/publications/rct-zephyr-endobronchial-valve-tx-emphysema-liberate-1055312389" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Research publications](https://www.sutterhealth.org/research/publications) / 4. RCT Zephyr Endobronchial Valve tx emphysema LIBERATE # A multicenter RCT of Zephyr® Endobronchial Valve treatment in heterogeneous emphysema (LIBERATE). 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 Jr, 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 DJ; LIBERATE Study Group. _Am J Respir Crit Care Med. doi: 10.1164/rccm.201803-0590OC. \[Epub ahead of print\]_ 2018-05-22 ## 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. [PubMed abstract](https://www.ncbi.nlm.nih.gov/pubmed/29787288) ![Ganesh Krishna, M.D., FCCP](https://dyn.mktgcdn.com/p/7HZoN6h0d4phO4VQYcU6TE-_Cn72_cBpIS3NRGru51E/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Ganesh Krishna, M.D., FCCP Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/ganesh-krishna-md-fccp-1049681082) ## Research topics - [Disease Management](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Disease+Management%5C%22%22) - [Lung Diseases](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Lung+Diseases%5C%22%22) ## Related publications [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) - Publication ### [The dying thoracic patient.](https://www.sutterhealth.org/research/publications/dying-thoracic-patient-1055312967) Krishna G, Raffin TA. Chest Surg Clin N Am. 8(3):723-39. 1998 Aug 01 - Publication ### [Advances in the management of chronic obstructive pulmonary disease.](https://www.sutterhealth.org/research/publications/advances-mgmt-copd-1055312934) Meinke L, Chitkara R, Krishna G. Expert Opin Pharmacother. 8(1):23-37. 2007 Jan 01 - Publication ### [A 35-year-old man with fever, dyspnea, and diffuse reticular opacities.](https://www.sutterhealth.org/research/publications/35-yo-man-fever-dyspnea-reticular-oopacities-1055312816) Katikireddy CK, Krishna G, Keifer T, Kuschner W, Rosen G. Chest. 129(2):482-7. 2006 Feb 01 - Publication ### [Transbronchial Cryobiopsies for the Diagnosis of Diffuse Parenchymal Lung Diseases: Expert Statement from the Cryobiopsy Working Group on Safety and Utility and a Call for Standardization of the Procedure.](https://www.sutterhealth.org/research/publications/transbronchial-cryobx-dx-diffuse-parenchymal-lung-diseases-1055312384) Hetzel J, Maldonado F, Ravaglia C, Wells AU, Colby TV, Tomassetti S, Ryu JH, Fruchter O, Piciucchi S, Dubini A, Cavazza A, Chilosi M, Sverzellati N, Valeyre D, Leduc D, Walsh SLF, Gasparini S, Hetzel M, Hagmeyer L, Haentschel M, Eberhardt R, Darwiche K, Yarmus LB, Torrego A, Krishna G, Shah PL, Annema JT, Herth FJF, Poletti V. Respiration. doi: 10.1159/000484055. \[Epub ahead of print\] 2018 Jan 09 - Publication ### [Effect of endobronchial coils vs usual care on exercise tolerance in patients with severe emphysema: the RENEW randomized clinical trial.](https://www.sutterhealth.org/research/publications/endobronchial-coils-severe-emphysema-trial-1055312472) Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslée G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. JAMA. 315(20):2178-2189. doi: 10.1001/jama.2016.6261. 2016 May 24 [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/publications/rct-zephyr-endobronchial-valve-tx-emphysema-liberate-1055312389#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Research publications","item":"https://www.sutterhealth.org/research/publications"},{"@type":"ListItem","position":4,"name":"RCT Zephyr Endobronchial Valve tx emphysema LIBERATE"}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalScholarlyArticle","@id":"https://www.sutterhealth.org/research/publications/rct-zephyr-endobronchial-valve-tx-emphysema-liberate-1055312389#medicalscholarlyarticle","name":"A multicenter RCT of Zephyr® Endobronchial Valve treatment in heterogeneous emphysema (LIBERATE).","headline":"RCT Zephyr Endobronchial Valve tx emphysema LIBERATE","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\u003c0.001). ΔEBV-SoC at 12-months was statistically and clinically significant: for FEV1 (L), 0.106L (p\u003c0.001); 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\u003c0.001), mMRC, -0.8 points (p\u003c0.001), 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. 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