التفاصيل البيبلوغرافية
العنوان:
A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)
المؤلفون:
Gerard J. Criner , Richard Sue , Shawn Wright , Mark Dransfield , Hiram Rivas-Perez , Tanya Wiese , Frank C. Sciurba , Pallav L. Shah , Momen M. Wahidi , Hugo Goulart de Oliveira , Brian Morrissey , Paulo F. G. Cardoso , Steven Hays , Adnan Majid , Nicholas Pastis , Lisa Kopas , Mark Vollenweider , P. Michael McFadden , Michael Machuzak , David W. Hsia , Arthur Sung , Nabil Jarad , Malgorzata Kornaszewska , Stephen Hazelrigg , Ganesh Krishna , Brian Armstrong , Narinder S. Shargill , Dirk-Jan Slebos , Francis Cordova , Parag Desai , Nathaniel Marchetti , Victor Kim , Kartik Shenoy , John Travaline , Jiji Thomas , Lii-Yoong H. Criner , Aaron Thornburg , Terry Thomas , Surya Bhatt , James Michael Wells , Necole Seabron-Harris , Umair Gauhar , Crissie Despirito , Frank Sciurba , Jessica Bon Field , Divay Chandra , Joseph Leader , Roy Semaan , Christina Ledezma , Pallav Shah , Samuel Kemp , Justin Garner , Arafa Aboelhassan , Karthi Srikanthan , Eric Tenda , Anita Abraham , Cai Sim , Momen Wahidi , Kamran Mahmood , Scott Shofer , Kathleen Coles , Guilherme Augusto Oliveira , Betina Machado , Igor Benedetto , Fabio Svartman , Amarilio de Macedo Neto , Leonardo Schreiner , Taiane Vieira , Ken Yoneda , Tina Tham , Daniel Tompkins , Paulo F. Guerreiro Cardoso , Rodrigo Athanazio , Felipe Nominando , Samia Rached , Luciana Cassimiro , Eric Seeley , Pavan Shrestha , Gabriela R. Dincheva , Daniel Alape-Moya , Mihir Parikh , Alichia Paton , Alexis Agnew , Charlie Strange , Tatsiana Beiko , Danielle Woodford , Mary Blanton , Timothy Connolly , Jose Fernando Santacruz , Bhavin Shah , Luis Herrera , Rumi Khan , Kristine Sernulka , Richard Barbers , Michelle Hernandez , Francisco Almeida , Joseph Cicenia , Thomas Gildea , Atul Mehta , Sonali Sethi , Yvonne Meli , David Hsia , Richard Casaburi , William Stringer , Leticia Diaz , Meghan Ramsey , Ryan Van Wert , Karen Morris , Tim Batchelor , Iara Sequeiros , Katy Tucker , Malgorzata Kornaszweska , Hazem Fallouh , Ramsey Sabit , Hatam Naase , Joseph George , Azin Salimian , Helen Dyer , Kristal Adams , Karen Bade , Bryan S. Benn , Michelle Canfield , Sharmila Vetri Villalan , Travis Stewart , Nick H. T. ten Hacken , Karin Klooster , Jorine Hartman , Sonja Augustijn
المساهمون:
Groningen Research Institute for Asthma and COPD (GRIAC)
المصدر:
American Journal of Respiratory and Critical Care Medicine, 198(9), 1151-1164. AMER THORACIC SOC
بيانات النشر:
American Thoracic Society, 2018.
سنة النشر:
2018
مصطلحات موضوعية:
Male , Pulmonary and Respiratory Medicine , CLINICAL-OUTCOMES , medicine.medical_specialty , Randomization , SURGERY , lung reduction , Bronchi , Critical Care and Intensive Care Medicine , OBSTRUCTIVE PULMONARY-DISEASE , chronic obstructive pulmonary disease , MEDICAL THERAPY , Collateral ventilation , law.invention , 03 medical and health sciences , 0302 clinical medicine , Primary outcome , Randomized controlled trial , law , Forced Expiratory Volume , Surveys and Questionnaires , Internal medicine , Bronchoscopy , Correspondence , Humans , COPD , Medicine , 030212 general & internal medicine , LUNG-VOLUME-REDUCTION , Respiratory system , Exercise Tolerance , IMPORTANT DIFFERENCE , business.industry , Walk distance , OPERATIVE MORTALITY , Endobronchial valve , Equipment Design , Prostheses and Implants , Middle Aged , NATIONAL EMPHYSEMA , medicine.disease , Treatment Outcome , emphysema , Pulmonary Emphysema , 030228 respiratory system , TESTS , Female , business
الوصف:
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 Delta EBV-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 Delta FEV1 greater than or equal to 15% (P 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.
وصف الملف:
application/pdf
تدمد:
1535-4970
URL الوصول:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::451518baf5c128d44b564cea76382ade https://doi.org/10.1164/rccm.201803-0590oc
حقوق:
OPEN
رقم الأكسشن:
edsair.doi.dedup.....451518baf5c128d44b564cea76382ade
قاعدة البيانات:
OpenAIRE
