| Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. | |
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MedLine Citation:
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PMID: 21907863 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Airway bypass is a bronchoscopic lung-volume reduction procedure for emphysema whereby transbronchial passages into the lung are created to release trapped air, supported with paclitaxel-coated stents to ease the mechanics of breathing. The aim of the EASE (Exhale airway stents for emphysema) trial was to evaluate safety and efficacy of airway bypass in people with severe homogeneous emphysema. METHODS: We undertook a randomised, double-blind, sham-controlled study in 38 specialist respiratory centres worldwide. We recruited 315 patients who had severe hyperinflation (ratio of residual volume [RV] to total lung capacity of ≥0·65). By computer using a random number generator, we randomly allocated participants (in a 2:1 ratio) to either airway bypass (n=208) or sham control (107). We divided investigators into team A (masked), who completed pre-procedure and post-procedure assessments, and team B (unmasked), who only did bronchoscopies without further interaction with patients. Participants were followed up for 12 months. The 6-month co-primary efficacy endpoint required 12% or greater improvement in forced vital capacity (FVC) and 1 point or greater decrease in the modified Medical Research Council dyspnoea score from baseline. The composite primary safety endpoint incorporated five severe adverse events. We did Bayesian analysis to show the posterior probability that airway bypass was superior to sham control (success threshold, 0·965). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00391612. FINDINGS: All recruited patients were included in the analysis. At 6 months, no difference between treatment arms was noted with respect to the co-primary efficacy endpoint (30 of 208 for airway bypass vs 12 of 107 for sham control; posterior probability 0·749, below the Bayesian success threshold of 0·965). The 6-month composite primary safety endpoint was 14·4% (30 of 208) for airway bypass versus 11·2% (12 of 107) for sham control (judged non-inferior, with a posterior probability of 1·00 [Bayesian success threshold >0·95]). INTERPRETATION: Although our findings showed safety and transient improvements, no sustainable benefit was recorded with airway bypass in patients with severe homogeneous emphysema. FUNDING: Broncus Technologies. |
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Authors:
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P L Shah; D-J Slebos; P F G Cardoso; E Cetti; K Voelker; B Levine; M E Russell; J Goldin; M Brown; J D Cooper; G W Sybrecht; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Lancet Volume: 378 ISSN: 1474-547X ISO Abbreviation: Lancet Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-09-12 Completed Date: 2011-09-21 Revised Date: 2013-04-11 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: England |
Other Details:
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Languages: eng Pagination: 997-1005 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2011 Elsevier Ltd. All rights reserved. |
Affiliation:
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National Institute for Health Research Respiratory Biomedical Research Unit at Royal Brompton and Harefield NHS Foundation Trust, Imperial College, London, UK. pallav.shah@imperial.ac.uk |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00391612 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Bronchoscopy* Double-Blind Method Drug-Eluting Stents* Female Forced Expiratory Volume Humans Lung Volume Measurements* Male Middle Aged Paclitaxel Pulmonary Emphysema / physiopathology, surgery* Residual Volume Total Lung Capacity Vital Capacity |
| Chemical | |
Reg. No./Substance:
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33069-62-4/Paclitaxel |
| Investigator | |
Investigator/Affiliation:
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Pallav L Shah / ; David Alexander / ; Emma Cuerden / ; Michael Dusmet / ; Matthew Hind / ; Nicholas S Hopkinson / ; Samuel Kemp / ; Onn Min Kon / ; Michael I Polkey / ; Dirk-Jan Slebos / ; Rob Douma / ; Huib Kerstjens / ; Peter Vennik / ; Karin Klooster / ; Alie Smidt / ; Sandra Snijders / ; Paulo F G Cardoso / ; Adalberto Rubin / ; Paula Berto / ; Manuela Cavalcanti / ; Fernanda Brum Spilimbergo / ; Fernando Frosi / ; Marcia Schmitt / ; Patricia R Soares / ; Kirk Voelker / ; Gregory Ferreira / ; Todd Horiuchi / ; Kisha Morgan / ; Mary Bradley / ; Nancy Clapp / ; Karen Gormley / ; Amanda Miller / ; Kathy Pope-Nix / ; Bernard Levine / ; David Baratz / ; Robert Comp / ; Mark Gotfried / ; Burr Ross / ; Vincent DeLaCruz / ; LiYi Fu / ; Sherry Harker / ; Gerhard Sybrecht / ; Karin Franzen / ; Andreas Gröschel / ; Katharina Rentz / ; Heinrike Wilkens / ; Iris Schaeck / ; Marion Sollgan / ; Bettina Weingard / ; William Leeds / ; Laura Ludlow / ; Osman Malik / ; Suzanne Nicklin / ; Dusty Griggs / ; Roger Maxfield / ; William Bulman / ; Angela DiMango / ; David Lederer / ; Frances Brogan / ; Patricia Jellen / ; Otto Burghuber / ; Hubert Koller / ; Arschang Valipour / ; Irene Firlinger / ; Maria Ruis / ; Stephen Hazelrigg / ; Theresa Boley / ; Jeffrey Christy / ; Cathy Leslie / ; Armin Ernst / ; Gaetene Michaud / ; Malcolm DeCamp / ; Arthur Dea / ; Christina Carbone / ; David Kopman / ; Paula Mulkern / ; Marina Lima / ; Alexandre P Cardoso / ; Jose R L Silva / ; Amir Szlko / ; Marcia Luduvice / ; Lilian Rodrigues / ; Michael Simoff / ; Jennifer McCann-Swiderek / ; Cynthia Ray / ; Geneva Tatem / ; Roel Almario / ; Wanda Bibbs / ; Kimberly Dempsey / ; Steven Gay / ; Kristy Bauman / ; Kevin Chan / ; Andrew Chang / ; Fernando Martinez / ; Cheryl Majors / ; Ali Musani / ; Barry Make / ; Kim McPeak / ; Diane Rhodes / ; Geoffrey McLennan / ; Kimberly Baker / ; Scott Ferguson / ; Karl Thomas / ; Andrea Chapman / ; Janet Keating / ; Phyllis Pirotte / ; Kimberly Sprenger / ; Luis Losso / ; Sonia Gasques / ; Tais Frizzo Vieira / ; Andrew Chan / ; Mark Avdalovic / ; Timothy Albertson / ; Roblee Allen / ; Richart Harper / ; Brian Morrissey / ; Nicholas Stollenwerk / ; Sandy Algaze / ; Krysta Chaldekas / ; Maya Juarez / ; Macey Kelly / ; Greg Snell / ; Dominic Keating / ; Glen Westall / ; Helen Whitford / ; Trevor Williams / ; Tania Dunn / ; Sue Fowler / ; Lynda Holsworth / ; Bronwyn Levvey / ; Christianne Manterfield / ; Momen Wahidi / ; Thomas D'Amico / ; Monica Kraft / ; Njira Lugogo / ; Scott Shofer / ; Christine Willis / ; Denise Beaver / ; Matthew Beyea / ; Catherine Foss / ; Catherine Hathcock / ; Jane Stiles / ; Jas Parmar / ; Mike Davies / ; Dennis Wat / ; Heather Millington-Parrish / ; Alison Mitchell / ; John Kucharczuk / ; Colin Gillepsie / ; Andrew Haas / ; Daniel Sterman / ; Holly McConville / ; Marie Kromplewski / ; Janet Riggs / ; Sally Thompson / ; William Tillis / ; Patrick E Whitten / ; Mary Dorrington / ; Kimberly L Hartwig / ; Ashley L Scott / ; Jim Egan / ; Huzaifa Adamali / ; Waldemar Bartosik / ; Eoin Judge / ; Majella Tuohy / ; Yusuf Vapra / ; Crona Bolger / ; Iain Lawrie / ; Lorna Murphy / ; Sara Winward / ; Zab Mosenifar / ; David Balfe / ; George Chaux / ; Jeremy Falk / ; Michael Lewis / ; Carol Geaga / ; Lisa Freiler / ; Richard Sellman / ; W B Bekemeyer / ; Rolf Holle / ; Shull Lemire / ; Kelli Hoffman / ; Brooke Krininger / ; Karl Van Gundy / ; Kathryn Bilello / ; Timothy Evans / ; Jose Joseph / ; Michael Peterson / ; Janna Blaauw / ; Rebekah Garcia / ; Joseph Newton / ; Catherine Brisland / ; Kirk Fleischer / ; Carolyn Fruci / ; Nadeem Inayat / ; Michelle Collier / ; Melissa Connolly / ; Marci Holladay / ; Laura Pine / ; David McCormack / ; Donald Farquhar / ; Sandra Halko / ; Chris Licskai / ; Leila MacBean / ; Ruth Strapp / ; Rabih Bechara / ; David Berkowitz / ; Daniel Miller / ; Christopher Parks / ; Rafael Perez / ; Linda Wolfenden / ; Jane Guidot / ; Tamra Perez / ; Cicely Ross / ; Michel Laviolette / ; Francois Maltais / ; Simon Martel / ; Julie Milot / ; Marthe Belanger / ; Marie-Josee Breton / ; Luce Trepanier / ; Thomas Gildea / ; Michael Machuzak / ; Brian Mann / ; David Mason / ; Atul Mehta / ; Omar Minai / ; Sudish Murthy / ; Georgean Krizmanich / ; Yvonne Meli / ; Joseph Parambil / ; Richard Rice / ; Felix Herth / ; Ralf Eberhardt / ; Jutta Kappes / ; Brigitte Rump / ; Franz Stanzel / ; Patric Littersk / ; K Robert Shen / ; Stephen Cassivi / ; Eric Edell / ; Sanjay Kaira / ; David Mithun / ; James Utz / ; Dennis Wigle / ; Kathy Mieras / ; Javier Flandes / ; Iker Fernandez-Navamuel / ; Sarah Heili / ; Maria J R Nieto / |
| Comments/Corrections | |
Comment In:
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Lancet. 2011 Sep 10;378(9795):962
[PMID:
21907845
]
Lancet. 2011 Sep 10;378(9795):966-7 [PMID: 21907848 ] Am J Respir Crit Care Med. 2012 Jun 15;185(12):1323-4 [PMID: 22707735 ] Internist (Berl). 2013 Mar;54(3):373-5 [PMID: 23389326 ] |
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