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Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial.

Publication ,  Journal Article
Shah, PL; Slebos, D-J; Cardoso, PFG; Cetti, E; Voelker, K; Levine, B; Russell, ME; Goldin, J; Brown, M; Cooper, JD; Sybrecht, GW ...
Published in: Lancet
September 10, 2011

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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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

September 10, 2011

Volume

378

Issue

9795

Start / End Page

997 / 1005

Location

England

Related Subject Headings

  • Vital Capacity
  • Total Lung Capacity
  • Residual Volume
  • Pulmonary Emphysema
  • Paclitaxel
  • Middle Aged
  • Male
  • Lung Volume Measurements
  • Humans
  • General & Internal Medicine
 

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Shah, P. L., Slebos, D.-J., Cardoso, P. F. G., Cetti, E., Voelker, K., Levine, B., … EASE trial study group, . (2011). Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet, 378(9795), 997–1005. https://doi.org/10.1016/S0140-6736(11)61050-7
Shah, P. L., D. -. J. Slebos, P. F. G. Cardoso, E. Cetti, K. Voelker, B. Levine, M. E. Russell, et al. “Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial.Lancet 378, no. 9795 (September 10, 2011): 997–1005. https://doi.org/10.1016/S0140-6736(11)61050-7.
Shah PL, Slebos D-J, Cardoso PFG, Cetti E, Voelker K, Levine B, et al. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet. 2011 Sep 10;378(9795):997–1005.
Shah, P. L., et al. “Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial.Lancet, vol. 378, no. 9795, Sept. 2011, pp. 997–1005. Pubmed, doi:10.1016/S0140-6736(11)61050-7.
Shah PL, Slebos D-J, Cardoso PFG, Cetti E, Voelker K, Levine B, Russell ME, Goldin J, Brown M, Cooper JD, Sybrecht GW, EASE trial study group. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet. 2011 Sep 10;378(9795):997–1005.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

September 10, 2011

Volume

378

Issue

9795

Start / End Page

997 / 1005

Location

England

Related Subject Headings

  • Vital Capacity
  • Total Lung Capacity
  • Residual Volume
  • Pulmonary Emphysema
  • Paclitaxel
  • Middle Aged
  • Male
  • Lung Volume Measurements
  • Humans
  • General & Internal Medicine