ArticlesBronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial
Introduction
Surgery to reduce lung volume in patients with pulmonary emphysema can increase residual volume (RV) and improve breathing mechanics and dyspnoea, even in individuals with homogeneous disease. However, with substantial surgical morbidity, adoption of this procedure has been low.1, 2, 3
Airway bypass is a bronchoscopic procedure to reduce lung volume that is designed for treatment of severe homogeneous emphysema. With this technique, passages are created in the bronchial airways to deflate air trapped in the emphysematous regions, and paclitaxel-eluting stents are placed to maintain passageway patency.4, 5 In preclinical, ex-vivo, and pretransplant studies, airway bypass released trapped air by bronchoscopic creation of transbronchial passageways.5, 6, 7, 8 In a feasibility study,5 efficacy was shown for airway bypass at 6 months in patients with a ratio of RV to total lung capacity (TLC) of more than 67%, a proportion that is also predictive of improvement in forced vital capacity (FVC) after lung-volume reduction surgery.9
The Exhale drug-eluting stent (Broncus Technologies, Mountain View, CA, USA) is composed of stainless steel and silicone and contains paclitaxel, which is intended to inhibit fibrotic responses.7 We designed the Exhale airway stents for emphysema (EASE) trial to investigate safety and efficacy of airway bypass for patients with severe homogeneous emphysema.
Section snippets
Participants
We undertook a multicentre, double-blind, randomised, sham-controlled trial at 38 specialist respiratory centres worldwide. The adaptive study design of the EASE trial and screening process to select patients with severe homogeneous disease has been published previously.10
Panel 1 summarises key inclusion and exclusion criteria. We focused inclusion criteria on definition of a population with severe hyperinflation. All participants had to undergo at least 6 weeks of pulmonary rehabilitation
Results
Between Oct 18, 2006, and April 8, 2009, 1522 people were screened for the study and 319 underwent randomisation. 212 participants were randomly assigned airway bypass (four were allocated after enrolment closed so did not receive the intervention) and 107 were allocated sham control (figure 1). 6-month follow-up data were available for 195 (94%) patients in the airway bypass arm and 90 (84%) who were assigned sham control. Seven (3%) participants in the airway bypass arm and seven (7%) who
Discussion
Findings of the EASE trial showed that at day 1, airway bypass released trapped gas from hyperinflated regions, thereby improving pulmonary function. However, durability was limited by pulmonary function tests and subjective, functional, and post-hoc CT measures. Outcomes for sham control and airway bypass were similar at months 3, 6, and 12. Although the EASE trial failed to show a difference between treatment arms with respect to the 6-month primary efficacy endpoint, invaluable lessons were
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See end of report for details of the EASE trial study group