ArticlesEndobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial
Introduction
Severe emphysema is a challenging respiratory disease with few treatment options. In 2010, 4·3 million adults in the USA were diagnosed with emphysema.1 Corresponding statistics for Europe are difficult to estimate because patients are often classified as having chronic obstructive pulmonary disease (COPD). However, the prevalence of emphysema is about 3·2% with an overall pooled prevalence for COPD of 7·6%.2 Globally, COPD is the third most common cause of death.3
Emphysema is one of the key pathological features of COPD. It is characterised by alveolar destruction, which, combined with a loss of surrounding connective tissue, reduces the degree of tethering of small airways and the elastic recoil of the lung. The resultant expiratory airway collapse leads to gas trapping and increased lung volumes which increases the effort needed to breathe, causing breathlessness. Physical exertion exacerbates the problem because increased respiratory rate further diminishes expiratory time, leading to dynamic hyperinflation. Because of the restricted success of pharmacological treatment in these patients and the early morbidity and mortality associated with lung volume reduction surgery,4 alternative bronchoscopic techniques for volume reduction have been developed.5, 6, 7
Endobronchial valve placement has shown benefit, especially in upper lobe-predominant emphysema,6, 8, 9 but it is only effective in the absence of collateral ventilation, which restricts its application for a broader population of patients with emphysema. Few treatment options exist for homogeneous or lower lobe-predominant distribution of emphysema. Airway bypass has been shown to release trapped gas and improve lung function, but the beneficial effects are short-lived.7 Endobronchial lung volume reduction coils (LVRC; PneumRx Inc, Mountain View, CA, USA), which, when deployed, re-tension lung tissue and reduce dynamic airway collapse, have shown evidence of efficacy and a good safety profile in two small cohorts of patients with emphysema.10, 11 The objective of this randomised, prospective, multicentre study was to assess the clinical benefits and safety of LVRCs for the treatment of severe emphysema with hyperinflation.
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Study design and participants
This study was a prospective, randomised, multicentre trial. Patients with severe emphysema (FEV1 <45% predicted) who were on optimum medical treatment were eligible for inclusion (panel 1). Eligible patients were screened and recruited at three sites in the UK from Jan 27, 2010, to Oct 25, 2011.
The final protocol was approved by the National and Local Ethical Committees. However, due to an administrative error the trial was not registered until after enrolment of 20 patients and before any
Results
We randomly allocated 47 patients to either treatment (23 patients) or usual care (24 patients (figure 1); 23 patients in each group were included in the intention-to-treat analysis. Baseline characteristics were much the same between the two groups, apart from SGRQ total score and mMRC dyspnoea scale, which were both higher in the treatment group, with all participants having severe airflow obstruction and substantial hyperinflation (table 1). The imbalance in SGRQ and total score mMRC
Discussion
In this study, LVRC placement improved quality of life, exercise capacity, and pulmonary function in patients with severe emphysema who were already on best possible medical treatment. The primary efficacy endpoint, SGRQ, improved by more than the 4-point reduction considered to be clinically meaningful,14 and also exceeded the 8-point response defined as clinically significant in the NETT trial (panel 2).4
However, these results should be interpreted with caution because this was not a blinded
References (28)
- et al.
Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010
Lancet
(2013) - et al.
Bronchoscopic volume reduction with valve implants in patients with severe emphysema
Lancet
(2003) - et al.
Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial
Lancet
(2011) - et al.
Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema
Chest
(2012) - et al.
Allocation concealment in randomised trials: defending against deciphering
Lancet
(2002) - et al.
A prospective evaluation of lung volume reduction surgery in 200 consecutive patients
Chest
(2003) - et al.
Summary health statistics for US adults: National Health Interview Survey, 2010
Vital Health Stat 10
(2012) - et al.
Global burden of COPD: systematic review and meta-analysis
Eur Respir J
(2006) - et al.
A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema
N Engl J Med
(2003) - et al.
A randomized study of endobronchial valves for advanced emphysema
N Engl J Med
(2010)
Effect of bronchoscopic lung volume reduction on dynamic hyperinflation and exercise in emphysema
Am J Respir Crit Care Med
Atelectasis and survival after bronchoscopic lung volume reduction for COPD
Eur Respir J
Bronchoscopic lung volume reduction with a dedicated coil: a clinical pilot study
Ther Adv Respir Dis
A self-complete measure of health status for chronic airflow limitation. The St George's Respiratory Questionnaire
Am Rev Respir Dis
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