Discussion
death, emphysema, COPD, pulmonary hypertension, hyperinflation
ADVERSE EVENTS, DISEASE, EMPHYSEMA, COPD, SECONDARY, PULMONARY HYPERTENSION
The CELEB trial is the first randomised controlled trial to compare the effects of LVRS with BLVR. We found that surgery was not substantially superior to bronchoscopic treatment in patients with intact fissures and that both were similarly safe. Both approaches produced a clinically meaningful reduction in hyperinflation and similar improvements, assessed using either the i-BODE composite index or its individual components, were seen in both treatment arms at 1-year post-procedure. The initial length of hospital stay was longer following LVRS, but the BLVR group were more likely to have undergone a further intervention. There were also no significant differences found between the two groups in other secondary outcome measures (FFMI, physical activity experience and steps per day), with the exception of the CAT score which favoured LVRS at 12 months.The use of a composite measure is considered a more meaningful way to evaluate prognosis and response to disease-modifying interventions than FEVThe greater the reduction in lung volume following lung volume reduction intervention, the greater the improvement in other outcomes such as lung function, exercise capacity and quality of life [The improvement in gas trapping observed in both study arms was accompanied by improvements in participants’ experience of physical activity assessed using the c-PPAC score of two to three times the established MCID of 6 points (c-PPAC Amount: LVRS 18.3 Safety outcomes were similar, with no statistical differences in adverse events between the two groups. There was no peri-operative (30-day) mortality in either group and a single death in each arm by 12 months. This rate is not more than would be expected without intervention in patients with this severity of disease and indeed a low mortality rate is expected given the survival benefit associated with effective lung volume reduction in people with COPD [Although LVRS required a longer initial hospital stay, it was associated with fewer subsequent procedures and more participants crossed over in the BLVR group (LVRS 1 (2.4%) We acknowledge a number of limitations and methodological issues with the present study. First, the findings relate to a very specific COPD phenotype, namely people who were considered to be suitable for both interventions, and cannot therefore be extrapolated to all people being considered for lung volume reduction. Some individuals have a non-anatomical pattern of emphysema where surgery may be more effective. Others may have comorbidities such as pulmonary hypertension that could preclude LVRS but where valve treatment could be considered. Second, although this first head-to-head study did not demonstrate that LVRS was substantially more effective than BLVR to an extent that would change existing clinical equipoise, that does not necessarily mean that they are equivalent and further larger trials will need to address this. Third, due in large part to the logistical difficulties conducting clinical visits during the COVID-19 pandemic, although we had complete data for survival, there were missing data for some end-points. However, the sensitivity analysis using a prespecified multiple imputation approach to missing data supports the headline findings of the study (