Endobronchial valves for emphysema: an individual patient-level reanalysis of randomised controlled trials

• Published in: BMJ open respiratory research 2017-11, Vol.4 (1), p.e000214-e000214
• Main Authors: Klooster, Karin, Slebos, Dirk-Jan, Zoumot, Zaid, Davey, Claire, Shah, Pallav L, Hopkinson, Nicholas S
• Format: Article
• Language: English
• Subjects: Chronic Obstructive Pulmonary Disease; Emphysema; Evidence-based medicine; Exercise; Patients; Physical fitness; Questionnaires; Respiration; Ventilation
• ISSN: 2052-4439; 2052-4439
• DOI: 10.1136/bmjresp-2017-000214

IntroductionEndobronchial valve placement has potential as a treatment for patients with chronic obstructive pulmonary disease (COPD). However, a robust evidence base will be needed to convince commissioners of healthcare that it is a high-value treatment. We sought to develop the evidence base by performing an individual patient-level analysis of randomised controlled trials in people with heterogeneous emphysema and an absence of collateral ventilation.MethodsA literature search (PROSPERO register CRD42016048127) identified two trials meeting these criteria, the BelieVeR-HIFi and STELVIO studies. Anonymised individual patient data were obtained from investigators and analysed. The primary outcome measure was a comparison of change in forced expiratory volume in 1 s (FEV1) from baseline between the treatment and control groups. Secondary end points were change from baseline in 6 min walk distance (6MWD), Medical Research Council dyspnoea score and St George’s Respiratory Questionnaire (SGRQ).Results114 individuals were treated with 3-month to 6-month follow-up data available for 101 individuals. FEV1 improved by 23.1 (±28.3)% in patients treated with valves with a mean (95% CI) difference in response between groups of 17.8 (26.5, 9.2)% (p