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Endobronchial valves for emphysema: an individual patient-level reanalysis of randomised controlled trials
  1. Karin Klooster1,
  2. Dirk-Jan Slebos1,
  3. Zaid Zoumot2,
  4. Claire Davey3,
  5. Pallav L Shah3 and
  6. Nicholas S Hopkinson3
  1. 1Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  2. 2Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
  3. 3NIHR Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, UK
  1. Correspondence to Dr Nicholas S Hopkinson; n.hopkinson{at}ic.ac.uk

Abstract

Introduction Endobronchial 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.

Methods A 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).

Results 114 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<0.0001). Relative to controls valve placement was associated with a fall in residual volume of 0.64 (0.43, 0.86) L (p<0.0001), a 9.5 (3.5, 15.6) unit fall in SGRQ (p=0.0022) and a 64.2 (94.0, 34.5) m increase in 6MWD. There were three deaths in the treatment arm and the pneumothorax rate was 15%.

Conclusions These data strengthen the evidence that endobronchial valve treatment can produce clinically meaningful improvements in appropriately selected COPD patients.

  • bronchoscopy
  • emphysema

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors KK, ZZ, CD, D-JS and PLS conceived the study and developed the search strategy. NSH performed the literature search, collected data, performed the analysis and wrote the first draft to which all authors contributed. All authors have approved the submitted version. NSH is the guarantor.

  • Funding This analysis was supported by the NIHR Respiratory Biomedical Research Unit at Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, UK.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. NSH was principal investigator in a UK NIHR funded trial (BeLieVeR-HIFi) for which PulmonX provided endobronchial valves free of charge. PLS has been an investigator on studies funded by PulmonX, Uptake, Holaria, CSA Medical, Uptake Medical, Olympus and PneumRx/BTG and received consultancy fees from for Broncus, CSA Medical, Medtronic, Olympus, PneumRx/BTG and Pulmonx. KK received lecture fees from Pulmonx and devices for treatments, travel support, and grant support from PneumRx/BTG and Pulmonx. D-JS has been an investigator on studies funded by CSA Medical, Holaira, PulmonX and PneumRx/BTG and received consultancy fees from CSA Medical, Holaira, PneumRx/BTG and Pulmonx.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Requests to access the data can be made to the corresponding author.

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