Comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement: a randomised controlled trial

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Abstract

Background: lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves (EBVs) can improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema. However, no direct comparison data exists to inform clinical decision-making in people who appear suitable for both procedures. Our aim was to investigate whether LVRS produces superior health outcomes when compared to BLVR at 12 months.

Methods: the CELEB study was a multi-centre, single-blind parallel-group trial randomising patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR, and comparing outcomes at one year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obstruction, dyspnoea and exercise capacity (incremental shuttle walk test). The researchers responsible for collecting outcomes were masked to treatment allocation. All outcomes were assessed in the intention-to-treat population.

Findings: between 16 th September 2016 and 22 nd July 2019, 88 participants (48% female, mean (±SD) age 64.6±7.7, FEV 1 %predicted 31.0±7.9) were recruited at five specialist centres across the UK and randomised to either LVRS(n=41) or BLVR(n=47). At 12 months follow up, the complete i-BODE was available in 49 participants (21 LVRS/ 28 BLVR). Neither improvement in the i-BODE composite score (LVRS: -1.10 (1.44), BLVR: -0.82 (1.61) p=0.54) nor its individual components differed between treatment arms. Both treatments produced similar improvements in gas trapping; RV% predicted (LVRS -36.1 (-54.1, -10), BLVR: -30.1 (-53.7, -9) p=0.81). There was one death in each treatment arm.

Interpretation: our findings do not support the hypothesis that LVRS is a substantially superior treatment to BLVR in individuals who are suitable for both treatments.

Trial Registration Details: the trial was registered prospectively; ISRCTN19684749.

Funding Information: this project was funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014-35051). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Imperial College, London will support the reporting of this manuscript. Trial sponsor representative: Patrik Pettersson, Royal Brompton and Harefield NHS Foundation Trust (RB&HFT), Royal Brompton Hospital.

Declaration of Interests: PLS and DW have received payment from PulmonX for educational lectures. NG has received grants to institution from GSK and Genentech and grants for lectures and travel from AZ and Chiesi. RL is a member of the British Thoracic Society COPD Specialist Advisory group, a member of South Yorkshire Clinical Senate and a member of South Yorkshire and Bassetlaw Respiratory Clinical Network. All other authors have nothing to declare.

Ethics Approval Statement: ethical approval was obtained from Fulham Research Ethics Committee, London, UK (REC reference: 16/LO/0286). The trial protocol has been published previously (20). A trial steering committee with an independent chair met quarterly to review progress, conduct and safety throughout the course of the trial.

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Contributors

Author: Adam Lewis

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