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Randomized Controlled Trial
. 2023 Apr 27;61(4):2202063.
doi: 10.1183/13993003.02063-2022. Print 2023 Apr.

Lung volume reduction surgery versus endobronchial valves: a randomised controlled trial

Sara C Buttery  1   2 , Winston Banya  1 , Rocco Bilancia  3 , Elizabeth Boyd  3 , Julie Buckley  3 , Neil J Greening  4   5 , Kay Housley  6 , Simon Jordan  2 , Samuel V Kemp  1 , Alan J B Kirk  3 , Lorna Latimer  4   5 , Kelvin Lau  7 , Rod Lawson  6 , Adam Lewis  8 , John Moxham  9 , Sridhar Rathinam  5 , Michael C Steiner  4   5 , Sara Tenconi  6 , David Waller  7 , Pallav L Shah  1   2 , Nicholas S Hopkinson  10   2 ; CELEB investigators
Affiliations
Randomized Controlled Trial

Lung volume reduction surgery versus endobronchial valves: a randomised controlled trial

Sara C Buttery et al. Eur Respir J. .

Abstract

Background: Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves can improve outcomes in appropriately selected patients with emphysema. However, no direct comparison data exist 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 with BLVR at 12 months.

Methods: This multicentre, single-blind, parallel-group trial randomised patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR and compared outcomes at 1 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.

Results: 88 participants (48% female, mean±sd age 64.6±7.7 years, forced expiratory volume in 1 s percent 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 score (LVRS -1.10±1.44 versus BLVR -0.82±1.61; p=0.54) nor in its individual components differed between groups. Both treatments produced similar improvements in gas trapping (residual volume percent predicted: LVRS -36.1% (95% CI -54.6- -10%) versus BLVR -30.1% (95% CI -53.7- -9%); p=0.81). There was one death in each treatment arm.

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

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Conflict of interest statement

Conflict of interest: D. Waller reports lecture honoraria from PulmonX Ltd, outside the submitted work. N.J. Greening reports grants from GSK, consulting fees from Genentech, lecture honoraria from AstraZeneca and Chiesi, travel support from Chiesi, outside the submitted work. P.L. Shah reports lecture honoraria from PulmonX Ltd, outside the submitted work. R. Bilancia reports lecture honoraria and travel support from Intuitive, outside the submitted work. R. Lawson is a Member of 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, outside the submitted work. All other authors have nothing to disclose.

Figures

FIGURE 1
FIGURE 1
Trial profile. BLVR: bronchoscopic lung volume reduction; LVRS: lung volume reduction surgery.
FIGURE 2
FIGURE 2
Effect of lung volume reduction interventions on i-BODE score. Data are presented as mean±sd for baseline, 3 months and 12 months post-procedure, and are based on all available data in the intention-to-treat population. LVRS: lung volume reduction surgery; BLVR: bronchoscopic lung volume reduction. Between-group difference at 12 months: p=0.54.
FIGURE 3
FIGURE 3
Effect of lung volume reduction procedures on i-BODE score component measures: a) body mass index (BMI), b) forced expiratory volume in 1 s (FEV1), c) Medical Research Council (MRC) dyspnoea score and d) incremental shuttle walk test (ISWT) distance. Data are presented as a, b) mean±sd or c, d) median (interquartile range) for baseline, 3 months and 12 months post-procedure and are based on all available data in the intention-to-treat population. LVRS: lung volume reduction surgery; BLVR: bronchoscopic lung volume reduction. Between-group difference at 12 months: a) p=0.16, b) p=0.11, c) p=0.19 and d) p=0.09.
FIGURE 4
FIGURE 4
Responders based on minimal clinically important difference (MCID) for the i-BODE index (complete case analysis). Each bar represents an individual subject. Blue bars represent subjects that met or exceeded the MCID for the i-BODE index (−1 point). Black bars represent subjects who did not meet the MCID. Dotted line represents the MCID. Red bars represent those patients that either crossed over or had valves removed, where data was collected. LVRS: lung volume reduction surgery; BLVR: bronchoscopic lung volume reduction.
FIGURE 5
FIGURE 5
Responders based on minimal clinically important difference (MCID): i-BODE index components (complete case analysis). Each bar represents an individual subject. Blue bars represent subjects that met or exceeded the MCID for the specific outcome: a) body mass index (BMI) (no established MCID), b) forced expiratory volume in 1 s (FEV1) % pred (12%), c) Medical Research Council (MRC) dyspnoea score (−1 point) and d) incremental shuttle walk test (ISWT) distance (35 m). Black bars represent subjects who did not meet the MCID. Dotted line represents the MCID. Red bars represent those patients that either crossed over or had valves removed, where data was collected. BLVR: bronchoscopic lung volume reduction; LVRS: lung volume reduction surgery.
FIGURE 6
FIGURE 6
Responders based on minimal clinically important difference (MCID): important secondary outcomes (complete case analysis). Each bar represents an individual subject. Blue bars represent subjects that met or exceeded the MCID for a) residual volume (RV) % pred (−6.1%) and b) COPD Assessment Test (CAT) score (−2 points). Black bars represent subjects who did not meet the MCID. Dotted line represents the MCID. Red bars represent those patients that either crossed over or had valves removed, where data was collected. BLVR: bronchoscopic lung volume reduction; LVRS: lung volume reduction surgery.
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