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

Abstract

Copyright © The authors. Background: Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves (EBVs) 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 to BLVR at 12 months.

Methods: this multi-centre, 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.

Findings: 88 participants (48% female, mean (sd) age 64.6 (7.7), FEV1%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), BLVR: −0.82 (1.61) p=0.54) nor in its individual components differed between groups. 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.