Randomized controlled trials of bronchoscopic lung volume reduction
| BELIEVER-HIFI19 2015 (N=50) | STELVIO20 2015 (N=68) | IMPACT21 2016 (N=93) | TRANSFORM22 2017 (N=97) | LIBERATE23 2018 (N=190) | REACH24 2019 (N=107) | EMPROVE25 2018 (N=172) | |
|---|---|---|---|---|---|---|---|
| Design | Single-center 1:1; BLVR vs sham procedure over 3 months | Single-center 1:1;BLVR vs standard care over 6 months | Multicenter 1:1; BLVR vs standard care over 3 months | Multicenter 2:1; BLVR vs standard of care over 3 months | Multicenter 2:1; BLVR vs standard care over 12 months | Multicenter 2:1; BLVR vs standard care over 3 months | Multicenter 2:1; BLVR vs standard care over 12 months |
| Emphysema type | Heterogeneousa | Heterogeneous, homogeneous | Homogeneousb | Heterogeneousc | Heterogeneousd | Heterogeneousd | Heterogeneousc |
| Valve system | Zephyr | Zephyr | Zephyr | Zephyr | Zephyr | Spiration | Spiration |
| Pulmonary function test criteria | FEV1 < 50% TLC > 100% RV > 150% | FEV1 < 60% TLC > 100% RV > 150% | FEV1 < 15-45% TLC > 100% RV > 200% | FEV1 < 15-45% TLC > 100% RV > 180% | FEV1 < 15-45% TLC > 100% RV > 150% DLCO > 20% | FEV1 < 45% TLC > 100% RV > 150% | FEV1 < 45% TLC > 100% RV > 150% |
| Collateral ventilation, fissure integrity assessment | High-resolution CT | Chartis system | Chartis system | Chartis system | Chartis system | High-resolution CT | High-resolution CT |
| Clinical outcome, change from baseline | |||||||
| FEV1, % of predicted | 8.7 | 20.9 | 13.7 | 20.7 | 17.1 | 13.5 | 12.1 |
| 6-min walk distance (m) | 25 | 60 | 22.6 | 36.2 | 12.9 | 27.1 | 6.9 |
| Reduction in RV (L) | 0.26 | 0.86 | 0.42 | 0.66 | 0.49 | 0.52 | 0.36 |
| Quality of life scoree | 8.6 | 17.3 | 8.6 | 7.2 | 7.5 | 7.6 | 9.5 |
| Pneumothorax occurrence, % | 8.6 | 17.6 | 27.9 | 23 | 34.3 | 7.6 | 12.4 |
↵a Defined as a National Emphysema Treatment Trial score of > 2 and a difference of > 1 emphysema score from ipsilateral lobes. Emphysema score ranges from 0-4; 0 represents absence of emphysema, and 1-4 represents quartiles of emphysematous lung involvement. For example, a score of 3 means 50% to 75% involvement with emphysema.
↵b Defined as a < 15% difference in destruction score by quantitative high-resolution computed tomography (CT).
↵c Defined as a > 10% difference in destruction score by quantitative high-resolution computed tomography.
↵d Defined as a > 15% difference in destruction score by quantitative high-resolution computed tomography.
↵e St. George Respiratory Questionnaire score.
DLCO = diffusing capacity for carbon monoxide; FEV1 = forced expiratory volume in 1 second; RV = residual volume; TLC = total lung capacity