Table 2.
Comparison of Patient Baseline Characteristicsa
| Baseline characteristic | LIBERATE trialb |
EMPROVE trialc |
||
|---|---|---|---|---|
| SoC | EBV | SoC | EBV | |
| Patients, n | 62 | 128 | 59 | 113 |
| Enrollment | October 13 to September 16, 24 sites | October 13 to May 7, 41 sites | ||
| COPD stage, n (%)d | ||||
| III | 16 (25.8) | 54 (42.2) | NR | NR |
| IV | 46 (74.2) | 74 (57.8) | NR | NR |
| FEV1 (L), mean ± SD | 0.75 ± 0.22 | 0.76 ± 0.25 | 0.792 ± 0.260 | 0.825 ± 0.264 |
| FEV1 (% predicted), mean ± SD | 26.2 ± 6.28 | 28.0 ± 7.45 | 28.5 ± 8.5 | 30.8 ± 8.1 |
| FVC (L), mean ± SD | 2.63 ± 0.79 | 2.60 ± 0.86 | 2.63 ± 0.76 | 2.49 ± 0.75 |
| FVC (% predicted), mean ± SD | 68.5 ± 13.59 | 71.2 ± 15.99 | 70.5 ± 16.7 | 70.2 ± 16.5 |
| RV (L), mean ± SD | 4.76 ± 0.90 | 4.71 ± 1.05 | 4.85 ± 1.20 | 4.57 ± 1.25 |
| RV (% predicted), mean ± SD | 224.6 ± 38.86 | 224.5 ± 42.45 | 213.4 ± 49.3 | 207.5 ± 45.0 |
| TLC (L), mean ± SD | 7.63 ± 1.37 | 7.54 ± 1.59 | 7.65 ± 1.43 | 7.22 ± 1.53 |
| TLC (% predicted), mean ± SD | 130.2 ± 12.44 | 133.5 ± 21.17 | 128.2 ± 17.0 | 126.5 ± 14.5 |
| DLCO (% predicted), mean ± SD | 33.1 ± 9.84 | 34.6 ± 11.34 | NR | NR |
| PaO2 (mm Hg) | 67.8 ± 11.72 | 68.7 ± 11.62 | 68.0 ± 11.6 | 67.9 ± 10.2 |
| PaCO2 (mm Hg), mean ± SD | 41.3 ± 5.33 | 40.1 ± 4.91 | 40.9 ± 6.0 | 40.2 ± 5.7 |
| 6MWD (m), mean ± SD | 302 ± 79 | 311 ± 81 | 306.9 ± 104.2 | 303.5 ± 84.6 |
| SGRQ, mean ± SD | 53.10 ± 14.14 | 55.15 ± 14.08 | 54.6 ± 13.6 | 57.2 ± 14.8 |
| MMRC (points), mean ± SD | 2.2 ± 0.83 | 2.4 ± 0.97 | 2.7 ± 0.6 | 2.7 ± 0.7 |
| CAT (points), mean ± SD | 19.3 ± 6.35 | 19.2 ± 6.32 | 20.0 ± 6.3 | 21.8 ± 6.8 |
| Pulmonary rehabilitation (%) [pre, post] | 100, 100 | 100, 100 | 100, 30.5 | 100, 34.5 |
| Target lobe volume (L), mean ± SD | NR | NR | 1.82 ± 0.46 | 1.84 ± 0.60 |
| Emphysema target lobe severity (%), mean ± SDe | 70.9 ± 8.77 | 70.9 ± 8.52 | 61.6 ± 11.6 | 63.6 ± 10.1 |
| Emphysema heterogeneity (%), mean ± SDf | 26.1 ± 9.81 | 25.5 ± 9.85 | 23.3 ± 11.6 | 25.3 ± 12.0 |
6MWD = 6-minute walk distance; CAT = COPD assessment test; COPD = chronic obstructive pulmonary disease; DLCO = diffusion capacity for carbon monoxide; EBV = endobronchial valve; EMPROVE = Evaluation of the Spiration Valve System for Emphysema to Improve Lung Function; FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; LIBERATE = Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema; MMRC = Modified Medical Research Council dyspnea scale; NR = not reported; RV = residual volume; SGRQ = St. George’s Respiratory Questionnaire; SOC = standard of care; TLC = total lung capacity.
Subjects randomized after Chartis CV-exam confirmed.
Subjects randomized after quantitative computed tomography confirmed fissure integrity >90%.
Stage III = FEV1, 30-50% predicted; stage IV = FEV1 < 30% predicted.
Quantitative computed tomography software measuring percent of voxels <–910 HU (StratX software) for LIBERATE or <–920 HU (SeleCT software) for EMPROVE.
Difference in the percentage of emphysema between the target and ipsilateral lobes.