Table 3.
| Outcome Measured | LIBERATE trial |
EMPROVE trial |
||||
|---|---|---|---|---|---|---|
| Control | EBV | diff T-C | Control | EBV | diff T-C | |
| Patients, n | 62 | 128 | 59 | 113 | ||
| Procedure | ||||||
| Mean procedure time, minutes (range) | NA | 29 (4-123) | NA | 24.3 (9-73) | ||
| Valves (average number per patient) | NA | 4 | NA | 3.83 | ||
| Mean and median hospitalization days (range) | NA | NR | NA | 3.83, 1 (1-95) | ||
| Efficacy | ||||||
| Change in lung function from baseline, L (%) | ||||||
| TLV reduction, 6 mo | NA | NR | — | NA | –0.97 ± 0.74 | –0.97 |
| TLV reduction, 12 mo | NA | −1.142 ± 0.702 | –1.142 | NA | NR | — |
| FEV1, 6 mo | — | +18%c | — | –0.002 ± 0.098 | 0.099 ± 0.154 | 0.101 |
| FEV1, 12mo (% change from baseline) | –0.003 ± 0.194 (–0.80 ± 26.94) | 0.104 ± 0.200 (17.16 ± 27.93) | 0.106 (17.96) | –0.032 ±0.114 | 0.067 ± 0.167 | 0.099 |
| RV, 6 mo | NR | NR | — | –0.04 ± 0.58 | –0.40 ± 0.85 | –0.36 |
| RV, 12 mo | 0.03 ± 0.66 | –0.49 ± 0.83 | –0.522 | NR | NR | |
| FVC, 0 to 6 mo | NR | NR | — | –0.098 ± 0.252 | 0.147 ± 0.485 | 0.245 |
| FVC, 0 to 12 mo | NR | NR | — | –0.103 ± 0.369 | 0.097 ± 0.536 | 0.2 |
| Change in exercise, m | ||||||
| 6MWD, 6 mo | — | +39c | — | –11.3 ± 51.4 | –4.4 ± 76.7 | 6.9d |
| 6MWD, 12 mo | –26.33 ± 81.50 | 12.98 ± 81.54 | 39.31 (14.64-63.98) | NR | NR | — |
| Change in patient-centered outcomes | ||||||
| SGRQ total score, 0-6 mo | — | −7.1c | — | 4.8 ± 10.6 | –8.1 ± 17.1 | –13.0 |
| SGRQ total score, 0-12 mo | –0.50 ± 15.50 | –7.55 ± 15.71 | –7.05 (–11.84 to –2.27) | 3.7 ± 10.9 | –5.8 ± 16.8 | –9.5 |
| mMRC change, 0-6 mo | — | −0.8c | — | 0.0 ± 0.6 | –0.6 ± 1.0 | –0.6 |
| mMRC change, 0-12 mo | 0.3 ± 1.03 | –0.5 ± 1.17 | –0.8 (–0.4 to –1.1) | 0.2 ± 0.6 | –0.6 ± 1.1 | –0.9 |
| CAT change, 0-6 mo | NR | NR | — | 1.6 ± 5.3 | –3.0 ± 7.8 | –4.3 |
| CAT change, 0-12 mo | NR | NR | — | 3.0 ± 5.7 | –2.3 ± 8.1 | –5.3 |
| Responder ratese | ||||||
| FEV1 ≥ 15% | ||||||
| 6 months, n/N (%) | 12.3% | 49.6% | 37.30% | 5/50 (10%) | 39/106 (36.8%) | 25.70% |
| 12 months, n/N (%) | 16.8% | 47.7% | 31% | 2/39 (5.1%) | 32/86 (37.2%) | 30.40% |
| RV ≥ 310 reduction | ||||||
| 45 days, % | 22 | 66.4 | 44 | NR | NR | — |
| 6 months, n/N (%) | NR | NR | — | 16/50 (32%) | 53/105 (50.5%) | 18.50% |
| 12 months, % | 22.4 | 61.6 | 39.2 | NR | NR | — |
| TLV (≥350-L reduction) | ||||||
| 45 days | NA | 79.1% | — | NA | — | — |
| 6 months, n/N | NA | NR | — | NA | 76/102 (74.5%) | — |
| 12 months | NA | 84.2% | — | NA | NR | — |
| Lobar atelectasis complete by imaging | NA | NR | — | NA | 40%, 6 months | — |
| 6MWD ≥ 25 m, 6 mo (%) | 27.2 | 39.4 | 12.2 | 22.9 | 32.4 | 9.5 |
| 6MWD ≥ 25 m, 12 mo (%) | 19.6 | 41.8 | 22.2 | NR | NR | — |
| SGRQ ≥ 4-point reduction | ||||||
| 6 months, n/N (%) | 36.5% | 55.7% | 19.2% | 9/50 (18%) | 57/105 (54.3%) | 36.3% |
| 12 months, n/N (%) | 30.2% | 56.2% | 26% | 9/41 (22%) | 48/95 (50.5%) | 28.5% |
| MMRC ≥ 1-point reduction | ||||||
| 6 months, n/N (%) | 21.1% | 46.5% | 25.4% | 9/50 (18%) | 57/107 (53.3%) | 35.3% |
| 12 months, n/N (%) | 18.6% | 47.8% | 29.2% | 3/41 (7.3%) | 46/94 (48.9%) | 41.6% |
6MWD = 6-minute walk distance; CAT = chronic obstructive pulmonary disease assessment test; 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; NA = not applicable; NR = not reported; RV = residual volume; SGRQ= St. George’s Respiratory Questionnaire; TLV = total lung volume.
Data are presented as median (range) or mean change, unless otherwise stated.
Intention to treat analysis.
Not statistically significant.
Percentage of patients who reached the earlier established minimal important difference reported at 45 days and 12 months for the LIBERATE trial; reported at 6 months and 12 months for the EMPROVE trial.