Change in lung function, health status and exercise tolerance at 90 days
| Open label valve treated patients (n=12) | p Value | Original Chartis CV− treatment arm patients (n=19) | p Value | All CV− treated patients (per Chartis) (n=31) | p Value | |
|---|---|---|---|---|---|---|
| %ΔFEV1 | 24.2 (27.3) | 0.06 | 28.9 (40.1) | 0.001 | 27.3 (36.4) | 0.0002 |
| ΔFEV1 (l) | 0.14 (0.20) | 0.06 | 0.23 (0.28) | 0.001 | 0.19 (0.25) | 0.0002 |
| %ΔFVC | 5.1 (13.0) | 0.5 | 7.51 (16.9) | 0.03 | 6.5 (15.6) | 0.02 |
| ΔTLC (l) | −0.23 (0.49) | 0.13 | −0.37 (0.56) | 0.01 | −0.33 (0.53) | 0.002 |
| ΔRV (l) | −0.42 (0.80) | 0.41 | −0.54 (0.76) | 0.01 | −0.49 (0.76) | 0.007 |
| ΔRV/TLC % | −3.50 (6.77) | 0.10 | −4.6 (6.9) | 0.03 | −4.3 (6.85) | 0.004 |
| ΔFRC (l) | −0.28 (0.83) | 0.27 | −0.42 (0.69) | 0.04 | −0.38 (0.75) | 0.009 |
| ΔTLco (absolute percentage points) | 3.5 (6.77) | 0.005 | 3.45 (6.2) | 0.02 | 3.62 (5.16) | 0.0007 |
| ΔKco (mmol/min/kPa/l) | 0.10 (0.07) | 0.007 | 0.05 (0.07) | 0.009 | 0.07 (0.07) | <0.0001 |
| ΔCAT | −3.9 (5.5) | 0.05 | −4.2 (10.1) | 0.20 | −4.1 (8.5) | 0.03 |
| ΔSGRQc total | −7.5 (14.9) | 0.08 | −7.5 (20.8) | 0.3 | −8.5 (20.2) | 0.05 |
| Δ6MWD | 29 (48) | 0.16 | 33.2 (80.2) | 0.02 | 32.6 (68.7) | 0.01 |
| ΔTLim | 138 (312) | 0.08 | 165 (260) | 0.07 | 155 (275) | 0.01 |
Data are presented as mean (SD). The p values are for the Wilcoxon signed-rank test.
6MWD, 6-min walk distance; CAT, COPD assessment test score; Chartis CV−, no interlobar collateral ventilation on Chartis assessment; CV−, collateral ventilation negative; FRC, functional residual capacity; Kco, carbon monoxide transfer coefficient; RV, residual volume; SGRQc, St George's Respiratory Questionnaire for COPD; TLC, total lung capacity; TLco, carbon monoxide transfer factor; Tlim, endurance time on cycle ergometry at 70% of peak workload.