Table 4.
Efficacy endpoints of postmarketing surveillance and phase IIb/III clinical studies
| Parameter | Postmarketing study treatment group and significance of in-group differences, M ± m | Registration phase IIb/III study treatment group and significance of in-group differences, M ± m | Significance of differences between groups, p value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 3 months | 6 months | Baseline | 3 months | 6 months | Baseline | 3 months | 6 months | |
| PWD (150/75) | 100.3 ± 6.9 | 191.3 ± 11.9 (p = 0.007) | 277.1 ± 16.2 (p = 0.000) | 135.3 ± 12.2 | 233.2 ± 11.6 (p = 0.000) | 284.7 ± 29.8 (p = 0.000) | 0.004 | 0.078 | 0.781 |
| 2A (11/9) | 253.1 ± 23.4 | 323.6 ± 28.8 (p = 0.004) | 466.2 ± 39.5 (p = 0.007) | 320 ± 45.9 | 536.6 ± 50.6 (p = 0.007) | 610 ± 129.4 (p = 0.017) | a | a | a |
| 2B (79/57) | 104.45 ± 5.1 | 191.7 ± 13.5 (p = 0.000) | 278.08 ± 19.9 (p = 0.000) | 119.5 ± 7.9 | 208.9 ± 7.9 (p = 0.000) | 248.9 ± 23.6 (p = 0.000) | 0.711 | 0.804 | 0.919 |
| 3 (60/9) | 24.6 ± 14.6 | 136.7 ± 26.2 (p = 0.000) | 188.5 ± 31.6 (p = 0.000) | 41.7 ± 2.9 | 127 ± 16.2 (p = 0.001) | 138.1 ± 19.7 (p = 0.386) | a | a | a |
| Proximal level (35/38) | 96.7 ± 11.2 | 186.5 ± 20.4 (p = 0.000) | 264.1 ± 33.7 (p = 0.000) | 122.7 ± 11.1 | 159.2 ± 7.4 (p = 0.000) | 210.5 ± 24 (p = 0.000) | 0.048 | 0.856 | 0.810 |
| Distal level (97/16) | 98.8 ± 9.65 | 193.7 ± 16.4 (p = 0.000) | 282.3 ± 21.3 (p = 0.000) | 135.7 ± 22.3 | 305.2 ± 21.4 (p = 0.000) | 315.4 ± 54.7 (p = 0.000) | 0.034 | 0.003 | 0.274 |
| Multilevel disease (18/21) | 110.7 ± 14.9 | 163.6 ± 17 (p = 0.000) | 246 ± 30 (p = 0.000) | 143.3 ± 38.3 | 307.9 ± 35.6 (p = 0.000) | 402.3 ± 89.3 (p = 0.000) | 0.758 | 0.184 | 0.334 |
| ABI (150/75) | 0.49 ± 0.01 | 0.58 ± 0.02 (p = 0.000) | 0.61 ± 0.02 (p = 0.000) | 0.51 ± 0.02 | 0.57 ± 0.01 (p = 0.012) | 0.56 ± 0.02 (p = 0.017) | 0.440 | 0.971 | 0.887 |
| BFLV (150/75) | 23.9 ± 2 | 28.2 ± 1.7 (p = 0.000) | 29.7 ± 1.7 (p = 0.000) | 14.2 ± 1.6 | 20.2 ± 0.9 (p = 0.011) | 22.6 ± 2 (p = 0.007) | 0.277 | 0.120 | 0.336 |
ABI ankle brachial index, BLFV blood flow linear velocity, CAD coronary artery disease, M median, m standard error of the mean, PWD pain-free walking distance
aSelection is too small to calculate statistical significance