Table 3.
Primary and secondary efficacy endpoints in the postmarketing surveillance study
| Parameter | Treatment group and statistical significance of in-group differences, M ± m | Control group and statistical 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 (150/60) | 100.3 ± 6.9 | 191.3 ± 11.9 (p = 0.007) | 277.1 ± 16.2 (p = 0.000) | 110.3 ± 3.0 | 112.8 ± 11.5 (p = 0.318) | 111.5 ± 11.5 (p = 0.218) | 0.672 | 0.000 | 0.000 |
| 2A (11/7) | 253.1 ± 23.4 | 323.6 ± 28.8 (p = 0.004) | 466.2 ± 39.5 (p = 0.007) | 265.2 ± 13.5 | 262.1 ± 13.1 (p = 1.000) | 250.8 ± 16.1 (p = 1.000) | a | a | a |
| 2B (79/34) | 104.45 ± 5.1 | 191.7 ± 13.5 (p = 0.000) | 278.08 ± 19.9 (p = 0.000) | 119.4 ± 7.7 | 118.4 ± 9.2 (p = 0.864) | 111.2 ± 9.5 (p = 0.029) | 0.372 | 0.000 | 0.000 |
| 3 (60/19) | 24.6 ± 14.6 | 136.7 ± 26.2 (p = 0.000) | 188.5 ± 31.6 (p = 0.000) | 24.3 ± 1.6 | 33.6 ± 2.64 (p = 0.010) | 38.8 ± 3.8 (p = 0.345) | 0.074 | 0.000 | 0.000 |
| Proximal level (35/19) | 96.7 ± 11.2 | 186.5 ± 20.4 (p = 0.000) | 264.1 ± 33.7 (p = 0.000) | 100 ± 19.0 | 113.6 ± 16.8 (p = 0.483) | 108.4 ± 19.0 (p = 0.423) | 0.381 | 0.097 | 0.015 |
| Distal level (97/24) | 98.8 ± 9.65 | 193.7 ± 16.4 (p = 0.000) | 282.3 ± 21.3 (p = 0.000) | 112 ± 25.0 | 119.5 ± 25.3 (p = 0.069) | 113.7 ± 23.2 (p = 0.131) | 0.737 | 0.013 | 0.000 |
| Multilevel disease (18/17) | 110.7 ± 14.9 | 163.6 ± 17 (p = 0.000) | 246 ± 30 (p = 0.000) | 107.1 ± 19.7 | 102.3 ± 20.4 (p = 0.553) | 112 ± 23.1 (p = 0.905) | 0.141 | 0.018 | 0.000 |
| ABI (150/60) | 0.49 ± 0.01 | 0.58 ± 0.02 (p = 0.000) | 0.61 ± 0.02 (p = 0.000) | 0.51 ± 0.01 | 0.51 ± 0.02 (p = 0.669) | 0.50 ± 0.01 (p = 0.731) | 0.406 | 0.009 | 0.000 |
| BFLV (150/60) | 23.9 ± 2 | 28.2 ± 1.7 (p = 0.000) | 29.7 ± 1.7 (p = 0.000) | 18.2 ± 0.8 | 18.1 ± 0.8 (p = 0.811) | 17.6 ± 0.9 (p = 0.546) | 0.191 | 0.000 | 0.000 |
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