Table 3.
Primary results, hypothesis-tested secondary outcomes, and secondary observations
| Primary outcome measures | PTS subgroup N = 93 | NIVL subgroup N = 77 | All treated N = 170 | p value [90% CI] |
|---|---|---|---|---|
| Primary Patency1, % (n//N) | 81.7 (67/82) | 97.1 (66/68) | 88.62 |
< 0.00013 [82.8, 94.4] |
| Freedom from MAEs4, % (n/N) | 88.2 (82/93) | 100 (77/77) | 93.5 |
0.0325 [89.5, 96.3] |
| Secondary outcome measures (hypothesis tested) | p value | |||
|---|---|---|---|---|
| VCSS Pain Score6 | ||||
| Baseline |
2.27 [2.1, 2.4] |
2.3 [2.1, 2.4] |
2.3 [2.2, 2.4] |
|
| 12 Months |
0.7 [0.5, 0.9] |
0.5 [0.3, 0.7] |
0.6 [0.5, 0.7] |
|
| Change from Baseline |
−1.5 [−1.8, −1.3] |
−1.8 [−2.0, −1.6] |
−1.7 [−1.8, −1.5] |
< 0.00018 |
| CIVIQ-20 Score9 | ||||
| Baseline |
52.510 [48.6, 56.4] |
45.7 [41.8, 49.5] |
49.3 [46.5, 52.0] |
|
| 12 Months |
34.0 [30.5, 37.6] |
33.1 [29.3, 36.9] |
33.6 [31.0, 36.2] |
|
| Change from Baseline |
−18.5 [−22.2, −14.7] |
−12.6 [−16.5, −8.7] |
−15.7 [−18.4, −13.0] |
< 0.000111 |
| Secondary observations | [95% CI] | |||
|---|---|---|---|---|
| CEAP Score, mean ± SD | ||||
| Baseline | 3.4 ± 1.0 | 3.5 ± 0.8 | 3.5 ± 0.9 | |
| 36 Months | 2.1 ± 1.6 | 2.0 ± 1.5 | 2.1 ± 1.6 | |
| Change from Baseline |
−1.3 [−1.7, −1.0] |
−1.5 [−1.9, −1.2] |
−1.412 [−1.7, −1.2] |
|
| Freedom from TVR/TLR | ||||
| 12 Months, % (n/N) | 87.6 (78/89) | 98.6 (73/74) | 92.6 (151/163) | [87.5, 96.1] |
| 24 Months, % (n/N) | 82.8 (72/87) | 97.3 (72/74) | 89.4 (144/161) | [83.6, 93.7] |
| 36 Months, % (n/N) | 80.5 (66/82) | 97.1 (67/69) | 88.1 (133/151) | [81.8, 92.8] |
| Primary Patency13, % (n/N) | [90% CI] | |||
| 24 Months | 75.6 (62/82) | 95.4 (62/65) | 84.4 (124/147) | [78.6, 89.1] |
| 36 Months | 70.0 (49/70) | 93.6 (44/47) | 79.5 (93/117) | [72.4, 85.4] |
| Stent Migration14, % (n/N) | 0 (0/93) | 0 (0/77) | 0 (0/170) | |
| Stent Fracture15, % (n/N) | ||||
| 12 Months | 0 (0/72) | 0 (0/65) | 0 (0/137)16 | |
| 24 Months | 0 (0/65) | 0 (0/63) | 0 (0/128) | |
| 36 Months | 0 (0/53) | 0 (0/45) | 0 (0/98) | |
1Primary patency was defined as freedom from TVR, thrombotic occlusion, or stenosis greater than 50% measured by duplex ultrasonography (DUS) and reviewed by the DUS core laboratory
2Weighted mean based on the patency rates of PTS and NIVL subgroups
390% CI and one-sided p value is from the weighted Z-statistics and the combined patency rate was tested against the performance goal (PG) (74%)
4MAEs included target vessel revascularization (TVR), device- or procedure-related deep vein thrombosis (DVT), target-limb major amputation, symptomatic pulmonary embolism, vascular injury requiring either surgical or endovascular intervention, device migration, or death
5The p value is computed compared with performance goal of 89%. The 90% confidence interval is calculated using the exact binomial method
6Pain component of the venous clinical severity score (VCSS) hypothesis-tested against baseline values at 12 months
7Mean and 95% CI are presented based on normal assumption
8The p value is calculated from a two-sided paired t test
9The Chronic Venous Quality-of-Life Questionnaire (CIVIQ-20) score hypothesis-tested against baseline values at 12 months
10Mean and 95% CI are presented based on normal assumption
11The p value is calculated from a two-sided paired t test
12Mean and 95% CI are presented based on normal assumption
13Unweighted proportional values with 90% CI estimated by exact binomial method
14CEC adjudicated stent embolism/migration through 3 years
15Based on AP and lateral X-rays for each evaluated stent analyzed by the core laboratory
16Number of stents that had images available and readable for review