Table 3:
Binary Study Outcomes by Treatment Group (Intention-to-Treat Analysis)
| Outcome | PCDT n = 196 |
No PCDT n = 195 |
Risk Ratio | P Value |
|||
|---|---|---|---|---|---|---|---|
| Events | (%) | Events | (%) | Estimate | 95% CI | ||
| PTS*: | |||||||
| Ulcer (any assessment) | 9 | (4.6%) | 12 | (6.2%) | |||
| Villalta ≥ 5 (without ulcer) | 86 | (44%) | 88 | (45%) | |||
| Late endovascular procedure only | 1 | (0.5%) | 0 | (0%) | |||
| Total | 96 | (49%) | 100 | (51%) | 0.95* | 0.78, 1.15 | 0.59 |
| PTS: VCSS ≥ 4* | 59 | (30%) | 78 | (40%) | 0.75* | 0.57, 0.98 | 0.034 |
| PTS incidence proportion: † | |||||||
| At 6 months | 50/169 | (30%) | 68/149 | (46%) | 0.65 | 0.48, 0.87 | |
| At 12 months | 58/155 | (37%) | 49/137 | (36%) | 1.05 | 0.77, 1.42 | |
| At 18 months | 46/139 | (33%) | 47/123 | (38%) | 0.87 | 0.63, 1.20 | |
| At 24 months | 48/145 | (33%) | 52/133 | (39%) | 0.85 | 0.62, 1.16 | |
| Moderate-severe PTS (Villalta ≥ 10) ‡ | 36 | (18%) | 55 | (28%) | 0.65* | 0.45, 0.94 | 0.021 |
| Moderate-severe PTS incidence proportion: § | |||||||
| At 6 months | 19/169 | (11%) | 29/149 | (19%) | 0.58 | 0.34, 0.99 | |
| At 12 months | 18/155 | (12%) | 24/137 | (18%) | 0.66 | 0.38, 1.17 | |
| At 18 months | 16/139 | (12%) | 23/123 | (19%) | 0.62 | 0.34, 1.11 | |
| At 24 months | 17/145 | (12%) | 25/133 | (19%) | 0.62 | 0.35, 1.10 | |
| Severe PTS: Villalta ≥ 15 ∥ | 17 | (8.7%) | 30 | (15%) | 0.57* | 0.32, 1.01 | 0.048 |
| Severe PTS: VCSS ≥ 8 ∥ | 13 | (6.6%) | 28 | (14%) | 0.46* | 0.24, 0.87 | 0.013 |
| Major non-PTS treatment failure | 4 | (2.0%) | 5 | (2.6%) | 0.80 | 0.22, 2.92 | 0.73 |
| Any treatment failure ** | 97 | (49%) | 103 | (53%) | 0.93* | 0.77, 1.13 | 0.47 |
| Major bleeding in first 10 days | 3 | (1.5%) | 1 | (0.5%) | 2.98 | 0.31, 28.4 | 0.32 |
| Any bleeding in first 10 days | 7 | (3.6%) | 4 | (2.1%) | 1.74 | 0.52, 5.85 | 0.36 |
| VTE: | |||||||
| First 30 days | 11 | (5.8%) | 6 | (3.1%) | 1.82 | 0.69, 4.83 | 0.22 |
| Total over 24 months | 26 | (13%) | 18 | (9.2%) | 1.44 | 0.81, 2.53 | 0.21 |
| Death | 6 | (3.1%) | 6 | (3.1%) | 0.99 | 0.33, 3.03 | 0.99 |
Cochran-Mantel-Haenszel (CMH) test adjusted for center, cumulative proportion of patients who developed PTS at any time between 6-24 months, inclusive. Villalta scores (0-33 range); VCSS scores (0-27 range), higher is worse for both.
At each visit, the proportion of patients with any PTS according to the Villalta scale among those who had an assessment performed (denominator)
Cumulative proportion with moderate or severe PTS (pre-specified analysis)
At each visit, the proportion of patients with moderate or severe PTS according to the Villalta scale among those who had an assessment performed (denominator)
Cumulative proportion with severe PTS
Composite of PTS or major non-PTS treatment failure.
PTS, post-thrombotic syndrome; CI, confidence interval; VTE, venous thromboembolism