Table 3.
Clinical Outcome | Status of CFV at 1 Month | Status of FV and PV at 1 Month | |||||
---|---|---|---|---|---|---|---|
Compressible | p-value | Both compressible | p-value | ||||
Overall Trial | Any PTS, n (%) | 205/447 (46%) | <0.001 | 70/160 (44%) | 0.07 | ||
Moderate-or-Severe PTS, n (%) | 85/447 (19%) | 0.003 | 30/160 (19%) | 0.23 | |||
Villalta score at 24 montds, mean (SD) | 4.0 (4.6) | 0.10 | 3.9 (4.4) | 0.24 | |||
VCSS score at 24 montds, mean (SD) | 2.1 (2.7) | 0.21 | 1.7 (2.4) | 0.02 | |||
VEINES-QOL score at 24 montds, mean (SD) | 81.4 (20) | 0.004 | 79.3 (24) | 0.26 | |||
Anatomical/Physiological Outcome | Status of CFV at 1 Month | Status of FV and PV at 1 Month | |||||
Compressible | p-value | Both compressible | p-value | ||||
Ultrasound Substudy | Non-compressible CFV at 12 months, n (%) | 1/83 (1%) | <0.001 | 5/28 (18%) | 0.86 | ||
Non-compressible FV at 12 months, n (%) | 46/84 (55%) | 0.35 | 2/28 (7%) | <0.001 | |||
Non-compressible PV at 12 months, n (%) | 53/84 (63%) | 0.18 | 0/28 (0%) | <0.001 | |||
Obstruction score at 12 months, mean (SD) | 0.1 (0.4) | 0.15 | 0.04 (0.2) | 0.33 | |||
CFV diameter (mm), mean (SD) | 0.05 (0.4) | <0.001 | 0.6 (1.5) | 0.57 | |||
PV diameter (mm), mean (SD) | 2.8 (2.4) | 0.07 | 0 (0.0) | <0.001 | |||
Reflux score at 12 months, mean (SD) | 2.8 (1.7) | 0.57 | 1.9 (1.7) | 0.002 | |||
Any reflux present at 12 months, n (%) | 74/84 (88%) | 0.76 | 19/27 (70%) | 0.002 | |||
Deep reflux present at 12 months, n (%) | 71/84 (85%) | 0.87 | 19/27 (70%) | 0.02 |
CFV=Common Femoral Vein, FV=Femoral Vein, PTS=Post-thrombotic syndrome, PV=Popliteal Vein, SD=Standard Deviation, VCSS=Venous Clinical Severity Score, VEINES-QOL=Venous Insufficiency Epidemiological and Economic Study Quality of Life