Table 2.
Efficacy Outcomes: Long‐Term Follow‐Up
|
Additional Thrombolysis (n=62) |
Standard Treatment (n=58) |
Difference Between Treatment Groups, (95% CI) | OR (95% CI) | |
|---|---|---|---|---|
| Primary outcome | ||||
| PTS at final follow‐up visit assessed by Villalta criteria18 | 19 (30.6) | 26 (44.8) | −14.2% (−32.0% to 4.8%) | 0.54 (0.26 to 1.15) |
| PTS diagnosed at 12 mo | 8 (12.9) | 6 (10.3) | 2.6% (−9.8% to 13.5%) | 1.28 (0.42 to 3.96) |
| PTS diagnosed at final follow‐up visit | 3 (4.8) | 5 (8.6) | −3.8% (−11.0% to 5.8%) | 0.54 (0.12 to 2.36) |
| None (<5) | 43 (69.4) | 32 (55.2) | 14.2% (−4.8% to 32.0%) | 1.84 (0.87 to 3.88) |
| Mild (5–9) | 5 (8.1) | 12 (20.7) | −12.6% (−22.7% to 1.5%) | 0.34 (0.11 to 1.02) |
| Moderate (10–14) | 13 (21.0) | 10 (17.2) | 3.7% (−11.6% to 17.9%) | 1.27 (0.51 to 3.18) |
| Severe (≥15) | 1 (1.6) | 4 (6.9) | −5.3% (−8.4% to 3.0%) | 0.22 (0.02 to 2.04) |
| Moderate/severe (≥10) | 14 (22.6) | 14 (24.1) | −1.6% (−17.6% to 14.5%) | 0.92 (0.39 to 2.14) |
| Additional outcomes | ||||
| Mean Villalta score18 at final follow‐up visit, total | 4.19±3.90 | 4.40±3.03 | −0.20 (−1.47 to 1.07) | … |
| Mean score objective items | 1.40±1.76 | 1.28±1.36 | 0.13 (−0.44 to 0.70) | … |
| Mean score subjective items | 2.79±2.69 | 3.12±2.64 | −0.33 (−1.30 to 0.63) | … |
| PTS at final follow‐up visit according to the ISTH score17 | 29 (46.8) | 40 (69.0) | −22.2% (−39.8% to −2.8%) | 0.40 (0.19 to 0.84) |
| PTS diagnosed at 12 mo | 10 (16.1) | 10 (17.2) | −1.1% (−15.1% to 12.9%) | 0.92 (0.35 to 2.41) |
| PTS diagnosed at final follow‐up visit | 5 (8.1)‡ | 13 (22.4) | −14.3% (−24.4% to 0.1%) | 0.30 (0.10 to 0.92) |
| None (<5) | 33 (53.2)† | 18 (31.0) | 22.2% (2.8% to 39.8%) | 2.53 (1.20 to 5.34) |
| Mild (5–9) | 12 (19.4)† | 24 (41.4) | −22.0% (−37.5% to −4.0%) | 0.34 (0.15 to 0.77) |
| Moderate (10–14) | 15 (24.2) | 12 (20.7) | 3.5% (−12.7% to 18.8%) | 1.22 (0.52 to 2.89) |
| Severe (≥15) | 2 (3.2) | 4 (6.9) | −3.7% (−9.1% to 4.8%) | 0.45 (0.08 to 2.56) |
| Moderate/severe (≥10) | 17 (27.4) | 16 (27.6) | −0.2% (−17.3% to 16.8%) | 0.99 (0.45 to 2.21) |
| Mean venous clinical severity score19 at final follow‐up visit | 2.82±2.36 | 3.48±2.34 | −0.66 (−1.52 to 0.19) | … |
| Ulceration at any follow‐up assessment | 0 | 3 (5.2) | −5.1% (−6.8% to 2.3%) | 0.13 (0.01 to 2.51) |
Data are number (percentage) or mean±SD. In the case of bilateral deep vein thrombosis, the least favorable clinical scores were used. ISTH indicates International Society of Thrombosis and Haemostasis; OR, odds ratio; and PTS, post‐thrombotic syndrome.
†
P=0.01.
‡
P=0.05.