Table 1.
Baseline Characteristics: Long‐Term Follow‐Up
| Additional Thrombolysis (n=62) | Standard Treatment (n=58) | Total (N=120) | |
|---|---|---|---|
| Age, y | 46.5 (37.0–63.3) | 52.0 (37.8–64.0) | 49.0 (37.3–63.8) |
| Age, category | |||
| <40 y | 20 (32.3) | 16 (27.6) | 36 (30.0) |
| 40–65 y | 27 (43.5) | 31 (53.4) | 58 (48.3) |
| >65 y | 15 (24.2) | 11 (19.0) | 26 (21.7) |
| Sex | |||
| Women | 32 (51.6) | 31 (53.4) | 63 (52.5) |
| Men | 30 (48.4) | 27 (46.6) | 57 (47.5) |
| BMI* | 27.7±5.4 | 27.4±4.3 | 27.6±4.8 |
| BMI, category* | |||
| <25.0 | 18 (29.0) | 18 (31.0) | 36 (30.0) |
| 25.0–30.0 | 27 (43.5) | 24 (41.4) | 51 (42.5) |
| ≥30.0 | 14 (22.6) | 12 (20.7) | 26 (21.7) |
| Unknown | 3 (4.8) | 4 (6.9) | 7 (5.8) |
| Provoked DVT† | 29 (46.8) | 26 (44.8) | 55 (45.8) |
| No. of known risk factors | |||
| 1 | 24 (38.7) | 17 (29.3) | 41 (34.2) |
| >1 | 5 (8.1) | 9 (15.5) | 14 (11.7) |
| Surgery in the previous 2 mo | 6 (9.7) | 8 (13.8) | 14 (11.7) |
| Trauma in the previous 2 mo | 2 (3.2) | 3 (5.2) | 5 (4.2) |
| Pregnancy or childbirth in the previous 3 mo | 8 (12.9) | 4 (6.9) | 12 (10.0) |
| Hormone replacement therapy | 2 (3.2) | 0 | 2 (1.7) |
| Oral contraceptives | 8 (12.9) | 12 (20.7) | 20 (16.7) |
| Previous contralateral DVT | 6 (9.7) | 4 (6.9) | 10 (8.3) |
| Previous pulmonary embolism | 2 (3.2) | 4 (6.9) | 6 (5.0) |
| Active malignancy‡ | 1 (1.6) | 1 (1.7) | 2 (1.7) |
| Thrombus location | |||
| Left | 42 (67.7) | 44 (75.9) | 86 (71.7) |
| Right | 18 (29.0) | 12 (20.7) | 30 (25.0) |
| Bilateral§ | 2 (3.2) | 2 (3.4) | 4 (3.3) |
| Duration of symptoms at inclusion, d | 6.0 (3.0–11.0) | 6.5 (3.0–10.3) | 6.0 (3.0–11.0) |
| Anticoagulant therapy at inclusion | |||
| Vitamin K antagonistsǁ | 51 (82.3) | 50 (86.2) | 101 (84.2) |
| Direct oral anticoagulants# | 10 (16.1) | 5 (8.6) | 15 (12.5) |
Data are number (percentage), mean±SD, or median (interquartile range). Data represent the modified intention‐to‐treat population, which was included in this prespecified long‐term follow‐up analysis.
Body mass index (BMI) is defined as the patient’s weight in kilograms divided by the square of the patient’s height in meters (kg/m2).
Acute deep vein thrombosis (DVT) is considered unprovoked in the absence of the following risk factors: surgery in the previous 2 months, trauma in the previous 2 months, pregnancy or childbirth in the previous 3 months, use of hormone replacement therapy, use of oral contraceptives, and active malignancy.
Active malignancy is defined as a current metastatic or progressive cancer diagnosis or having received cancer treatment within the previous 6 months.
In the case of bilateral DVT, the leg with the most proximal localization was considered to be the index leg.
The vitamin K antagonists used during the study were acenocoumarol and phenprocoumon.
The direct oral anticoagulants used during the study were rivaroxaban, apixaban, and dabigatran.