Table 1.
Characteristics of the Patients at Baseline.*
| Characteristic | Pharmacomechanical-Thrombolysis Group (N = 336) |
Control Group (N = 355) |
Total (N = 691) |
|---|---|---|---|
| Median age (IQR) — yr | 52 (41–62) | 53 (43–62) | 53 (42–62) |
| Male sex — no. (%) | 205 (61) | 221 (62) | 426 (62) |
| Race — no. (%)† | |||
| White | 265 (79) | 276 (78) | 541 (78) |
| Black | 61 (18) | 62 (17) | 123 (18) |
| Other | 10 (3) | 17 (5) | 27 (4) |
| Median weight (IQR) — kg | 95 (81–111) | 92 (79–110) | 93 (80–110) |
| Median body-mass index (IQR)‡ | 31 (27–36) | 30 (26–35) | 31 (27–35) |
| Villalta score — no. (%)§ | |||
| 0–4 | 57 (17) | 69 (19) | 126 (18) |
| 5–9 | 115 (34) | 124 (35) | 239 (35) |
| 10–14 | 98 (29) | 94 (26) | 192 (28) |
| ≥15 | 66 (20) | 66 (19) | 132 (19) |
| Index deep-vein thrombosis in left leg — no. (%) | 207 (62) | 218 (61) | 425 (62) |
| Deep-vein thrombosis extends into common femoral vein, iliac vein, or both — no. (%) | 195 (58) | 196 (55) | 391 (57) |
| Previous deep-vein thrombosis or pulmonary embolism — no. (%) | 83 (25) | 87 (25) | 170 (25) |
| Previous ipsilateral deep-vein thrombosis — no. (%) | 5 (1) | 14 (4) | 19 (3) |
| Deep-vein thrombosis risk factors — no. (%)¶ | |||
| Major surgery | 27 (8) | 34 (10) | 61 (9) |
| Hospitalization | 26 (8) | 38 (11) | 64 (9) |
| Plaster cast immobilization | 8 (2) | 9 (3) | 17 (2) |
| Childbirth | 3 (1) | 5 (1) | 8 (1) |
| Outpatient — no. (%) | 268 (80) | 300 (85) | 568 (82) |
| Median interval from start of symptoms of deep-vein thrombosis to randomization (IQR) — days | 6 (4–10) | 6 (4–9) | 6 (4–10) |
| Aspirin use within 7 days before randomization — no. (%) | 68 (20) | 74 (21) | 142 (21) |
| Median estimated glomerular filtration rate (IQR) — ml/min | 86 (70–102) | 86 (71–102) | 86 (71–102) |
| Prerandomization anticoagulant therapy — no. (%)¶‖ | 314 (93) | 331 (93) | 645 (93) |
| Low-molecular-weight heparin | 180 (57) | 205 (62) | 385 (60) |
| Unfractionated heparin | 99 (32) | 99 (30) | 198 (31) |
| Rivaroxaban | 16 (5) | 11 (4) | 27 (4) |
| Other | 18 (5) | 16 (5) | 34 (5) |
| Warfarin | 154 (49) | 179 (57) | 333 (52) |
IQR denotes interquartile range.
Race was reported by the patient.
Body-mass index is the weight in kilograms divided by the square of the height in meters.
The Villalta scale is an assessment of five patient-reported symptoms (cramps, itching, pins and needles, leg heaviness, and pain) and six signs reported by clinicians who were unaware of the treatment assignments (pretibial edema, skin induration, hyperpigmentation, venous ectasia, redness, and pain during calf compression), scored on a 4-point scale (a score of 0 denotes none or minimal, 1 mild, 2 moderate, and 3 severe) and summed into a total score for each leg; a leg with an ulcer was assigned a minimum score of 15 points. Total scores range from 0 to 33, with higher scores indicating more severe post-thrombotic syndrome; a score of 0 to 4 denotes none or minimal, 5 to 9 mild, 10 to 14 moderate, and 15 or higher severe. Two patients in the control group were not assessed.
Patients could be included in more than one category.
Anticoagulant therapy that was given after the diagnosis of deep-vein thrombosis and before randomization is shown.