Table 1:
Baseline Characteristics by Treatment Group
| Baseline Characteristic | PCDT n = 196 |
No PCDT n = 195 |
Total N = 391 |
|---|---|---|---|
| Age, years: median (IQR) | 51 (39, 62) | 52 (42, 61) | 52 (39, 62) |
| Male: n (%) | 107 (55) | 101 (52) | 208 (53) |
| Race: n (%) | |||
| White | 158 (81) | 148 (76) | 306 (78) |
| Black/African-American | 33 (17) | 35 (18) | 68 (17) |
| Other | 5 (3) | 12 (6) | 17 (4) |
| Body mass index, kg/m2: median (IQR) | 31 (28, 37) | 31 (26, 36) | 31 (27, 37) |
| Symptom severity (Villalta*) class: n (%)† | |||
| None or minimal (score 0-4) | 24 (12) | 31 (16) | 55 (14) |
| Mild (score 5-9) | 65 (33) | 65 (33) | 130 (33) |
| Moderate (score 10-14) | 60 (31) | 56 (29) | 116 (30) |
| Severe (score ≥ 15) | 47 (24) | 42 (22) | 89 (23) |
| Leg with index DVT, Left: n (%) | 124 (63) | 125 (64) | 249 (64) |
| Previous DVT or PE: n (%) | 48 (24) | 45 (23) | 93 (24) |
| Previous ipsilateral DVT: n (%) | 3 (2) | 10 (5) | 13 (3) |
| DVT risk factors: n (%)‡ | |||
| Major surgery | 19 (10) | 21 (11) | 40 (10) |
| Hospitalization | 17 (9) | 29 (15) | 46 (12) |
| Plaster cast immobilization | 7 (4) | 3 (2) | 10 (3) |
| Childbirth | 3 (2) | 5 (3) | 8 (2) |
| Outpatient: n (%) | 156 (80) | 156 (80) | 312 (80) |
| Days from start of DVT symptoms to rand: median (IQR) | 6 (3, 9) | 6 (3, 9) | 6 (3, 9) |
| eGFR, mL/min: median (IQR) | 84 (67, 103) | 88 (72, 104) | 86 (70, 103) |
| Leg pain severity: n (%) | |||
| 0-2 | 34 (17) | 43 (22) | 77 (20) |
| 3-4 | 60 (31) | 59 (30) | 119 (30) |
| 5-7 | 99 (51) | 91 (47) | 190 (49) |
| Unknown | 3 (2) | 2 (1) | 5 (1) |
| Between-leg circumference difference§, cm: median (IQR) | 3 (2, 5) | 3 (2, 4) | 3 (2, 5) |
| Pre-randomization AC∥ therapy: n (%)‡ | 180 (92) | 184 (94) | 364 (93) |
| LMWH | 101 (56) | 110 (60) | 211 (58) |
| UFH | 61 (34) | 60 (33) | 121 (33) |
| Rivaroxaban | 7 (4) | 7 (4) | 14 (4) |
| Warfarin | 89 (49) | 98 (53) | 187 (51) |
| Other | 11 (6) | 7 (4) | 18 (5) |
Villalta Scale: 5 patient-reported signs (cramps, itching, pins & needles, leg heaviness, pain) and 6 blinded clinician-reported symptoms (pretibial edema, skin induration, hyperpigmentation, venous ectasia, redness, pain during calf compression) scored on a 4-point scale (0=none/minimal, 1=mild, 2=moderate, 3=severe) and summed into a total score, or the presence of an ulcer (score=15), for the leg with index DVT
One patient in the No PCDT was not assessed
Subjects may fit into more than one category
Leg circumference with index DVT minus Leg circumference of the other leg
Anticoagulant (AC) therapy that was given after DVT diagnosis and before randomization
IQR, inter-quartile range; DVT, deep vein thrombosis; PE, pulmonary embolism; rand, randomization; eGFR, estimated glomerular filtration rate; LMWH, low molecular weight heparin; UFH, unfractionated heparin