Table 2:
Study Treatments Post Randomization
| Treatment over Time | PCDT n = 196 |
No PCDT n = 195 |
|---|---|---|
| Initial AC* therapy: n (%)† | n = 194 | n = 193 |
| UFH | 73 (38) | 42 (22) |
| LMWH | 99 (51) | 132 (68) |
| Other | 29 (15) | 28 (15) |
| At 30 days: n (%)† | n = 183 | n = 173 |
| Any AC Therapy | 177 (97) | 167 (97) |
| Antiplatelet Therapy | 30 (16) | 26 (15) |
| Compression stockings used ≥ 3 days per week | 135 (74) | 136 (79) |
| At 6 months: n (%)† | n = 169 | n = 150 |
| Any AC Therapy | 136 (80) | 126 (84) |
| Antiplatelet Therapy | 34 (20) | 23 (15) |
| Compression stockings used ≥ 3 days per week | 111 (66) | 108 (72) |
| At 24 months: n (%)† | n = 141 | n = 131 |
| Any AC Therapy | 66 (47) | 68 (52) |
| Antiplatelet Therapy | 44 (31) | 39 (30) |
| Compression stockings used ≥ 3 days per week | 77 (55) | 74 (56) |
| Duration of AC therapy: n (%) | ||
| Never started | 2 (1) | 2 (1) |
| Not stopped during study period | 106 (54) | 108 (55) |
| Stopped during study period: | 88 (45) | 85 (44) |
| Days to stopping: median (IQR) | 213 (182, 367) | 270 (182, 395) |
| PCDT Procedure Details (PCDT Arm only) | |
|---|---|
| Initial rt-PA delivery method: | |
| Infusion-First: n (%) | 102 (52) |
| rt-PA total dose, mg: median (IQR) | 21 (18, 26) |
| rt-PA duration, hours: % below 4h, mean (SD)‡ | 0%,23 (7.2) |
| AngioJet: n (%) | 46 (24) |
| rt-PA total dose, mg: median (IQR) | 21 (15, 28) |
| rt-PA duration, hours: % below 4h, mean (SD)‡ | 46%, 20 (5.5) |
| Trellis: n (%) | 38 (19) |
| rt-PA total dose, mg: median (IQR) | 20 (12, 30) |
| rt-PA duration, hours: % below 4h, mean (SD)‡ | 58%, 20 (4.6) |
| Other§: n (%) | 10 (5) |
| Additional endovascular methods used: n (%) | |
| None | 18 (9) |
| 1 or more | 178 (91) |
| Type of additional method: n (%)† | |
| Balloon venoplasty | 128 (72) |
| Balloon maceration | 105 (59) |
| Rheolytic thrombectomy (AngioJet) | 104 (58) |
| Stent placement | 70 (39) |
| Large-bore catheter aspiration | 44 (25) |
| Isolated thrombolysis (Trellis) | 11 (6) |
| Veins that were accessed: n (%)† | 192 (98) |
| Ipsilateral Popliteal Vein | 172 (90) |
| Ipsilateral Tibial Vein | 12 (6) |
| Ipsilateral Common Femoral Vein | 5 (3) |
| Internal Jugular Vein | 12 (6) |
| Other Vein | 17 (9) |
| Marder scores: median (IQR) | |
| Pre-lysis (n=180) | 11 (8, 16) |
| Post-lysis (n=178) | 2 (0, 4) |
| Pre-post Decrease (n=176) | 9 (4, 13) |
*
Anticoagulation (AC) therapy given post randomization
†
Subjects may fit into more than one category
‡
Distributions are bimodal with spikes below 4 hours (means and SDs are for post 4-hour data)
§
6 PCDT procedures where there was no acute thrombus on venogram and 4 not attempted
IQR, Inter-quartile range; rt-PA, recombinant tissue plasminogen activator; SD, standard deviation