Table 4.
Binary Trial Outcomes
| All proximal DVT | Control* All patients (n = 191) |
PCDT All methods (n = 173) |
P value (All methods vs control arm) |
PCDT Initial AngioJet only (n = 75) |
P value (Initial AngioJet vs control arm) |
|---|---|---|---|---|---|
| PTS between 6 and 24 mo | |||||
| Ulcer at any follow-up assessment | 9 (4.7) | 7 (4.0) | .76 | 3 (4.0) | .80 |
| Villalta scale score ≥5 without ulcer | 70 (36.6) | 69 (39.9) | .53 | 30 (40.0) | .61 |
| Late endovascular procedure only | 0 (0.0) | 0 (0.0) | 1.0† | 0 (0.0) | 1.0* |
| Total | 79 (41.4) | 76(43.9) | .62 | 33 (44.0) | .69 |
| PTS: VCSS score ≥ 4 | 64 (33.5) | 53(30.6) | .56 | 21 (28.0) | .39 |
| PTS incidence proportion according to follow-up visit | |||||
| At 6 mo | 60/150 (40.0) | 37/153 (24.2) | .003 | 18/63 (28.6) | .11 |
| At 12 mo | 42/135 (31.1) | 44/145 (30.3) | .89 | 17/56 (30.4) | .92 |
| At 18 mo | 35/117 (29.9) | 45/125 (36.0) | .31 | 13/48 (27.1) | .72 |
| At 24 mo | 41/123 (33.3) | 34/132 (25.8) | .18 | 14/49 (28.6) | .55 |
| Moderate-to-severe PTS (Villalta scale score ≥ 10) | 38 (19.9) | 29 (16.8) | .44 | 12 (16.0) | .46 |
| Moderate-to-severe PTS incidence proportion according to follow-up visit | |||||
| At 6 mo | 18/150 (12.0) | 17/153 (11.1) | .81 | 9/63 (14.3) | .65 |
| At 12 mo | 14/135 (10.4) | 17/145 (11.7) | .72 | 8/56 (14.3) | .44 |
| At 18 mo | 17/117 (14.5) | 12/125 (9.6) | .24 | 4/48 (8.3) | .28 |
| At 24 mo | 22/123 (17.9) | 13/132 (9.8) | .06 | 4/49 (8.2) | .11 |
| Severe PTS: Villalta scale score ≥ 15 | 21 (11.0) | 13 (7.5) | .25 | 7 (9.3) | .69 |
| Severe PTS: VCSS score ≥ 8 | 19 (9.9) | 11 (6.4) | .21 | 7 (9.3) | .88 |
| Major bleeding | |||||
| First 30 d | 0 (0.0) | 3 (1.7) | .11† | 0 (0.0) | 1.0* |
| Total over 24 mo | 6 (3.1) | 9 (5.2) | .32 | 4 (5.3) | .40 |
| Any bleeding | |||||
| First 30 d | 4 (2.1) | 10 (5.8) | .07 | 1 (1.3) | .99* |
| Total over 24 mo | 19 (9.9) | 23 (13.3) | .32 | 7 (9.3) | .88 |
| Symptomatic VTE | |||||
| First 30 d | 3 (1.6) | 8 (4.6) | .09 | 4 (5.3) | .09 |
| Total over 24 mo | 13 (6.8) | 24 (13.9) | .03 | 10 (13.3) | .09 |
| Death | 3 (1.6) | 2 (1.2) | .99† | 1 (1.3) | .99* |
| Venous status at 1 mo | |||||
| Noncompressible CFV, n (%) | 48/167 (28.7) | 30/167 (18.0) | .009 | 11/72 (15.2) | .004 |
| Noncompressible FV, n (%) | 110/169 (65.0) | 81/167 (48.5) | .002 | 20/72 (27.8) | <.001 |
| Noncompressible PV, n (%) | 121/169 (71.6) | 93/166 (56.0) | .001 | 27/71 (38.0) | <.001 |
| Ultrasound substudy ‡ | |||||
| Venous status at 12 mo | |||||
| Noncompressible CFV, n (%) | 4/20 (20.0) | 3/24 (12.5) | 1/11 (9.1) | ||
| Noncompressible FV, n (%) | 11/20 (55.0) | 10/25 (40.0) | 3/11 (27.2) | ||
| Noncompressible PV, n (%) | 14/20 (70.0) | 10/25 (40.0) | 3/11 (27.2) | ||
| Any reflux present, n (%) | 17/19 (89%) | 20/23 (87%) | 7/9 (78%) | ||
| Deep reflux present, n (%) | 17/19 (89%) | 20/23 (87%) | 7/9 (78%) | ||
| Iliofemoral DVT subgroup | Control (n = 100) |
PCDT (n = 95) |
P value (All patients) |
PCDT: initial AngioJet (n = 46) |
P value (Initial AngioJet) |
| PTS between 6 and 24 mo | |||||
| Ulcer at any follow-up assessment | 5 (5.0) | 5 (5.3) | - | 3 (6.5) | - |
| Villalta scale score ≥5 without ulcer | 35 (35.0) | 36 (37.9) | - | 19 (41.3) | - |
| Late endovascular procedure only | 0 (0.0) | 0 (0.0) | - | 0 (0.0) | - |
| Total | 40 (40.0) | 41 (43.2) | .65 | 22 (47.8) | .37 |
| PTS: VCSS score ≥ 4 | 32 (32.0) | 31 (32.6) | .92 | 15 (32.6) | .94 |
| PTS incidence proportion according to follow-up visit | |||||
| At 6 mo | 29/74 (39.2) | 22/84 (26.2) | .08 | 13/40 (32.5) | .48 |
| At 12 mo | 17/68 (25.0) | 26/80 (32.5) | .32 | 13/36 (36.1) | .23 |
| At 18 mo | 18/63 (28.6) | 23/69 (33.3) | .55 | 8/31 (25.8) | .78 |
| At 24 mo | 20/66 (30.3) | 19/70 (27.1) | .68 | 9/32 (28.1) | .82 |
| Moderate-to-severe PTS (Villalta scale score ≥ 10) | 20 (20.0) | 16 (16.8) | .57 | 8 (17.4) | .71 |
| Moderate-to-severe PTS incidence proportion according to follow-up visit | |||||
| At 6 mo | 8/74 (10.8) | 12/84 (14.3) | .51 | 7/40 (17.5) | .31 |
| At 12 mo | 7/68 (10.3) | 9/80 (11.3) | .85 | 5/36 (13.9) | .59 |
| At 18 mo | 9/63 (14.3) | 8/69 (11.6) | .64 | 4/31 (12.9) | .86 |
| At 24 mo | 11/66(16.7) | 8/70 (11.4) | .38 | 2/32 (6.3) | .15 |
| Severe PTS: Villalta scale score ≥ 15 | 9 (9.0) | 9 (9.5) | .91 | 6 (13.0) | .45 |
| Severe PTS: VCSS score ≥ 8 | 9 (9.0) | 6 (6.3) | .48 | 4 (8.7) | .95 |
| Femoral-popliteal DVT subgroup | Control (n = 91) |
PCDT (n = 78) |
P value (All patients) |
PCDT: initial AngioJet (n = 29) |
P value (Initial AngioJet) |
| PTS between 6 and 24 mo † | |||||
| Ulcer at any follow-up assessment | 4 (4.4) | 2 (2.6) | - | 0 (0.0) | - |
| Villalta scale score ≥5 without ulcer | 35 (38.5) | 33 (42.3) | - | 11 (37.9) | - |
| Late endovascular procedure only | 0 (0.0) | 0 (0.0) | - | 0 (0.0) | - |
| Total | 39 (42.9) | 35 (44.9) | .79 | 11 (37.9) | .64 |
| PTS: VCSS score ≥ 4 | 32 (35.2) | 22 (28.2) | .33 | 6 (20.7) | .14 |
| PTS incidence proportion according to follow-up visit | |||||
| At 6 mo | 31/76 (40.8) | 15/69 (21.7) | .01 | 5/23 (21.7) | .10 |
| At 12 mo | 25/67 (37.3) | 18/65 (27.7) | .24 | 4/20 (20.0) | .15 |
| At 18 mo | 17/54 (31.5) | 22/56 (39.3) | .39 | 5/17 (29.4) | .87 |
| At 24 mo | 21/57 (36.8) | 15/62 (24.2) | .13 | 5/17 (29.4) | .57 |
| Moderate-to-severe PTS (Villalta scale score ≥ 10) | 18 (19.8) | 13 (16.7) | .60 | 4 (13.8) | .47 |
| Moderate-to-severe PTS according to follow-up visit | |||||
| At 6 mo | 10/76 (13.2) | 5/69 (7.2) | .24 | 2/23 (8.7) | .57 |
| At 12 mo | 7/67 (10.4) | 8/65 (12.3) | .74 | 3/20 (15.0) | .58 |
| At 18 mo | 8/54 (14.8) | 4/56 (7.1) | .20 | 0/17 (0.0) | .09 |
| At 24 mo | 11/57 (19.3) | 5/62 (8.1) | .07 | 2/17 (11.8) | .47 |
| Severe PTS: Villalta scale score ≥ 15 | 12 (13.2) | 4 (5.1) | .07 | 1 (3.4) | .14 |
| Severe PTS: VCSS score ≥ 8 | 10 (11.0) | 5 (6.4) | .30 | 3 (10.3) | .92 |
CFV = common femoral vein; DVT = deep vein thrombosis; FV = femoral vein; PCDT = pharmacomechanical catheter-directed venous thrombolysis; PTS = postthrombotic syndrome; PV = popliteal vein; VCSS = venous clinical severity scale; VTE = venous thromboembolism.
*
Treatment groups are per-protocol patients.
†
Fisher exact test.
‡
Comparisons adjusted for baseline compressibility status for CFV, PV, and FV at 1 month and 1 year.