Background
Methods
Study design and patients
Treatment regimens and randomization
Surveillance and follow-up
Study outcomes
Statistical analysis
Results
Patients
Rivaroxaban 10 mg bid/ 15 mg od N = 23
|
Rivaroxaban 15 mg bid/ 15 mg od N = 55
|
UFH/warfarin N = 19
| |
---|---|---|---|
Sex, male, n (%) | 16 (69.6) | 25 (45.5) | 10 (52.6) |
Age, years, mean (SD) | 65.0 (9.9) | 68.8 (12.2) | 63.4 (18.3) |
Body weight <70 kg, n (%) | 15 (65.2) | 41 (74.5) | 15 (78.9) |
Creatinine clearance <80 ml/min, n (%) | 9 (39.1) | 36 (65.5) | 11 (57.9) |
DVT only, n (%) | 23 (100.0) | 25 (45.5) | 12 (63.2) |
Unprovoked VTE, n (%) | 11 (47.8) | 31 (56.4) | 8 (42.1) |
Provoked VTE, n (%) | 12 (52.2) | 24 (43.6) | 11 (57.9) |
Previous VTE, n (%) | 0 | 8 (14.5) | 1 (5.3) |
Recent surgery or trauma, n (%) | 6 (26.1) | 11 (20.0) | 2 (10.5) |
Active cancer, n (%) | 2 (8.7) | 3 (5.5) | 2 (10.5) |
Thrombophilia, n (%) | 2 (8.7) | 1 (1.8) | 3 (15.8) |
Protein S deficiency | 0 | 0 | 1 (5.3 %) |
Protein C deficiency | 1 (4.3) | 1 (1.8) | 2 (10.5) |
Antithrombin deficiency | 1 (4.3) | 0 | 0 |
Prolonged immobilization, n (%) | 3 (13.0) | 8 (14.5) | 4 (21.1) |
Intended treatment duration | |||
3 months, n (%) | 4 (17.4) | 10 (18.2) | 4 (21.1) |
6 months, n (%) | 12 (52.2) | 26 (47.3) | 9 (47.4) |
12 months, n (%) | 7 (30.4) | 19 (34.5) | 6 (31.6) |
Mean treatment duration, days (SD) | 191.8 (106.9) | 196.6 (121.7) | 199.8 (101.9) |
Adherence to study treatment | |||
Missing n (%) | 1 (4.3) | 0 | 0 |
≥50% to <80% | 0 | 0 | 4 (21.1) |
≥80% | 22 (95.7) | 55 (100.0) | 15 (78.9) |
Treatment and follow-up
Clinical outcomes
Repeat imaging
Rivaroxaban 10 mg bid/15 mg od
|
Rivaroxaban 15 mg bid/15 mg od
|
Rivaroxaban combined
|
UFH/warfarin
| |
---|---|---|---|---|
DVT patients
|
N = 23
|
N = 24
|
N = 47
|
N = 12
|
Improved or normalized, n (%) | 18 (78.3) | 18 (75.0) | 36 (76.6) | 10 (83.3) |
Normalized
|
4 (17.4)
|
6 (25.0)
|
10 (21.3)
|
2 (16.7)
|
Unchanged, n (%) | 4 (17.4) | 5 (20.8) | 9 (19.1) | 2 (16.7) |
Deteriorated, n (%) | 1 (4.3) | 1 (4.2) | 2 (4.3) | 0 |
Asymptomatic
|
1 (4.3)
|
0
|
1 (2.1)
|
0
|
Symptomatic*
|
0
|
1 (4.2)
|
1 (2.1)
|
0
|
PE patients
|
–
|
N = 28
|
N = 28
|
N = 7
|
Improved or normalized, n (%) |
–
| 27 (96.4) | 27 (96.4) | 7 (100) |
Normalized
|
10 (35.7)
|
10 (35.7)
|
1 (14.3)
| |
Unchanged, n (%) |
–
| 0 | 0 | 0 |
Deteriorated, n (%) |
–
| 1 (3.6) | 1 (3.6) | 0 |
Asymptomatic
|
1 (3.6)
|
1 (3.6)
|
0
| |
Symptomatic*
|
0
|
0
|
0
| |
DVT and PE patients
|
N = 23
|
N = 52
|
N = 75
|
N = 19
|
Improved or normalized, n (%) | 18 (78.3) | 45 (86.5) | 63 (84.0) | 17 (89.5) |
Normalized
|
4 (17.4)
|
16 (30.8)
|
20 (26.7)
|
3 (15.8)
|
Unchanged, n (%) | 4 (17.4) | 5 (9.6) | 9 (12.0) | 2 (10.5) |
Deteriorated, n (%) | 1 (4.3) | 2 (3.8) | 3 (4.0) | 0 |
Asymptomatic
|
1 (4.3)
|
1 (1.9)
|
2 (2.7)
|
0
|
Symptomatic*
|
0
|
1 (1.9)
|
1 (1.3)
|
0
|
Rivaroxaban 10 mg bid/15 mg od
|
Rivaroxaban 15 mg bid/15 mg od
|
Rivaroxaban combined
|
UFH/warfarin
| |
---|---|---|---|---|
DVT patients
|
N = 20
|
N = 23
|
N = 43
|
N = 12
|
Improved or normalized, n (%) | 20 (100) | 20 (87.0) | 40 (93.0) | 11 (91.7) |
Normalized
|
10 (50.0)
|
10 (43.5)
|
20 (46.5)
|
4 (33.3)
|
Unchanged, n (%) | 0 | 2 (8.7) | 2 (4.7) | 1 (8.3) |
Deteriorated, n (%) | 0 | 1 (4.3) | 1 (2.3) | 0 |
Asymptomatic
|
0
|
0
|
0
|
0
|
Symptomatic*
|
0
|
1 (4.3)
|
1 (2.3)
|
0
|
PE patients
|
-
|
N = 28
|
N = 28
|
N = 7
|
Improved or normalized, n (%) | - | 28 (100) | 28 (100) | 6 (85.7) |
Normalized
|
24 (85.7)
|
24 (85.7)
|
2 (28.6)
| |
Unchanged, n (%) | - | 0 | 0 | 0 |
Deteriorated, n (%) | - | 0 | 0 | 1 (14.3) |
Asymptomatic
|
0
|
0
|
1 (14.3)
| |
Symptomatic*
|
0
|
0
|
0
| |
DVT and PE patients
|
N = 20
|
N = 51
|
N = 71
|
N = 19
|
Improved or normalized, n (%) | 20 (100) | 48 (94.1) | 68 (95.8) | 17 (89.5) |
Normalized
|
10 (50.0)
|
34 (66.7)
|
44 (62.0)
|
6 (31.6)
|
Unchanged, n (%) | 0 | 2 (3.9) | 2 (2.9) | 1 (5.3) |
Deteriorated, n (%) | 0 | 1 (2.0) | 1 (1.4) | 1 (5.3) |
Asymptomatic
|
0
|
0
|
0
|
1 (5.3)
|
Symptomatic*
|
0
|
1 (2.0)
|
1 (1.4)
|
0
|