01.12.2015 | Original clinical investigation | Ausgabe 1/2015 Open Access

Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism – the J-EINSTEIN DVT and PE program
- Zeitschrift:
- Thrombosis Journal > Ausgabe 1/2015
Electronic supplementary material
Competing interests
Authors’ contributions
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
|