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| |
Rivaroxaban
|
p-value
|
Placebo
|
p-value
|
|---|
| |
Patients treated with statins (n=113)
|
Patients not treated with statins (n=485)
| |
Patients treated with statins (n=117)
|
Patients not treated with statins (n=473)
| |
|---|
|
Mean age, years
|
64.3
|
56.7
|
<0.01
|
66.9
|
56.3
|
<0.01
|
|
Men, n (%)
|
62 (54.9)
|
289 (59.6)
|
0.36
|
66 (56.4)
|
272 (57.5)
|
0.42
|
|
Mean BMI, kg/m2
|
29.9
|
28.1
|
<0.01
|
29.8
|
28.0
|
<0.01
|
|
Creatinine clearance, n (%)
| | |
0.20
| | |
<0.01
|
|
<50 ml/min
|
10 (8.8)
|
31 (6.4)
| |
17 (14.5)
|
33 (7.0)
| |
|
50–<80 ml/min
|
33 (29.2)
|
113 (23.3)
| |
39 (33.3)
|
96 (20.3)
| |
|
≥80 ml/min
|
68 (60.2)
|
335 (69.1)
| |
60 (51.3)
|
340 (71.9)
| |
|
Missing
|
2 (1.8)
|
6 (1.2)
| |
1 (0.9)
|
4 (0.8)
| |
|
Planned treatment duration, n (%)
| | |
0.14
| | |
0.19
|
|
6 months
|
61 (54.0)
|
298 (61.4)
| |
68 (58.1)
|
285 (60.3)
| |
|
12 months
|
52 (46.0)
|
187 (38.6)
| |
49 (41.9)
|
188 (39.7)
| |
|
Index event, n (%)
| | |
<0.01
| | |
<0.01
|
|
Only DVT
|
48 (42.5)
|
325 (67.0)
| |
54 (46.2)
|
292 (61.7)
| |
|
PE ± DVT
|
61 (54.0)
|
151 (31.1)
| |
61 (52.1)
|
172 (36.4)
| |
|
Index event not confirmed
|
4 (3.5)
|
9 (1.9)
| |
2 (1.7)
|
9 (1.9)
| |
|
Immobilization at randomization, n (%)
|
17 (15.0)
|
72 (14.8)
|
0.96
|
17 (14.5)
|
59 (12.5)
|
0.66
|
|
Active cancer at randomization, n (%)
|
5 (4.4)
|
23 (4.7)
|
0.89
|
6 (5.1)
|
20 (4.2)
|
0.85
|
|
Ischemic heart disease, n (%)
|
19 (16.8)
|
14 (2.9)
|
<0.01
|
40 (34.2)
|
20 (4.2)
|
<0.01
|
|
Peripheral arterial disease, n (%)
|
1 (0.9)
|
2 (0.4)
| |
1 (0.9)
|
0
| |
|
Ischemic cerebrovascular disease, n (%)
|
0
|
4 (0.8)
| |
2 (1.7)
|
5 (1.1)
| |
|
ASA use at baseline, n (%)
|
5 (4.4)
|
15 (3.1)
|
<0.01
|
29 (24.8)
|
18 (3.8)
|
<0.01
|
|
ASA stopped at randomization, n
|
0
|
3
| |
0
|
0
| |
|
Hypertension, n (%)
|
80 (70.8)
|
161 (33.2)
|
<0.01
|
73 (62.4)
|
154 (32.6)
|
<0.01
|
|
Diabetes, n (%)
|
30 (26.5)
|
28 (5.8)
|
<0.01
|
35 (29.9)
|
21 (4.4)
|
<0.01
|
- ASA, acetylsalicylic acid; BMI, body mass index; DVT, deep vein thrombosis; PE, pulmonary embolism.
- Data from EINSTEIN Extension, safety population.
