Table 2.
Baseline characteristics with/without statin therapy for patients allocated to rivaroxaban and placebo (shown separately)
| 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.