Table 1.
Baseline characteristics of patients with and without statin therapy for rivaroxaban and enoxaparin/VKA combined
| Characteristic | Patients treated with statins (n=1509) | Patients not treated with statins (n=6731) | p-value |
|---|---|---|---|
| Mean age, years | 66.5 | 54.9 | <0.01 |
| Men, n (%) | 847 (56.1) | 3650 (54.2) | 0.18 |
| Mean BMI, kg/m2 | 29.3 | 27.8 | <0.01 |
| Creatinine clearance, n (%) | <0.01 | ||
| <50 ml/min | 207 (13.7) | 442 (6.6) | |
| 50–<80 ml/min | 515 (34.1) | 1500 (22.3) | |
| ≥80 ml/min | 775 (51.4) | 4736 (70.4) | |
| Missing | 12 (0.8) | 53 (0.8) | |
| Planned treatment duration, n (%) | <0.01 | ||
| 3 months | 75 (5.0) | 580 (8.6) | |
| 6 months | 858 (56.9) | 4056 (60.3) | |
| 12 months | 576 (38.2) | 2095 (31.1) | |
| Index event, n (%) | <0.01 | ||
| Only DVT | 489 (32.4) | 2880 (42.8) | |
| PE ± DVT | 1012 (67.1) | 3783 (57.2) | |
| Index event not confirmed or evaluable | 8 (0.5) | 68 (1.0) | |
| Immobilization at randomization, n (%) | 232 (15.4) | 1051 (15.6) | 0.82 |
| Active cancer at randomization, n (%) | 76 (5.0) | 352 (5.2) | 0.76 |
| Ischemic heart disease, n (%) | 410 (27.2) | 229 (3.4) | <0.01 |
| Peripheral arterial disease, n (%) | 39 (2.6) | 29 (0.4) | <0.01 |
| Ischemic cerebrovascular disease, n (%) | 53 (3.5) | 45 (0.7) | <0.01 |
| ASA use at baseline, n (%) | 387 (26.5) | 337 (5.0) | <0.01 |
| ASA stopped at randomization, n | 85 | 122 | |
| Hypertension, n (%) | 1052 (69.7) | 2181 (32.4) | <0.01 |
| Diabetes, n (%) | 392 (26.0) | 512 (7.6) | <0.01 |
ASA, acetylsalicylic acid; BMI, body mass index; DVT, deep vein thrombosis; PE, pulmonary embolism; VKA, vitamin K antagonist.
Data from EINSTEIN DVT and EINSTEIN PE combined, safety population.