Table 1.
Demographics and clinical characteristics
| Risk factor profile | EINSTEIN EXTENSION | EINSTEIN CHOICE | EINSTEIN CHOICE | EINSTEIN EXTENSION and EINSTEIN CHOICE | EINSTEIN EXTENSION | EINSTEIN CHOICE |
|---|---|---|---|---|---|---|
| Rivaroxaban 20 mg (N = 598) | Rivaroxaban 20 mg (N = 1107) | Rivaroxaban 10 mg (N = 1127) | All rivaroxaban (N = 2832) | Placebo (N = 590) | Aspirin (N = 1131) | |
| Unprovoked | ||||||
| Age, mean, y | 59.0 ± 14.5 | 59.2 ± 13.5 | 60.0 ± 13.9 | 59.5 ± 13.9 | 57.2 ± 15.4 | 59.2 ± 13.8 |
| Male sex, n (%) | 168 (66.7) | 280 (63.5) | 294 (61.3) | 742 (63.3) | 152 (62.6) | 314 (67.1) |
| Index DVT only, n (%) | 168 (66.7) | 246 (55.8) | 250 (52.1) | 664 (56.6) | 158 (65.0) | 253 (54.1) |
| Index PE ± DVT, n (%) | 84 (33.3) | 195 (44.2) | 230 (47.9) | 509 (43.4) | 85 (35.0) | 215 (45.9) |
| Duration of previous anticoagulation, n (%) | ||||||
| <9 mo | 177 (70.2) | 311 (70.5) | 330 (68.8) | 818 (69.7) | 178 (73.3) | 335 (71.6) |
| ≥9 mo | 75 (29.8) | 130 (29.5) | 150 (31.3) | 355 (30.3) | 65 (26.7) | 133 (28.4) |
| Provoked by major persistent risk factors | ||||||
| Age, mean, y | 71.8 ± 9.4 | 62.8 ± 12.4 | 63.3 ± 10.8 | 65.0 ± 11.7 | 65.3 ± 10.3 | 66.2 ± 11.1 |
| Male sex, n (%) | 13 (68.4) | 17 (48.6) | 14 (50.0) | 44 (53.7) | 13 (50.0) | 19 (48.7) |
| Index DVT only, n (%) | 6 (31.6) | 17 (48.6) | 12 (42.9) | 35 (42.7) | 15 (57.7) | 21 (53.8) |
| Index PE ± DVT, n (%) | 13 (68.4) | 18 (51.4) | 16 (57.1) | 47 (57.3) | 11 (42.3) | 18 (46.2) |
| Duration of previous anticoagulation, n (%) | ||||||
| <9 mo | 11 (57.9) | 27 (77.1) | 22 (78.6) | 60 (73.2) | 20 (76.9) | 28 (71.8) |
| ≥9 mo | 8 (42.1) | 8 (22.9) | 6 (21.4) | 22 (26.8) | 6 (23. 1) | 11 (28.2) |
| Provoked by minor persistent risk factors | ||||||
| Age, mean, y | 57.5 ± 16.4 | 58.3 ± 14.9 | 59.2 ± 15.1 | 58.4 ± 15.3 | 60.8 ± 16.0 | 59.4 ± 15.2 |
| Male sex, n (%) | 122 (49.6) | 244 (51.3) | 233 (50.4) | 599 (50.6) | 141 (56.9) | 242 (51.9) |
| Index DVT only, n (%) | 164 (66.7) | 235 (49.4) | 224 (48.6) | 623 (52.6) | 145 (58.5) | 223 (47.9) |
| Index PE ± DVT, n (%) | 82 (33.3) | 241 (50.6) | 238 (51.5) | 561 (47.4) | 103 (41.5) | 243 (52.1) |
| Duration of previous anticoagulation, n (%) | ||||||
| <9 mo | 180 (73.2) | 324 (68.1) | 312 (67.5) | 816 (68.9) | 167 (67.3) | 380 (66.1) |
| ≥9 mo | 66 (26.8) | 152 (31.8) | 150 (32.5) | 368 (31.1) | 81 (32.7) | 158 (33.9) |
| Provoked by minor transient risk factors | ||||||
| Age, mean, y | 53.2 ± 15.5 | 49.3 ± 16.7 | 50.9 ± 16.6 | 50.8 ± 16.4 | 48.3 ± 15.9 | 51.0 ± 15.4 |
| Male sex, n (%) | 36 (57.1) | 38 (36.5) | 49 (47.5) | 122 (45.5) | 21 (37.5) | 46 (38.0) |
| Index DVT only, n (%) | 38 (60.3) | 46 (44.2) | 52 (51.5) | 136 (50.7) | 32 (57.1) | 64 (52.9) |
| Index PE ± DVT, n (%) | 25 (39.7) | 58 (55.8) | 49 (48.5) | 132 (49.3) | 24 (42.9) | 57 (47.1) |
| Duration of previous anticoagulation, n (%) | ||||||
| <9 mo | 50 (79.4) | 71 (68.3) | 77 (76.2) | 198 (73.9) | 44 (78.6) | 94 (77.7) |
| ≥9 mo | 13 (20.6) | 33 (31.7) | 24 (23.8) | 70 (26.1) | 12 (21.4) | 37 (22.3) |
| Provoked by major transient risk factors | ||||||
| Age, mean, y | 59.1 ± 16.1 | 56.7 ± 14.7 | 58.1 ± 12.8 | 57.7 ± 14.0 | 63.4 ± 17.0 | 60.6 ± 11.9 |
| Male sex, n (%) | 12 (66.7) | 23 (45.1) | 31 (55.4) | 66 (52.8) | 11 (64.7) | 22 (59.5) |
| Index DVT only, n (%) | 10 (55.6) | 26 (51.0) | 29 (51.8) | 65 (52.0) | 7 (41.2) | 21 (56.8) |
| Index PE ± DVT, n (%) | 8 (44.4) | 25 (49.0) | 27 (48.2) | 60 (48.0) | 10 (58.8) | 16 (43.2) |
| Duration of previous anticoagulation, n (%) | ||||||
| <9 mo | 14 (77.8) | 41 (80.4) | 41 (73.2) | 96 (76.8) | 13 (76.5) | 28 (75.7) |
| ≥9 mo | 4 (22.2) | 10 (19.6) | 15 (26.8) | 29 (23.2) | 4 (23.5) | 9 (24.3) |
Plus-minus values are means ± SD.