Outcomes by randomised treatment groups from time of randomisation to final contact after switching to non-study aspirin at the time of early stopping
| Rivaroxaban 2.5 mg two times per day plus aspirin 100 mg od (n=9152) | Aspirin 100 mg od (n=9126) | Rivaroxaban 2.5 mg two times per day plus aspirin 100 mg od versus aspirin 100 mg od | ||||
| N (%) | Per 100 py | N (%) | Per 100 py | HR (95% CI) | P value | |
| Myocardial infarction, stroke or cardiovascular death | 566 (6.2) | 2.2 | 677 (7.4) | 2.7 | 0.82 (0.74 to 0.92) | 0.0007 |
| Death | 528 (5.8) | 2.0 | 563 (6.2) | 2.2 | 0.93 (0.83 to 1.05) | 0.23 |
| Cardiovascular death | 261 (2.9) | 1.0 | 296 (3.2) | 1.1 | 0.87 (0.74 to 1.03) | 0.11 |
| Non-cardiovascular death | 267 (2.9) | 1.0 | 267 (2.9) | 1.0 | 0.99 (0.84 to 1.18) | 0.92 |
| Stroke | 137 (1.5) | 0.5 | 183 (2.0) | 0.7 | 0.74 (0.59 to 0.92) | 0.007 |
| Haemorrhagic stroke | 19 (0.2) | <0.1 | 12 (0.1) | <0.1 | 1.72 (0.82 to 3.61) | 0.15 |
| Ischaemic or uncertain stroke | 118 (1.3) | 0.5 | 171 (1.9) | 0.7 | 0.68 (0.54 to 0.86) | 0.001 |
| Myocardial infarction | 239 (2.6) | 0.9 | 279 (3.1) | 1.1 | 0.85 (0.71 to 1.01) | 0.06 |
| Revascularisation | 792 (8.7) | 3.2 | 867 (9.5) | 3.5 | 0.90 (0.82 to 0.99) | 0.03 |
| Heart failure | 256 (2.8) | 1.0 | 251 (2.8) | 1.0 | 1.01 (0.85 to 1.20) | 0.89 |
| Acute limb ischaemia | 32 (0.3) | 0.1 | 53 (0.6) | 0.2 | 0.60 (0.39 to 0.93) | 0.02 |
| Total vascular amputations | 21 (0.2) | <0.1 | 37 (0.4) | 0.1 | 0.56 (0.33 to 0.96) | 0.03 |
| Venous thromboembolism | 41 (0.4) | 0.2 | 60 (0.7) | 0.2 | 0.68 (0.45 to 1.01) | 0.05 |
| Hospitalisation | 3259 (35.6) | 15.7 | 3295 (36.1) | 16.1 | 0.98 (0.93 to 1.03) | 0.43 |
| Cardiovascular hospitalisation | 1698 (18.6) | 7.2 | 1832 (20.1) | 7.9 | 0.91 (0.85 to 0.97) | 0.006 |
| Non-cardiovascular hospitalisation | 2153 (23.5) | 9.5 | 2065 (22.6) | 9.1 | 1.05 (0.98 to 1.11) | 0.15 |
Data are in per cent (%) or per 100 py (/100 py).
od, once a day; py, person-years.