Outcomes by randomised groups from time of switching to non-study aspirin to last contact in participants who took study antithrombotic treatments until the time of early stopping
| Rivaroxaban 2.5 mg two times per day plus aspirin 100 mg od (n=7027) | Aspirin 100 mg od (n=7041) | 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 | 125 (1.8) | 2.1 | 115 (1.7) | 2.0 | 1.08 (0.84 to 1.39) | 0.56 |
| Death | 111 (1.6) | 1.9 | 88 (1.2) | 1.5 | 1.25 (0.95 to 1.65) | 0.12 |
| Cardiovascular death | 57 (0.8) | 1.0 | 45 (0.6) | 0.8 | 1.26 (0.85 to 1.86) | 0.25 |
| Non-cardiovascular death | 54 (0.8) | 0.9 | 43 (0.6) | 0.7 | 1.25 (0.83 to 1.86) | 0.28 |
| Stroke | 42 (0.6) | 0.7 | 24 (0.3) | 0.4 | 1.74 (1.05 to 2.87) | 0.03 |
| Haemorrhagic stroke | 3 (<0.1) | <0.1 | 0 | 0 | – | – |
| Ischaemic or uncertain stroke | 39 (0.6) | 0.7 | 24 (0.3) | 0.4 | 1.62 (0.97 to 2.69) | 0.06 |
| Myocardial infarction | 40 (0.6) | 0.7 | 55 (0.8) | 0.9 | 0.72 (0.48 to 1.08) | 0.11 |
| Revascularisation | 152 (2.2) | 2.6 | 179 (2.5) | 3.1 | 0.84 (0.68 to 1.04) | 0.11 |
| Heart failure | 40 (0.6) | 0.7 | 41 (0.6) | 0.7 | 0.97 (0.63 to 1.50) | 0.88 |
| Acute limb ischaemia | 5 (<0.1) | <0.1 | 10 (0.1) | 0.2 | 0.50 (0.17 to 1.45) | 0.19 |
| Total vascular amputations | 4 (<0.1) | <0.1 | 5 (<0.1) | <0.1 | 0.79 (0.21 to 2.96) | 0.73 |
| Venous thromboembolism | 11 (0.2) | 0.2 | 10 (0.1) | 0.2 | 1.09 (0.46 to 2.57) | 0.84 |
| Major bleeding* | 24 (0.3) | 0.4 | 28 (0.4) | 0.5 | 0.85 (0.49 to 1.47) | 0.56 |
| Total hospitalisation | 703 (17.0) | 12.6 | 733 (10.4) | 13.4 | 0.95 (0.85 to 1.05) | 0.31 |
| Cardiovascular hospitalisation | 344 (4.9) | 6.0 | 365 (5.2) | 6.4 | 0.93 (0.80 to 1.08) | 0.35 |
| Non-cardiovascular hospitalisation | 402 (5.7) | 7.0 | 412 (5.9) | 7.3 | 0.97 (0.84 to 1.11) | 0.63 |
Data are per cent (%) or per 100 py (/100 py).
*Includes fatal bleeding, non-fatal symptomatic intracerebral haemorrhage, non-fatal non-intracerebral haemorrhage, symptomatic bleeding into critical organ and other major bleeding.
od, once a day; py, person-years.