Table 2.
Efficacy and safety outcomes (intention-to-treat analysis)
| Rivaroxaban (n=159) | Control (n=159) | Relative risk (95% CI) | p values (two-sided) | ||
|---|---|---|---|---|---|
| Primary efficacy outcome | 5/159 (3·14%) | 15/159 (9·43%) | 0·33 (0·13–0·90) | 0·0293 | |
| Secondary efficacy outcomes | |||||
| Symptomatic and fatal VTE | 1/159 (0·63%) | 8/159 (5·03%) | 0·13 (0·02–0·99) | 0·0487 | |
| Symptomatic VTE and all-cause mortality | 4/159 (2·52%) | 9/159 (5·66%) | 0·44 (0·14–1·41) | 0·1696 | |
| Composite of symptomatic VTE, myocardial infarction, stroke, and cardiovascular death | 1/159 (0·63%) | 9/159 (5·66%) | 0·11 (0·01–0·87) | 0·0360 | |
| Components of the primary outcome | |||||
| Symptomatic DVT | 0 | 3 (1·89%) | 0·14 (0·01–2·74) | 0·1968 | |
| Symptomatic pulmonary embolism | 1 (0·63%) | 2 (1·26%) | 0·50 (0·05–5·46) | 0·5698 | |
| Fatal pulmonary embolism | 0 | 3 (1·89%) | 0·14 (0·01–2·74) | 0·1968 | |
| Asymptomatic DVT on duplex scan | 3 (1·89%) | 1 (0·63%) | 3·00 (0·32–28·53) | 0·3391 | |
| Asymptomatic pulmonary embolism on CT pulmonary angiogram | 1 (0·63%) | 4 (2·52%) | 0·25 (0·03–2·21) | 0·2127 | |
| Symptomatic arterial thrombosis | 0 | 1 (0·63%) | 0·33 (0·01–8·12) | 0·5001 | |
| Myocardial infarction | 0 | 0 | NA | NA | |
| Non-haemorrhagic stroke | 0 | 0 | NA | NA | |
| Major adverse limb event | 0 | 0 | NA | NA | |
| Cardiovascular death | 0 | 1 (0·63%) | 0·33 (0·01–8·12) | 0·5001 | |
| Primary safety outcome | |||||
| Major bleeding | 0 | 0 | NA | NA | |
| Secondary safety outcomes | |||||
| CRNM | 2/159 (1·26%) | 2/159 (1·26%) | 1·00 (0·14–7·01) | 1·0000 | |
| Other bleeding | 2/159 (1·26%) | 1/159 (0·63%) | 2·00 (0·18–21·84) | 0·5698 | |
| Combination of major, CRNM, and other bleeding | 4/159 (2·51%) | 3/159 (1·89%) | 1·33 (0·30–5·86) | 0·7034 | |
Data are n/N (%), or n (%), unless otherwise specified. CRNM=clinically relevant non-major. DVT=deep vein thrombosis. NA=not applicable. VTE=venous thromboembolism.