Table 2. Primary and secondary endpoints among patients with versus without prior revascularisation.
| Patients with prior revascularisation | Patients without prior revascularisation | p for interaction | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Endpoints | Rivaroxaban monotherapy (n=847) (per patient-year) | Combination therapy (n=850) (per patient-year) | Hazard ratio (95% CI) | p-value | Rivaroxaban monotherapy (n=260) (per patient-year) | Combination therapy (n=258) (per patient-year) | Hazard ratio (95% CI) | p-value | |
| Efficacy endpoints | |||||||||
| Primary efficacy endpoint | 63 (3.83) | 100 (6.18) | 0.62 (0.45-0.85) | 0.003 | 26 (5.14) | 21 (4.34) | 1.19 (0.67-2.12) | 0.554 | 0.055 |
| Death from any cause | 29 (1.72) | 59 (3.53) | 0.49 (0.31-0.77) | 0.001 | 12 (2.28) | 14 (2.84) | 0.80 (0.37-1.73) | 0.565 | 0.289 |
| Cardiovascular death | 17 (1.01) | 35 (2.10) | 0.48 (0.27-0.86) | 0.011 | 9 (1.71) | 8 (1.62) | 1.05 (0.40-2.71) | 0.925 | 0.172 |
| Ischaemic stroke | 14 (0.84) | 22 (1.33) | 0.63 (0.32-1.23) | 0.171 | 7 (1.35) | 6 (1.23) | 1.10 (0.37-3.28) | 0.860 | 0.392 |
| Haemorrhagic stroke | 2 (0.12) | 12 (0.72) | 0.17 (0.04-0.74) | 0.007 | 2 (0.38) | 1 (0.20) | 1.90 (0.17-20.98) | 0.593 | 0.092 |
| Myocardial infarction | 10 (0.60) | 6 (0.36) | 1.66 (0.60-4.57) | 0.320 | 3 (0.58) | 2 (0.41) | 1.45 (0.24-8.66) | 0.684 | 0.890 |
| Unstable angina requiring revascularisation | 9 (0.54) | 16 (0.97) | 0.55 (0.25-1.25) | 0.150 | 4 (0.77) | 2 (0.41) | 1.93 (0.35-10.54) | 0.440 | 0.197 |
| Systemic embolism | 1 (0.06) | 0 (0) | - | - | 1 (0.19) | 1 (0.20) | 0.96 (0.06-15.29) | 0.975 | 0.995 |
| Safety endpoints | |||||||||
| Primary safety endpoint | 29 (1.76) | 46 (2.85) | 0.62 (0.39-0.98) | 0.042 | 6 (1.17) | 12 (2.48) | 0.47 (0.18-1.26) | 0.134 | 0.633 |
| Any bleeding | 116 (7.50) | 191 (13.20) | 0.57 (0.46-0.72) | <0.001 | 31 (6.41) | 48 (11.14) | 0.59 (0.38-0.93) | 0.022 | 0.893 |
| Non-major bleeding | 97 (6.17) | 162 (10.89) | 0.57 (0.44-0.73) | <0.001 | 25 (5.09) | 37 (8.43) | 0.62 (0.38-1.04) | 0.066 | 0.760 |
| Data are expressed as n (%). CI: confidence interval | |||||||||