Table 1.
| Endpoint, n (%)b | Rivaroxaban 2.5 mg bid | Rivaroxaban 5 mg bid | Placebo | Rivaroxaban 2.5 mg bid vs. Placebo | Rivaroxaban 5 mg bid vs. Placebo | ||
|---|---|---|---|---|---|---|---|
| HR (95% CI)c | P-valued | HR (95% CI)c | P-valued | ||||
| Efficacy outcomese | N = 5114 | N = 5115 | N = 5113 | ||||
| Primary endpointf | 313 (9.1) | 313 (8.8) | 376 (10.7) | 0.84 (0.72–0.97) | P = 0.02 | 0.85 (0.73–0.98) | P = 0.03 |
| Death from CV causes | 94 (2.7) | 132 (4.0) | 143 (4.1) | 0.66 (0.51–0.86) | P = 0.002 | 0.94 (0.75–1.20) | P = 0.63 |
| MI | 205 (6.1) | 179 (4.9) | 229 (6.6) | 0.90 (0.75–1.09) | P = 0.27 | 0.79 (0.65–0.97) | P = 0.02 |
| Stroke | |||||||
| Any | 46 (1.4) | 54 (1.7) | 41 (1.2) | 1.13 (0.74–1.73) | P = 0.56 | 1.34 (0.90–2.02) | P = 0.15 |
| Ischaemic | 30 (1.0) | 35 (0.9) | 34 (1.0) | 0.89 (0.55–1.45) | P = 0.64 | 1.05 (0.65–1.68) | P = 0.84 |
| All-cause death | 103 (2.9) | 142 (4.4) | 153 (4.5) | 0.68 (0.53–0.87) | P = 0.002 | 0.95 (0.76–1.19) | P = 0.66 |
| Stent thrombosis | 47 (2.2) | 51 (2.3) | 72 (2.9) | 0.65 (0.45–0.94) | P = 0.02 | 0.73 (0.51–1.04) | P = 0.08 |
| Safety outcomesf | N = 5115 | N = 5110 | N = 5125 | ||||
| TIMI major bleeding not related to CABG | 65 (1.8) | 82 (2.4) | 19 (0.6) | 3.46 (2.08–5.77) | P < 0.001 | 4.47 (2.71–7.36) | P < 0.001 |
| TIMI minor bleeding | 32 (0.9) | 49 (1.6) | 20 (0.5) | 1.62 (0.92–2.82) | P = 0.09 | 2.52 (1.50–4.24) | P < 0.001 |
| Intracranial haemorrhage | 14 (0.4) | 18 (0.7) | 5 (0.2) | 2.83 (1.02–7.86) | P = 0.04 | 3.74 (1.39–10.07) | P = 0.005 |
| Fatal bleeding | 6 (0.1) | 15 (0.4) | 9 (0.2) | 0.67 (0.24–1.89) | P = 0.45 | 1.72 (0.75–3.92) | P = 0.20 |
bid, twice-daily; CABG, coronary artery bypass graft; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; PCI, percutaneous coronary intervention; TIA, transient ischaemic attack.
Event rates are reported as Kaplan–Meier estimates through 24 months and so are not presented as numerical percentages.
n (%): n is the number of subjects with event, % = hazard rate in the corresponding treatment group based on a stratified Cox proportional hazards model.
HR (95% CI): Hazard ratios (95% confidence interval) as compared to placebo arm are based on the stratified (by standard of care with ASA or ASA + thienopyridine) Cox proportional hazards model.
P-values (two-sided) as compared to placebo arm are based on the stratified (by standard of care with ASA or ASA + thienopyridine) log rank test.
n = number of subjects at risk; for efficacy events the mITT (excluding three potentially noncompliant study sites) Analysis Set was used; for safety events the treatment-emergent Safety Analysis Set was used.
Primary efficacy endpoint as adjudicated by the CEC: first occurrence of CV death, MI or stroke.