Table 2. Incidence of the Primary and Secondary End Points.
| End points | No. (%) | Rivaroxaban 2.5 mg vs Enoxaparin | Rivaroxaban 5 mg vs Enoxaparin | ||||
|---|---|---|---|---|---|---|---|
| Enoxaparin, 1 mg/kg (n = 680) | Rivaroxaban | ||||||
| 2.5 mg (n = 683) | 5 mg (n = 683) | HR (95% CI) | P valuea | HR (95% CI) | P valuea | ||
| Safety | |||||||
| Any bleedingb | 46 (6.8) | 32 (4.7) | 36 (5.3) | 0.68 (0.43-1.07) | .005b | 0.88 (0.70-1.09) | .001b |
| ISTH | |||||||
| Major bleeding | 8 (1.2) | 5 (0.7) | 5 (0.7) | 0.62 (0.20-1.90) | NA | 0.62 (0.20-1.90) | NA |
| CRNM bleeding | 9 (1.3) | 8 (1.2) | 8 (1.2) | 0.89 (0.34-2.29) | NA | 0.88 (0.34-2.28) | NA |
| Minor bleeding | 29 (4.3) | 19 (2.8) | 23 (3.4) | 0.68 (0.43-1.07) | NA | 0.77 (0.50-1.19) | NA |
| Efficacy | |||||||
| Composite end pointb | 23 (3.4) | 16 (2.3) | 14 (2.1) | 0.68 (0.36-1.30) | .05b | 0.60 (0.31-1.16) | .02b |
| Cardiac death | 3 (0.4) | 2 (0.3) | 2 (0.3) | 0.66 (0.11-3.98) | NA | 0.66 (0.11-3.97) | NA |
| Myocardial infarction | 9 (1.3) | 6 (0.9) | 5 (0.7) | 0.66 (0.24-1.86) | NA | 0.55 (0.18-1.64) | NA |
| Re-revascularization | 3 (0.4) | 2 (0.3) | 2 (0.3) | 0.66 (0.11-3.97) | NA | 0.66 (0.11-3.97) | NA |
| Stroke | |||||||
| Any | 8 (1.2) | 6 (0.9) | 5 (0.7) | 0.74 (0.26-2.14) | NA | 0.62 (0.20-1.90) | NA |
| Ischemic | 4 (0.6) | 2 (0.3) | 3 (0.4) | 0.50 (0.09-2.71) | NA | 0.74 (0.17-3.33) | NA |
| Secondary efficacy end points | |||||||
| All-cause death | 5 (0.7) | 3 (0.4) | 4 (0.6) | 0.60 (0.14-2.50) | NA | 0.80 (0.21-2.97) | NA |
| Cardiac-related rehospitalization | 56 (8.7) | 49 (7.2) | 51 (7.5) | 0.85 (0.58-1.25) | NA | 0.89 (0.61-1.30) | NA |
Abbreviations: CRNM, clinically relevant nonmajor; HR, hazard ratio; ISTH, International Society on Thrombosis and Haemostasis; NA, not applicable.
a
P values for noninferiority were calculated by PROBNORM ([estimate-LN(L)]/SE), where PROBNORM is the standard normal distribution function, estimate = Parameter estimate, L = Margin.
b
Primary end points were tested sequentially from any bleeding in rivaroxaban 2.5 mg vs enoxaparin to any bleeding in rivaroxaban 5 mg vs enoxaparin to the composite efficacy end point (cardiac death, myocardial infarction, re-revascularization, or stroke) in rivaroxaban 5 mg vs enoxaparin to the composite efficacy end point in rivaroxaban 2.5 mg vs enoxaparin.