Table 4.
Events | Rivaroxaban (n=2165 Patients, 3393 TIs)
|
Warfarin (n=2527 Patients, 4162 TIs)
|
HR (CI) for Rivaroxaban vs Warfarin | P Value | ||
---|---|---|---|---|---|---|
No. of Events | Event Rate per 30 d, % | No. of Events | Event Rate per 30 d % | |||
Stroke/systemic embolism | 12 | 0.30 | 20 | 0.41 | 0.74 (0.36, 1.50) | 0.40 |
Death | 7 | 0.17 | 9 | 0.18 | 0.93 (0.34, 2.56) | 0.89 |
MI | 11 | 0.28 | 18 | 0.37 | 0.75 (0.36, 1.59) | 0.46 |
Stroke/systemic embolism/MI/death | 26 | 0.66 | 46 | 0.95 | 0.70 (0.43, 1.13) | 0.14 |
Major/NMCR bleeding | 95 | 3.33 | 111 | 3.00 | 1.12 (0.85, 1.47) | 0.43 |
Major bleeding | 37 | 0.99 | 37 | 0.79 | 1.26 (0.80, 2.00) | 0.32 |
Stroke/systemic embolism/MI/death as a composite does not include multiple events in the same patient. CI indicates confidence interval; HR, hazard ratio; MI, myocardial infarction; NMCR, nonmajor clinically relevant; and TI, temporary interruption.