Table 5.
Efficacy (intention-to-treat population) and safety (on-treatment population) outcomes in patients with and without significant valvular disease in patients randomized to rivaroxaban and warfarin
| SVD |
No SVD |
P-value for interaction of SVD and treatment | |||||
|---|---|---|---|---|---|---|---|
| Rivaroxaban events/100 pt-yrs (total events) | Warfarin events/100 pt-yrs (total events) | Rivaroxaban vs. Warfarin HR (95% CI) | Rivaroxaban events/100 pt-yrs (total events) | Warfarin events/100 pt-yrs (total events) | Rivaroxaban vs. Warfarin HR (95% CI) | ||
| Efficacy outcomes | |||||||
| Stroke or SE | 2.01 (38) | 2.43 (50) | 0.83 (0.55–1.27) | 1.96 (231) | 2.22 (256) | 0.89 (0.75–1.07) | 0.76 |
| Stroke, SE, or vascular death | 5.14 (94) | 5.26 (105) | 0.99 (0.75–1.31) | 4.16 (478) | 4.47 (504) | 0.94 (0.83–1.06) | 0.72 |
| Stroke, SE, vascular death, or MI | 6.09 (110) | 6.62 (130) | 0.94 (0.73–1.21) | 4.81 (549) | 5.17 (579) | 0.94 (0.83–1.05) | 0.98 |
| All-cause death | 5.48 (100) | 5.60 (112) | 0.98 (0.75–1.29) | 4.19 (482) | 4.60 (520) | 0.91 (0.80–1.03) | 0.60 |
| Safety outcomes | |||||||
| Major or NMCR bleeding | 19.81 (253) | 16.83 (240) | 1.25 (1.05–1.49) | 14.19 (1222) | 14.14 (1209) | 1.01 (0.94–1.10) | 0.034 |
| Major bleeding | 6.14 (88) | 4.20 (68) | 1.56 (1.14–2.14) | 3.22 (307) | 3.33 (318) | 0.98 (0.84–1.15) | 0.010 |
| ICH | 0.88 (13) | 0.73 (12) | 1.27 (0.58–2.79) | 0.43 (42) | 0.74 (72) | 0.59 (0.40–0.86) | 0.084 |
Data are based on multivariable analysis (see Methods). The overall ICH-adjusted hazard ratio (95% confidence interval) were 0.67 (0.47–0.93) P = 0.02.6
CI, confidence interval; HR, hazard ratio; ICH, intracranial haemorrhage: NMCR, non-major clinically relevant; MI, myocardial infarction; pt-yrs, patient-years; SE, systemic embolism; SVD, significant vascular disease.