Table 2. Patients with at least one CV or bleeding event, by treatment group (VKA: VKA Group—NOAC: NOAC Group).
Group | VKA | NOAC | Switch | ||
---|---|---|---|---|---|
N of patients | 1355 | 577 | 239 | ||
VKA+NOAC | Started with VKA | Proceed with NOAC | |||
Effectiveness end-point: CV events | |||||
N (%) | 198 (14.6%) | 57 (9.9%) | 43 (18.0%) | 32 (13.4%) | 14 (5.9%) |
P-value¥ | - | 0.0049* | 0.1788 | 0.6197 | 0.0002* |
Hazard ratio [95% CI] for comparison vs. VKA alone | 1.0 | 0.9 [0.6–1.2] | 1.1 [0.8–1.5] | 1.2 [0.8–1.8] | 0.5 [0.8–1.5] |
P-value from Cox proportional hazards model for comparison vs. VKA alone | - | 0.3425 | 0.5481 | 0.2773 | 0.0255 |
Safety end-point: bleeding | |||||
N (%) | 154 (11.4%) | 32 (5.5%) | 26 (10.9%) | 17 (7.1%) | 10 (4.2%) |
P-value¥ | - | <0.0001* | 0.8265 | 0.0502 | 0.0008* |
Hazard ratio [95% CI] for comparison vs. VKA alone | 1.0 | 0.6 [0.4–0.9] | 0.8 [0.5–1.4] | 0.8 [0.5–1.4] | 0.5 [0.3–1.0] |
P-value from Cox proportional hazards model for comparison vs. VKA alone | - | 0.0230 | 0.3612 | 0.5084 | 0.0419 |
¥ Pair-wise P-value for comparison vs. VKA
*Statistically significant i.e. p<0,05