Table 6.
Effectiveness and safety outcomes of 716 patients at day 30 after transition from VKA to dabigatran or rivaroxaban, according to performed INR testing
| All patients n = 716 n (%; 95% CI) | Transition not evaluable n = 170 n (%, 95% CI) | Transition with INR testing n = 410 n (%, 95% CI) | Transition without INR testing n = 136 n (%, 95% CI) | P value INR testing vs. no INR testing | |
|---|---|---|---|---|---|
| Major CV events | 6 (0.8; 0.3, 1.8) | 3 (1.8; 0.4, 5.1) | 3 (0.7; 0.2, 2.1) | 0 (0.0; 0.0, 2.7) | >0.999 |
| Any bleeding | 87 (12.2; 9.8, 14.8) | 15 (8.8; 5.0, 14.1) | 55 (13.4; 10.3, 17.1) | 17 (12.5; 7.5, 19.3) | 0.884 |
| Minor bleeding | 48 (6.7; 5.0, 8.8) | 11 (6.5; 3.3, 11.3) | 27 (6.6; 4.4, 9.4) | 10 (7.4; 3.6, 13.1) | 0.844 |
| NMCR bleeding | 27 (3.8; 2.5, 5.4) | 3 (1.8; 0.4, 5.1) | 22 (5.4; 3.4, 8.0) | 2 (1.5; 0.2, 5.2) | 0.056 |
| Major bleeding | 2 (0.3; 0.0, 1.0) | 0 (0.0; 0.0, 2.1) | 2 (0.5; 0.1, 1.8) | 0 (0.0; 0.0, 2.7) | >0.999 |
| Death | 4 (0.5; 0.1, 1.5) | 2 (1.2; 0.1, 4.2) | 1 (0.2; 0.0, 1.4) | 1 (0.7; 0.0, 4.0) | 0.436 |
Abbreviations are as follows: CI, confidence interval; CV, cardiovascular; INR, international normalized ratio; NMCR, non-major clinically relevant bleeding.