Table 4. Per-protocol analyses for the primary and key secondary outcome after 24 monthsa.
| Intervention (n = 313) |
Control (n = 360) |
Effect size | 95% CI | P Value | ||
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| Patients suffering a thromboembolic or major bleeding event, no. (%) | 30 (9.6) | 48 (13.3) | HR | 0.70 | (0.44–1.09) | 0.12 |
| Key secondary outcomes | ||||||
| All-cause mortality, no. (%) | 17 (5.4) | 30 (8.3) | HR | 0.64 | (0.36–1.17) | 0.15 |
| Cause-related mortality, no. (%) | 3 (1.0) | 4 (1.1) | HR | 0.86 | (0.21–3.46) | 0.83 |
| Number of patients suffering a thromboembolic event, no. (%)a | 14 (4.5) | 26 (7.2) | OR | 0.59 | (0.28–1.27) | 0.18 |
| Number of patients suffering a major bleeding event, no. (%)a | 17 (5.4) | 25 (6.9) | OR | 0.77 | (0.40–1.47) | 0.43 |
| Hospitalized patients, no. (%) | 150 (47.9) | 202 (56.1) | OR | 0.72 | (0.53–0.97) | 0.031 |
| Number of hospitalizations per patient, median (IQR)b | 2 (1–3) | 2 (1–4) | RR | 0.85 | (0.72–1.00) | 0.047 |
| Days of hospitalization per patient, median (IQR)b | 12 (5–32) | 15 (6–35) | RR | 0.82 | (0.61–1.08) | 0.16 |
| Health-related quality of life (EQ-5D), mean (SD)c | -0.04 (0.2) | -0.02 (0.2) | MD | -0.02 | (-0.05, 0.02) | 0.27 |
| Number of patients suffering a potentially severe treatment interaction, no. (%) | 144 (46.0) | 139 (38.6) | OR | 1.35 | (0.93–1.94) | 0.11 |
| Number of patients suffering an adverse event, no. (%) | 73 (23.3) | 61 (16.9) | OR | 1.51 | (0.73–3.14) | 0.26 |
| Time within therapeutic range, mean (SD)d | 73.3 (18.3) | 71.5 (18.0) | MD | 1.65 | (-2.36, 5.67) | 0.42 |
aAs defined for the primary endpoint.
bOf those patients ever hospitalized.
cChanges from baseline to 24 months, n = 545.
dPercentage of time within therapeutic range calculated using the Rosendaal algorithm, n = 637.