Table 4.
Kaplan-Meier Estimated 2-Year Event Rate
| Endpoints | Overall cohort | PSM cohort | ||||||
|---|---|---|---|---|---|---|---|---|
| Standard dose group |
Off-label reduced dose group |
HR (95% CI) |
P-value | Standard dose group |
Off-label reduced dose group |
HR (95% CI) |
P-value | |
| DOAC only | n=753 | n=248 | n=212 | n=212 | ||||
| Clinically significant bleeding |
29.0 (2.5) | 28.7 (3.8) | 1.082 (0.785–1.493) |
0.630 | 26.3 (4.3) | 30.5 (4.4) | 1.123 (0.730–1.728) |
0.596 |
| Major bleeding | 9.1 (2.0) | 6.7 (2.2) | 0.925 (0.452–1.892) |
0.831 | 8.3 (3.4) | 7.3 (2.6) | 0.959 (0.368–2.503) |
0.932 |
| MACE | 6.2 (1.5) | 7.7 (2.2) | 1.609 (0.822–3.147) |
0.165 | 11.3 (4.2) | 7.7 (2.5) | 1.107 (0.463–2.648) |
0.819 |
| All-cause death | 2.6 (1.1) | 5.0 (1.8) | 3.100 (1.207–7.960) |
0.019 | 8.0 (3.7) | 5.9 (2.2) | 1.351 (0.486–3.756) |
0.564 |
| MI | 0.9 (0.7) | NE | 0.027 (0.000–9.04×104) |
0.579 | 2.1 (2.1) | NE | 0.010 (0.000–1.63×105) |
0.585 |
| Stroke | 3.5 (1.1) | 2.4 (1.4) | 0.711 (0.233–2.166) |
0.548 | 2.9 (1.4) | 2.3 (1.6) | 0.462 (0.084–2.529) |
0.373 |
| DOAC+antiplatelets | n=154 | n=90 | n=62 | n=62 | ||||
| Clinically significant bleeding |
51.4 (5.7) | 32.0 (6.6) | 0.534 (0.316–0.902) |
0.019 | 60.2 (9.8) | 28.5 (7.5) | 0.429 (0.212–0.868) |
0.019 |
| Major bleeding | 10.7 (4.1) | 5.2 (3.1) | 0.748 (0.224–2.498) |
0.637 | NE | 5.5 (3.9) | 51.552 (0.003–7.62×105) |
0.421 |
| MACE | 7.6 (2.9) | 8.8 (3.5) | 1.574 (0.549–4.508) |
0.398 | 5.3 (3.7) | 8.5 (4.2) | 2.205 (0.424–11.477) |
0.348 |
| All-cause death | 6.3 (2.6) | 7.7 (3.3) | 1.384 (0.422–4.540) |
0.592 | 6.8 (4.9) | 8.5 (4.2) | 1.882 (0.344–10.308) |
0.466 |
| MI | NE | NE | NA | NE | NE | NA | ||
| Stroke | 2.8 (2.1) | 1.2 (1.2) | 1.358 (0.187–9.864) |
0.762 | NE | NE | 36.743 (0.000–1.80×109) |
0.690 |
Data given as % (SE). DOAC, direct oral anticoagulant; MACE, major adverse cardiovascular event; MI, myocardial infarction; NA, not assessed; NE, not estimable due to the small number of events; PSM, propensity score-matched.