Table 4.
Clinical outcome at 2-year follow-up.
|
All N = 1,080 |
HBR N = 354 |
LBR N = 726 |
p-value | |
|---|---|---|---|---|
| Bleeding | ||||
| Any bleeding, n (%) | 189 (17.5) | 94 (26.6) | 95 (13.1) | <0.01 |
| Cumulative incidence, in % (95% CI) | 17.9 (1.2–15.7) | 27.7 (23.3–32.8) | 13.3 (1.3–11.0) | |
| Major bleeding (BARC 3-5) at 1 year, n (%) | 41 (3.8) | 31 (8.8) | 10 (1.4) | <0.01 |
| Cumulative incidence, in % (95% CI) | 3.9 (0.3–5.2) | 9.0 (6.4–12.6) | 1.4 (0.8–2.6) | |
| Major bleeding (BARC 3–5) at 2 years, n (%) | 48 (4.4) | 37 (10.5) | 11 (1.5) | <0.01 |
| Cumulative incidence, in % (95% CI) | 4.6 (3.5–6.0) | 11.0 (8.1–14.8) | 1.6 (0.9–2.8) | |
| POCE | ||||
| Any POCE, n (%) | 230 (21.3) | 100 (27.4) | 130 (18.2) | <0.01 |
| Any death, n (%) | 72 (6.7) | 51 (14.0) | 21 (2.9) | <0.01 |
| MI, n (%) | 54 (5.0) | 28 (7.7) | 26 (3.6) | <0.01 |
| Repeat revascularization, n (%) | 150 (13.9) | 49 (13.4) | 101 (14.1) | 0.99 |
BARC, Bleeding Academic Research Consortium; CI, confidence interval; HBR, high bleeding risk; LBR, low bleeding risk; MI, myocardial infarction; POCE, patient-oriented composite endpoints.