Table 2.
Model 2: Association between risk of mortality and BARC 1, 2, 3a, 3b, and 3c bleeding events occurring more than 30 days after randomization (adjusted for known mortality risk factors)
| Covariate | Definition | Death for no event | Death for event | Adjusteda HR (95% CI) | P-value for covariate risk (HR) |
|---|---|---|---|---|---|
| MI | — | 3.19% | 16.43% | 6.15 | <0.001 |
| (382/11 984) | (118/718) | (4.90–7.74) | |||
| Major bleeding | |||||
| BARC 3a | Overt bleeding with hgb drop 3–5 g/dL or any transfusion | 3.75% | 18.29% | 2.77 | <0.001 |
| (470/12 538) | (30/164) | (1.86–4.12) | |||
| BARC 3b | Overt bleeding with hgb drop > 5 g/dL, requiring vasopressors, surgical intervention, or due to cardiac tamponade | 3.78% | 20.00% | 4.51 | <0.001 |
| (475/12 577) | (25/125) | (2.86–7.10) | |||
| BARC 3c | Intracranial or intraocular bleeding | 3.76% | 42.11% | 28.2 | <0.001 |
| (476/12 645) | (24/57) | (17.5–45.7) |
CI, confidence interval; hgb, haemoglobin; HR, hazard ratio; MI, myocardial infarction; BARC, Bleeding Academic Research Consortium.
a
Adjustment covariates include: MI and BARC bleeding through Day 30 post-randomization, age, body mass index, female sex, Killip class ≤2 at enrolment, history of peripheral arterial disease, prior stroke, prior MI, hypertension, hyperlipidaemia, diabetes mellitus, smoker at enrolment, and systolic blood pressure at enrolment.