TABLE I.
Baseline Patient Characteristics
| All (N = 1,080) | No major bleeding (n = 1,032) | BARC types 3-5a (n = 48) | P value | |
|---|---|---|---|---|
| Age, median (IQR), y | 67 (58-75) | 67 (58-74) | 76 (70-83) | <.01 |
| Male sex, No. (%) | 824 (76.3) | 791 (76.6) | 33 (68.8) | .21 |
| Hypertension, No. (%) | 664 (61.5) | 626 (60.7) | 38 (79.2) | .01 |
| Diabetes, No. (%) | 263 (24.4) | 245 (23.7) | 18 (37.5) | .03 |
| Insulin dependent, No. (%) | 78 (7.2) | 73 (7.1) | 5 (10.4) | .38 |
| Smoking, No. (%) | 305 (28.2) | 297 (28.8) | 8 (16.7) | .07 |
| Dyslipidemia, No. (%) | 501 (46.4) | 483 (46.8) | 18 (37.5) | .21 |
| Body mass index, median (IQR) | 27.0 (24.2-29.8) | 27 (24.2-29.8) | 27.4 (24.7-29.4) | .92 |
| Estimated glomerular filtration rate, median (IQR), mL/min/1.73 m2 | 82.2 (62.3-107.2) | 83.1 (63.5-107.7) | 61.9 (47.2-79.6) | <.01 |
| Hemoglobin, median (IQR), g/dL | 14.2 (12.9-15.3) | 14.3 (13.1-15.3) | 12.1 (10.8-13.9) | <.01 |
| Thrombocytes, median (IQR), ×109/L | 232.0 (193.0-275.5) | 232 (194-275) | 228 (177-300) | .62 |
| Family history of myocardial infarction,b No. (%) | 227 (21.0) | 224 (21.7) | 3 (6.3) | .01 |
| Previous PCI, No. (%) | 319 (29.5) | 304 (29.5) | 15 (31.3) | .79 |
| Previous coronary artery bypass graft, No. (%) | 115 (10.6) | 109 (10.6) | 6 (12.5) | .67 |
| Previous myocardial infarction, No. (%) | 137 (12.7) | 132 (12.8) | 5 (10.4) | .63 |
BARC, Bleeding Academic Research Consortium; PCI, percutaneous coronary intervention.
P < .05 was considered statistically significant.
SI conversion factor: To convert g/dL to g/L, multiply by 10.
The following are the BARC type 3-5 definitions. Type 3a: overt bleeding plus a hemoglobin drop of 3-5 g/dL (provided the hemoglobin drop is related to the bleeding event); any transfusion with overt bleeding. Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL (provided the hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control (excluding dental, nasal, skin, and hemorrhoid); bleeding requiring intravenous vasoactive agents. Type 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging or lumbar puncture; intraocular bleed compromising vision. Type 4: bleeding related to coronary artery bypass grafting; perioperative intracranial bleeding within 48 hours; reoperation after closure of sternotomy for the purpose of controlling bleeding; transfusion of 5 units of whole blood or packed red blood cells within a 48-hour period; chest tube output 2 L within a 24-hour period. Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. Type 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation.
“Family history of myocardial infarction” indicates a first-degree relative diagnosed with myocardial infarction before age 55 years (men) or 65 years (women).