Table 1.
Demographic and Clinical Characteristics of the Patients
| Characteristic | Major GI Bleeding | Major Non‐GI Bleedinga | CRNM Bleeding | Minor Bleeding | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Event (N=207) | No Eventb (N=9801) | P Value | Event (N=152) | No Eventb (N=9836) | P Value | Event (N=1419) | No Eventb (N=8874) | P Value | Event (N=714) | No Eventb (N=9418) | P Value | |
| Age, y, mean±SD | 74.6±8.6 | 70.3±9.5 | <0.001 | 73.6±8.8 | 70.4±9.5 | <0.001 | 72.1±9.2 | 70.2±9.5 | <0.001 | 72.3±9.2 | 70.3±9.5 | <0.001 |
| Male | 61.4 | 61.5 | 0.974 | 69.7 | 61.4 | 0.035 | 60.2 | 61.7 | 0.291 | 61.9 | 61.4 | 0.777 |
| Previous use of vitamin K antagonist | 64.7 | 58.8 | 0.084 | 64.5 | 58.8 | 0.156 | 62.6 | 58.2 | 0.001 | 67.1 | 58.4 | <0.001 |
| Diabetes mellitus | 38.2 | 36.6 | 0.639 | 40.8 | 36.5 | 0.281 | 38.3 | 36.4 | 0.159 | 40.9 | 36.3 | 0.014 |
| Dyslipidemia | 57.5 | 54.7 | 0.421 | 58.6 | 54.6 | 0.335 | 58.4 | 54.3 | 0.003 | 65.4 | 54.0 | <0.001 |
| Hypertension | 95.2 | 95.0 | 0.933 | 95.4 | 95.1 | 0.853 | 93.9 | 95.2 | 0.051 | 94.1 | 95.1 | 0.252 |
| Prior MI | 13.5 | 11.3 | 0.328 | 11.8 | 11.3 | 0.848 | 11.6 | 11.5 | 0.883 | 10.8 | 11.4 | 0.632 |
| Prior stroke | 16.4 | 18.3 | 0.485 | 17.8 | 18.3 | 0.864 | 18.3 | 18.3 | 0.952 | 17.1 | 18.4 | 0.401 |
| Prior transient ischemic attack | 11.1 | 12.2 | 0.649 | 12.5 | 12.1 | 0.895 | 13.5 | 12.0 | 0.107 | 14.8 | 12.1 | 0.031 |
| Prior PAD | 7.7 | 4.2 | 0.014 | 3.9 | 4.3 | 0.849 | 4.2 | 4.2 | 0.996 | 4.8 | 4.2 | 0.503 |
| Congestive heart failure | 61.8 | 60.0 | 0.584 | 48.0 | 60.1 | 0.002 | 51.2 | 61.1 | <0.001 | 47.9 | 60.6 | <0.001 |
| Prior CAD | 38.8 | 33.5 | 0.106 | 37.5 | 33.5 | 0.303 | 35.5 | 33.4 | 0.120 | 35.3 | 33.5 | 0.338 |
| Prior CABG | 14.0 | 7.3 | <0.001 | 13.8 | 7.4 | 0.002 | 10.0 | 7.2 | <0.001 | 14.8 | 7.1 | <0.001 |
| History of ICH bleed | 0.0 | 0.1 | 1.000 | 0.0 | 0.1 | 1.000 | 0.2 | 0.1 | 0.407 | 0.1 | 0.1 | 0.584 |
| History of non‐ICH bleed | 17.4 | 9.0 | <0.001 | 13.2 | 9.0 | 0.078 | 16.8 | 8.3 | <0.001 | 16.1 | 8.8 | <0.001 |
| History of gastrointestinal bleed | 5.8 | 3.0 | 0.018 | 4.6 | 3.0 | 0.225 | 5.1 | 2.8 | <0.001 | 5.3 | 2.9 | <0.001 |
| Creatinine clearance in mg/dL, mean±SD | 69.4±28.4 | 79.1±32.4 | <0.001 | 76.2±38.7 | 78.9±32.2 | 0.307 | 76.1±31.0 | 79.2±32.5 | <0.001 | 76.8±31.1 | 79.1±32.5 | 0.074 |
| CHADS2 score (0–6), mean±SD | 3.0±1.1 | 2.8±1.0 | 0.004 | 2.9±1.0 | 2.9±1.0 | 0.259 | 2.9±1.0 | 2.8±1.0 | 0.386 | 2.9±1.0 | 2.9±1.0 | 0.488 |
| EuroQol‐5D utility, mean±SD | 0.821±0.166 | 0.837±0.152 | 0.147 | 0.843±0.159 | 0.837±0.152 | 0.619 | 0.843±0.147 | 0.836±0.153 | 0.110 | 0.833±0.163 | 0.837±0.152 | 0.522 |
CABG indicates coronary artery bypass graft; CAD, coronary artery disease; CHADS2, scoring system for the long‐term risk of stroke in atrial fibrillation: acronym stands for Congestive heart failure, Hypertension, Age≥75y, Diabetes mellitus, and prior Stroke; CRNM, clinically relevant nonmajor; EuroQol 5 Dimension questionnaire; GI, gastrointestinal; ICH intracranial hemorrhage; MI, myocardial infarction; PAD, peripheral arterial disease.
a
Only extracranial bleeds are included.
b
The sample sizes for the “no event” categories differ according to the category of bleed because of censoring in data selection. All results are % of patients unless otherwise specified.