Table 4.
Adverse events based on use of aspirin at baseline
| Event | On Aspirin at Baseline (n = 272) |
Not On Aspirin at Baseline (n = 377) |
Hazard Ratio (95% Confidence Interval)a | ||
|---|---|---|---|---|---|
| Number of Patients (%) | First Event Rate per Patient-Yearb | Number of Patients (%) | First Event Rate per Patient-Yearb | ||
| Any serious adverse event | 155 (56%) | 1.34 | 194 (53%) | 1.30 | 0.90 (0.71 to 1.13) |
| Bleedingc | 37 (13%) | 0.24 | 40 (11%) | 0.20 | 1.31 (0.80 to 2.17) |
| intermediate/minor bleeding | 24 (9%) | 0.15 | 25 (7%) | 0.13 | |
| major bleeding | 4 (1%) | 0.02 | 11 (3%) | 0.05 | |
| life threatening | 9 (3%) | 0.06 | 8 (2%) | 0.04 | |
| Hospitalization | 151 (54%) | 1.30 | 192 (52%) | 1.29 | 0.89 (0.70 to 1.12) |
| ischemic heart disease | 23 (8%) | 0.15 | 14 (4%) | 0.07 | |
| congestive heart failure | 17 (6%) | 0.11 | 22 (6%) | 0.11 | |
| Arrhythmia | 6 (2%) | 0.04 | 12 (3%) | 0.06 | |
| cerebrovascular disease | 5 (2%) | 0.03 | 3 (1%) | 0.02 | |
| peripheral vascular disease | 8 (3%) | 0.05 | 11 (3%) | 0.06 | |
| vascular access event: study access | 42 (15%) | 0.27 | 68 (18%) | 0.35 | 0.79 (0.52 to 1.20) |
| vascular access event: nonstudy access | 9 (3%) | 0.06 | 20 (5%) | 0.10 | 0.74 (0.32 to 1.73) |
| death | 18 (7%) | 0.11 | 12 (3%) | 0.06 | 1.52 (0.68 to 3.39) |
aHazard ratio, time to first event per patient. P > 0.27 for each category of serious adverse effect.
bEvent rate was a patient-level analysis calculated as the ratio of the number of first serious adverse effects to the total patient-years of follow-up until the first serious adverse effect of this type in each patient.
cIntermediate or minor bleeding events were those that were not classified as major, life threatening, or fatal. Major bleeding was defined as a confirmed retroperitoneal, intra-articular, intraocular, or intracranial bleed or any bleed that led to a drop in hemoglobin by 2 g/dl and required hospitalization or the need for a transfusion. Life-threatening bleeding was defined as any bleed leading to a drop in hemoglobin of ≥5 g/dl, required emergency surgical intervention, caused a symptomatic intracranial hemorrhage, or required a transfusion of more than 4 units of packed red blood cells or whole blood. Fatal bleeding was any bleed that caused or precipitated death.