Table 2.
Efficacy and Safety Outcomes.
| Outcome | Clopidogrel plus Aspirin (N = 2432) | Aspirin (N = 2449) | Hazard Ratio (95% CI) | P Value |
|---|---|---|---|---|
| number (percent) | ||||
| Primary efficacy outcome | ||||
| Composite of ischemic stroke, myocardial infarction, or death from ischemic vascular causes | 121 (5.0) | 160 (6.5) | 0.75 (0.59–0.95) | 0.02 |
| Secondary efficacy outcomes | ||||
| Ischemic stroke | 112 (4.6) | 155 (6.3) | 0.72 (0.56–0.92) | 0.01* |
| Myocardial infarction | 10 (0.4) | 7 (0.3) | 1.44 (0.55–3.78) | 0.46* |
| Death from ischemic vascular causes | 6 (0.2) | 4 (0.2) | 1.51 (0.43–5.35) | 0.52* |
| Ischemic or hemorrhagic stroke | 116 (4.8) | 156 (6.4) | 0.74 (0.58–0.94) | 0.01* |
| Composite of ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage | 141 (5.8) | 167 (6.8) | 0.84 (0.67–1.05) | 0.13* |
| Primary safety outcome | ||||
| Major hemorrhage | 23 (0.9) | 10 (0.4) | 2.32 (1.10–4.87) | 0.02 |
| Other safety outcomes | ||||
| Hemorrhagic stroke | 5 (0.2) | 3 (0.1) | 1.68 (0.40–7.03) | 0.47 |
| Symptomatic intracerebral hemorrhage | 2 (0.1) | 2 (0.1) | 1.01 (0.14–7.14) | 0.99 |
| Other symptomatic intracranial hemorrhage | 2 (0.1) | 0 | 0.16 | |
| Major hemorrhage other than intracranial hemorrhage | 17 (0.7) | 7 (0.3) | 2.45 (1.01–5.90) | 0.04 |
| Minor hemorrhage | 40 (1.6) | 13 (0.5) | 3.12 (1.67–5.83) | <0.001 |
| Death from any cause | 18 (0.7) | 12 (0.5) | 1.51 (0.73–3.13) | 0.27 |
*
Post hoc correction for multiple testing of five secondary end points by the Bonferroni method resulted in a P value of 0.01 to indicate a significant difference between groups.