Table 3. Clinical Outcomes with Aspirin or Placebo.
Outcome | Aspirin (N = 2860) |
Placebo (N = 2853) |
Hazard Ratio (95% CI)* |
---|---|---|---|
Primary outcome | |||
Death from cardiovascular causes, myocardial infarction, or stroke — no. (%) | 116 (4.1) | 134 (4.7) | 0.86 (0.67–1.10) |
Secondary Outcome | |||
Death from cardiovascular causes, myocardial infarction, stroke, or cancer — no. (%) | 153 (5.3) | 177 (6.2) | 0.86 (0.69–1.07) |
Components of the primary and secondary outcomes | |||
Death from cardiovascular causes — no. (%)† | 85 (3.0) | 100 (3.5) | 0.85 (0.64–1.14) |
Myocardial infarction — no. (%) | 22 (0.8) | 21 (0.7) | 1.04 (0.57–1.89) |
Stroke — no. (%) | 23 (0.8) | 39 (1.4) | 0.58 (0.35–0.98) |
Cancer — no. (%) | 38 (1.3) | 46 (1.6) | 0.83 (0.54–1.27) |
Other efficacy outcomes | |||
Death from any cause — no. (%) | 145 (5.1) | 167 (5.9) | 0.87 (0.70–1.09) |
First and recurrent events of the primary outcome | |||
No. of participants with ≥1 event | 116 | 134 | — |
No. of participants with ≥2 events | 8 | 10 | — |
Total no. of events | 124 | 144 | 0.86 (0.67–1.11)‡ |
First and recurrent events of the secondary outcome | |||
No. of participants with ≥1 event | 153 | 177 | — |
No. of participants with ≥2 events | 12 | 17 | — |
Total no. of events | 165 | 194 | 0.85 (0.68–1.06)‡ |
The widths of the confidence intervals have not been adjusted for multiplicity, so the intervals should not be used to infer definitive treatment effects.
Death from cardiovascular causes included confirmed death from cardiovascular causes (in 68 participants in the aspirin group and in 69 in the placebo group) and death from an unknown cause, which was categorized according to the protocol definition as presumed death from cardiovascular causes (in 17 and 31 participants, respectively).
The analysis was conducted with the use of a proportional-means model.