Table 4. Clinical Outcomes with Polypill plus Aspirin or Double Placebo.
| Outcome | Polypill plus Aspirin (N = 1429) | Double Placebo (N = 1421) | Hazard Ratio (95% CI)* |
|---|---|---|---|
| Primary outcome | |||
| Death from cardiovascular causes, myocardial infarction, stroke, heart failure, resuscitated cardiac arrest, or arterial revascularization — no. (%) | 59 (4.1) | 83 (5.8) | 0.69 (0.50–0.97) |
| Secondary outcomes | |||
| Death from cardiovascular causes, myocardial infarction, or stroke — no. (%) | 52 (3.6) | 75 (5.3) | 0.68 (0.47–0.96) |
| Death from cardiovascular causes, myocardial infarction, stroke, heart failure, resuscitated cardiac arrest, arterial revascularization, or angina with evidence of ischemia — no. (%) | 61 (4.3) | 86 (6.1) | 0.69 (0.50–0.96) |
| Components of the primary and secondary outcomes | |||
| Death from cardiovascular causes — no. (%)† | 38 (2.7) | 54 (3.8) | 0.69 (0.46–1.05) |
| Myocardial infarction — no. (%) | 10 (0.7) | 14 (1.0) | 0.69 (0.31–1.56) |
| Stroke — no. (%) | 10 (0.7) | 23 (1.6) | 0.42 (0.20–0.89) |
| Heart failure — no. (%) | 7 (0.5) | 3 (0.2) | 2.30 (0.60–8.90) |
| Resuscitated cardiac arrest — no. (%) | 0 | 0 | — |
| Arterial revascularization — no. (%) | 5 (0.3) | 12 (0.8) | 0.40 (0.14–1.14) |
| Angina with evidence of ischemia — no. (%) | 6 (0.4) | 10 (0.7) | 0.59 (0.22–1.63) |
| Other outcomes | |||
| Death from any cause — no. (%) | 75 (5.2) | 93 (6.5) | 0.80 (0.59–1.08) |
| Cancer — no. (%) | 19 (1.3) | 24 (1.7) | 0.78 (0.43–1.42) |
| Primary-outcome event or cancer — no. (%) | 76 (5.3) | 106 (7.5) | 0.70 (0.52–0.94) |
| First and recurrent events of the primary outcome | |||
| No. of participants with ≥1 event | 59 | 83 | |
| No. of participants with ≥2 events | 5 | 10 | |
| Total no. of events | 64 | 93 | 0.68 (0.48–0.96)‡ |
*
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 24 participants in the polypill-plus-aspirin group and in 36 in the double-placebo group) and death from an unknown cause, which was categorized according to the protocol definition as presumed death from cardiovascular causes (in 14 and 18 participants, respectively).
‡
The analysis was conducted with the use of a proportional-means model.