Table 1. Randomized clinical trials of aspirin for primary prevention.
| Trials | Aspirin dose (mg/day)/median FU | No. of subjects (aspirin/control) | Population | Definition | HR or RR (95% CI) with No. of events (aspirin/control) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary outcome | MI | Stroke | Cardiovascular mortality | All-cause mortality | Hemorrhagic events | Cancer | |||||
| ARRIVE | 100/60 | 6,270/6,276 | • *Cardiovascular risk ≥3 | CV death, MI, unstable angina, stroke, TIA | 0.96 (0.81–1.13) | 0.85 (0.64–1.11) | 1.12 (0.80–1.55) | 0.97 (0.62–1.52) | 0.99 (0.80–1.24) | 2.11 (1.36–3.28) | No results |
| • Men ≥55 (women ≥60) | 269 (4.29%)/281 (4.48%) | 95 (1.52%)/112 (1.78%) | 75 (1.20%)/67 (1.07%) | 38 (0.61%)/39 (0.62%) | 160 (2.55%)/161 (2.57%) | 61 (0.97%)/29 (0.46%) | |||||
| ASCEND | 100/88 | 7,740/7,740 | • DM | MI, stroke or TIA, death from any vascular cause | 0.88 (0.79–0.97) | 0.98 (0.80–1.19) (Nonfatal) | 0.88 (0.73–1.06) (Nonfatal) | No Results | No Results | 1.29 (1.09–1.52) | 1.01 (0.92–1.11) |
| • Age ≥40 | 658 (8.5%)/743 (9.6%) | 191 (2.5%)/195 (2.5%) | 202 (2.6%)/229 (3.0%) | 314 (4.1%)/245 (3.2%) | 897 (11.6%)/887 (11.5%) | ||||||
| ASPREE | 100/55 | 9,525/9,589 | • Healthy individuals (without CVD, dementia, disability) | All-cause mortality, dementia, physical disability | 1.01 (0.92–1.11) | 0.93 (0.76–1.15) (Fatal or nonfatal) | 0.89 (0.71–1.11) (Fatal or nonfatal) | 0.82 (0.62–1.08) | 1.14 (1.01–1.29) | 1.38 (1.18–1.62) | 1.31 (1.10–1.56) |
| • Age ≥70 | 921 (9.7%)/914 (9.5%) | 171 (1.8%)/184 (1.9%) | 148 (1.6%)/167 (1.7%) | 91 (1.0%)/112 (1.2%) | 558 (5.9%)/494 (5.2%) | 361 (3.8%)/265 (2.7%) | 295 (3.1%)/227 (2.3%) | ||||
| JPPP | 100/60 | 7,220/7,244 | • †Cardiovascular risk ≥1 | CV death, MI, stroke | 0.94 (0.77–1.15) | 0.53 (0.31–0.91) (Nonfatal) | 1.04 (0.80–1.34) (Nonfatal) | 1.03 (0.71–1.48) | 0.99 (0.85–1.17) | 1.85 (1.22–2.81) | No results |
| • Age 60 to 85 | 193 (2.6%)/207 (2.8%) | 20 (0.30%)/38 (0.58%) | 117 (1.65%)/114 (1.64%) | 58 (0.86%)/57 (0.78%) | 297 (4.29%)/303 (4.11%) | 62 (0.86%)/34 (0.51%) | |||||
HR, hazard ratio; RR, relative risk; ARRIVE, Aspirin to Reduce Risk of Initial Vascular Events; ASCEND, A Study of Cardiovascular Events in Diabetes; ASPREE, Aspirin in Reducing Events in the Elderly; JPPP, Japanese Primary Prevention Project; CV, cardiovascular; MI, myocardial infarction; TIA, transient ischemic attack; CVD, cardiovascular disease; DM, diabetes mellitus; HTN, hypertension.
*Dyslipidemia, current smoking, HTN, family history of CVD; †Dyslipidemia, HTN, DM.