Background In addition to the treatment of specific cardiovascular risk fac
tors, intervention which interferes with the general mechanisms of atherosc
lerosis could further reduce the incidence of cardiovascular events. We aim
ed to investigate in general practice the efficacy of antiplatelets and ant
ioxidants in primary prevention of cardiovascular events in people with one
or more major cardiovascular risk factors.
Methods We did a randomised controlled open 2x2 factorial trial to investig
ate low-dose aspirin (100 mg/day) and vitamin E (300 mg/day) in the prevent
ion of cardiovascular events, in people with one or more of the following:
hypertension, hypercholesterolaemia, diabetes, obesity, family history of p
remature myocardial infarction, or individuals who were elderly.
Findings 4495 people (2583 female, mean age 64.4 years) were included in th
e trial. After a mean follow-up of 3.6 years the trial was prematurely stop
ped on ethical grounds when newly available evidence from other trials on t
he benefit of aspirin in primary prevention was strictly consistent with th
e results of the second planned interim analysis. Aspirin lowered the frequ
ency of all the endpoints, being significant for cardiovascular death (from
1.4 to 0.8%; relative risk 0.56 [95% CI 0.31-0.99]) and total cardiovascul
ar events (from 8.2 to 6.3%; 0.77 [0.62-0.95]). Severe bleedings were more
frequent in the aspirin group than the no-aspirin group (1.1% vs 0.3%; p<0.
0008). Vitamin E showed no effect on any prespecified endpoint. Analyses we
re by intention-to-treat. p<0.0008).
Interpretation In women and men at risk of having a cardiovascular event be
cause of the presence of at least one major risk factor, law-dose aspirin g
iven in addition to treatment of specific risk factors contributes an addit
ional preventive effect, with an acceptable safety profile. The results on
vitamin E's cardiovascular primary preventive efficacy are not conclusive p
er se, although our results are consistent with the negative results of oth
er large published trials on secondary prevention.