R. Cote et al., LACK OF EFFECT OF ASPIRIN IN ASYMPTOMATIC PATIENTS WITH CAROTID BRUITS AND SUBSTANTIAL CAROTID NARROWING, Annals of internal medicine, 123(9), 1995, pp. 649
Objective: To determine the effectiveness of aspirin in preventing isc
hemic events in patients with asymptomatic carotid stenosis. Design: D
ouble-blind, placebo-controlled trial. Setting: University-affiliate h
ospitals. Patients: 372 neurologically asymptomatic patients with caro
tid stenosis of 50% or more in at least one artery as determined by lu
minal diameter reduction on duplex ultrasonography. Intervention: Pati
ents were randomly assigned to receive either enteric coated aspirin,
325 mg/d, or identically appearing placebo. Duration of therapy was 2.
0 years for the aspirin recipients and 1.9 years for the placebo recip
ients.Outcome Measures: Patients were scheduled for a clinical examina
tion every 6 months for assessment of the occurrence of any clinical e
vent in the composite end point, which consisted of transient ischemic
attack, stroke, myocardial infarction, unstable angina, or death. Res
ults: At baseline, the 188 patients receiving aspirin and the 184 pati
ents receiving placebo had similar demographic, ultrasonographic, and
laboratory characteristics. The median duration of follow-up was 2.3 y
ears. The annual rate of all ischemic events and death from any cause
was 12.3% for the placebo group and 11.0% for the aspirin group (P = 0
.61). The Cox proportional hazards analysis yielded an adjusted hazard
ratio (aspirin-placebo) of 0.99 (95% CI, 0.67 to 1.46; P = 0.95). The
annual rates for vascular events only were 11% for the placebo group
and 10.7% for the aspirin group (P = 0.99). The multivariate analysis
yielded a hazard ratio of 1.08 (CI, 0.72 to 1.62; P = 0.71). Conclusio
n: Aspirin did not have a significant longterm protective effect in as
ymptomatic patients with high-grade (greater than or equal to 50%) car
otid stenosis.