Lack of effect of aspirin in asymptomatic patients with carotid bruits and substantial carotid narrowing. The Asymptomatic Cervical Bruit Study Group.
OBJECTIVE
To determine the effectiveness of aspirin in preventing ischemic events in patients with asymptomatic carotid stenosis.


METHODS
Double-blind, placebo-controlled trial.


METHODS
University-affiliated hospitals.


METHODS
372 neurologically asymptomatic patients with carotid stenosis of 50% or more in at least one artery as determined by luminal diameter reduction on duplex ultrasonography.


METHODS
Patients 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 recipients.


METHODS
Patients were scheduled for a clinical examination every 6 months for assessment of the occurrence of any clinical event in the composite end point, which consisted of transient ischemic attack, stroke, myocardial infarction, unstable angina, or death.


RESULTS
At baseline, the 188 patients receiving aspirin and the 184 patients receiving placebo had similar demographic, ultrasonographic, and laboratory characteristics. The median duration of follow-up was 2.3 years. 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).


CONCLUSIONS
Aspirin did not have a significant long-term protective effect in asymptomatic patients with high-grade (> or = 50%) carotid stenosis.
Côté
R
R
Montreal General Hospital, Quebec, Canada.
Battista
R N
RN
Abrahamowicz
M
M
Langlois
Y
Y
Bourque
F
F
Mackey
A
A
D000368:Aged; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D002545:Brain Ischemia / Q000517:prevention & control*; D002339:Carotid Arteries / Q000503:physiopathology*; D016893:Carotid Stenosis / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010349:Patient Compliance; D016016:Proportional Hazards Models
D001241:Aspirin