Circulation, Vol 90, 762-768, Copyright © 1994 by American Heart Association
CJ Pepine, PF Cohn, PC Deedwania, RS Gibson, E Handberg, JA Hill, E Miller, RG Marks and U Thadani
BACKGROUND: Detection of asymptomatic ischemia in patients with coronary
artery disease has been associated with increased risk for adverse outcome,
but treatment of patients with asymptomatic ischemia remains controversial.
Accordingly, the purpose of this study was to determine if treatment
reduces adverse outcome in patients with daily life ischemia. METHODS AND
RESULTS: A multicenter, randomized, double- blind, placebo-controlled study
of asymptomatic or minimally symptomatic outpatients with daily life silent
ischemia due to coronary artery disease was conducted. The primary outcome
measure was event- free survival at 1 year by Kaplan-Meier analysis. Events
were death, resuscitated ventricular tachycardia/fibrillation, myocardial
infarction, hospitalization for unstable angina, aggravation of angina, or
revascularization. The secondary outcome was ischemia during ambulatory ECG
monitoring at 4 weeks. Three hundred six outpatients with mild or no angina
(Canadian Cardiovascular Society class I or II), abnormal exercise tests,
and ischemia on ambulatory monitoring were randomized to receive either
atenolol (100 mg/d) or placebo. After 4 weeks of treatment, the number
(mean +/- SD, 3.6 +/- 4.2 versus 1.7 +/- 4.6 episodes, P < .001) and
average duration (30 +/- 3.3 versus 16.4 +/- 6.7 minutes, P < .001) of
ischemic episodes per 48 hours of ambulatory monitoring decreased in
atenolol- compared with placebo-assigned patients (4.4 +/- 4.6 to 3.1 +/-
6.0 episodes and 36.6 +/- 4.1 to 30 +/- 5.5 minutes). Event-free survival
improved in atenolol-treated patients (P < .0066), who had an increased
time to onset of first adverse event (120 versus 79 days) and fewer total
first events compared with placebo (relative risk, 0.44; 95% confidence
intervals, 0.26 to 0.75; P = .001). There was a nonsignificant trend for
fewer serious events (death, resuscitation from ventricular
tachycardia/fibrillation, nonfatal myocardial infarction, or
hospitalization for unstable angina) in atenolol-treated patients (relative
risk, 0.55; 95% confidence intervals, 0.22 to 1.33; P = .175). The most
powerful univariate and multivariate correlate of event-free survival was
absence of ischemia on ambulatory monitoring at 4 weeks. Side effects were
mild and generally similar comparing atenolol- and placebo-treated
patients, although bradycardia was more frequent with atenolol.
CONCLUSIONS: Atenolol treatment reduced daily life ischemia and was
associated with reduced risk for adverse outcome in asymptomatic and mildly
symptomatic patients compared with placebo.
ARTICLES
Effects of treatment on outcome in mildly symptomatic patients with ischemia during daily life. The Atenolol Silent Ischemia Study (ASIST)
University of Florida, Gainesville.
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