The AHA Guidelines and Scientifi c Statements Handbook
trial [2], the largest reported RCT in chronic coro-
nary artery disease, enrolled 2287 patients with
signifi cant coronary artery disease and inducible
ischemia; 70% had multivessel disease, and more
than one third had stenoses in the proximal left
anterior descending artery [2] (see Figure A.1). The
trial compared optimal medical therapy with and
without PCI. Unlike medical therapy in earlier trials
that focused on antianginal medication, all patients
in the COURAGE trial received intensive, goal-
directed risk factor reduction therapy that resulted
in very high rates of adherence to guideline recom-
mendations for blood pressure, lipid levels, exercise,
diet, and smoking cessation [2]. When added to
such intensive medical therapy, PCI had no advan-
tage in terms of the primary end point of death or
myocardial infarction and only a modest advantage
in relief of angina that decreased over time. These
results suggest that revascularization can safely be
deferred for many patients if the standards for medi-
cal therapy in the COURAGE trial are strictly
followed.
Lack of suffi cient RCT data
Bravata and colleagues’ review raises several con-
cerns. The 23 RCTs meta-analysis included 9963
patients and spanned 40 years; however, in 2005
alone, more than 900,000 revascularization pro-
cedures were performed in the United States [2].
The number of these procedures performed on
Fig. A.1 Kaplan-Meier COURAGE Trial survival curves.
In A, the estimated 4.6-year rate of the composite primary outcome of death from any cause and nonfatal myocardial infarction was 19.0% in
the PCI group and 18.5% in the medical-therapy group. In B, the estimated 4.6-year rate of death from any cause was 7.6% in the PCI group
and 8.3% in the medical-therapy group. In C, the estimated 4.6-year rate of hospitalization for acute coronary syndrome (ACS) was 12.4% in
the PCI group and 11.8% in the medical-therapy group. In D, the estimated 4.6-year rate of acute myocardial infarction was 13.2% in the PCI
group and 12.3% in the medical-therapy group. From Passamani et al., A randomized trial of coronary bypass surgery. Survival of patients
with a low ejection fraction. N Engl J Med. 1985;312:1665–1671.