NEW YORK (Reuters Health) – Compared with a strategy of optimal medical therapy alone for treatment of stable coronary artery disease (CAD), the addition of percutaneous coronary intervention (PCI) during initial management does not decrease the incidence of major cardiovascular outcomes.

That’s the conclusion of the COURAGE trial investigators, who assessed the impact of randomized treatment on prespecified tertiary end points over long-term follow-up.

As reported in the American Journal of Cardiology for July 1, the trial included 1149 patients with stable CAD or high-grade angina that subsequently stabilized on its own. All had at least one stenosis of 70% or more in a proximal epicardial coronary artery and objective evidence of myocardial ischemia.

Lead author Dr. William E. Boden at the State University of New York at Buffalo, and colleagues randomly assigned subjects to PCI plus optimal medical therapy (n = 1149) or optimal medical therapy alone (n = 1138). The subjects were treated between 1999 and 2004 at one of 50 US or Canadian centers, with median follow-up of 4.6 years (range 2.5 to 7 years).

“Overall,” Dr. Boden’s team writes, “all composite cardiovascular outcomes showed no significant between-group differences and paralleled closely the primary and secondary composite outcomes of the trial as a whole that included all-cause mortality.”

For example, cardiac death occurred in 3.4% of subjects in the PCI arm and in 3.9% of the optimal medical therapy alone arm. Corresponding proportions for the composite endpoint of cardiac death, MI, acute coronary syndrome, and stroke were 27.2% and 26.8%, respectively.

The authors note that the rate of the composite outcome exceeded 5% per year over 7 years of follow-up, “which indicates that patients enrolled in COURAGE, contrary to certain views that this was a low-risk group, were in fact not low risk.”

Reference:
Am J Cardiol 2009;104:1-4.