Summary

A year after their initial presentation, the findings of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE] trial continued to generate debate and uncertainty. This article helps provide clarity about the trial results and their implications for specific subgroups of patients.

  • interventional techniques & devices
  • coronary artery disease

A year after their initial presentation, the findings of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial continue to generate debate and uncertainty. The session, “COURAGE in Perspective,” was designed to help provide clarity about the trial results and their implications for specific subgroups of patients.

In brief, the findings of the COURAGE study demonstrated that routine percutaneous coronary intervention (PCI) in patients receiving optimal medical therapy (OMT) did not provide additional benefit compared with OMT alone in patients with chronic angina and stable coronary artery disease. There were no differences between the 2 treatment strategies in terms of overall mortality, hospitalization for acute coronary syndrome, or myocardial infarction (MI), although anginal symptoms were reduced for the first 3 years in the PCI group.

Questions have surrounded the implications of the COURAGE findings in terms of the age and gender of patients. William E. Boden, MD, State University of New York, Buffalo, NY, lead investigator of the COURAGE trial, said that although there were numerically higher death and death/MI rates in older patients (≥65 years) in the trial, there was no evidence that an initial strategy of PCI plus OMT was better than OMT alone in mitigating clinical events in this population. “These data support adherence to published American College of Cardiology/American Heart Association (ACC/AHA) treatment guidelines that recommend OMT as the preferred initial management strategy, regardless of age,” he said. He added that PCI appeared to be of benefit for women in the overall trial, but a gender subset analysis indicated no significant differences between PCI plus OMT and OMT alone for major prespecified cardiovascular events in women. He explained that the subset analysis involved adjustments to account for differences in baseline clinical characteristics between the men and women in the study, which eliminated differences in outcomes between the genders.

Data from the nuclear substudy of COURAGE have begun to answer other questions about how the trial findings apply to varying degrees of ischemia [Shaw et al. Circulation 2008]. The results of this subanalysis indicated that PCI plus OMT was associated with a higher rate of ≥5% reduction in ischemic myocardium (33% vs 19%; p=0.0004), especially among patients who had moderate to severe ischemia before treatment (78% vs 52%; p=0.007). Carl Tomasso, MD, Evanstown Northwestern Healthcare, Skokie, IL, suggested that PCI is indicated for patients who have a large amount of jeopardized myocardium or if OMT alone does not provide adequate relief of angina or the desired level of physical activity. He also emphasized that COURAGE did show several benefits of PCI: it led to a lower rate of subsequent revascularization, to better relief of angina over 1–3 years, and to better quality of life over 1–2 years.

Bernard J. Gersh, Mayo Clinic, Rochester, MN, commented that the COURAGE substudy results also suggest that the ACC/AHA guidelines for chronic stable angina are applicable to patients with silent ischemia. For patients with silent ischemia without overt angina or anginal equivalents, high-risk features on stress testing should be used as indications for angiography, said Dr. Gersh, and revascularization should be performed if “compelling” anatomy is identified.

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