The COURAGE trial compared the risk of cardiovascular events among patients with stable CAD assigned to a treatment strategy of intensive pharmacologic therapy and lifestyle intervention (OMT) alone with those assigned to treatment with PCI followed by OMT. No previous studies involved the intensity of OMT attempted in COURAGE, which included the use of aspirin, beta-blockers, ACE inhibitors, statins, and clopidogrel, as well as diet, exercise, and smoking-cessation counseling. Medication doses were repeatedly intensified in pursuit of aggressive blood-pressure and LDL-cholesterol targets.
Previous CAD trials suffered from limited generalizability because they enrolled highly selected patient populations. Patients were commonly under the age of 65, less likely to have depressed left ventricular function, less likely to have clinical instability, and less likely to have undergone previous coronary artery bypass graft (CABG) surgery or PCI than patients typically seen in nonexperimental settings (O’Rourke, 2008). COURAGE was designed to enroll a moderate- to high-risk population with less-restrictive inclusion criteria.
The primary outcome for the efficacy study was a composite outcome of death from any cause and nonfatal MI. A quality-of-life substudy assessed changes in angina frequency and quality of life using the Seattle Angina Questionnaire and the RAND-36 health survey. The trial’s “nuclear substudy” compared the effectiveness of PCI with or without OMT in reducing the frequency of results suggestive of ischemia among a subset of patients who underwent myocardial perfusion single-photon emission computed tomography (MPS) (Shaw, Berman, et al., 2008).