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COURAGE substudy: Angina, treatment dissatisfaction lead to revascularization at 1 year
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Results of a COURAGE substudy have concluded that the strongest predictors of patients who require revascularization within 1 year of randomization to optimal medical therapy are severe angina and dissatisfaction with their current treatment for stable ischemic heart disease.
For the analysis, researchers from the COURAGE trial compared the outcomes of crossover patients with a matched cohort randomized to immediate stenting. Of the 1,148 patients randomized to optimal medical therapy (OMT), 185 (16.1%) underwent early revascularization. From these patients, 166 (90%) underwent PCI and 19 (10%) were treated with CABG.
Patient characteristics that independently predicted early revascularization included baseline Seattle Angina Questionnaire (SAQ) scores and health care system. Researchers matched 156 OMT patients undergoing early revascularization to 156 patients randomized to PCI and observed that mortality (HR=0.51; 95% CI, 0.13-2.1) and nonfatal MI (HR=1.9; 95% CI, 0.75-4.6) were similar, as were 1-year SAQ scores. However, OMT patients had worse health status over the initial year of treatment and more unstable angina admissions (HR=2.8; 95% CI, 1.1-7.5), although their symptoms, function and quality of life at 1 year were similar.
Researchers reported no difference in the outcomes of death or MI between patients who crossed over from OMT and similar patients who were randomized to upfront PCI, although there was a greater risk for unstable angina admissions during follow-up.
Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, researchers wrote that an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients is appropriate.
“We found that patients with worsening (lower SAQ angina stability scores) and more frequent angina (lower SAQ angina frequency scores) were more likely to require early crossover, which is congruent with the clinical reality of attempting to achieve the therapeutic goal of angina elimination and optimal QOL for patients with chronic CAD,” they said.
Disclosure: Spertus reports holding the copyright to the Seattle Angina Questionnaire and has received grant support from the American Heart Association, American College of Cardiology Foundation, Eli Lilly, Genentech and the NIH; he also serves as a consultant to St. Jude Medical, United Healthcare and the American Heart Association, where he serves as an editor for Circulation and Circulation: Cardiovascular Quality and Outcomes.
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