Analysis of COURAGE Crossover Patients Supports an Initial Trial of Optimal Medical Therapy for Stable Ischemic Heart Disease

July 9, 2013—An analysis of the frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy (OMT) in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial was published by John A. Spertus, MD, et al on behalf of the COURAGE trial investigators and coordinators in Circulation: Cardiovascular Quality and Outcomes (2013;6:409–418).

In the COURAGE trial, some patients with stable ischemic heart disease randomized to OMT crossed over to early revascularization; however, the predictors and outcomes of these crossover patients are unknown, noted the investigators.

As summarized in Circulation: Cardiovascular Quality and Outcomes, the COURAGE investigators compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire (SAQ). To quantify the potential consequences of initiating OMT without percutaneous coronary intervention (PCI), the investigators compared the outcomes of crossover patients with a matched cohort randomized to PCI.

The investigators reported that among 1,148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline SAQ scores and health care system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to PCI, rates of mortality (hazard ratio = 0.51 [0.13–2.1]) and nonfatal myocardial infarction (hazard ratio = 1.9 [0.75–4.6]) were similar, as were 1-year SAQ scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio = 2.8 [1.1–7.5]).

The investigators found that among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients, concluded the COURAGE investigators in Circulation: Cardiovascular Quality and Outcomes.