Comparison of Characteristics and Outcomes of Veterans With Stable Ischemic Heart Disease Enrolled in the COURAGE Trial Versus the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program

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Randomized clinical trials have not demonstrated a survival benefit with percutaneous coronary intervention in stable ischemic heart disease (SIHD). We evaluated the generalizability of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial findings to the broader population of veterans with SIHD. Veterans who underwent coronary angiography between 2005 and 2013 for SIHD were identified from the Veterans Affairs Clinical Assessment, Reporting and Tracking Program (VA CART). Patient-level comparisons were made between patients from VA CART who met the eligibility criteria for COURAGE and veterans enrolled in COURAGE between 1999 and 2004. All-cause mortality over long-term follow-up was assessed using Cox proportional hazards models. COURAGE-eligible patients from VA CART (n = 59,758) were older, had a higher body mass index, a greater prevalence of co-morbidities, but fewer diseased vessels on index coronary angiography, and were less likely to be on optimal medical therapy at baseline and on 1-year follow-up compared with VA COURAGE participants (n = 968). Patients from VA CART (median follow-up 6.5 years) had higher all-cause mortality (adjusted hazard ratio [aHR] 1.98 [1.61 to 2.43]) than participants from VA COURAGE (median follow-up: 4.6 years). Risks of mortality were greater in the 56.4% patients from CART who were medically managed (aHR 1.94 [1.49 to 2.53]) and in the 43.6% who underwent percutaneous coronary intervention (aHR 1.99 [1.45 to 2.74]), compared with their respective VA COURAGE arms. In conclusion, in this noncontemporaneous patient-level analysis, veterans in the randomized COURAGE trial had more favorable outcomes than the population of veterans with SIHD at large.

Introduction

Randomized clinical trials have not demonstrated a survival benefit for percutaneous coronary intervention (PCI) in patients with stable ischemic heart disease (SIHD).1, 2, 3 However, the applicability of clinical trials that inform the management of patients with SIHD may be limited by selection bias.4, 5, 6, 7, 8 Furthermore, participants of randomized clinical trials may represent a particularly engaged patient subset, with greater involvement in their own medical care. The large, multicenter, randomized COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial compared an initial strategy of optimal medical therapy (OMT) to an initial strategy of OMT and PCI in patients with SIHD and found no significant differences in the risk of death, myocardial infarction, or other major cardiovascular events between the 2 groups, even with up to 15 years of follow-up.9,10 A little less than half of the participants of COURAGE were enrolled and randomized at Veterans Affairs (VA) hospitals. The primary objective of this study was to evaluate the generalizability of the COURAGE trial to the broader population of veterans with SIHD referred for invasive coronary angiography.

Section snippets

Methods

The VA CART Program is a national quality improvement program supporting all VA cardiac catheterization laboratories. The CART Program is a clinical software application that collects standardized data on diagnostic and interventional cardiac procedures.11,12 These data are combined with other VA data sources to generate a longitudinal data repository. All patients who underwent diagnostic coronary angiography for SIHD between January 1, 2005, when the CART program was launched, and September

Results

Baseline characteristics of the COURAGE-eligible patients from VA CART with SIHD (n = 59,758) and participants of VA COURAGE (n = 968) are shown in Table 1. Patients from VA CART with SIHD were older, more likely to be White, and had a higher body mass index than participants of VA COURAGE. Patients from VA CART with SIHD were more likely to have diabetes mellitus, hypertension, pulmonary disease, previous coronary revascularization with PCI or CABG, and lower glomerular filtration rates than

Discussion

In this comparison of patients from VA CART with SIHD who received routine clinical care after coronary angiography and veterans enrolled in the COURAGE trial, real-world patients were older, more likely to have traditional cardiovascular risk factors, pulmonary and renal disease, previously revascularized coronary artery disease, more favorable lipid profiles, and less extensive coronary artery disease than trial participants. At baseline and at 1 year after the index coronary angiogram,

Disclosures

Dr. Smilowitz serves on an advisory board for Abbott Vascular. Dr. Shah serves on an advisory board for Philips Volcano and Terumo Medical. The remaining authors have no conflicts of interest to declare.

Acknowledgment

The authors dedicate this manuscript to the memory of Steven P. Sedlis, a Professor of Medicine, consummate mentor, and dedicated physician, who devoted his career to improving patient outcomes, educating the next generation of physicians, and advancing science.

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  • Cited by (0)

    Dr. Shah was supported, in part, by the Biomedical Laboratory Research & Development Service of the VA Office of Research and Development, Washington, District of Columbia, iK2CX001074 and the National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland, R01HL146206. Dr. Smilowitz is supported, in part, by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL150315.

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