Ischemic heart disease is the most common cause of heart failure in the US, and is associated with increased mortality risk when compared with non-ischemic causes of heart failure. Ischemic heart disease may be treated with lifestyle modification and medications alone or in combination with revascularization by coronary artery bypass grafts (CABG) or percutaneous coronary interventions (PCI), but the optimal revascularization approach in patients with chronic heart failure with reduced ejection fraction (HFrEF) due to ischemic heart disease is unknown. Based on existing data from randomized trials of CABG vs. PCI in non-heart failure patients, and the results of a meta-analysis comparing CABG vs. PCI in HFrEF patients, we hypothesize that CABG is superior to PCI to reduce risk of adverse clinical outcomes. The long-term goal of the proposed research is to carry out an international multisite randomized clinical trial to compare the effects of myocardial revascularization with CABG vs. PCI on clinical outcomes in HFrEF patients with ischemic heart disease and suitable coronary anatomy. Successful design and execution of the future clinical trial is dependent on access to study sites with the necessary multidisciplinary expertise and adequate numbers of potential participants with ischemic cardiomyopathy, and development of study entry criteria and study interventions that will promote robust recruitment based on both investigator and participant preferences. The current application proposes three objectives; for Objective 1, site surveys will be designed and implemented to acquire data on the number and clinical characteristics of potential participants with ischemic cardiomyopathy, site resources for treatment of ischemic cardiomyopathy, clinical practice patterns for ischemic cardiomyopathy, and potential barriers to enrollment at sites currently recruiting for the NHLBI-funded ISCHEMIA trial (NCT01471522). For Objective 2. questionnaires based on clinical scenarios will be designed and implemented to characterize clinician equipoise for the perceived clinical utility of CABG vs. PCI in ischemic cardiomyopathy patients based on anatomic complexity of coronary artery disease, patient symptoms, non-invasive testing, and co-morbid diabetes mellitus. For Objective 3. a mixed methods approach that integrates qualitative data collected from patient interviews and quantitative methods based on Best-Worst scaling surveys and discrete choice experiments will be implemented to determine patient preferences for CABG vs. PCI among ischemic heart disease patients (based on attributes including mortality risk, procedural complications, quality of life, convenience, and costs), and the willingness to accept randomized treatment assignment. The data obtained for each of the objectives will be used to assess feasibility and optimize study design (entry criteria, study endpoints, sample size calculation, site selection, and recruitment strategies) and recruitment strategy for the future randomized clinical trial of CABG vs. PCI in HFrEF patients with ischemic cardiomyopathy.
Heart failure is a common form of heart disease that may lead to disability and premature death. Blockage in the coronary arteries (the arteries that carry oxygen to the heart) is the most common cause of heart failure. This planning grant aims to gather information to support the design and execution of a clinical trial to determine the best treatment for patients who have heart failure due to blockages in the coronary arteries (open heart bypass surgery vs. use of catheters, balloons, and stents) in order to improve quality of life and survival in these patients.
