Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL)

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PROJECT SUMMARY/ABSTRACT Coronary heart disease (CHD) affects over 18.2 million Americans and it is rising globally. Coronary artery bypass graft (CABG) surgery is the standard of care for multi-vessel CHD and has dramatically improved life expectancy. However, it is not known how CABG surgery impacts symptom burden or health related quality of life (HRQOL), two outcomes that matter to patients. Furthermore, CABG surgery can use single arterial grafts (SAG) or multiple arterial grafts (MAG). Observational research suggests that MAG prolongs survival compared to SAG and decreases risk of surgical complications, heart attack, stroke, infection, and death; however, differences in HRQOL between these two surgical standards of care are not known. The investigators aim to define the impact of CABG surgery on HRQOL and symptom burden among 2,111 men and women with multi- vessel CHD in the context of the large multinational ROMA trial that is testing the hypothesis that clinical outcomes with MAG are superior to SAG over 5 years. The ROMA:QOL ancillary study leverages the infrastructure of the parent trial to add HRQOL and symptom outcomes. The overall goal of this R01 is to compare HRQOL and symptoms following SAG vs. MAG CABG surgery. In Aim 1, the investigators will quantify changes in the well-validated Seattle Angina Questionnaire as a measure of disease-specific HRQOL and the widely used Short Form 12-item survey as a generic measure of HRQOL. In Aim 2, the investigators will quantify changes in physical and mental health symptoms and physical functioning using the NIH Patient Reported Outcomes Measure Information System (PROMIS). A secondary goal is to quantify minimally important clinical differences for the PROMIS measures post CABG surgery. Pre-specified subgroup analyses will evaluate HRQOL and symptom burden in women compared with men, and patients with and without diabetes. Compared to men, women are more likely to be underdiagnosed with CHD and are less likely to be referred for CABG surgery. Diabetes is an established CHD risk factor, especially multi-vessel CHD, and diabetic patients are at higher risk for surgical complications, poor wound healing, and worse clinical outcomes after CABG surgery. The hypothesis is that both groups will experience improvements in HRQOL and symptoms at 12 months, but MAG will be superior to SAG. The results will generate missing evidence about the impact of MAG vs. SAG surgery on dimensions of health prioritized by patients. This missing evidence prevents fully informed decision-making about the risks and benefits of CABG surgery in general, and MAG vs. SAG specifically. This study will influence future treatment recommendations and clinical practice guidelines and lay the foundation for shared decision- making tools to communicate risks and benefits to patients. The proposed study addresses NIH’s call to investigate factors that account for differences in health and treatment response to novel surgical strategies, overall and by sex.