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

> **NIH NIH R01** · WEILL MEDICAL COLL OF CORNELL UNIV · 2020 · $814,827

## Abstract

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 str...

## Key facts

- **NIH application ID:** 9946979
- **Project number:** 1R01HL152021-01
- **Recipient organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** Mario FL Gaudino
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $814,827
- **Award type:** 1
- **Project period:** 2020-04-21 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9946979

## Citation

> US National Institutes of Health, RePORTER application 9946979, Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL) (1R01HL152021-01). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9946979. Licensed CC0.

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