# CABG vs. PCI to Improve Outcomes in Systolic Heart Failure: A Pilot Feasibility Study - Resubmission - 1

> **NIH NIH R34** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $378,955

## Abstract

Project Summary/Abstract
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 st...

## Key facts

- **NIH application ID:** 9842562
- **Project number:** 5R34HL141621-02
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** STUART D KATZ
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $378,955
- **Award type:** 5
- **Project period:** 2019-01-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9842562

## Citation

> US National Institutes of Health, RePORTER application 9842562, CABG vs. PCI to Improve Outcomes in Systolic Heart Failure: A Pilot Feasibility Study - Resubmission - 1 (5R34HL141621-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9842562. Licensed CC0.

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