Abstract Body (Do not enter title and authors here): Background
In patients undergoing valve surgery with concomitant coronary artery disease, coronary angiography (CAG) is the standard method to guide coronary artery bypass grafting (CABG). It is uncertain whether use of angiography-derived fractional flow reserve (AngioFFR) to guide CABG improves outcomes compared to CAG.
Methods
This was a multicenter, randomized, triple-blinded, parallel-group trial conducted in 12 hospitals in China. Enrollment occurred between August 2019 and August 2024, with 1-year follow-up completed in July 2025. A total of 794 participants were randomized to undergo CAG-guided or AngioFFR-guided CABG.
Eligible patients were ≥18 years of age, undergoing planned valve surgery with concomitant coronary artery disease defined as ≥50% stenosis by visual estimation on CAG. Patients with prior cardiac surgery, planned transcatheter valve or coronary interventions, secondary valvular heart disease, insufficient CAG image quality, target vessels unsuitable for CABG, and life expectancy <3 years were excluded.
AngioFFR was calculated using the AngioPlus system by a core laboratory. In the AngioFFR-guided arm, CABG was performed only for vessels with ≥50% stenosis, diameter ≥1.5 mm, and AngioFFR ≤0.80. In the CAG-guided arm, CABG was performed for all vessels with ≥50% stenosis and diameter ≥1.5 mm.
The trial has 80% power (two-sided α=0.05) to detect a reduction in the primary outcome from 12% in the CAG-guided arm to 6% in the AngioFFR-guided arm, accounting for a 10% dropout rate. The primary endpoint is a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, or new renal failure requiring dialysis at 30 days after surgery. Secondary endpoints included a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, hospitalization for unstable angina or heart failure; and graft failure (defined as ≥50% stenosis or occlusion), both assessed at 1 and 3 years after surgery. A modified intention-to-treat analysis will be used.
Results
Will be available in September 2025 and presented at AHA.
Clinical implications
This trial will provide evidence on whether a physiology-guided approach to CABG can improve outcomes in patients undergoing valve surgery with concomitant coronary artery disease.
Trial Registration
ClinicalTrials.gov NCT03977129