Key Points:
- The FAVOR IV-QVAS trial tested the hypothesis physiology-guided coronary artery bypass grafting (CABG) using angiography-derived fractional flow reserve (Angio-FFR) improves outcomes compared with conventional angiography-guided CABG in patients undergoing valve surgery with concomitant coronary artery disease (CAD).
- Angio-FFR–guided CABG cut perioperative complications by nearly half compared with angiography-guided CABG in patients undergoing valve surgery with concomitant coronary disease.
- AI-powered physiologic guidance reduced graft numbers without compromising safety or completeness of revascularization.
- Findings offer the first randomized evidence supporting physiology-based surgical revascularization.
The FAVOR IV-QVAS trial (NCT03977129) provides pivotal randomized evidence that physiology-guided coronary artery bypass grafting (CABG) using angiography-derived fractional flow reserve (Angio-FFR) improves outcomes compared with conventional angiography-guided CABG in patients undergoing valve surgery with concomitant coronary artery disease (CAD). The primary endpoint was a composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, and new renal failure requiring dialysis evaluated 30 days after surgery.
Conducted from 2019 to 2024 across 12 centers in China, the investigator-initiated, multicenter, triple-blind trial enrolled 793 patients scheduled for primary valve surgery who had at least one coronary stenosis ≥50% in a major epicardial vessel suitable for grafting. Participants were randomized 1:1 to Angio-FFR–guided CABG, in which grafts were performed only for vessels ≥1.5 mm with ≥50% stenosis and Angio-FFR ≤0.80, or conventional CAG-guided CABG, where all angiographic stenoses ≥50% were bypassed.
The AI-powered Angio-FFR technology estimated the physiological significance of coronary lesions directly from standard angiograms, eliminating the need for pressure wires or pharmacologic hyperemia. Using this physiologic guidance, the approach significantly reduced the number of grafts per patient (56% vs 98%) and lowered the rate of the primary composite endpoint of death, myocardial infarction, stroke, unplanned revascularization, or new renal failure requiring dialysis within 30 days after surgery (7.8% vs 13.4%; RR 0.58; p=0.01). Over a mean follow-up of 30 months, the key secondary composite outcome of all-cause death, myocardial infarction, stroke, unplanned revascularization, or hospitalization for unstable angina or heart failure also favored the Angio-FFR group (20.7% vs 26.8%; HR 0.74; p=0.04), demonstrating sustained clinical benefit.
“These results fill a significant gap in knowledge by challenging the angiography-only paradigm and providing novel evidence for an Angio-FFR–guided CABG strategy that significantly simplifies the procedural complexity in a high-risk population of combined valve and CABG surgery,” said Qiang Zhao, MD, principal investigator and director of cardiac surgery at Ruijin Hospital, Shanghai. He added that physiological lesion assessment has long improved outcomes in percutaneous interventions, and Angio-FFR may represent the next evolution in surgical planning. “Angio-FFR may be more suitable and accurate for patients undergoing valve surgery with concomitant coronary artery disease without the need for pressure wire or pharmacologic hyperemia,” Zhao noted.
These findings suggest that AngioFFR-guidance may be an adjunctive tool in surgical planning, allowing surgeons to tailor revascularization to hemodynamically relevant lesions even in the context of combined valve procedures. As the first randomized evidence bridging physiologic assessment with operative strategy, FAVOR 4-QVAS underscores the growing role of functional coronary evaluation beyond the catheterization laboratory, potentially setting the stage for wider integration of AngioFFR into hybrid and surgical revascularization workflows.
