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Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial.

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Primary Outcome
Composite of death, myocardial infarction, stroke, unplanned coronary revascularisation, and new renal failure requiring dialysis within 30 days after surgery
Key Finding
Physiologically guided CABG using angiography-derived FFR significantly reduced the 30-day composite perioperative outcome compared with anatomically guided CABG (7.8% vs 13.4%; RR 0.58, 95% CI 0.38-0.89; p=0.011) in patients undergoing valve surgery with concomitant coronary artery disease.

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Angiography-Derived FFR Guidance Reduces 30-Day Complications in Valve Surgery with Concomitant CABG

In patients undergoing surgical valve procedures with concomitant coronary artery disease, a physiologically guided revascularisation strategy using angiography-derived fractional flow reserve (FFR) cut 30-day major adverse events nearly in half compared with conventional anatomical guidance — 7.8% versus 13.4%, representing about a 42% lower relative risk (RR 0.58, 95% CI 0.38–0.89; p=0.011). The benefit extended beyond the perioperative window, with the physiologically guided group also showing meaningfully fewer events over a median follow-up of approximately two years.

What Was Studied

The trial asked whether surgical coronary revascularisation decisions during valve surgery should be driven by physiological assessment rather than by the conventional anatomical appearance of stenosis severity on coronary angiography. Current guidelines default to an anatomical threshold — grafting any vessel with a stenosis diameter of 50% or greater — yet this approach may lead to unnecessary grafts and attendant surgical risk. The study tested whether restricting bypass grafting to lesions that are functionally significant, as identified by angiography-derived FFR, would yield superior short- and longer-term clinical outcomes.

How It Was Studied

FAVOR IV-QVAS was an investigator-initiated, multicentre, randomised, triple-blind trial enrolling 793 adults (aged 18 years or older) scheduled for surgical valve procedures with at least one clinically significant coronary stenosis, conducted across 12 tertiary hospitals in China. Participants were allocated 1:1 to either physiologically guided CABG — in which bypass grafting was performed only for lesions with an angiography-derived FFR value of 0.80 or below — or anatomically guided CABG, where any stenosis of 50% diameter reduction or greater was grafted. Blinding was applied to patients, surgeons, follow-up physicians, and outcome assessors, reducing performance and ascertainment bias. The primary analysis used a modified intention-to-treat population, with follow-up extending to a median of 27 months across both groups.

What Was Observed

  • Perioperative composite outcome: The 30-day composite endpoint — comprising death, myocardial infarction, stroke, unplanned coronary revascularisation, and new renal failure requiring dialysis — occurred in 7.8% of the FFR-guided group versus 13.4% in the angiography-guided group, an absolute reduction of 5.6 percentage points (95% CI −9.9 to −1.3) and about 42% lower relative risk (RR 0.58, 95% CI 0.38–0.89; p=0.011). This represents the primary prespecified endpoint and was statistically significant.
  • Selective revascularisation rate: Concomitant CABG was performed in only 56% of patients in the FFR-guided group compared with 98% in the angiography-guided group, demonstrating that physiological assessment substantially reduced the proportion of patients receiving bypass grafts — meaning many lesions that appeared anatomically significant were not haemodynamically obstructive.
  • 30-day mortality: Numerical fewer deaths occurred in the FFR-guided group within 30 days — 2.8% versus 4.3% — though this individual component was not independently powered for statistical testing and should be interpreted as directionally consistent rather than conclusive.
  • Longer-term composite outcome: At a median follow-up of 27 months, the key secondary composite endpoint of death, myocardial infarction, stroke, unplanned revascularisation, or hospitalisation for unstable angina or heart failure occurred in 20.7% versus 26.8% of patients, a roughly 26% lower hazard in the FFR-guided group (HR 0.74, 95% CI 0.55–0.98; p=0.036).

Why This Matters

These results directly challenge the longstanding anatomical-only paradigm for surgical coronary revascularisation during valve procedures, demonstrating that a more selective, physiology-informed approach is associated with meaningfully better clinical outcomes rather than the assumed harm of leaving moderate lesions ungrafted. By integrating angiography-derived FFR — a non-invasive, image-based functional assessment — into surgical planning, this work establishes a potential new standard for hybrid cardiac decision-making. The finding that nearly half of patients randomised to physiological guidance avoided CABG entirely, without apparent clinical detriment, has direct implications for surgical risk stratification and resource utilisation.

How to Read This Result

This is a high-quality, triple-blind randomised trial with a statistically significant primary outcome, and the direction of findings is consistent across both short- and longer-term endpoints; however, the study was conducted exclusively in Chinese tertiary hospitals, which may limit generalisability to other healthcare settings, and extended follow-up remains ongoing, so the durability of the observed benefit beyond two years has not yet been fully characterised.

Limitations

The abstract does not explicitly report study limitations.

Quality: High High-impact journal Randomized Controlled Trial
Source
Lancet· PMID: 41864747
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