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.

Physiologically guided CABG using angiography-derived FFR significantly reduced the 30-day composite primary outcome compared with anatomically guided CABG.

• The primary outcome (composite of death, myocardial infarction, stroke, unplanned coronary revascularisation, and new renal failure requiring dialysis within 30 days) occurred in 31 (7.8%) patients in the angiography-derived FFR group versus 53 (13.4%) in the coronary angiography group.
• Absolute difference was -5.6 percentage points (95% CI -9.9 to -1.3).
• Risk ratio was 0.58 (95% CI 0.38 to 0.89); p=0.011.
• Trial was multicentre, triple-blind, and randomised (1:1) at 12 tertiary hospitals in China, with 793 patients enrolled between Aug 4, 2019, and Aug 13, 2024.

Physiologically guided CABG significantly reduced the key secondary composite outcome at a median follow-up of 27 months.

• The key secondary outcome (composite of death, myocardial infarction, stroke, unplanned coronary revascularisation, and hospitalisation for unstable angina or heart failure) occurred in 82 (20.7%) patients in the angiography-derived FFR group versus 106 (26.8%) in the coronary angiography group.
• Hazard ratio was 0.74 (95% CI 0.55–0.98); p=0.036.
• Median follow-up was 28 months (IQR 18–44) in the angiography-derived FFR group and 27 months (IQR 18–42) in the coronary angiography group.

Physiologically guided CABG resulted in substantially fewer patients receiving concomitant CABG compared with anatomically guided CABG.

• Concomitant CABG was performed in 223 (56%) patients in the angiography-derived FFR group versus 388 (98%) patients in the coronary angiography group.
• This reflects the selective revascularisation strategy: grafting only lesions with angiography-derived FFR ≤0.80 versus all lesions with stenosis diameter ≥50% on coronary angiography.
• The modified intention-to-treat population included 396 patients in the FFR group and 396 in the coronary angiography group (one patient in the coronary angiography group declined surgery and was excluded).

30-day mortality was numerically lower in the angiography-derived FFR group compared with the coronary angiography group.

• Death within 30 days occurred in 11 (2.8%) patients in the angiography-derived FFR group and 17 (4.3%) patients in the coronary angiography group.
• This was a component of the composite primary outcome rather than a separately powered endpoint.

The trial population had a median age of 65 years and was predominantly male.

• Median age was 65 years (IQR 59–70).
• 221 (28%) patients were female and 571 (72%) were male.
• Eligible patients were aged 18 years or older, scheduled for valve surgery, with at least one clinically significant stenosis in a major coronary artery.
• 793 total patients were enrolled across 12 tertiary hospitals in China.

The trial used a physiological threshold of angiography-derived FFR ≤0.80 to guide selective surgical coronary revascularisation, compared with an anatomical threshold of stenosis diameter ≥50% by coronary angiography.

• Patients were randomly assigned 1:1 to physiologically guided CABG (angiography-derived FFR ≤0.80) or anatomically guided CABG (stenosis diameter ≥50% on coronary angiography).
• Randomisation was stratified by site with fixed blocks of four using a web-based program.
• Patients, surgeons, follow-up physicians, and outcome assessors were all masked to treatment allocation (triple-blind design).
• Missing data for the primary outcome were analysed using complete-case analysis or multiple imputation, with 2% as the threshold for missing data proportion.