FAVOR III China: Improved 2-Year Clinical Outcomes with QFR-Guided Lesion Selection in PCI compared with standard angiography guidance

Invasive wire-based physiological assessments have been shown to be more accurate than angiography alone in identifying flow-limiting lesions, but their adoption in clinical practice has been limited. QFR, on the other hand, uses 3D coronary reconstruction and computational fluid dynamics to estimate Fractional Flow Reserve (FFR) based solely on angiography.

The FAVOR III China trial, a multicenter, randomized, sham-controlled study, demonstrated the superior 1-year clinical outcomes of quantitative flow ratio (QFR)-based lesion selection over conventional angiographic guidance for percutaneous coronary intervention (PCI). The primary aim of this study was to assess whether the advantages of QFR guidance persisted at the 2-year mark, particularly among patients for whom QFR prompted a change in the revascularization strategy.

Eligible patients were randomly allocated to one of two strategies: a QFR-guided approach (PCI performed only if QFR ≤0.80) or a conventional angiography-guided approach. Major adverse cardiac events (MACE), defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization within 2 years, were evaluated in the intention-to-treat population.

Among the 3,825 participants randomly assigned, the 2-year MACE occurred in 8.5% patients in the QFR-guided group and in 12.5% patients in the angiography-guided group (Hazard Ratio [HR]: 0.66; 95% Confidence Interval [CI]: 0.54-0.81; P < 0.0001). This difference was primarily driven by fewer MIs (4.0% vs. 6.8%; HR: 0.58; 95% CI: 0.44-0.77; P = 0.0002) and ischemia-driven revascularizations (4.2% vs. 5.8%; HR: 0.71; 95% CI: 0.53-0.95; P = 0.02) in the QFR-guided group. Landmark analysis indicated consistent results within the first year and between 1-2 years (Pint = 0.99). Notably, while the 2-year MACE rate was lower in the QFR-guided group, this improvement was more pronounced (Pint = 0.009) among patients for whom the initial PCI strategy was modified based on QFR assessment.

QFR-guided lesion selection yielded superior 2-year clinical outcomes compared to conventional angiographic guidance. These benefits were most prominent among patients for whom QFR assessment prompted a modification in the planned revascularization strategy.