Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial.

Summary

In 1,839 randomized patients with significant CAD lesions eligible for both strategies, angiography‑derived FFR guidance was noninferior to IVUS guidance for the 12‑month composite of death/MI/revascularization (6.3% vs 6.0%; absolute difference 0.2 pp, upper 97.5% CI 2.4). The FFR strategy was associated with a lower proportion of vessels undergoing revascularization (69.5% vs 81.0%).

Key Findings

• Noninferiority for the 12‑month composite endpoint (death/MI/revascularization) between angiography‑derived FFR and IVUS guidance.
• Lower proportion of target vessels revascularized in the angiography‑derived FFR arm (69.5% vs 81.0%).
• Trial standardized decision and optimization criteria per arm; simultaneous dual‑modality use was prohibited.

Clinical Implications

Angiography‑derived FFR can be adopted as a comprehensive PCI guidance tool (decision and optimization) when IVUS is not available or to streamline procedures, with awareness of local expertise and patient selection.

Limitations

• Open-label design in a single-country setting (China) may limit generalizability
• Noninferiority margin interpretation and operator technique variability

Future Directions

Head‑to‑head comparisons integrating cost‑effectiveness, patient‑reported outcomes, and long‑term durability; hybrid strategies and training standardization.