FLAVOUR II: Novel non-invasive PCI-guidance strategy non-inferior to standard-of-care

An angiography-derived fractional flow reserve (AngioFFR)-guided strategy for percutaneous coronary intervention (PCI) was non-inferior to standard intravascular ultrasound (IVUS)-guided PCI in terms of clinical outcomes at 1 year of follow-up, results of the FLAVOUR II trial showed.

AngioFFR, a new, non-invasive AI-powered method to guide PCI revascularisation decision-making and stent implantation optimisation was compared with IVUS-guided PCI in 1,839 Chinese participants undergoing PCI who had at least 50% stenosis by angiography-based visual estimation [1]. The FLAVOUR II trial (NCT04397211) randomised participants 1:1 to AngioFFR-guided PCI or to IVUS-guided PCI to compare the strategies in terms of a composite of death, myocardial infarction (MI), or revascularisation at 1 year of follow-up. “Each strategy was employed for both PCI decision-making and procedure optimisation,” clarified Dr Jian’an Wang (Second Affiliated Hospital of Zhejiang University School of Medicine, China).

AngioFFR-guided PCI was non-inferior to IVUS-guided PCI for the composite of clinical outcomes, with rates of 6.3% and 6.0%, respectively (P_{non-inferiority}=0.022). In addition, no differences were observed between the study arms regarding stroke rates, MI rates, cardiovascular death, or revascularisation (see Table).

Table: Key secondary outcomes of the FLAVOUR II study [1]



AngioFFR, angiography-derived fractional flow reserve; CI, confidence interval; IVUS, intravascular ultrasound.

Thus, the non-invasive AngioFFR-guided PCI strategy, encompassing both PCI decision-making and stent optimisation, was non-inferior to the standard IVUS-guided PCI strategy. “This finding may have implications for future guidelines about the role and application of PCI-guidance strategies,” reasoned Dr Wang. “We will continue to follow these patients to explore long-term differences between the 2 strategies.”

1. Wang J, et al. Comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided PCI strategies: FLAVOUR II. Late-breaking Clinical Trials V, ACC 2025 Scientific Session, 29–31 March, Chicago, USA.

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Posted on 22 May 202522 May 2025