Fractional flow reserve (FFR) guidance is noninferior to intravascular ultrasound (IVUS) guidance regarding 12-month clinical outcomes in patients undergoing percutaneous coronary intervention (PCI), data from the FLAVOUR II trial shows. “This is the first such study to be conducted in patients with angiographically significant lesions,” said Jian-an Wang, MD, PhD, from the Zhejiang University School of Medicine, China, in a press release on Sunday. These results were presented by Dr. Wang on behalf of the FLAVOUR II investigators, during a late-breaking clinical trial session on Sunday at the American College of Cardiology (ACC) Scientific Sessions 2025. These results were also simultaneously published in the Lancet. In patients with angiographically significant stenosis, FFR has been shown to outperform angiography alone in PCI but has not demonstrated noninferiority to IVUS. The investigators in this study compared angiography-guided FFR to IVUS for PCI decision-making. FLAVOUR II (Comparison of Angiography-Derived Fractional Flow Reserve and Intravascular Ultrasound-Guided Intervention Strategy for Clinical Outcomes in Patients with Coronary Artery Disease)— an investigator-initiated, open-label, multicenter, randomized controlled trial across 22 centers in China — randomly assigned patients 1:1 between May 29, 2020, and September 20, 2023, to undergo angioFFR-guided or IVUS-guided PCI. The FFR was powered by artificial intelligence. A composite of death, myocardial infarction (MI) or revascularization at 12-months was the primary outcome in this study. A total of 923 patients were randomized to the FFR group and 916 to the IVUS group (mean age of total study population=66 years, 32.1% female). In the FFR group, revascularization was performed in 688 of 990 target vessels, and 767 of 984 in the IVUS group. At 12-months follow-up, 56 patients in the FFR group and 54 patients in the IVUS group experienced a primary outcome event (pnoninferiority=0.22, hazard ratio [HR]=1.34, 95% confidence interval [CI]=0.71-1.51). No between-group differences were observed in mortality (1.8% in FFR, 1.3% in IVUS; 95% CI: -0.7 to 1.6, HR=1.34, p=0.45). Additionally, the rate of recurring angina was low in both groups (2.8% in FFR, 3.8% in IVUS). Overall, FFR was noninferior to IVUS in patients who underwent PCI regarding death, MI or revascularization at 12-months. Source: Hu X, Zhang J, Jiang J, et al. 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. Lancet. 2025 March 30 (Article in press). Image Credit: Screenshot by Bailey G. Salimes. Image Caption: Jian-an Wang, MD, PhD, presents during a press conference on Sunday at the American College of Cardiology (ACC) Scientific Sessions 2025.