medwireNews: Angiography-derived fractional flow reserve (FFR) is noninferior to intravascular ultrasound imaging when used for combined percutaneous coronary intervention (PCI) decision-making and procedural optimization in patients with suspected ischemic heart disease and at least 50% stenosis on coronary angiography, suggests the FLAVOUR II study.
The randomized phase 3 trial conducted in China showed that 6.3% of 923 patients undergoing angiography-derived FFR and 6.0% of 916 undergoing intravascular ultrasound experienced a composite outcome event of death, myocardial infarction, or revascularization at 12 months. This gave a 0.2 percentage point difference that was within the 2.5 percentage point margin for noninferiority of angiography-derived FFR.
The study team notes that mortality did not differ between the angiography-derived FFR and intravascular ultrasound groups (1.8 vs 1.3%).
The results were published in The Lancet and simultaneously presented at the American College of Cardiology annual meeting in Chicago, Illinois, USA.
Researcher Bon-Kwon Koo (Seoul National University College of Medicine, South Korea) and colleagues say the findings provide clinical evidence that in patients with noncomplex coronary artery disease, angiography-derived FFR, a wire-free computational physiological index obtained from angiography readings, “can perform as effectively as the most commonly used invasive intravascular imaging technique when used as a comprehensive strategy.”
The two techniques were compared based on prespecified PCI criteria and optimal PCI goals, the team notes. Specifically, for the angiography-derived FFR group, the criterion for revascularization was 0.80 or less and optimal PCI was defined as as a post-procedural angiography-derived FFR of at least 0.88 or up to a 0.05 difference in the angiography-derived FFR across the stent.
For the intravascular ultrasound group, the revascularization criteria were a minimal lumen area of 3 mm² or less, or 3–4 mm² with a plaque burden of more than 70%, and the optimal PCI was defined as a plaque burden at the stent edge of up to 55%, and a minimal stent area of at least 5.5 mm² or equal to or larger than the distal reference lumen area.
The researchers note that using angiography-derived FFR led to significantly fewer patients undergoing PCI than with intravascular ultrasound (73.9 vs 83.1%), significantly fewer and shorter stent implantations per patient (mean 1.06 vs 1.22 implantations, and 27.6 vs 32.3 mm, respectively), and a significantly lower rate of antiplatelet therapy use (77.0 vs 82.4%).
“Our study suggests that if physicians opt for a single adjunctive approach to conventional coronary angiography to manage non-complex coronary lesions, angiography-derived FFR is a suitable choice for both lesion selection and stent optimisation when minimising unnecessary PCI is a priority,” comment the study authors.
They add that intravascular ultrasound may be favored when a more aggressive PCI approach is needed to reduce future coronary events.
“Clinicians can select the approach that best aligns with their practice preferences, with no differences in the 1-year clinical outcome between these two strategies,” the team says.
The study involved 1839 adults with a new stenosis of at least 50% and visually estimated to be at least 2.5 mm on coronary angiography. They had a median age of 66.0 years, 67.9% were men, and 59.1% had acute coronary syndrome.
Revascularization was performed in 69.5% of 990 target vessels in the angiography-derived FFR group and in 81.0% of 984 target vessels in the intravascular ultrasound group.
Patrick Serruys and colleagues, from the University of Galway in Ireland, say in a related comment that the findings steer “PCI practice towards a more favorable direction—one that achieves equivalent results with less permanent metallic stenting by using more accessible and streamlined diagnostic tools in modern cardiac catheterisation.”
They also point out that angiography-derived FFR “does not require additional hyperaemia or repeated instrumentation as with pressure wire assessments.”
However, the commentators highlight some study limitations, including that the findings applied “only to patients with angiographically significant stenosis,” and “might not extend to non-obstructive lesions, as only patients with at least 50% stenosis were assessed.”
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Lancet 2025; doi:10.1016/S0140-6736(25)00504-5
Lancet 2025; doi:10.1016/S0140-6736(25)00576-8
ACC.25; Chicago, Illinois, USA: 29–31 March
