Vessel fractional flow reserve (vFFR)-guided revascularization was noninferior to pressure-wire-based fractional flow reserve (FFR)-guided revascularization in patients with intermediate coronary lesions, according to results from the FAST III trial presented during a Late-Breaking Clinical Trials session at ACC.26 in New Orleans and simultaneously published in NEJM.

vFFR is a novel technique that uses 3D quantitative coronary angiography, without the need for a pressure wire or hyperemic agent.

Across 37 sites in seven European countries, the investigator-initiated, open-label trial randomized 2,211 patients with either an acute (19%) or chronic coronary syndromes (81%) and intermediate coronary lesions (diameter stenosis 30-80%) to either vFFR-guided revascularization (n=1,116) or FFR-guided revascularization (n=1,095).

The patients were 67 years old and 24% were women; 27% had diabetes, 72% hypertension, 71% dyslipidemia, 23% had prior myocardial infarction (MI) and 35% had prior revascularization.

In the vFFR and FFR groups, respectively, the mean number of lesions was 1.27 and 1.28 and complete physiological assessment was successful in 97% and 99%; revascularization was performed in 45% and 36% of patients.

Results at one year showed that 7.5% of patients in both groups experienced the primary endpoint, a composite of all-cause death, any MI or any revascularization. The risk difference was –0.02 percentage points, within the noninferiority margin of 3.0 percentage points (p=0.004).

Looking at the key secondary endpoint of study-vessel failure that had been examined by vFFR or FFR, a composite of cardiac death, MI or any revascularization, the incidence was similar (4% of the vFFR group and 4.6% of the FFR group).

vFFR identified a higher percentage of functionally significant lesions, which investigators mark as an area of future study. It was associated with shorter procedural time compared with FFR (55.8 minutes vs. 60.9 minutes), did not require the use of pressure wire and adenosine, and was associated with fewer intraprocedural complications (3.7% vs. 6.0%). Adverse events were similar between the two groups.

Trial limitations include its open-label design, small percentage of patients with an acute coronary syndrome, lack of investigator experience with vFFR compared to FFR, and a solely European patient population.

"Our new method produced very similar outcomes at one year compared with the standard of care," said Joost Daemen, MD, PhD, first author of the study. "We have also shown that this technique can easily be incorporated into routine clinical practice."

In an accompanying editorial comment, Yiannis S. Chatzizisis, MD, PhD, FACC, notes the burdens, cost and complexity of traditional wire-based FFR, and calls the FAST III trial, "an important step toward a new standard of care."

He adds, "In an era dominated by artificial intelligence, the trial provides meaningful support for a less-invasive physiology-guided strategy that may simplify decision making in treating the majority of patients with stable or unstable intermediate coronary lesions."

Clinical Topics: Acute Coronary Syndromes, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging, Hypertension

Keywords: ACC Annual Scientific Session, ACC26, Fractional Flow Reserve, Myocardial, Angiography, New Orleans, Constriction, Pathologic, Acute Coronary Syndrome, Diabetes Mellitus, Dyslipidemias, Myocardial Infarction, Coronary Angiography, Adenosine, Hypertension