FFRangio, a minimally invasive, artificial intelligence (AI)-assisted, novel method of measuring fractional flow reserve (FFR), performed similarly to traditional wire-based testing in patients with coronary artery disease (CAD) undergoing assessment for PCI, according to results from the ALL-RISE trial presented during a Late-Breaking Clinical Trial session at ACC.26 in New Orleans and simultaneously published in NEJM.

In the large, international noninferiority trial, investigators William Fuller Fearon, MD, FACC, et al., randomized 1,930 patients with CAD (mean age, 68; 25% women; 60% White) across the U.S., Israel, Japan, Switzerland and the U.K. 1:1 to either the FFRangio technique (n=965) or conventional invasive pressure-wire measurements (n=965). Many participants carried substantial cardiovascular history and risk: 17% had a previous myocardial infarction (MI), about 40% had prior PCI; roughly 80% had hypertension, 80% high cholesterol and 38% had diabetes.

At one year, results showed that a similar number of patients in the FFRangio arm and the pressure-wire arm experienced a composite primary endpoint of death, MI or unplanned clinically indicated revascularization (64 vs. 65 patients, respectively; Kaplan-Meier estimate, 6.9% vs. 7.1%; hazard ratio, 0.98; p<0.001 for noninferiority).

No differences were observed in bleeding, acute kidney injury or procedure-related adverse events. The FFRangio approach, compared with the pressure-wire approach, was faster (39 vs. 42 minutes), required lower fluoroscopy exposure and use of contrast material, and avoided additional procedural steps.

“We have shown that using this (FFRangio) software-based tool in the cath lab results in similar clinical outcomes at one year compared with the current gold standard of invasive wire-based assessment,” said Ajay J. Kirtane, MD, FACC, the study’s senior author. “Our hope is that these findings – with a technology that does not require further coronary manipulation beyond a routine angiogram – will lead to increased adoption of coronary physiologic testing as recommended by current guidelines.”

“The broader implication is not a comparison between angiography-derived and wire-based testing but a shift away from reliance on anatomy alone,” writes Gianluca Campo, MD, in an accompanying editorial comment. “Angiography-derived FFR may serve as an integrated, first-line physiological assessment during diagnostic imaging, providing an immediate functional estimate to inform revascularization decisions.”

Noted limitations of the trial include its open-label design and exclusion of patients with prior CABG.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: ACC Annual Scientific Session, ACC26, Angiography, New Orleans