Angiography-Based FFR Approach Matches Gold Standard Results Without Wires

Accurately determining whether a coronary stenosis limits blood flow is essential to guide percutaneous coronary intervention, yet wire-based physiologic testing remains underused due to added procedural time and manipulation. A newly introduced software-based method aims to simplify this step within routine angiography. A large randomized study now shows that an angiography-derived fractional flow reserve approach, FFRangio, achieves one-year outcomes comparable to the invasive gold standard.

CathWorks' FFRangio is designed for use in the catheterization laboratory to assess coronary physiology without pressure wires or pharmacologic hyperemia. Developed as an AI–enabled platform, FFRangio reconstructs three-dimensional coronary anatomy from standard angiographic images and computes fractional flow reserve values to determine whether lesions restrict perfusion. Investigators involved in the work included faculty from Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian/Columbia University Irving Medical Center.

The international ALL-RISE randomized trial evaluated whether FFRangio could guide revascularization decisions as effectively as invasive wire-based measurements in patients with coronary artery disease referred for angiographic assessment. The study enrolled 1,930 patients in the United States, Israel, Japan, Switzerland, and the United Kingdom. Participants were assigned to FFRangio-guided assessment or conventional invasive pressure-wire testing to determine the need for percutaneous coronary intervention.

The primary endpoint was a one-year composite of all-cause death, myocardial infarction, or any unplanned revascularization. Event rates were similar between groups, occurring in 6.9% of patients with FFRangio versus 7.1% with wire-based assessment. The software-based strategy was also faster to perform in the catheterization laboratory and avoided additional steps such as introducing pressure wires or administering vasodilator medication.

The study was not blinded, and patients with prior coronary artery bypass grafting or those who might require surgery were excluded. The investigators plan follow-up analyses to assess potential cost differences between FFRangio and conventional wire-based testing. The trial results were presented at ACC.26 and published in the New England Journal of Medicine.

“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, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons, interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center, and director of Columbia Interventional Cardiovascular Care.

“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,” added Dr. Kirtane.

Related Links
Columbia University Vagelos College of Physicians and Surgeons
NewYork-Presbyterian/Columbia University Irving Medical Center
CathWorks