A large international randomized trial presented at the American College of Cardiology's Annual Scientific Session (ACC.26) on Mar. 29 found that a computer software-based method using artificial intelligence to assess blood flow in coronary arteries performed similarly to the standard, more invasive wire-based procedure.
This finding is significant because it could lead to wider adoption of less invasive techniques for assessing coronary artery disease, potentially reducing procedural risks and time for patients undergoing evaluation for blocked heart arteries.
"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 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."
The ALL-RISE trial enrolled 1,930 patients across five countries who were randomly assigned either FFRangio or conventional wire-based pressure measurements to guide decisions about percutaneous coronary intervention (PCI). The study found comparable outcomes between groups: 6.9% in the FFRangio group experienced major events such as death or heart attack within one year versus 7.1% in the wire-assessment group. Kirtane said FFRangio was also faster and avoided extra steps like inserting additional wires or administering medication.
Kirtane noted some limitations: "A limitation of the study is that it was not blinded, meaning patients, doctors and independent assessors all knew whether patients had received FFRangio or wire-based assessments." He added that further research is needed for patients with prior bypass surgery.
As a next step, researchers plan to analyze potential cost savings from using FFRangio over traditional methods based on these results. The study was funded by CathWorks Ltd., developer of FFRangio; Dr. Kirtane reported institutional funding from CathWorks and Medtronic.
