Global Clinical Trial Confirms AI Software Evaluates Heart Blockages as Effectively as Invasive Pressure Wires

Global ALL-RISE trial shows FFRangio AI software assesses coronary blood flow as accurately as invasive wires, reducing procedural time and patient risk.

By: AXL Media

Published: Mar 30, 2026, 4:07 AM EDT

Source: Information for this report was sourced from American College of Cardiology

A New Era of Artificial Intelligence in the Cardiac Catheterization Lab

The process of diagnosing coronary artery disease is undergoing a digital transformation that favors software over physical instrumentation. According to Ajay J. Kirtane, a professor of medicine at Columbia University, the ALL-RISE trial has successfully validated a novel artificial intelligence tool called FFRangio. This software-based approach allows interventional cardiologists to determine if a plaque is truly restricting blood flow without the traditional requirement of threading a pressure wire through the patient's arteries. By matching the clinical performance of more invasive methods, this technology aims to increase the adoption of physiological testing, ensuring that stents are only placed in patients who will genuinely benefit from the intervention.

Overcoming the Technical Hurdles of Conventional Physiological Testing

While treatment guidelines strongly recommend using pressure-based tests to guide stenting decisions, clinical usage has historically remained low. Traditional wire-based testing is often viewed as a burden due to the additional procedural time, the cost of specialized wires, and the necessity of administering drugs to simulate heart stress. The FFRangio system bypasses these obstacles by applying sophisticated AI modeling to the images already generated during a routine coronary angiogram. This effectively removes the need for further coronary manipulation, offering a streamlined workflow that provides critical data without the risks and delays associated with internal sensors and pharmaceutical stimulants.

Analyzing Parity in the ALL-RISE Global Randomized Trial

The scale of the ALL-RISE trial provides a robust foundation for the software's clinical standing, involving 1,930 patients across the United States, Japan, Israel, and Europe. After one year of follow-up, the primary composite endpoint—which tracks death, heart attacks, and unplanned procedures—occurred in 6.9% of the AI-guided group compared to 7.1% in the traditional wire-based group. This statistical equivalence proves that the AI model is a reliable surrogate for physical pressure measurements. The study included a high-risk population, with many participants suffering from diabetes, hypertension, and previous cardiac events, further demonstrating the tool's versatility in complex real-world...