The ALL-RISE trial was a large-scale, international, randomized, non-inferiority study designed to evaluate whether CathWorks FFRangio (an angiography-derived fractional flow reserve tool) performs as well as conventional pressure wire-based physiology (FFR/NHPR) in patients with coronary artery disease (CAD) being considered for percutaneous coronary intervention (PCI). The trial randomized 1,930 patients across 59 global sites in a 1:1 ratio to either the FFRangio group or the traditional pressure wire group.
Key Findings
Presented at ACC.26 and published in the New England Journal of Medicine, the trial results demonstrated that the AI-supported FFRangio software provided similar clinical outcomes to the gold-standard wire-based testing:
- Primary Endpoint: At one year, the composite primary endpoint of death, myocardial infarction, or unplanned clinically indicated revascularization occurred in 6.9% of the FFRangio group compared to 7.1% in the pressure wire group. This met the criteria for non-inferiority (hazard ratio, 0.98; p<0.001).
- Safety Profile: Both groups showed a similar safety profile, with no apparent differences in bleeding, acute kidney injury, or procedure-related adverse events.
- Resource Utilization: The FFRangio approach proved to be faster (39 vs. 42 minutes) and required less fluoroscopy exposure and contrast material than the pressure wire approach.
- Procedural Steps: FFRangio avoided the additional procedural steps required for wire-based testing, such as anticoagulation, guiding catheter engagement, and zeroing/equalizing the pressure system.
By eliminating the need for invasive pressure wires and drug administration (like adenosine), FFRangio streamlines the assessment process. The investigators hope that this simplified, wire-free approach will increase the adoption of coronary physiologic testing, which has historically been hindered by the cumbersome workflow of wire-based methods.