Coronary physiological assessment using pressure-wire techniques (FFR/iFR) carries a Class IA recommendation in ACC/AHA guidelines; however, its use remains limited due to factors such as longer procedural time, cost, technical complexity, and the need for intracoronary instrumentation. In this context, the FFRangio system emerges as an angiography-based alternative that, through artificial intelligence and three-dimensional reconstruction, allows estimation of coronary physiology without the need for a pressure wire. The ALL-RISE trial was designed to evaluate whether an FFRangio-guided strategy is comparable to conventional physiological assessment in patients with intermediate coronary lesions undergoing evaluation for revascularization.
This was a prospective, randomized, international multicenter non-inferiority clinical trial that included 1,924 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome (CAD/NSTE-ACS), presenting angiographic lesions of 50–90% suitable for physiological assessment. Patients were randomized 1:1 to an FFRangio-guided strategy or conventional pressure-wire guidance (FFR ≤0.80 or non-hyperemic indices ≤0.89). In both groups, decisions regarding PCI or deferral were based on physiological results. The analyzed population included 965 patients per group.
The primary endpoint was a composite of major adverse cardiovascular events (MACE) at one year (all-cause death, myocardial infarction, or clinically driven unplanned revascularization). Secondary endpoints included individual components and safety outcomes such as major bleeding and acute kidney injury.
At one year, the primary endpoint occurred in 6.9% of the FFRangio group versus 7.1% in the pressure-wire group (p for non-inferiority = 0.0008), meeting the non-inferiority criterion. Individual events were low and comparable between groups, with no significant differences. In terms of safety, major bleeding (BARC 3–5) was lower with FFRangio (0.7% vs. 1.5%), while the incidence of acute kidney injury was nearly negligible.
FFRangio in clinical practice: a safe and effective angiography-based alternative to pressure-wire guidance
In conclusion, the ALL-RISE trial demonstrates that an FFRangio-guided strategy is non-inferior to conventional pressure-wire physiological assessment in terms of one-year clinical outcomes in patients with intermediate coronary lesions. These results position FFRangio as a valid alternative with potential operational advantages, although without evidence of clinical superiority over the current standard.
Original Title: Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment: The ALL-RISE Randomized Trial.
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