ALL-RISE
CathWorks FFRangio vs Invasive Pressure Wire-Based Physiology Assessment for Coronary Revascularization Guidance
Published in NEJM
Key Result
FFRangio (AI-based angiography-derived FFR) was noninferior to invasive pressure wire for guiding PCI: 1-year MACE 6.9% vs 7.1% (HR 0.98, noninferiority p=0.0008). First FDA-approved angiography-derived physiology trial in the US.
What did this trial find?
The ALL-RISE trial randomized 1,930 patients across 59 global sites to FFRangio (AI-based angiography-derived FFR) vs invasive pressure wire for guiding PCI decisions, finding noninferiority for 1-year MACE (6.9% vs 7.1%, HR 0.98, p=0.0008). FFRangio also demonstrated shorter procedure times, less contrast use, and reduced radiation exposure. This was the first US randomized controlled trial of an FDA-approved angiography-derived physiology solution. Coverage is largely straightforward and positive, with an accompanying NEJM editorial framing the broader implications for shifting away from anatomy-only assessment.
Why does this trial matter?
Mostly straightforward, positive coverage. The trial clearly met its noninferiority endpoint with procedural efficiency advantages. No meaningful controversy or debate emerged — author quotes are enthusiastic, the NEJM editorial is supportive, and no critical outside voices were found in the source material. The open-label design and exclusion of prior CABG patients were noted as limitations but not contested.
Study Design
Multinational, randomized, controlled trial across 59 sites
Clinical Implications
FFRangio offers a less invasive alternative to pressure wire-based FFR with similar outcomes, shorter procedures, less radiation, and reduced contrast use. May enable broader adoption of physiology-guided PCI decision-making.
Abstract
The ALL-RISE trial randomized 1,930 patients across 59 global sites to either FFRangio-guided assessment (angiography-derived FFR using AI, n=965) or conventional pressure wire-based assessment including FFR or NHPR (n=965). The primary composite endpoint of death, MI, or unplanned clinically indicated revascularization at 1 year was 6.9% in the FFRangio group vs 7.1% in the pressure wire group (HR 0.98, 95% CI 0.70-1.39, noninferiority p=0.0008). Both groups showed similar safety profiles. The FFRangio group demonstrated shorter assessment and procedure times, reduced radiation exposure, and less contrast medium use.