What is the clinical evidence from this study?

Study design: RCT. Population: Intermediate coronary-artery lesions. Intervention: Angiography-guided strategy involving FFRangio vs. Pressure-wire-guided strategy. Primary outcome: Composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 year.

What does this research mean for the field?

An angiography-guided strategy involving FFRangio is noninferior to a pressure-wire-guided strategy for a composite of death, myocardial infarction, or unplanned revascularization at 1 year in patients with intermediate coronary-artery lesions. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This research aims to evaluate whether angiography-derived fractional flow reserve (FFRangio) is as effective as pressure-wire guidance for coronary interventions.

ALL-RISENew England Journal of MedicineAll Hot Line trials →

Angiography-Derived Fractional Flow Reserve in PCI Guidance

View Full Paper

WFWilliam F. Fearon

Allen Jeremias GWGuy Witberg

Overview

Supports wire-free FFRangio adoption in cath labs now; confirms reliable alternative to pressure-wire guidance in RCT.

Key result

An angiography-guided strategy involving FFRangio was noninferior to a pressure-wire-guided strategy for a composite of death, MI, or unplanned revascularization at 1 year.

Discussion

ALL-RISE has reported — post the first read.

Expert takes

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.

Yiannis S. Chatzizisis

Director, Center for Digital Cardiovascular Innovations, University of Miami

“Is the FAST III trial practice-changing? It is definitely an important step toward a new standard of care. In an era dominated by artificial intelligence, the trial provides meaningful support for a less-invasive physiology-guided strategy that may simplify decision making in treating the majority of patients with stable or unstable intermediate coronary lesions.”

Ajay J. Kirtane

Interventional cardiologist, Columbia University Irving Medical Center

“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. 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.”

NewYork-Presbyterian/Columbia University Irving Medical Center

William Fearon

Director of interventional cardiology, Stanford University

“The key difference is that every time we bring a patient to the cath lab, we have to do an angiogram in order to see what's going on. Since you're already doing that, the FFRangio is basically just using that information to calculate the FFR, and it takes an extra six minutes – I think that could be even quicker as people get more familiar with the system. But either way, that was significantly less time than it took to do a pressure wire measurement in the study.”

Stanford University

Gianluca Campo

Cardiologist, accompanying NEJM editorialist

“The broader implication is not a comparison between angiography-derived and wire-based testing but a shift away from reliance on anatomy alone. Angiography-derived FFR may serve as an integrated, first-line physiological assessment during diagnostic imaging, providing an immediate functional estimate to inform revascularization decisions.”

Key Points

This research aims to evaluate whether angiography-derived fractional flow reserve (FFRangio) is as effective as pressure-wire guidance for coronary interventions.
Randomized trial involving patients with intermediate coronary-artery lesions undergoing physiological assessments.
Comparison of outcomes between angiography-guided FFR and pressure-wire-guided strategies.
Follow-up duration of 1 year for assessing composite outcomes.
Angiography-guided strategy (FFRangio) showed noninferior outcomes compared to pressure-wire guidance with regard to death, myocardial infarction, or unplanned coronary revascularization.
No significant differences in the composite endpoint were observed between the two strategies, indicating effective alternative guidance.

Study Design

Type

RCT

Structured PICO

Does an angiography-guided strategy involving FFRangio reduce the composite of death, myocardial infarction, or unplanned clinically indicated coronary revascularization in patients with intermediate coronary-artery lesions compared to a pressure-wire-guided strategy?

Population

Patients with intermediate coronary-artery lesions undergoing physiological assessment in the cardiac catheterization laboratory

Intervention

Angiography-guided strategy involving FFRangio

Comparator

Pressure-wire-guided strategy

Outcome

Composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 yearcomposite

An angiography-guided strategy using FFRangio is noninferior to a pressure-wire-guided strategy for clinical outcomes at 1 year in patients with intermediate coronary lesions.

AIに質問

Bookmark

View Full Paper

AIに質問

Bookmark

View Full Paper

Angiography-Derived Fractional Flow Reserve in PCI Guidance

Discussion

Key Points

Study Design

Structured PICO

Cite This Study