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.
Why the trial?
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?
RCT
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?
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.
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Experts read ALL-RISE as a positive, practice-relevant result that could make physiology-guided PCI decisions easier by replacing the pressure wire with an AI-based angiography tool, though questions remain about whether this will translate into broader adoption beyond current wire users.
Cardiologists and editorialists view the noninferiority finding favorably, framing it less as a head-to-head contest with the pressure wire and more as a way to lower the barrier to routine physiologic assessment in the cath lab. Several voices stress that the real opportunity is shifting practice away from anatomy-alone decision-making. The open question is whether the simpler workflow will actually drive wider uptake of physiology-guided revascularization as guidelines recommend.
Multiple experts converge on the idea that FFRangio matching the pressure wire on outcomes should encourage broader adoption of physiology-guided decision-making in the cath lab, moving practice away from anatomy-alone assessment.
Whether the faster, wire-free workflow will actually increase real-world adoption of physiologic testing remains unproven. Experts have not addressed how FFRangio performs in complex lesion subsets or whether longer-term outcomes beyond one year will hold. It is also unclear how this result will interact with guideline updates and reimbursement decisions.
Chatzizisis describes the result as meaningful support for a less-invasive, physiology-guided strategy that may simplify decision-making for the majority of patients with stable or unstable intermediate coronary lesions in an AI-driven era.
Kirtane highlights that the software-based tool delivered similar one-year outcomes to the invasive wire-based gold standard. He frames the key practical benefit as removing the need for further coronary manipulation beyond a routine angiogram, which he hopes will increase adoption of physiologic testing as current guidelines recommend.
Fearon emphasizes the workflow advantage: because every patient already undergoes angiography, FFRangio simply uses that existing information to calculate FFR with minimal added time. He notes this was significantly faster than pressure wire measurement in the study and expects the time to shrink further with experience.
Supports wire-free FFRangio adoption in cath labs now; confirms reliable alternative to pressure-wire guidance in RCT.
BACKGROUND: Assessing intermediate coronary lesions with an intracoronary pressure wire improves clinical outcomes in patients undergoing cardiac catheterization and percutaneous coronary intervention (PCI). However, clinical use of pressure-wire-based physiological assessment remains low. Measurement of fractional flow reserve (FFR) derived from coronary angiographic images alone correlates well with pressure-wire-based FFR measurements and may simplify procedures, but its effect on clinical outcomes is unknown. METHODS: In this international noninferiority trial, we randomly assigned patients undergoing coronary angiography who were found to have at least one intermediate coronary stenosis to physiological assessment with measurements derived from angiographic images (FFRangio) or with pressure-wire-based measurements. The primary end point was a composite of death, myocardial infarction, or unplanned, clinically indicated coronary revascularization at 1 year. The noninferiority margin was 3.5 percentage points. RESULTS: A total of 1930 patients were randomly assigned to physiological assessment with FFRangio (FFRangio group; 965 patients) or a pressure-wire-based approach (pressure-wire group; 965 patients). The mean age of the patients was 68.4 years, and 25.0% of the patients were women. At 1 year, a primary end-point event had occurred in 64 patients (Kaplan-Meier estimate, 6.9%) in the FFRangio group and 65 patients (Kaplan-Meier estimate, 7.1%) in the pressure-wire group (hazard ratio, 0.98; 95% confidence interval, 0.70 to 1.39; difference, -0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.1 percentage points; P<0.001 for noninferiority). There were no apparent differences between the groups with respect to the incidence of bleeding, acute kidney injury, or procedure-related adverse events. CONCLUSIONS: Among patients with intermediate coronary-artery lesions undergoing physiological assessment in the cardiac catheterization laboratory, an angiography-guided strategy involving FFRangio was noninferior to a pressure-wire-guided strategy with respect to a composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 year. (Funded by CathWorks; ALL-RISE ClinicalTrials.gov number, NCT05893498.).
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Fearon et al. (2026) conducted an RCT in Intermediate coronary-artery lesions. Angiography-guided strategy involving FFRangio vs. Pressure-wire-guided strategy was evaluated on Composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 year. 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.
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