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.
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.
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.).
“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.”
Fearon et al. (Sun,) conducted a 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.