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FFRangio is noninferior to pressure-wire measurements for intermediate coronary stenosis at 1 yearTrial shows imaging technology matches wire measurements for heart disease

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Key Takeaway
Note that FFRangio is noninferior to pressure-wire for assessing intermediate coronary lesions at 1 year.

This randomized controlled trial evaluated the noninferiority of FFRangio, a physiological assessment using measurements derived from angiographic images, compared to traditional pressure-wire based measurements. The study was conducted in a cardiac catheterization laboratory setting and included 1930 patients undergoing coronary angiography with at least one intermediate coronary stenosis.

The primary objective was to determine if FFRangio could provide equivalent clinical outcomes to the gold standard of pressure-wire measurement for managing intermediate lesions. Patients were randomized to receive either physiological assessment via FFRangio or traditional pressure-wire measurements to guide clinical decision making during the procedure.

The primary outcome was a composite of death, myocardial infarction, or unplanned, clinically indicated coronary revascularization at 1 year. In the FFRangio group, 64 patients reached the endpoint (6.9%), while in the pressure-wire group, 65 patients reached the endpoint (7.1%). The calculated difference was -0.2 percentage points. The hazard ratio was 0.98 with a 95% confidence interval of 0.70 to 1.39. The upper boundary of the one-sided 97.5% confidence interval was 2.1 percentage points, and the p-value for noninferiority was less than 0.001.

Secondary outcomes included assessments of bleeding, acute kidney injury, and procedure-related adverse events. The study reported no apparent differences between the FFRangio and pressure-wire groups regarding these safety metrics. No data were provided for serious adverse events or treatment discontinuations.

These results provide evidence that FFRangio may offer a comparable clinical pathway to invasive pressure-wire measurements in patients with intermediate coronary stenosis. While pressure-wire remains a standard, the noninferiority of FFRangio suggests it could potentially streamline procedures while maintaining safety and efficacy for revascularization decisions.

Methodological considerations include the specific focus on noninferiority rather than superiority. The study was funded by CathWorks (NCT05893498). While the sample size of 1930 is robust, the results are specifically tied to the assessment of intermediate coronary lesions. Clinical implications suggest that FFRangio may be a viable alternative for clinicians seeking to avoid wire-based measurements where appropriate.

Questions remain regarding the long-term durability of these findings and how FFRangio performs in complex multi-vessel disease compared to pressure-wire. Further data on specific procedure-related complications beyond the primary safety metrics would provide more granular detail on the nuances of each technique.

How this fits prior evidence

How this fits prior evidence This finding addresses a gap in noninvasive or image-based physiological assessment tools for coronary artery disease. While previous coverage noted that extended DAPT with clopidogrel and aspirin reduces cardiovascular death, myocardial infarction, and stroke risk, this study specifically focuses on the intraprocedural selection of revascularization using FFRangio versus pressure-wire.

People living with coronary artery disease often need medical procedures to improve blood flow to the heart. During these procedures, doctors must decide how to treat specific areas where arteries are narrowed. Traditionally, they have used a physical wire to measure pressure and flow directly inside the vessel. This method is accurate but can be more invasive for the patient. New research looks at whether an imaging-based tool can provide the same reliable information without the need for a physical wire.

The study involved 1,930 patients who were undergoing coronary angiography. These patients had at least one area of intermediate narrowing in their heart arteries. The researchers divided the patients into two groups. One group received measurements based on an imaging tool called FFRangio, which uses data from angiographic images. The other group received the standard treatment using a pressure-wire to measure blood flow.

The primary goal was to see if the imaging tool was just as safe and effective as the traditional wire method over a one-year period. Researchers looked for serious events such as death, heart attacks, or the need for unplanned surgery. The results showed that 6.9 percent of patients in the imaging group experienced these issues, compared to 7.1 percent in the wire group. This tiny difference shows that the imaging tool performed just as well as the traditional method.

Safety was also a key focus of the study. Researchers monitored patients for complications like bleeding or kidney problems caused by the procedure. The results showed no significant differences between the two groups regarding these safety concerns. Both methods appeared to be well-tolerated by the patients during and after the procedure.

It is important to note that this was a noninferiority trial. This means the study was specifically designed to see if the new imaging tool was at least as good as the current standard, rather than proving it was better. While the results are encouraging for the use of imaging technology, this single study does not change immediate clinical practice on its own. It provides evidence that a less invasive method may be a viable option.

For patients today, this means that new technologies are making heart procedures potentially less invasive. While your doctor will continue to use the methods they find best for your specific case, these findings suggest that imaging tools can provide reliable data for treating narrowed heart arteries.

What this means for you:
An imaging tool showed results similar to traditional wire measurements for evaluating heart artery blockages.

Study Details

Study typeRct
Sample sizen = 1,930
EvidenceLevel 2
Follow-up12.0 mo
PublishedJul 2026
View Original Abstract ↓
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.).
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