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Diagnostic Performance of FFRangio
Study Questions:
What is the diagnostic performance of FFRangio, an angiogram-derived fractional flow reserve (FFR) technology?
Methods:
The investigators performed an analysis of pooled patient- and lesion-level data from five prospective cohort studies that examined the diagnostic performance of FFRangio (CathWorks, Kfar-Saba, Israel), compared to the reference standard wire-based FFR. The primary endpoint was diagnostic performance (sensitivity, specificity, and diagnostic accuracy) of the dichotomously scored FFRangio per lesion as compared with FFR; values ≤0.80 were categorized as “positive” and values >0.8 as “negative” physiologic assessments. The discrimination ability of FFRangio as a binary variable to detect a “positive” lesion was plotted using the receiver operating characteristic curve and expressed using the C-statistic.
Results:
A total of 700 lesions from 588 patients were analyzed. Mean age was 65 years, 71% were male, and 40% presented with acute coronary syndromes (ACS). Mean FFR and FFRangio were 0.81 ± 0.12 and 0.81 ± 0.11, with 31.6% and 31.4% of lesions in the 0.75–0.85 range, respectively. When using a binary cut-off FFR value of 0.80, FFRangio showed a sensitivity of 91%, a specificity of 94%, and a diagnostic accuracy of 93%. The mean difference between FFR and FFRangio was 0.0 (95% confidence interval, ± 0.12). The correlation coefficient between FFR and FFRangio was 0.83 (p < 0.001). The C-statistic for FFRangio was 0.95 (p < 0.001). The accuracy of FFRangio was consistent across all subgroups examined.
Conclusions:
The authors concluded that FFRangio showed excellent diagnostic performance, which was robust and consistent across all patient and lesion subgroups.
Perspective:
This study reports that when compared with traditional FFR (as the reference standard for physiologic assessment of coronary lesions), FFRangio showed excellent diagnostic performance, strong correlation with and minimal difference from FFR, as well as excellent discrimination ability for identifying physiologically significant coronary lesions. These results were robust across a wide spectrum of patient and lesion characteristics. Given multiple limitations of the current analysis including modest sample size, patients with mostly single-vessel disease, selected patient population, and lack of assess microcirculatory dysfunction, additional studies are indicated to validate these results and explore the potential of FFRangio utilization to improve the implementation of functional assessment of coronary lesions in routine clinical practice.
Clinical Topics: Acute Coronary Syndromes, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Acute Coronary Syndrome, Angiography, Diagnostic Imaging, Fractional Flow Reserve, Myocardial, Geriatrics, Microcirculation, Myocardial Ischemia, Physiology, Secondary Prevention, Sensitivity and Specificity
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