Comparison of vessel fractional flow reserve with invasive resting full-cycle ratio in patients with intermediate coronary lesions

https://doi.org/10.1016/j.ijcard.2023.01.062Get rights and content

Highlights

  • vFFR has a high diagnostic accuracy with invasive RFR to identify functional significance of coronary stenoses.

  • The good diagnostic performance of vFFR was maintained among subgroups of patients with diabetes, severe aortic stenosis, female gender and lesions located in the left anterior descending artery.

  • vFFR is a promising novel non-invasive tool that may be used in a broad range of clinical settings.

Abstract

Background

Vessel fractional flow reserve (vFFR) is a novel angiography-derived index for the assessment of myocardial ischemia without the need for pressure wires and hyperemic agents. vFFR has demonstrated very good diagnostic performance compared with the hyperemic index fractional flow reserve (FFR). The aim of this study was to compare vFFR to the non-hyperemic pressure ratio resting full-cycle ratio (RFR).

Methods

This was a retrospective, observational, single-center study of an all-comer cohort undergoing RFR assessment. Invasive coronary angiography was obtained without a dedicated vFFR acquisition protocol, and vFFR calculation was attempted in all vessels interrogated by RFR (1483 lesions of 1030 patients).

Results

vFFR could be analyzed in 986 lesions from 705 patients. Median diameter stenosis was 37% (interquartile range (IQR): 30.0–44.0%), vFFR 0.86 (IQR: 0.81–0.91) and RFR 0.94 (IQR: (0.90–0.97). The correlation between vFFR and RFR was strong (r = 0.70, 95% confidence interval (CI): 0.66–0.74, p < 0.001). Using RFR ≤0.89 as reference, the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy for vFFR were 77%, 93%, 77%, and 92% and 89%. vFFR yielded a high area under the curve (AUC) of 0.92 (95% CI: 0.90–0.94). The good diagnostic performance of vFFR was confirmed among subgroups of patients with diabetes, severe aortic stenosis, female gender and lesions located in the left anterior descending artery.

Conclusion

vFFR has a high diagnostic performance taking RFR as the reference standard for evaluating the functional significance of coronary stenoses.

Introduction

Guiding revascularization of intermediate coronary stenoses by invasive physiological assessment using pressure-wires is supported by numerous trials [[1], [2], [3], [4]] and recommended by current guidelines [5,6]. Fractional flow reserve (FFR), which requires application of adenosine to induce hyperemia, was first introduced for clinical use >20 years ago and is still considered as reference standard. About a decade ago, instantaneous wave-free ratio (iFR) was proposed as a non-hyperemic pressure ratio (NHPR) calculated during the wave-free period of diastole [7], which facilitated pressure wire recordings, since adenosine application was not necessary. In two large scale randomized trials, iFR-guided revascularization showed a similar clinical outcome as an FFR-guided approach among patients with chronic or acute coronary syndromes [8,9]. More recently, due to the copyright protection of iFR, further NHPRs were established, including the resting full-cycle ratio (RFR), which assesses both systole and diastole [10]. Although NHPRs are increasingly used in clinical practice and have improved the adoption rate of pressure wire recordings, they still require additional invasive steps after diagnostic angiography and are expensive, resulting in a still insufficient adoption rate.

Thus, there is a demand for further facilitating physiological assessment of stenosis severity, which could be fulfilled by new software-based, wire-free methods assessing FFR from 3-dimensional quantitative coronary angiography (3D-QCA). Vessel fractional flow reserve (vFFR) emerged as a promising software, which demonstrated a superior diagnostic performance over a conventional angiography-based approach and a good agreement with the hyperemic FFR for predicting ischemia [[11], [12], [13]]. Evidence regarding the agreement and diagnostic performance of vFFR vs. NHPRs in the functional assessment of intermediate coronary stenoses is scant [14,15]. Since NHPRs have become the first choice for assessment of lesion severity in many cath labs, the purpose of this study was to evaluate the diagnostic performance of vFFR compared to RFR in a large European all-comers cohort.

Section snippets

Patient population

The study included patients with a pressure wire assessment of intermediate coronary stenoses (diameter stenosis 30–80%) as part of the routine clinical work-up at our center over a period of 4 years until June 2022. No patients were excluded from the analysis based on baseline or procedural characteristics, except for insufficient quality of recorded traces impeding a reliable retrospective analysis. Pressure wire recordings were not performed in patients with contraindication for adenosine,

Baseline characteristics of patients

705 patients with 986 lesions were included in the final analysis. Median age was 72 (IQR: 62, 79) years, 29.2% were females, and 80.4% presented with a chronic coronary syndrome. As typical for coronary artery disease patients, the cohort had a high incidence of cardiovascular risk factors, including hypertension, former or current smoking and diabetes mellitus (Table 1).

Vessel characteristics

The analyzed vessels had a reference diameter of 2.65 (IQR: 2.31, 3.06) mm and a lesion length of 11.8 (IQR: 8.4, 17.6) mm.

Discussion

The present study evaluated the diagnostic performance of the software-based, wire-free vFFR compared to the invasively measured RFR in an all comers cohort. vFFR showed a strong correlation and agreement with RFR and had a high diagnostic accuracy, which was confirmed in different clinical subsets such as female sex, diabetes, and aortic valve stenosis.

Several pressure-derived physiological indices are available to determine the functional significance of coronary stenoses [1,7,10]. FFR is

Conclusion

vFFR yielded a good diagnostic performance and correlation with RFR in this large retrospective cohort study. The diagnostic performance remained good among the subgroups of patients with diabetes, severe aortic stenosis, female gender and lesions located in the LAD. These results encourage the broad use of vFFR for assessment of coronary physiology without the need for additional invasive steps after diagnostic angiography.

Declaration of Competing Interest

Prof. Baldus and Prof. Halbach received institutional grant support and speakers' honoraria from Abbott Vascular. Dr. Wienemann received institutional grant support from Abbott Vascular. Abbott Vascular and Pie Medical had no influence on the design of the study, data analysis or interpretation of findings. The other authors have no conflicts of interest to declare.

Acknowledgment

The software for vFFR calculation was provided free of charge by Pie Medical.

References (41)

  • S. Tu et al.

    Diagnostic accuracy of fast computational approaches to derive fractional flow reserve from diagnostic coronary angiography: the international multicenter FAVOR pilot study

    JACC Cardiovasc. Interv.

    (2016)
  • H. Wienemann et al.

    Diagnostic performance of quantitative flow ratio versus fractional flow reserve and resting full-cycle ratio in intermediate coronary lesions

    Int. J. Cardiol.

    (2022)
  • P. Ely Pizzato et al.

    Feasibility of coronary angiogram-derived vessel fractional flow reserve in the setting of standard of care percutaneous coronary intervention and its correlation with invasive FFR

    Int. J. Cardiol.

    (2020)
  • Y. Kobayashi et al.

    Effect of sex differences on invasive measures of coronary microvascular dysfunction in patients with angina in the absence of obstructive coronary artery disease

    JACC Cardiovasc. Interv.

    (2015)
  • C.H. Kim et al.

    Sex differences in instantaneous wave-free ratio or fractional flow reserve-guided revascularization strategy

    JACC Cardiovasc. Interv.

    (2019)
  • Y. Kobayashi et al.

    The influence of lesion location on the diagnostic accuracy of adenosine-free coronary pressure wire measurements

    JACC Cardiovasc. Interv.

    (2016)
  • F. Ledru et al.

    New diagnostic criteria for diabetes and coronary artery disease: insights from an angiographic study

    J. Am. Coll. Cardiol.

    (2001)
  • Z. Jin et al.

    Coronary intervention guided by quantitative flow ratio vs angiography in patients with or without diabetes

    J. Am. Coll. Cardiol.

    (2022)
  • P. Xaplanteris et al.

    Five-year outcomes with PCI guided by fractional flow reserve

    N. Engl. J. Med.

    (2018)
  • P.A.L. Tonino et al.

    Fractional flow reserve versus angiography for guiding percutaneous coronary intervention, N

    Engl. J. Med.

    (2009)
  • 1

    Philipp Lake and Marcel Halbach contributed equally and share the first authorship of this work.

    View full text