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Anonymous Comparison of Various Angiography-Derived Fractional Flow Reserve Software With Pressure-Derived Physiological Assessment

https://doi.org/10.1016/j.jcin.2023.04.026Get rights and content

Abstract

Background

Software to compute angiography-derived fractional flow reserve (angio-FFR) have been validated against pressure wire–derived fractional flow reserve (PW-FFR) with an area under the receiver-operating characteristic curve (AUC) of 0.93 to 0.97.

Objectives

The aim of this study was to investigate diagnostic accuracies of 5 angio-FFR software/methods by an independent core lab in a prospective cohort of 390 vessels with carefully documented sites of PW-FFR and pressure wire–derived instantaneous wave-free ratio.

Methods

One “matcher investigator” colocalized on angiography the sites of pressure wire measurement with angio-FFR measurements and provided the same 2 optimal angiographic views and frame selection to independent analysts who were blinded to invasive physiological results and results from other software. The results were anonymized and randomly presented. The AUC of each angio-FFR was compared with 2-dimensional quantitative coronary angiography (QCA) percent diameter stenosis (%DS) using a 2-tailed paired comparison of AUC.

Results

All 5 software/methods yielded a high proportion of analyzable vessels (A: 100%, B: 100%, C: 92.1%, D: 99.5%, and E: 92.1%). The AUCs for predicting fractional flow reserve ≤0.8 for software A, B, C, D, E, and 2-dimensional QCA %DS were 0.75, 0.74, 0.74, 0.73, 0.73, and 0.65, respectively. The AUC for each angio-FFR was significantly greater than that for 2-dimensional QCA %DS.

Conclusions

This head-to-head comparison by an independent core lab demonstrated that the diagnostic accuracy of various angio-FFR software for predicting PW-FFR ≤0.80 was useful, with a higher discrimination compared with 2-dimensional QCA %DS; however, it did not reach the diagnostic accuracy previously reported in validation studies of various vendors. Therefore, the intrinsic clinical value of “angiography-derived fractional flow reserve” requires confirmation in large clinical trials.

Section snippets

Patient selection

This study is a centralized off-line analysis by an independent academic core laboratory (CORRIB Corelab, University of Galway) of a prospective cohort of 444 vessels with both PW-iFR and PW-FFR measurements (NCT03857503).

The study population consisted of patients presenting with chronic coronary syndrome and having at least 1 epicardial coronary artery lesion with a 40% to 90% diameter stenosis by visual assessment on invasive coronary angiography. The angiographic exclusion criteria are

Study Population

The study enrolled 355 patients with 444 target vessels, 390 (87.8%) of which met the criteria for optimum quality (no table movement, optimal contrast filling, and separated angulation by 30° of the 2 angiographic views with minimal overlap/foreshortening), and their angiographies were provided to each analyst by the independent MI (Figure 1).

Patient and vessel characteristics are shown in Tables 1 and 2. The mean age of the patients was 68 ± 10 years, and 70% were men. The vessels included

Discussion

As illustrated in the Central Illustration, the main findings of our study are as follows:

  • 1.

    All 5 angio-FFR software/methods had good feasibility and comparable diagnostic accuracies.

  • 2.

    The diagnostic accuracy of angio-FFR software for predicting PW-FFR ≤0.80 was useful, with a higher discrimination compared with 2-dimensional QCA; however, it did not reach the diagnostic accuracy (AUC ≥0.9) reported in validation studies from the various vendors.6, 7, 8, 9

  • 3.

    Although angio-FFR is more reliable than

Conclusions

All 5 software/methods of angio-FFR tested in this blinded independent core lab analysis failed to achieve the previously reported high diagnostic performances achieved in validation trials when using PW-iFR/FFR as the reference standard. Therefore, further large studies are warranted to validate the intrinsic clinical value of angio-FFR.

WHAT IS KNOWN? Software to compute angiography-derived FFR have been validated in clinical trials against PW-derived FFR with an AUC of 0.93 to 0.97. However,

Funding Support and Author Disclosures

Dr Serruys has received institutional grants from Sinomedical Sciences Technology, SMT (Sahajanand Medical Technologies), Philips/Volcano, Xeltis, and HeartFlow outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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    The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.

    Drs Ninomiya and Serruys contributed equally to this work.

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