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Observational Study
. 2022 Apr 22;17(18):1498-1505.
doi: 10.4244/EIJ-D-21-00471.

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study

Kaneshka Masdjedi  1 , Nobuhiro Tanaka  2 , Eric Van Belle  3 , Sina Porouchani  3 , Axel Linke  4   5 , Felix J Woitek  4 , Antonio L Bartorelli  6 , Ziad A Ali  7   8 , Wijnand K den Dekker  1 , Jeroen Wilschut  1 , Roberto Diletti  1 , Felix Zijlstra  1 , Eric Boersma  1 , Nicolas M Van Mieghem  1 , Ernest Spitzer  9 , Joost Daemen  1
Affiliations
Observational Study

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study

Kaneshka Masdjedi et al. EuroIntervention. .

Abstract

Background: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues.

Aims: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80).

Methods: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR.

Results: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (area under the curve [AUC] 0.93; 95% confidence interval [CI]: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively.

Conclusions: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.

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Conflict of interest statement

Z. Ali received grants from Abbott Vascular, Cardiovascular Systems Inc., personal fees from Amgen, AstraZeneca and Boston Scientific, and equity from Shockwave Medical, outside the submitted work. N. Van Mieghem received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, Abiomed, Daiichi Sankyo, and Pie Medical. J. Daemen received institutional grant/research support from AstraZeneca, Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, MicroPort, Pie Medical, and ReCor Medical. N. Tanaka serves as a consultant for Abbott Medical Japan, Kaneka Medix, and Boston Scientific Japan. The other authors have no conflicts of interest to declare.

Figures

Central Illustration
Central Illustration. Vessel FFR calculation and the diagnostic performance of vFFR.
NPV: negative predictive value; PPV: positive predictive value; vFFR core lab: vFFR calculated by independent core lab; vFFR site: vFFR calculated by participating centres.
Figure 1
Figure 1. Three-dimensional reconstruction of coronary artery and computation of vFFR, using two angiographic projections at least 30° apart and invasively measured aortic root pressure.
CRA: cranial; LAO: left anterior oblique; RAO: right anterior oblique; vFFR: vessel fractional flow reserve
Figure 2
Figure 2. Flow chart of all included and excluded patients.
FFR: fractional flow reserve; vFFR: vessel fractional flow reserve
Figure 3
Figure 3. ROC for core lab vFFR, site vFFR and 3D-QCA.
ROC for core lab vFFR, site vFFR and 3D-QCA. Comparison is made with a pressure wire-based FFR at a cut point of 0.80. AUC: area under the curve; DS: diameter stenosis; ROC: receiver operating characteristic; 3D-QCA: three-dimensional quantitative coronary angiography; vFFR: vessel fractional flow reserve
Figure 4
Figure 4. Scatter plots showing the relationship between core lab vFFR vs pressure wire-based FFR and Bland-Altman plots of differences against the means.
The mean bias is represented by the dashed grey line and the 95% confidence interval is represented by the dashed red lines. Grey dots represent true positive and true negative vFFR while red dots represent false positive and false negative vFFR.
Figure 5
Figure 5. Scatter plots showing the relationship between site vFFR vs pressure wire-based FFR and Bland-Altman plots of differences against the means.
The mean bias is represented by the dashed grey line and the 95% confidence interval is represented by the dashed red lines. Grey dots represent true positive and true negative vFFR while red dots represent false positive and false negative vFFR.
See this image and copyright information in PMC

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