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. 2018 Nov 1;39(41):3701-3711.
doi: 10.1093/eurheartj/ehy530.

Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry

Timothy A Fairbairn  1 , Koen Nieman  2 , Takashi Akasaka  3 , Bjarne L Nørgaard  4 , Daniel S Berman  5 , Gilbert Raff  6 , Lynne M Hurwitz-Koweek  7 , Gianluca Pontone  8 , Tomohiro Kawasaki  9 , Niels Peter Sand  10 , Jesper M Jensen  4 , Tetsuya Amano  11 , Michael Poon  12 , Kristian Øvrehus  10 , Jeroen Sonck  13 , Mark Rabbat  14 , Sarah Mullen  15 , Bernard De Bruyne  16 , Campbell Rogers  15 , Hitoshi Matsuo  17 , Jeroen J Bax  18 , Jonathon Leipsic  19 , Manesh R Patel  7
Affiliations

Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry

Timothy A Fairbairn et al. Eur Heart J. .

Abstract

Aims: Non-invasive assessment of stable chest pain patients is a critical determinant of resource utilization and clinical outcomes. Increasingly coronary computed tomography angiography (CCTA) with selective CCTA-derived fractional flow reserve (FFRCT) is being used. The ADVANCE Registry, is a large prospective examination of using a CCTA and FFRCT diagnostic pathway in real-world settings, with the aim of determining the impact of this pathway on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE).

Methods and results: A total of 5083 patients with symptoms concerning for coronary artery disease (CAD) and atherosclerosis on CCTA were enrolled at 38 international sites from 15 July 2015 to 20 October 2017. Demographics, symptom status, CCTA and FFRCT findings, treatment plans, and 90 days outcomes were recorded. The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management plans occurred in 66.9% [confidence interval (CI): 64.8-67.6] of patients. Non-obstructive coronary disease was significantly lower in ICA patients with FFRCT ≤0.80 (14.4%) compared to patients with FFRCT >0.80 (43.8%, odds ratio 0.19, CI: 0.15-0.25, P < 0.001). In total, 72.3% of subjects undergoing ICA with FFRCT ≤0.80 were revascularized. No death/myocardial infarction (MI) occurred within 90 days in patients with FFRCT >0.80 (n = 1529), whereas 19 (0.6%) MACE [hazard ratio (HR) 19.75, CI: 1.19-326, P = 0.0008] and 14 (0.3%) death/MI (HR 14.68, CI 0.88-246, P = 0.039) occurred in subjects with an FFRCT ≤0.80.

Conclusions: In a large international multicentre population, FFRCT modified treatment recommendation in two-thirds of subjects as compared to CCTA alone, was associated with less negative ICA, predicted revascularization, and identified subjects at low risk of adverse events through 90 days.

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Figures

Figure 1
Figure 1
Degree of coronary artery disease (% stenosis) and coronary computed tomography angiography-derived fractional flow reserve positive/negative ratio stratified by coronary artery territory: (A) left anterior descending; (B) left circumflex, and (C) right coronary artery.
Figure 2
Figure 2
Clinical management strategies and reclassification of post-coronary computed tomography angiography, following coronary computed tomography angiography-derived fractional flow reserve and actual management at 90 days (A Core and B Site).
Figure 3
Figure 3
Actual treatment at 90 days (medical therapy, percutaneous intervention, and coronary bypass grafting) by post-coronary computed tomography angiography-derived fractional flow reserve treatment strategy.
Figure 4
Figure 4
Actual treatment at 90 days (medical therapy, percutaneous intervention, and coronary bypass grafting) stratified by coronary computed tomography angiography-derived fractional flow reserve values (0.05 increments).
Figure 5
Figure 5
Major adverse cardiac events (A) (all-cause mortality, myocardial infarction, unplanned hospitalization with urgent revascularization) and (B) myocardial infarction/all-cause mortality alone at 90 days for coronary computed tomography angiography-derived fractional flow reserve positive (≤0.80) and negative values (>0.80).
Figure 6
Figure 6
Three-dimensional coronary computed tomography angiography-derived fractional flow reserve pressure model of (A) a 59-year-old male with a 50–70% mid left anterior descending coronary artery stenosis yet severe ischaemia (coronary computed tomography angiography-derived fractional flow reserve ≤0.50) who experienced an NSTEMI in follow-up. (B) In comparison, a 71-year-old male with a more severe stenosis (70–90%) in the mid-left anterior descending without lesion specific ischaemia (coronary computed tomography angiography-derived fractional flow reserve 0.83) who was clinically well through 90 days follow-up.
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