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*, Koen Nieman, Takashi Akasaka, Bjarne L. Nørgaard, Daniel S. Berman, Gilbert Raff, Lynne M. Hurwitz-Koweek, Gianluca Pontone, Tomohiro Kawasaki, Niels Peter Sand, Jesper M. Jensen, Tetsuya Amano, Michael Poon, Kristian Øvrehus, Jeroen Sonck, Mark Rabbat, Sarah Mullen, Bernard De Bruyne, Campbell Rogers, Hitoshi Matsuo & 3 andre Jeroen J. Bax, Jonathon Leipsic, Manesh R. Patel

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Resumé

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.

OriginalsprogEngelsk
TidsskriftEuropean Heart Journal
Vol/bind39
Udgave nummer41
Sider (fra-til)3701-3711
ISSN0195-668X
DOI
StatusUdgivet - 1. nov. 2018

Fingeraftryk

Registries
Coronary Angiography
Confidence Intervals
Coronary Artery Disease
Clinical Decision-Making
Computed Tomography Angiography
Odds Ratio
Population

Citer dette

Fairbairn, Timothy A. ; Nieman, Koen ; Akasaka, Takashi ; Nørgaard, Bjarne L. ; Berman, Daniel S. ; Raff, Gilbert ; Hurwitz-Koweek, Lynne M. ; Pontone, Gianluca ; Kawasaki, Tomohiro ; Sand, Niels Peter ; Jensen, Jesper M. ; Amano, Tetsuya ; Poon, Michael ; Øvrehus, Kristian ; Sonck, Jeroen ; Rabbat, Mark ; Mullen, Sarah ; De Bruyne, Bernard ; Rogers, Campbell ; Matsuo, Hitoshi ; Bax, Jeroen J. ; Leipsic, Jonathon ; Patel, Manesh R. / Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve : Lessons from the ADVANCE Registry. I: European Heart Journal. 2018 ; Bind 39, Nr. 41. s. 3701-3711.
@article{548a45d747ee45f9986e66139aae6c67,
title = "Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: Lessons from the ADVANCE Registry",
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.",
keywords = "Coronary CT angiography, FFRCT, Fractional flow reserve, Invasive coronary angiography",
author = "Fairbairn, {Timothy A.} and Koen Nieman and Takashi Akasaka and N{\o}rgaard, {Bjarne L.} and Berman, {Daniel S.} and Gilbert Raff and Hurwitz-Koweek, {Lynne M.} and Gianluca Pontone and Tomohiro Kawasaki and Sand, {Niels Peter} and Jensen, {Jesper M.} and Tetsuya Amano and Michael Poon and Kristian {\O}vrehus and Jeroen Sonck and Mark Rabbat and Sarah Mullen and {De Bruyne}, Bernard and Campbell Rogers and Hitoshi Matsuo and Bax, {Jeroen J.} and Jonathon Leipsic and Patel, {Manesh R.}",
year = "2018",
month = "11",
day = "1",
doi = "10.1093/eurheartj/ehy530",
language = "English",
volume = "39",
pages = "3701--3711",
journal = "European Heart Journal",
issn = "0195-668X",
publisher = "Heinemann",
number = "41",

}

Fairbairn, TA, Nieman, K, Akasaka, T, Nørgaard, BL, Berman, DS, Raff, G, Hurwitz-Koweek, LM, Pontone, G, Kawasaki, T, Sand, NP, Jensen, JM, Amano, T, Poon, M, Øvrehus, K, Sonck, J, Rabbat, M, Mullen, S, De Bruyne, B, Rogers, C, Matsuo, H, Bax, JJ, Leipsic, J & Patel, MR 2018, 'Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: Lessons from the ADVANCE Registry', European Heart Journal, bind 39, nr. 41, s. 3701-3711. https://doi.org/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. / Fairbairn, Timothy A.; Nieman, Koen; Akasaka, Takashi; Nørgaard, Bjarne L.; Berman, Daniel S.; Raff, Gilbert; Hurwitz-Koweek, Lynne M.; Pontone, Gianluca; Kawasaki, Tomohiro; Sand, Niels Peter; Jensen, Jesper M.; Amano, Tetsuya; Poon, Michael; Øvrehus, Kristian; Sonck, Jeroen; Rabbat, Mark; Mullen, Sarah; De Bruyne, Bernard; Rogers, Campbell; Matsuo, Hitoshi; Bax, Jeroen J.; Leipsic, Jonathon; Patel, Manesh R.

I: European Heart Journal, Bind 39, Nr. 41, 01.11.2018, s. 3701-3711.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve

T2 - Lessons from the ADVANCE Registry

AU - Fairbairn, Timothy A.

AU - Nieman, Koen

AU - Akasaka, Takashi

AU - Nørgaard, Bjarne L.

AU - Berman, Daniel S.

AU - Raff, Gilbert

AU - Hurwitz-Koweek, Lynne M.

AU - Pontone, Gianluca

AU - Kawasaki, Tomohiro

AU - Sand, Niels Peter

AU - Jensen, Jesper M.

AU - Amano, Tetsuya

AU - Poon, Michael

AU - Øvrehus, Kristian

AU - Sonck, Jeroen

AU - Rabbat, Mark

AU - Mullen, Sarah

AU - De Bruyne, Bernard

AU - Rogers, Campbell

AU - Matsuo, Hitoshi

AU - Bax, Jeroen J.

AU - Leipsic, Jonathon

AU - Patel, Manesh R.

PY - 2018/11/1

Y1 - 2018/11/1

N2 - 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.

AB - 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.

KW - Coronary CT angiography

KW - FFRCT

KW - Fractional flow reserve

KW - Invasive coronary angiography

U2 - 10.1093/eurheartj/ehy530

DO - 10.1093/eurheartj/ehy530

M3 - Journal article

VL - 39

SP - 3701

EP - 3711

JO - European Heart Journal

JF - European Heart Journal

SN - 0195-668X

IS - 41

ER -