Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry

Kavitha M Chinnaiyan, Takashi Akasaka, Tetsuya Amano, Jeroen Bax, Philipp Blanke, Bernard de Bruyne, Tomohiro Kawasaki, Jonathon Leipsic, Hitoshi Matsuo, Yoshihiro Morino, Koen Nieman, Bjarne L Nørgaard, Manesh R Patel, Gianluca Pontone, Mark Rabbat, Campbell Rogers, Niels Peter Sand, Gilbert Raff

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

BACKGROUND: Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFRCT) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFRCT as an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina.

METHODS: The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFRCT-guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFRCT to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFRCT. The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up.

CONCLUSIONS: The ADVANCE registry is designed to assess the real-world impact of FFRCT on the clinical management of stable CAD when used along with coronary CTA.

Original languageEnglish
JournalJournal of Cardiovascular Computed Tomography
Volume11
Issue number1
Pages (from-to)62-67
ISSN1934-5925
DOIs
Publication statusPublished - 2017

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Coronary Angiography
Registries
Coronary Artery Disease
Stable Angina
Computed Tomography Angiography
Advisory Committees
Pathologic Constriction

Keywords

  • Journal Article

Cite this

Chinnaiyan, Kavitha M ; Akasaka, Takashi ; Amano, Tetsuya ; Bax, Jeroen ; Blanke, Philipp ; de Bruyne, Bernard ; Kawasaki, Tomohiro ; Leipsic, Jonathon ; Matsuo, Hitoshi ; Morino, Yoshihiro ; Nieman, Koen ; Nørgaard, Bjarne L ; Patel, Manesh R ; Pontone, Gianluca ; Rabbat, Mark ; Rogers, Campbell ; Sand, Niels Peter ; Raff, Gilbert. / Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry. In: Journal of Cardiovascular Computed Tomography. 2017 ; Vol. 11, No. 1. pp. 62-67.
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title = "Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry",
abstract = "BACKGROUND: Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFRCT) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFRCT as an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina.METHODS: The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFRCT-guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFRCT to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFRCT. The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up.CONCLUSIONS: The ADVANCE registry is designed to assess the real-world impact of FFRCT on the clinical management of stable CAD when used along with coronary CTA.",
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Chinnaiyan, KM, Akasaka, T, Amano, T, Bax, J, Blanke, P, de Bruyne, B, Kawasaki, T, Leipsic, J, Matsuo, H, Morino, Y, Nieman, K, Nørgaard, BL, Patel, MR, Pontone, G, Rabbat, M, Rogers, C, Sand, NP & Raff, G 2017, 'Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry', Journal of Cardiovascular Computed Tomography, vol. 11, no. 1, pp. 62-67. https://doi.org/10.1016/j.jcct.2016.12.002

Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry. / Chinnaiyan, Kavitha M; Akasaka, Takashi; Amano, Tetsuya; Bax, Jeroen; Blanke, Philipp; de Bruyne, Bernard; Kawasaki, Tomohiro; Leipsic, Jonathon; Matsuo, Hitoshi; Morino, Yoshihiro; Nieman, Koen; Nørgaard, Bjarne L; Patel, Manesh R; Pontone, Gianluca; Rabbat, Mark; Rogers, Campbell; Sand, Niels Peter; Raff, Gilbert.

In: Journal of Cardiovascular Computed Tomography, Vol. 11, No. 1, 2017, p. 62-67.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry

AU - Chinnaiyan, Kavitha M

AU - Akasaka, Takashi

AU - Amano, Tetsuya

AU - Bax, Jeroen

AU - Blanke, Philipp

AU - de Bruyne, Bernard

AU - Kawasaki, Tomohiro

AU - Leipsic, Jonathon

AU - Matsuo, Hitoshi

AU - Morino, Yoshihiro

AU - Nieman, Koen

AU - Nørgaard, Bjarne L

AU - Patel, Manesh R

AU - Pontone, Gianluca

AU - Rabbat, Mark

AU - Rogers, Campbell

AU - Sand, Niels Peter

AU - Raff, Gilbert

N1 - Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

PY - 2017

Y1 - 2017

N2 - BACKGROUND: Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFRCT) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFRCT as an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina.METHODS: The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFRCT-guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFRCT to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFRCT. The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up.CONCLUSIONS: The ADVANCE registry is designed to assess the real-world impact of FFRCT on the clinical management of stable CAD when used along with coronary CTA.

AB - BACKGROUND: Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFRCT) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFRCT as an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina.METHODS: The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFRCT-guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFRCT to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFRCT. The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up.CONCLUSIONS: The ADVANCE registry is designed to assess the real-world impact of FFRCT on the clinical management of stable CAD when used along with coronary CTA.

KW - Journal Article

U2 - 10.1016/j.jcct.2016.12.002

DO - 10.1016/j.jcct.2016.12.002

M3 - Journal article

C2 - 28017291

VL - 11

SP - 62

EP - 67

JO - Journal of Cardiovascular Computed Tomography

JF - Journal of Cardiovascular Computed Tomography

SN - 1934-5925

IS - 1

ER -