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 J Bax; Philipp Blanke; Bernard De Bruyne; Tomohiro Kawasaki; Jonathon Leipsic; Hitoshi Matsuo; Yoshihiro Morino; Koen Nieman; Bjarne L Norgaard; Manesh R Patel; Gianluca Pontone; Mark Rabbat; Campbell Rogers; Neils Peter Sand; Gilbert Raff

doi:10.1016/j.jcct.2016.12.002

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

J Cardiovasc Comput Tomogr. 2017 Jan-Feb;11(1):62-67. doi: 10.1016/j.jcct.2016.12.002. Epub 2016 Dec 14.

Authors

Kavitha M Chinnaiyan¹, Takashi Akasaka², Tetsuya Amano³, Jeroen J Bax⁴, Philipp Blanke⁵, Bernard De Bruyne⁶, Tomohiro Kawasaki⁷, Jonathon Leipsic⁸, Hitoshi Matsuo⁹, Yoshihiro Morino¹⁰, Koen Nieman¹¹, Bjarne L Norgaard¹², Manesh R Patel¹³, Gianluca Pontone¹⁴, Mark Rabbat¹⁵, Campbell Rogers¹⁶, Neils Peter Sand¹⁷, Gilbert Raff¹

Affiliations

¹ William Beaumont Hospital, Royal Oaks, MI, USA.
² Wakayama Medical University, Wakayama, Japan.
³ Aichi Medical University, Aichi, Japan.
⁴ Leiden University Medical Center, Leiden, The Netherlands.
⁵ Department of Radiology, University of British Columbia, Vancouver, BC, Canada.
⁶ Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium.
⁷ Shin Koga Hospital, Fukuoka, Japan.
⁸ Department of Radiology, University of British Columbia, Vancouver, BC, Canada. Electronic address: [email protected].
⁹ Gifu Heart Center, Gifu, Japan.
¹⁰ Iwate Medical University, Iwate, Japan.
¹¹ Erasmus Medical Center, Rotterdam, The Netherlands.
¹² Aarhus University Hospital, Aarhus Skejby, Denmark.
¹³ Duke University School of Medicine, Durham, NC, USA.
¹⁴ Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
¹⁵ Loyola University Medical Center, Maywood, IL, USA.
¹⁶ HeartFlow, Redwood City, CA, USA.
¹⁷ University of Southern Denmark, Odense, Denmark.

PMID: 28017291
DOI: 10.1016/j.jcct.2016.12.002

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 (FFR_CT) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFR_CT 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 FFR_CT-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 FFR_CT 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 FFR_CT. 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 FFR_CT on the clinical management of stable CAD when used along with coronary CTA.

Keywords: Coronary artery disease; FFRct; Ischemia; Reclassification.

Publication types

Multicenter Study

MeSH terms

Asia
Canada
Computed Tomography Angiography*
Coronary Angiography / methods*
Coronary Artery Disease / diagnostic imaging*
Coronary Artery Disease / physiopathology
Coronary Artery Disease / therapy
Coronary Stenosis / diagnostic imaging*
Coronary Stenosis / physiopathology
Coronary Stenosis / therapy
Europe
Fractional Flow Reserve, Myocardial*
Humans
Predictive Value of Tests
Prognosis
Prospective Studies
Registries
Research Design
Severity of Illness Index
United States