Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry.
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.
Chinnaiyan, KM; Akasaka, T; Amano, T; Bax, JJ; Blanke, P; De Bruyne, B; Kawasaki, T; Leipsic, J; Matsuo, H; Morino, Y; Nieman, K; Norgaard, BL; Patel, MR; Pontone, G; Rabbat, M; Rogers, C; Sand, NP; Raff, G
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