心脏血流评估冠状动脉护理中无创血流储备分数（FFR）诊断价值（ADVANCE）注册研究的原理、设计与目标。
Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFR in Coronary Care (ADVANCE) registry.
作者信息
Chinnaiyan Kavitha M, Akasaka Takashi, Amano Tetsuya, Bax Jeroen J, Blanke Philipp, De Bruyne Bernard, Kawasaki Tomohiro, Leipsic Jonathon, Matsuo Hitoshi, Morino Yoshihiro, Nieman Koen, Norgaard Bjarne L, Patel Manesh R, Pontone Gianluca, Rabbat Mark, Rogers Campbell, Sand Neils Peter, Raff Gilbert
机构信息
William Beaumont Hospital, Royal Oaks, MI, USA.
Wakayama Medical University, Wakayama, Japan.
出版信息
J Cardiovasc Comput Tomogr. 2017 Jan-Feb;11(1):62-67. doi: 10.1016/j.jcct.2016.12.002. Epub 2016 Dec 14.
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) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFR 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-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 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. 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 on the clinical management of stable CAD when used along with coronary CTA.
背景
冠状动脉CT血管造影（CTA）是检测冠状动脉疾病（CAD）的可靠工具，可提供重要的预后信息。它无法提供有关特定病变血流动力学意义的数据，尤其是在中度狭窄的情况下。CT血流储备分数（FFR）可以准确预测冠状动脉病变的血流动力学意义。本注册研究的主要目的是确定将FFR作为冠状动脉CTA的辅助手段是否会导致稳定型心绞痛患者CAD管理的显著改变。
方法
ADVANCE注册研究是一项多中心前瞻性注册研究，旨在评估在经冠状动脉CTA诊断为CAD的临床稳定、有症状患者中，FFR引导治疗后的效用、临床结局和资源利用情况。将从欧洲、美国、加拿大和亚洲的多达50个地点招募约5000名患者。入选要求是冠状动脉CTA显示存在动脉粥样硬化。对于每名入选患者，临床管理审查委员会将使用冠状动脉CTA和FFR的数据，依据以下标准确定管理计划：（a）优化药物治疗，（b）经皮冠状动脉介入治疗，（c）冠状动脉旁路移植术，或（d）需要更多信息。该注册研究的主要终点是仅基于冠状动脉CTA的管理计划与CTA加FFR的管理计划之间的重新分类率。该注册研究的次要终点包括评估侵入性冠状动脉造影（ICA）率、血运重建、主要不良冠状动脉事件、资源利用、累积辐射剂量暴露以及3年随访时无阻塞性CAD的ICA率。
结论
ADVANCE注册研究旨在评估FFR与冠状动脉CTA联合使用时对稳定型CAD临床管理的实际影响。
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