Comparative effectiveness of noninvasive cardiac imaging

描述(由申请人提供)：本申请涉及广泛的挑战领域(04)对现有数据进行二次分析，以回答重要的临床和预防医学研究问题，04-HL-104。非侵入性心脏成像方法在诊断冠心病和提供个体风险评估方面特别有用，有助于为管理决策提供信息。除了常规的成像方法(例如，心肌灌注SPECT)外，包括冠状动脉计算机断层扫描(CCTA)和正电子发射断层扫描(PET)在内的新的成像技术正受到相当大的关注，目的是改善疑似或已知CAD患者的诊断和风险分层。然而，当今医疗市场的经济现实要求所有的诊断模式都要经过严格的评估，特别是在其增量临床价值、成本效益和成本效益方面。数据是必要的，以确定它们的适应症，获得执业医生的临床接受，并证明付款人对这些方式的报销是合理的。心肌灌注和冠状动脉解剖成像在CAD中的作用研究(SPARC)是一项前瞻性的、开放的、多中心、顺序抽样的观察性注册，旨在比较SPECT、PET和CCTA成像相对于资源利用的主要终点，并改进对可疑和已知CAD中高可能性患者的成像前数据的风险重新分类。这项研究包括40个研究地点的患者，其中39个在美国，1个在加拿大。这项研究有3个预先指定的随访时间点：90天、1年和2年，其中90天和1年的时间点已经完成，2年的随访大约完成了58%。这一前瞻性登记的优势包括明确界定的患者群体、分布在美国所有地区的地点的地理多样性、实践地点和学术地点之间的平衡、多模式比较、对所有患者的集中随访以及丰富的所有患者研究图像数据的中央图像库。SPARC是一项由四个行业赞助商提供的无限制赠款资助的研究人员发起的研究。虽然这项研究不是为了解决关于成本效益的预定义问题而资助的，但测试后资源消耗模式的详细程度将为估计成本和洞察测试的潜在价值提供基础，以指导管理并检查相关临床亚组(包括占美国人口很大一部分的女性、糖尿病患者和肥胖症患者)中这些成像模式的有效性的重要差异。因此，这一挑战基金下的拟议应用试图回答以下问题：(1)SPECT、PET和CCTA在识别梗阻性CAD和临床事件风险重新分类方面的增量成本效益是什么，以及它们各自的准确性是什么？(2)这些诊断策略在所有患者亚组(包括女性、糖尿病患者和肥胖者)的风险预测方面是否表现相似？(3)这些诊断策略在通过预测治疗效益(药物治疗与血运重建)来确定最佳患者管理方面是否相同？(4)这些非侵入性模式在风险预测和成本效益方面的差异是否会受到图像解释质量的影响？我们预计，拟议的研究结果将对以下方面产生重大影响：加强心脏成像的适当使用，以识别CAD，预测未来不良心脏事件的风险，并指导患者管理，同时寻求成本效益的场所；这是这个医疗成本螺旋式上升的时代的一个主要目标。7.项目简介无创成像已被确定为影响卫生保健融资的关键因素之一，其年增长率远远超过导管术、血管重建术或急性心肌梗死。因此，对于已知或疑似冠心病的患者，需要比较无创性心脏成像在诊断、校正未来风险和指导治疗方面的临床和成本效益的数据。我们预计，拟议的研究结果将对以下方面产生重大影响：加强心脏成像的适当使用，以识别CAD，预测未来不良心脏事件的风险，并指导患者管理，同时寻求成本效益的场所；这是这个医疗成本螺旋式上升的时代的一个主要目标。

DESCRIPTION (provided by applicant): This application addresses broad Challenge area (04) Perform secondary analyses of existing data to answer important clinical and preventive medicine research questions, 04-HL-104. Noninvasive cardiac imaging approaches have been particularly useful to diagnose CAD and to provide individual estimates of risk that help inform management decisions. In addition to conventional imaging approaches (e.g., myocardial perfusion SPECT), newer imaging technology including coronary computed tomography angiography (CCTA), and positron emission tomography (PET) are receiving considerable attention with the goal of improving diagnosis and risk stratification of patients with suspected or known CAD. However, the economic reality of today's medical marketplace dictates that all diagnostic modalities undergo rigorous evaluation particularly with respect to their incremental clinical value, cost-effectiveness and cost-benefit. Data are necessary to define their indications, to gain clinical acceptance amongst practicing physicians, and to justify reimbursement for these modalities amongst payers. The Study of Myocardial Perfusion and Coronary Anatomy Imaging Roles in CAD (SPARC) is a prospective, open-label, multicenter, sequentially sampled, observational registry designed to compare SPECT, PET, and CCTA imaging with respect to the primary endpoints of resource utilization and improved risk re-classification over pre-imaging data in intermediate-high CAD likelihood patients with suspected and known CAD. The study included patients enrolled at 40 study sites including 39 in the US and 1 in Canada. The study has 3 pre-specified follow-up time points: 90 days, 1 year, and 2 years, with the 90-day and 1 year time-points already completed, and the 2 year follow approximately 58% completed. The strengths of this prospective registry include a well defined patient population, geographic diversity with sites distributed across all regions of the US, a balance between practice and academic sites, a multi-modality comparison, central follow up of all patients, and a rich central imaging repository of all patient study image data. SPARC is an investigator initiated study funded through unrestricted grants from four industry sponsors. Although this study was not funded to address pre- defined questions regarding cost-effectiveness, the level of detail on post-test resource consumption patterns will provide the bases for estimation of costs and insight into the potential value of testing to guide management and to examine important differences in the effectiveness of these imaging modalities in relevant clinical subgroups (including women, diabetics, and obese patients comprising a large segment of the US population). Consequently, the proposed application under this challenge grant seek to answer the following questions: (1) What is the incremental cost-effectiveness of SPECT, PET, and CCTA as well as their respective accuracy for identification of obstructive CAD, and clinical event risk re-classification?; (2) Do these diagnostic strategies perform similarly with respect to risk prediction in all patient subgroups including women, diabetics, and obese individuals?; (3) Are these diagnostic strategies equal in identifying optimal patient management by predicting therapeutic benefit (medical therapy vs. revascularization)?; (4) Are differences between these noninvasive modalities with respect to risk prediction and cost-effectiveness influenced by the quality of image interpretation? We anticipate that the results of the proposed studies will have major implications with respect to enhancing the appropriate use of cardiac imaging for identification of CAD, risk prediction of future adverse cardiac events, and guiding patient management, while seeking venues of cost efficiency; a major goal in this era of spiraling healthcare costs. 7. Project Narrative Noninvasive imaging has been identified as one of the key factors affecting health care financing, with an annual growth rate far exceeding that of catheterization, revascularization, or acute myocardial infarction. Thus, there is a need for data comparing the clinical- and cost-effectiveness of noninvasive cardiac imaging with respect to diagnosis, calibration of future risk, and guiding management in patients with known or suspected CAD. We anticipate that the results of the proposed studies will have major implications with respect to enhancing the appropriate use of cardiac imaging for identification of CAD, risk prediction of future adverse cardiac events, and guiding patient management, while seeking venues of cost efficiency; a major goal in this era of spiraling healthcare costs.