Comparative effectiveness of noninvasive cardiac imaging

描述（由申请人提供）：该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。无创心脏成像方法在诊断CAD和提供个人风险评估方面特别有用，有助于为管理决策提供信息。除了传统的成像方法（如心肌灌注SPECT）外，包括冠状动脉计算机断层扫描血管造影（CCTA）和正电子发射断层扫描（PET）在内的较新的成像技术正受到相当大的关注，其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诊断方式都要经过严格的评估，特别是在临床价值、成本效益和成本效益方面。数据是必要的，以确定其适应症，在执业医师中获得临床接受，并证明这些模式的付款人之间的报销。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、开放标签、多中心、顺序抽样、观察性注册研究，旨在比较SPECT、PET和CCTA成像在资源利用的主要终点方面，以及在疑似和已知CAD的中高CAD可能性患者中，与预成像数据相比，改进的风险再分类。该研究纳入了40个研究地点的患者，其中39个在美国，1个在加拿大。该研究有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年的随访时间点已经完成，2年的随访时间约为58%。该前瞻性登记的优势包括明确定义的患者群体、分布在美国所有地区的地理多样性、实践和学术地点之间的平衡、多模式比较、所有患者的中心随访以及所有患者研究图像数据的丰富的中央成像存储库。SPARC是一项由研究者发起的研究，由四个行业赞助商提供无限制的资助。虽然这项研究的资助不是为了解决有关成本效益的预先定义的问题，但对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，并检查这些成像方式在相关临床亚组（包括妇女，糖尿病患者和肥胖患者，占美国人口的很大一部分）的有效性的重要差异。因此，在这项挑战拨款下提出的申请寻求回答以下问题：(1)SPECT、PET和CCTA的增量成本效益是什么，以及它们各自在识别阻塞性CAD和临床事件风险重新分类方面的准确性是什么？(2)这些诊断策略在所有患者亚组（包括女性、糖尿病患者和肥胖个体）的风险预测方面是否表现相似？(3)通过预测治疗效益（药物治疗vs.血运重建），这些诊断策略在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受到图像解释质量的影响？我们预计，拟议研究的结果将在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，指导患者管理，同时寻求成本效益的场所；在这个医疗成本不断上升的时代，这是一个主要目标。7. 无创成像已被确定为影响医疗融资的关键因素之一，其年增长率远远超过导管插入术、血运重建术或急性心肌梗死。因此，对于已知或疑似CAD患者，需要比较无创心脏成像在诊断、未来风险校准和指导管理方面的临床和成本效益的数据。我们预计，拟议研究的结果将在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，指导患者管理，同时寻求成本效益的场所；在这个医疗成本不断上升的时代，这是一个主要目标。

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.