Cost savings from prioritization of non-invasive modalities within CAD diagnostic protocols: a systematic review

While the clinical benefits of non-invasive modalities to diagnose coronary artery disease (CAD) are well recognized, the economic implications of their use over invasive options remain unclear. This review aims to understand the health economic consequences of using non-invasive versus invasive modalities in symptomatic patients with low-to-intermediate pre-test probability (PTP) of CAD, and to explore whether economic and humanistic data can inform future investment decisions around non-invasive and invasive diagnostic modalities. We performed a systematic review of MEDLINE and Embase, MEDLINE In-process, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials. Studies from January 1992 to January 2023 were included, if they were based in the UK, France, Germany, Italy, Japan, China, and/or the USA (published in any language). Risk of bias was assessed using the Drummond checklist. We evaluated invasive techniques, including invasive catheterization angiography (ICA) and ICA with fractional flow reserve (ICA-FFR), as well as non-invasive modalities, including coronary computerized tomography angiography (CCTA), CCTA-FFR, cardiovascular magnetic resonance (CMR), stress electrocardiogram, myocardial perfusion scintigraphy-single photon emission computed tomography, positron emission tomography, and stress echocardiography. Thirty-nine unique records reported relevant outcomes and were fully extracted. In patients with a low-to-intermediate PTP of CAD, most of the comparisons of non-invasive modalities followed or not by confirmatory ICA imaging, versus ICA demonstrated cost savings. The use of non-invasive modalities, followed or not followed by confirmatory ICA, was reported to reduce the number of revascularizations and length of hospital stays, versus ICA alone. This study suggests that investment in CAD diagnosis should prioritize the use of CCTA and CMR imaging over ICA and other non-invasive modalities. Doctors choose imaging tests to diagnose patients who might have coronary heart disease based on whether they have a low, intermediate or high chance of having the disease. This chance is called a patient’s “pre-test probability.” There are invasive and non-invasive imaging tests. Non-invasive tests are often recommended before invasive tests, particularly for patients with a low or intermediate pre-test probability. However, we do not know the cost implications of choosing non-invasive tests first. We searched for studies published between 1992 and 2023 that compared the use of non-invasive tests with one kind of invasive test, called invasive coronary angiography. We were interested in studies that described the value of using non-invasive tests in terms of quality of life, healthcare costs and other kinds of value. We found 39 studies published between 1997 and 2022. Most compared using two tests—a non-invasive test followed by an invasive test—with using only an invasive test. We looked at the results in patients with a low or intermediate pre-test probability. Studies often found that, in these patients, a non-invasive test (before or instead of an invasive test) was better value than an invasive test alone. With non-invasive tests, patients needed fewer medical procedures or days in the hospital. Our results show that patients should receive non-invasive imaging before invasive imaging is considered. Therefore, more funding should go to non-invasive imaging.

尽管用于诊断冠状动脉粥样硬化性心脏病（coronary artery disease, CAD）的无创检测手段的临床获益已获广泛认可，但其相较于侵入性检测方案的经济学应用价值仍未明确。本综述旨在明确针对冠状动脉粥样硬化性心脏病（CAD）预测试概率（pre-test probability, PTP）为低至中度的有症状患者，使用无创与侵入性检测手段的卫生经济学影响，并探讨经济学与人文数据能否为无创及侵入性诊断手段的未来投资决策提供参考依据。
我们对MEDLINE、Embase、MEDLINE In-process、Cochrane系统评价数据库（Cochrane Database of Systematic Reviews）以及Cochrane对照试验中心注册库（Cochrane Central Register of Controlled Trials）进行了系统检索。纳入1992年1月至2023年1月期间发表的、基于英国、法国、德国、意大利、日本、中国及/或美国的研究（语言不限）。采用Drummond量表评估偏倚风险。我们对侵入性技术进行了评估，包括侵入性导管造影术（invasive catheterization angiography, ICA）、联合血流储备分数的侵入性导管造影术（ICA-FFR）；同时评估的无创检测手段包括冠状动脉计算机断层血管造影（coronary computerized tomography angiography, CCTA）、CCTA-FFR、心血管磁共振成像（cardiovascular magnetic resonance, CMR）、负荷心电图、心肌灌注显像-单光子发射计算机断层扫描、正电子发射断层扫描以及负荷超声心动图。
共检索到39篇独立相关记录并完成完整数据提取。针对冠状动脉粥样硬化性心脏病（CAD）预测试概率为低至中度的患者，多数对比研究显示，先使用或不使用确认性侵入性导管造影术（ICA）成像的无创检测手段，相较于单纯使用侵入性导管造影术（ICA）可实现成本节约。相较于单纯侵入性导管造影术（ICA），先使用或不使用确认性侵入性导管造影术（ICA）的无创检测手段可减少血管重建术次数与住院时长。
本研究表明，冠状动脉粥样硬化性心脏病（CAD）诊断的投资应优先选择冠状动脉计算机断层血管造影（CCTA）与心血管磁共振成像（CMR），而非侵入性导管造影术（ICA）及其他无创检测手段。
临床医师会依据患者冠状动脉粥样硬化性心脏病的患病概率分层（低、中、高风险），选择影像学检查以排查疑似患者，该分层概率即被称为患者的“预测试概率（pre-test probability）”。影像学检查分为侵入性与无创两类。无创检测通常优先于侵入性检查被推荐使用，尤其针对预测试概率为低至中度的患者。
然而，优先选择无创检测的成本影响尚未明确。我们检索了1992年至2023年间发表的、对比无创检测与侵入性冠状动脉造影（invasive coronary angiography）应用的研究，重点关注从生活质量、医疗成本及其他价值维度阐述无创检测应用价值的研究。
最终纳入1997年至2022年间发表的39项研究。多数研究对比了“无创检测联合或不联合确认性侵入性检测”与“单纯侵入性检测”的效果。我们针对预测试概率为低至中度的患者的研究结果进行分析，发现此类患者中，先使用或替代侵入性检测的无创检测手段，其性价比优于单纯侵入性检测。采用无创检测可减少患者所需的医疗操作次数与住院天数。
本研究结果提示，临床应优先考虑在侵入性成像前使用无创影像学检查，因此应加大对无创影像学领域的资金投入。