■CaRi-Heart®装置估计8年心源性死亡的风险,使用预后模型,其中包括血管周脂肪衰减指数,动脉粥样硬化斑块负荷和临床危险因素。
■为了提供对CaRi-Heart风险潜力的早期价值评估,将其作为评估心脏风险的有效且具有成本效益的辅助调查,在稳定的胸痛/怀疑冠状动脉疾病的人中,行计算机断层扫描冠状动脉造影。该评估包括概念建模,探索模型开发所需参数的结构和证据,但不是开发一个完全可执行的成本效益模型。
■二十四个数据库,包括MEDLINE,MEDLINE在过程和EMBASE,从成立之初到2022年10月进行了搜索。
■遵循已发布的指南审查方法。使用预测模型偏差风险评估工具评估研究质量。研究问题总结了结果:预后表现;风险类别的患病率;临床效果;CaRi-Heart的成本。进行了探索性搜索,以告知概念成本效益建模。
■唯一纳入的研究表明,CaRi-心脏风险可能是8年心源性死亡的预测因素。危险比,每单位增加CaRi-Heart风险,适应吸烟,高胆固醇血症,高血压,糖尿病,杜克指数,存在高危斑块特征和心外膜脂肪组织体积,在模型验证队列中为1.04(95%置信区间1.03至1.06)。基于偏差风险评估工具的预测模型,这项研究被认为存在较高的偏倚风险,并且对于这项早期价值评估规定的决策问题的适用性存在较高的担忧.我们没有发现任何研究报告有关使用CaRi-Heart评估心脏风险的临床效果或成本的信息。探索性搜索,为概念成本效益建模提供信息,表明在关于改变现有治疗或引入新治疗的影响的证据方面存在缺陷,基于对心脏风险的评估(通过任何方法),或血管炎症的测量(例如脂肪衰减指数)。描述了一种新的概念性决策分析模型,该模型可用于对CaRi-Heart的成本效益进行早期评估。短期诊断模型组件和评估下游后果的长期模型组件的组合预期捕获冠状动脉疾病的诊断和进展。
■用于告知此早期价值评估的快速审查方法和实用的附加搜索意味着,尽管已经描述了潜在的不确定性领域,我们无法明确说明存在证据空白的地方。
■关于CaRi-Heart风险的临床效用的证据尚不充分,并且具有相当大的局限性,在偏倚风险和对英国临床实践的适用性方面。有一些证据表明,CaRi-Heart风险可以预测8年的心脏死亡风险,对于因疑似冠状动脉疾病而接受计算机断层扫描冠状动脉造影的患者。然而,相对于目前的护理标准,CaRi-Heart是否以及在多大程度上表现出改善仍不确定.对CaRi-Heart装置的评估正在进行中,目前可用的数据不足以充分提供成本效益模型。
■一项大型(n=15,000)正在进行的研究,NCT05169333,牛津危险因素和非侵入性影像学研究,预计完成日期为2030年2月,可能会解决本早期价值评估中确定的一些不确定性。
■本研究注册为PROSPEROCRD42022366496。
■该奖项由美国国家卫生与护理研究所(NIHR)证据综合计划(NIHR奖项参考:NIHR135672)资助,并在《卫生技术评估》中全文发表;卷。28号31.有关更多奖项信息,请参阅NIHR资助和奖励网站。
冠状动脉疾病影响英国约230万人。它是由供应心肌的血管壁上的脂肪斑积聚引起的。这可以减少流向心脏的血液,导致人们经历胸痛(心绞痛),尤其是在锻炼的时候。随着时间的推移,脂肪斑块可以生长并阻塞更多或所有的动脉,也可以形成血凝块,造成堵塞。当心肌的血液供应受阻时,就会发生心脏病发作。有胸痛发作的人,他们的医生认为他们可能患有冠状动脉疾病,可以有一种类型的成像(计算机断层扫描冠状动脉造影),显示他们的冠状动脉是否有任何狭窄。当提供治疗时,专业心脏病医生可能会考虑一个人的症状和其他危险因素(例如心脏病家族史,糖尿病和吸烟史),以及动脉狭窄的程度。CaRi-Heart®是一种计算机程序,使用有关人冠状动脉炎症的信息,加上公认的风险因素,比如年龄,性别,吸烟,高胆固醇水平,高血压和糖尿病,估计一个人在未来8年内死于心脏病的风险。有证据表明,CaRi-Heart®比单独使用信息识别的风险因素更能估计这种风险。然而,目前缺乏关于使用CaRi-Heart®后治疗可能发生何种变化的信息,以及任何变化是否会改善患者的结局.也缺乏关于CaRi-Heart®将花费多少国家卫生服务的信息。
UNASSIGNED: The CaRi-Heart® device estimates risk of 8-year cardiac death, using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden and clinical risk factors.
UNASSIGNED: To provide an Early Value Assessment of the potential of CaRi-Heart Risk to be an effective and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease, undergoing computed tomography coronary angiography. This assessment includes conceptual modelling which explores the structure and evidence about parameters required for model development, but not development of a full executable cost-effectiveness model.
UNASSIGNED: Twenty-four databases, including MEDLINE, MEDLINE In-Process and EMBASE, were searched from inception to October 2022.
UNASSIGNED: Review methods followed published guidelines. Study quality was assessed using Prediction model Risk Of Bias ASsessment Tool. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. Exploratory searches were conducted to inform conceptual cost-effectiveness modelling.
UNASSIGNED: The only included study indicated that CaRi-Heart Risk may be predictive of 8 years cardiac death. The hazard ratio, per unit increase in CaRi-Heart Risk, adjusted for smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume, was 1.04 (95% confidence interval 1.03 to 1.06) in the model validation cohort. Based on Prediction model Risk Of Bias ASsessment Tool, this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this Early Value Assessment. We did not identify any studies that reported information about the clinical effects or costs of using CaRi-Heart to assess cardiac risk. Exploratory searches, conducted to inform the conceptual cost-effectiveness modelling, indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation (e.g. fat attenuation index). A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart is described. A combination of a short-term diagnostic model component and a long-term model component that evaluates the downstream consequences is anticipated to capture the diagnosis and the progression of coronary artery disease.
UNASSIGNED: The rapid review methods and pragmatic additional searches used to inform this Early Value Assessment mean that, although areas of potential uncertainty have been described, we cannot definitively state where there are evidence gaps.
UNASSIGNED: The evidence about the clinical utility of CaRi-Heart Risk is underdeveloped and has considerable limitations, both in terms of risk of bias and applicability to United Kingdom clinical practice. There is some evidence that CaRi-Heart Risk may be predictive of 8-year risk of cardiac death, for patients undergoing computed tomography coronary angiography for suspected coronary artery disease. However, whether and to what extent CaRi-Heart represents an improvement relative to current standard of care remains uncertain. The evaluation of the CaRi-Heart device is ongoing and currently available data are insufficient to fully inform the cost-effectiveness modelling.
UNASSIGNED: A large (n = 15,000) ongoing study, NCT05169333, the Oxford risk factors and non-invasive imaging study, with an estimated completion date of February 2030, may address some of the uncertainties identified in this Early Value Assessment.
UNASSIGNED: This study is registered as PROSPERO CRD42022366496.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135672) and is published in full in Health Technology Assessment; Vol. 28, No. 31. See the NIHR Funding and Awards website for further award information.
Coronary artery disease affects around 2.3 million people in the United Kingdom. It is caused by a build-up of fatty plaques on the walls of the blood vessels that supply the heart muscle. This can reduce the flow of blood to the heart and result in people experiencing chest pain (angina), especially when they exercise. Over time, the fatty plaques can grow and block more or all of the artery and blood clots can also form, causing blockage. A heart attack happens when the supply of blood to the heart muscle is blocked. People who have episodes of chest pain, whose doctors think that they may have coronary artery disease, can have a type of imaging (computed tomography coronary angiography) which shows whether there is any narrowing of their coronary arteries. When offering treatment, specialist heart doctors are likely to consider a person’s symptoms and other risk factors (such as family history of heart disease, diabetes and smoking history), as well as how much narrowing of the arteries has happened. CaRi-Heart® is a computer programme that uses information about inflammation in a person’s coronary arteries, together with recognised risk factors, such as age, sex, smoking, high cholesterol levels, high blood pressure and diabetes, to estimate an individual’s risk of dying from a heart attack in the next 8 years. There is evidence that CaRi-Heart® is better at estimating this risk than using information recognised risk factors alone. However, there is a lack of information about how treatment could change as a result of using CaRi-Heart® and whether any changes would improve outcomes for patients. There is also a lack of information about how much CaRi-Heart® would cost the National Health Service.