在 VICTORION-Spirit 研究中确定大曼彻斯特地区的心血管疾病高危患者

J. M. Gibson, John McCrae, Claire Williams, Paul M. Wilson, Peter Bower, Samantha Dixon
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摘要

背景介绍Inclisiran 是英国许可的一种降低胆固醇的小干扰 RNA 治疗方法,用于降低低密度脂蛋白胆固醇 (LDL-C)。VICTORION-Spirit(NCT04807400)是一项实施科学研究,旨在为国民健康服务机构实施 inclisiran 提供证据。目的是描述 VICTORION-Spirit 采用的患者识别过程:VICTORION-Spirit 是一项 IIIb 期、多中心、随机对照研究,旨在评估 inclisiran 在患有动脉粥样硬化性心血管疾病 (ASCVD) 或 ASCVD 风险等同物以及 LDL-C 升高的参与者中的实施情况。提高试验效率的可行性评估和招募系统 (FARSITE) 软件利用自然语言搜索功能确定了可能从 inclisiran 中获益的患者。FARSITE 在索尔福德、曼彻斯特、特拉福德和布里临床委托小组内进行搜索,以确定低密度脂蛋白胆固醇或总胆固醇升高、已有心血管疾病 (CVD) 或有 ASCVD 风险的患者:FARSITE 使用的术语是 "总胆固醇 >4 mmol/l",而不是 "低密度脂蛋白胆固醇";前者产生的合格患者数量是后者的 3 倍以上。在 560,969 人(4.3%)的人群中,对已有心血管疾病者的搜索发现了 24,196 人;包括 "总胆固醇 >4 mmol/l "在内的搜索发现了 10,431 名已有心血管疾病且总胆固醇升高的患者。在对有心血管疾病风险的人群进行搜索时,发现了 65,457 人,最后缩小到 26,580 人有心血管疾病风险且总胆固醇升高。最具鉴别性的 SNOMED 概念代码及其在数据集中的流行程度可为各国开展类似搜索提供参考:在 VICTORION-Spirit 中使用的 FARSITE 搜索确定了英国大曼彻斯特地区有 ASCVD 风险的人群,他们可能从 inclisiran 等降胆固醇药物中获益。
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Identification of patients at risk of cardiovascular disease in greater Manchester in the VICTORION-Spirit study
Background: Inclisiran is a cholesterol-lowering small interfering RNA treatment licensed in the UK for lowering low-density lipoprotein cholesterol (LDL-C). VICTORION-Spirit (NCT04807400) is an implementation science study designed to provide evidence for inclisiran implementation within the National Health Service. The aim was to describe the process of patient identification employed in VICTORION-Spirit. Methods: A Phase IIIb, multicentre, randomised controlled study, VICTORION-Spirit is evaluating inclisiran implementation in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C. Feasibility Assessment and Recruitment System for Improving Trial Efficiency (FARSITE) software utilising natural language search functions identified patients who may benefit from inclisiran. FARSITE searches were performed within Salford, Manchester, Trafford and Bury Clinical Commissioning Groups to identify individuals with elevated LDL-C or total cholesterol and pre-existing cardiovascular disease (CVD) or at risk of ASCVD. Results: FARSITE used ‘total cholesterol >4 mmol/l’ terminology rather than ‘LDL-C’; the former yielded >3 times the number of eligible patients. The search for individuals with pre-existing CVD identified 24,196 people in a population of 560,969 (4.3%); including ‘total cholesterol >4 mmol/l’ identified 10,431 individuals with pre-existing CVD and elevated total cholesterol. Searches for individuals at risk of ASCVD identified 65,457 people, narrowing to 26,580 at risk of ASCVD plus elevated total cholesterol. The most discriminatory SNOMED concept codes and their prevalence within the dataset can inform national approaches to develop similar searches. Conclusions: FARSITE searches employed in VICTORION-Spirit identified a population at risk of ASCVD in Greater Manchester, England, who may benefit from a cholesterol-lowering medication such as inclisiran.
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