Optimize Risk Assessment for Incident and Recurrent Atherosclerotic Cardiovascular Disease

优化事件和复发性动脉粥样硬化性心血管疾病的风险评估

• 批准号: 10447646
• 负责人: Jaejin An
• 金额: $ 71.18万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10447646
• 关键词: Address; Adult; Algorithms; American; American Heart Association; Asian; Asian population; Atherosclerosis; California; Cardiology; Cardiovascular system; Cholesterol; Chronic Kidney Failure; Clinical; Country; Data; Data Sources; Decision Making; Development; Discrimination; Dose; Dyslipidemias; East Asian; Electronic Health Record; Epidemiology; Equation; Equilibrium; Ethnic Origin; Ethnic group; European; Event; Future; Goals; Guidelines; Health Insurance; Heart failure; Hispanic; Hispanic Populations; Individual; Lipids; Literature; Mexican; Minority Groups; National Health and Nutrition Examination Survey; Outcome; Patients; Performance; Persons; Pharmaceutical Preparations; Population; Primary Prevention; Puerto Rican; Race; Recommendation; Recording of previous events; Recurrence; Resources; Risk; Risk Assessment; Risk Factors; Risk Reduction; Secondary Prevention; South Asian; Subgroup; Treatment Cost; Woman; cardiovascular disorder risk; cardiovascular health; cohort; college; cost effective; diverse data; enhancing factor; ethnic minority; ezetimibe; health disparity; health economics; health equity; health inequalities; high risk; improved; inhibitor; racial and ethnic; risk prediction; sex; social; social health determinants; tool; treatment guidelines

Recent American Heart Association (AHA) and American College of Cardiology (ACC) cholesterol guidelines put atherosclerotic cardiovascular disease (ASCVD) risk assessment at the center of decision-making for initiating and dosing of lipid-lowering therapies including statins, ezetimibe, and PCSK9 inhibitors. Nonetheless, there remains controversy regarding how efficiently this guideline directs medication to those who will receive a large absolute ASCVD risk reduction benefit. For primary prevention, the 2018 AHA/ACC guideline introduced the concept of risk-enhancing factors to identify individuals who have a risk higher than predicted by the pooled cohort equations (PCE). The presence of risk-enhancing factors supports a decision to initiate or intensify statin therapy in patients with borderline and intermediate risk. However, the guideline did not quantify how much a risk-enhancing factor changes an individual's 10-year risk, making decisions to treat or not to treat informed by the risk-enhancing factors ultimately subjective. Social determinants of health (SDOH) are important ASCVD risk factors. The PCE systematically underestimates risk for individuals who are socially deprived; however, SDOH are not included in the PCE or considered as risk-enhancing factors in the current guidelines. Additionally, the PCE's performance is questionable in Hispanics and Asians, the two fastest growing minority groups in the US. For secondary prevention, the 2018 guideline recommends high- intensity statin therapy for the 24 million US adults with established ASCVD, with ezetimibe and PCSK9 inhibitors recommended for a subset with a very high risk for recurrent ASCVD, defined by a history of multiple major ASCVD events or one major event with multiple high-risk conditions. However, recent evidence suggests that this definition may classify too many individuals (>50%) as having very high risk. Additionally, women, racial/ethnic minorities, and those with adverse SDOH may have a higher risk for recurrent ASCVD, but those factors were not considered in the current guideline when defining very high risk of recurrent ASCVD. To address these gaps in the literature and guidelines, our study proposes to 1) quantify how much the presence or absence of each risk-enhancing factor (including SDOH and Hispanic and Asian subgroups) and their combinations change 10-year ASCVD risk beyond PCE predictions; 2) determine the algorithm that optimizes the discrimination of individuals at very high risk for a recurrent ASCVD event; and 3) compare the health, economic, and health equity impact among US adults of selecting individuals for lipid-lowering therapies according to approaches identified in Aims 1 and 2 vs. in the 2018 cholesterol guideline. This study will develop approaches that improve the precision of cholesterol treatment guidelines in US adults, and help direct treatment to ethnic subgroups and groups with a high burden of adverse SDOH who have a high ASCVD risk but may not be recommended treatment by current national cholesterol guidelines. Findings from this study will inform future guidelines, improve cardiovascular outcomes, and narrow health inequities.

最近的美国心脏协会 (AHA) 和美国心脏病学会 (ACC) 胆固醇指南 将动脉粥样硬化性心血管疾病 (ASCVD) 风险评估置于决策的中心 降脂治疗的启动和给药，包括他汀类药物、依折麦布和 PCSK9 抑制剂。 尽管如此，关于该指南如何有效地将药物引导给那些人仍然存在争议。 谁将获得大量绝对 ASCVD 风险降低收益。对于一级预防，2018 年 AHA/ACC 指南引入了风险增强因素的概念，以识别风险高于 由汇总队列方程（PCE）预测。风险增强因素的存在支持以下决定： 对具有边缘和中等风险的患者开始或加强他汀类药物治疗。然而，该指南确实 没有量化风险增强因素对个人 10 年风险的改变程度，从而做出治疗决策 或不以最终主观的风险增强因素来对待。健康的社会决定因素 (SDOH) 是重要的 ASCVD 危险因素。 PCE 系统性地低估了以下个人的风险： 社会被剥夺的；然而，SDOH 并未包含在 PCE 中，也没有被视为风险增强因素。 当前的指导方针。此外，PCE 在西班牙裔和亚洲裔中的表现值得怀疑，这两个群体 美国增长最快的少数群体。对于二级预防，2018 年指南建议高 使用依折麦布和 PCSK9 对 2400 万患有 ASCVD 的美国成年人进行强度他汀类药物治疗 推荐用于具有极高复发性 ASCVD 风险的亚群（由多种疾病史定义） 重大 ASCVD 事件或具有多种高风险状况的一项重大事件。然而，最近的证据表明 该定义可能会将太多个人 (>50%) 归类为具有非常高的风险。此外，女性， 少数种族/族裔以及具有不良 SDOH 的人可能有较高的复发 ASCVD 风险，但那些 当前指南在定义 ASCVD 复发风险极高时未考虑因素。 为了解决文献和指南中的这些差距，我们的研究建议：1）量化 是否存在每个风险增强因素（包括 SDOH 以及西班牙裔和亚洲裔亚群）以及 它们的组合改变了 10 年 ASCVD 风险，超出了 PCE 的预测； 2）确定算法 优化对复发性 ASCVD 事件高风险个体的歧视； 3）比较 选择个人降脂对美国成年人的健康、经济和健康公平的影响 根据目标 1 和 2 与 2018 年胆固醇指南中确定的方法进行治疗。 这项研究将开发提高美国成年人胆固醇治疗指南精度的方法， 帮助对不良 SDOH 负担较高的种族亚群体和群体进行直接治疗 ASCVD 风险较高，但现行国家胆固醇指南可能不推荐治疗。发现 这项研究的结果将为未来的指导方针提供信息，改善心血管结果，并缩小健康不平等。