Using Claims-Based Signatures of Frailty to Support Individualized Treatment of Aortic Valve Stenosis and Coronary Artery Disease

使用基于索赔的虚弱特征来支持主动脉瓣狭窄和冠状动脉疾病的个体化治疗

• 批准号: 10363612
• 负责人: Robert Yeh
• 金额: $ 12.03万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10363612
• 关键词: Accounting; Age; Aortic Valve Stenosis; Aspirin; Cardiovascular Diseases; Cardiovascular system; Caring; Characteristics; Clinical Trials; Communities; Complement; Coronary; Coronary Arteriosclerosis; Coronary artery; Data; Data Collection; Data Set; Data Sources; Decision Aid; Decision Making; Development; Enrollment; Evaluation; Faculty; Frail Elderly; Funding; Grant; Health; Health system; Heart Diseases; Hemorrhage; Heterogeneity; Hospitals; Individual; Knowledge; Laboratories; Life; Link; Measurement; Measures; Medical; Medicare claim; Mentors; Mid-Career Clinical Scientist Award (K24); Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patients; Physiological; Population; Procedures; Public Health; Quality of life; Recommendation; Registries; Research; Research Personnel; Research Support; Research Training; Risk; Risk Estimate; Risk Factors; Source; Stents; Stroke; Subgroup; Talents; Translating; Treatment outcome; Work; adverse event risk; aggressive therapy; alternative treatment; aortic valve; aortic valve replacement; base; career; comorbidity; data registry; evidence base; frailty; hazard; high risk; improved; indexing; individual patient; individualized medicine; inhibitor; insight; minimally invasive; mortality; novel; older patient; patient oriented research; personalized approach; personalized decision; point of care; preference; prognostic; programs; prospective; randomized trial; research clinical testing; risk stratification; shared decision making; stent thrombosis; stressor; therapy duration; tool; treatment effect; treatment strategy

PROJECT SUMMARY/ABSTRACT Severe aortic valve stenosis and coronary artery disease afflict a large number of patients worldwide. Choosing the optimal management strategies among various alternatives requires accounting for the characteristics and comorbidities of individuals that best determine the potential benefits or harms from different treatment approaches. However, randomized trials often do not collect the information necessary to inform individualized treatment decisions – in particular, data on patient frailty is typically not captured. In this grant, we will take advantage of linkages between two trial programs, the Dual Antiplatelet Therapy Study (comparing shorter vs. longer duration of antiplatelet therapy after coronary stenting) and the US CoreValve Program (comparing surgical versus transcatheter aortic valve replacement), with data from Medicare claims as part of the NHLBI-sponsored Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study to answer these additional questions. First, we will identify variables available in administrative claims that correlate with frailty among individuals undergoing aortic valve replacement or coronary artery stenting and assess whether they predict long-term adverse cardiovascular outcomes above traditional risk factors ascertained in trials. Next, we will determine whether claims-based frailty indices derived from these non-trial data can identify heterogeneous treatment effects – i.e. treatment effects that differ between individuals based on their personal characteristics – within the trials' randomized populations. Based on these results, we will then create and pilot the implementation of quantitative decision tools to support individualized treatment approaches for patients with aortic stenosis requiring aortic valve replacement and those who require dual antiplatelet therapy after coronary stent procedures. The results of this research will greatly enhance our understanding of whether administrative claims data can be used to augment the evaluation of patient frailty within clinical trials, and determine whether frail patients with cardiovascular disease require different treatment strategies. The results may also greatly improve the ability to identify individual patients who have the most or least to gain from different treatment approaches for two common and highly morbid cardiovascular conditions. Finally, the proposed research will help create evidence- based decision tools that can be used to support shared decision making between clinicians and patients with aortic valve stenosis and coronary artery disease.

项目总结/文摘