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

项目总结/摘要 严重的主动脉瓣狭窄和冠状动脉疾病困扰着全世界大量的患者。 在各种备选方案中选择最佳管理战略需要考虑 最能确定潜在获益或危害的个体特征和合并症 不同的治疗方法。然而，随机试验往往没有收集必要的信息， 告知个体化治疗决策-特别是，通常不捕获关于患者虚弱的数据。在这 我们将利用两个试验项目之间的联系，双重抗血小板治疗研究 （比较冠状动脉支架植入术后较短与较长的抗血小板治疗持续时间）和US CoreValve 计划（比较手术与经导管主动脉瓣置换术），数据来自医疗保险索赔 作为NHLBI赞助的使用新型药物治疗的扩展试验评估的一部分， 数据来源（扩展）研究来回答这些额外的问题。首先，我们将确定变量 可用于与接受主动脉瓣置换术的个体虚弱相关的行政索赔 置换术或冠状动脉支架植入术，并评估它们是否预测长期不良心血管疾病 结果高于试验中确定的传统风险因素。接下来，我们将确定是否基于索赔 从这些非试验数据中得出的虚弱指数可以识别异质性治疗效果-即治疗 基于个人特征的个体间差异的影响-在试验的随机 人口。根据这些结果，我们将创建并试点实施定量决策 支持需要主动脉瓣的主动脉瓣狭窄患者个体化治疗方法的工具 冠状动脉支架植入术后需要双重抗血小板治疗的患者。的结果 这项研究将大大提高我们对行政索赔数据是否可以用于 在临床试验中增加对患者虚弱程度的评估，并确定虚弱患者是否 心血管疾病需要不同的治疗策略。结果也可能大大提高能力， 确定从两种不同的治疗方法中获益最多或最少的个体患者 常见且高度病态的心血管疾病。最后，拟议的研究将有助于创造证据- 的决策工具，可用于支持临床医生和患者之间的共享决策， 主动脉瓣狭窄和冠状动脉疾病

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.