Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial.

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Circulation: Cardiovascular Interventions Pub Date : 2025-01-01 Epub Date: 2025-01-21 DOI:10.1161/CIRCINTERVENTIONS.124.014592

Neel M Butala, Christina Lalani, Archana Tale, Yang Song, Dhaval Kolte, Suzanne Baron, Jordan Strom, David J Cohen, Robert W Yeh

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引用次数: 0

Abstract

Background: Food and Drug Administration-mandated postmarket studies for transcatheter aortic valve replacement in low-risk populations plan to use passively collected registry data linked to claims for long-term follow-up out to 10 years. Therefore, it is critically important to understand the validity of these claims-based end points. We sought to evaluate the ability of administrative claims with International Classification of Diseases-Tenth Revision (ICD-10) codes to identify trial-adjudicated end points and reproduce treatment comparisons of aortic valve replacement in the Evolut Low Risk Trial.

Methods: We linked Evolut Low Risk trial patients to the Medicare Provider Analysis and Review database. We calculated sensitivity, specificity, positive predictive value, negative predictive value, and κ agreement statistic of claims to detect clinical end points through 2 years in trial patients. We additionally compared end points across treatment arms using trial-adjudicated outcomes versus claims-based outcomes.

Results: Trial-adjudicated deaths were perfectly identified by claims. Claims had good performance in identifying trial-adjudicated disabling stroke (sensitivity 68.8%, specificity 99.0%, positive predictive value 64.7%, negative predictive value 99.1%, κ=0.66) and pacemaker placement (sensitivity 85.2%, specificity 98.4%, positive predictive value 90.4%, negative predictive value 97.5%, κ=0.86), but more modest performance in identifying trial-adjudicated myocardial infarction (κ=0.46) and vascular complications (κ=0.45). There was no difference between treatment arms for the primary end point of death or disabling stroke using trial data (hazard ratio, 0.83 [95% CI, 0.41-1.68]) or claims data (hazard ratio, 0.89 [95% CI, 0.43-1.81]; interaction P=0.71).

Conclusions: Claims-based end points performed well in ascertaining death, disabling stroke, and pacemaker placement and were able to reproduce principal trial findings. These results support the selective use of claims-based end points for transcatheter aortic valve replacement postmarketing surveillance.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

查看原文本刊更多论文

在Evolut低风险试验中使用索赔来评估结果和治疗效果。

背景：美国食品和药物管理局（fda）授权的经导管主动脉瓣置换术在低风险人群中的上市后研究计划使用被动收集的登记数据，并进行长达10年的长期随访。因此，理解这些基于索赔的终点的有效性是至关重要的。我们试图用国际疾病分类第十版（ICD-10）代码评估行政索赔的能力，以确定试验判定的终点，并在Evolut低风险试验中再现主动脉瓣置换术的治疗比较。方法：我们将Evolut低风险试验患者与医疗保险提供者分析和评价数据库联系起来。我们计算敏感性、特异性、阳性预测值、阴性预测值和κ协议统计量，以检测试验患者2年的临床终点。此外，我们使用试验结果和基于索赔的结果比较了治疗组的终点。结果：审判裁决的死亡与索赔完全一致。声明在识别试验判定的致残性卒中（敏感性68.8%，特异性99.0%，阳性预测值64.7%，阴性预测值99.1%,κ=0.66）和起搏器放置（敏感性85.2%，特异性98.4%，阳性预测值90.4%，阴性预测值97.5%,κ=0.86）方面表现良好，但在识别试验判定的心肌梗死（κ=0.46）和血管并发症（κ=0.45）方面表现较差。使用试验数据（风险比，0.83 [95% CI, 0.41-1.68]）或索赔数据（风险比，0.89 [95% CI, 0.43-1.81]），治疗组之间的主要终点死亡或致残性卒中没有差异；交互P = 0.71)。结论：基于索赔的终点在确定死亡、致残性卒中和起搏器放置方面表现良好，并且能够重现主要试验结果。这些结果支持选择性地使用基于索赔的终点进行经导管主动脉瓣置换术上市后监测。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT02701283。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.