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

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

SUBMITTER: Butala NM 

PROVIDER: S-EPMC11748901 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature