ArticleCirculation. Cardiovascular interventions2025
Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial.
Article in Circulation. Cardiovascular interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02701283 (Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement), which is not on this map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Who cites it
4 citing papers in PubMed.
- Validity of the International Classification of Diseases, Tenth Revision codes in diagnosing myocardial infarction subtypes.American heart journal · 2026Article
- Estimating the Effects of MTEER in U.S. Practice: A Transportability Analysis of the COAPT Trial.Journal of the American College of Cardiology · 2026Article
- Evaluating Cardiovascular Devices Using Observational Analyses.Circulation · 2026Review
- Sex Differences in Stroke Frequency and Severity Following Transcatheter Aortic Valve Replacement.Journal of the American Heart Association · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundFood 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
methodsWe 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
resultsTrial-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%,
conclusionsClaims-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.
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Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.