Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the EXTEND Study
Open accessAbstract
Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). Results: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial’s primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65–1.09]; P =0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66–1.11]; P =0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes ( P noninferiority <0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate, 60.5%), the trial’s primary end point was 12.9% for TAVR and 13.1% for SAVR using trial data (hazard ratio, 1.08 [95% CI, 0.79–1.48]; P =0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73–1.41]; P =0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims ( P non inferiority <0.001 for both). Rates of procedural secondary outcomes (eg, aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than nonprocedural outcomes (eg, stroke, bleeding, cardiogenic shock). Conclusions: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.
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30-40% of hospitalizations with primary ICD codes for HF do not meet established criteria upon medical record review.
“However, these codes can be imprecise: 30 -40 % of hospi talizations with primary ICD codes for HF do not meet the established criteria upon medical record review, such as iatrogenic volume overload following surgery or critical illness, or patients with chronic HF admitted for reasons other than acute HF (AHF) [7 -9].”
From Assessing large language models for acute heart failure classification and information extraction from French clinical notes (2025) · cites this paper as [7]
The Materials and Methods (Covariates and Outcomes; page unavailable) lists the outcomes compared between claims and adjudicated trial records, but not heart-failure hospitalization. The Discussion addresses coding discrepancies for stroke, bleeding, and cardiogenic shock; searches for the 30–40% estimate and heart-failure admissions found no passage supporting the claimed medical-record-review figure. (LLM, conf=0.76)
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- Authors
- Strom, J. B., Faridi, K. F., Butala, N. M., Zhao, Y., Tamez, H., Valsdottir, L. R., Brennan, J. M., Shen, C., Popma, J. J., Kazi, D. S., & Yeh, R. W.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Harvard University (US)
- Duke Clinical Research Institute (US)
- ORCID
- Venue
- Circulation
- Published
- 2020-07-21
- Volume
- 142
- Issue
- 3
- Pages
- 203-213
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- PMC
- PMC7672506
- OpenAlex
- W3028032072
- Cited by
- 37
- References
- 33
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 4 · 2023: 10 · 2022: 2 · 2021: 8 · 2020: 2
- FWCI
- 3.40
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR001863, KL2TR001862)
- National Heart, Lung, and Blood Institute (K23HL144907, R01HL136708, K24HL150321)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Health Professions › Health Information Management › Medical Coding and Health Information
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Aortic Disease and Treatment Approaches
- Keywords
- transcatheter aortic valve implantation, surgical aortic valve replacement, administrative claims data, all-cause mortality, non-inferiority, older adults, treatment effect estimation, reoperation, hospital readmission
- MeSH terms
- Aged, Aged, 80 and over, Female, Medicare, Humans, Male, United States, Incidence, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Health Care Surveys, Transcatheter Aortic Valve Replacement
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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