Valvular & structural heart disease
Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial
Authors' conclusion
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.
Study context
- Population
- Evolut Low Risk trial patients linked to the Medicare Provider Analysis and Review database
- Index test or model
- Administrative claims with ICD-10 codes vs trial-adjudicated end points
- Target condition
- Trial-adjudicated end points:
- Death
- Disabling stroke
- Pacemaker placement
- Myocardial infarction
- Vascular complications
Methodological detailsEvolut Low Risk Trial, linked to the Medicare Provider Analysis and Review database, ICD-10 claims codes, through 2 years
- Evolut Low Risk Trial
- Linked to the Medicare Provider Analysis and Review database
- ICD-10 claims codes
- Through 2 years
Performance
As reported in the abstract
through 2 years
| Test or model | Identification | Sensitivity | Specificity | Positive predictive value | Negative predictive value | κ |
|---|---|---|---|---|---|---|
| Death | perfectly identified by claims | |||||
| Disabling stroke | 68.8% | 99.0% | 64.7% | 99.1% | 0.66 | |
| Pacemaker placement | 85.2% | 98.4% | 90.4% | 97.5% | 0.86 | |
| Myocardial infarction | 0.46 | |||||
| Vascular complications | 0.45 |
Identification
Deathperfectly identified by claims
Disabling stroke— not stated in the abstract
Pacemaker placement— not stated in the abstract
Myocardial infarction— not stated in the abstract
Vascular complications— not stated in the abstract
Sensitivity
Death— not stated in the abstract
Disabling stroke68.8%
Pacemaker placement85.2%
Myocardial infarction— not stated in the abstract
Vascular complications— not stated in the abstract
Specificity
Death— not stated in the abstract
Disabling stroke99.0%
Pacemaker placement98.4%
Myocardial infarction— not stated in the abstract
Vascular complications— not stated in the abstract
Positive predictive value
Death— not stated in the abstract
Disabling stroke64.7%
Pacemaker placement90.4%
Myocardial infarction— not stated in the abstract
Vascular complications— not stated in the abstract
Negative predictive value
Death— not stated in the abstract
Disabling stroke99.1%
Pacemaker placement97.5%
Myocardial infarction— not stated in the abstract
Vascular complications— not stated in the abstract
κ
Death— not stated in the abstract
Disabling stroke0.66
Pacemaker placement0.86
Myocardial infarction0.46
Vascular complications0.45
Further findings
Death or disabling stroke (trial primary end point), between treatment arms
| Hazard ratio (95% CI) | P value | ||
|---|---|---|---|
| Treatment arms (trial data)Trial-adjudicated outcomes; arm order not stated | 0.83 (0.41–1.68) | ||
| Treatment arms (claims data)Claims-based outcomes; arm order not stated | 0.89 (0.43–1.81) | interaction P =0.71 | |
| 0.512Hazard ratio (log scale) |
- No difference between treatment arms
Original publication
Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial. Circ Cardiovasc Interv. Published 21 January 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →