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Association between Medicare high-risk criteria and outcomes after carotid revascularization procedures
Caitlin W Hicks1, Besma Nejim1, Satinderjit Locham1
1Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, Md.
Insights
The Centers for Medicare and Medicaid Services (CMS) high-risk criteria for carotid artery stenting (CAS) may overestimate benefits in high-risk patients and underappreciate utility in normal-risk patients. Re-evaluation of these criteria and national guidelines for CAS indications is needed.
Area of Science:
- Vascular Surgery
- Health Services Research
- Clinical Trial Analysis
Background:
- The Centers for Medicare and Medicaid Services (CMS) established high-risk criteria for carotid artery stenting (CAS).
- These criteria have not undergone validation to assess their accuracy in patient selection.
- This study validates the CMS high-risk criteria in a large, national cohort.
Purpose of the Study:
- To validate the CMS high-risk criteria for patient selection in carotid revascularization procedures.
- To compare stroke outcomes between CAS and carotid endarterectomy (CEA) in normal-risk and high-risk patient groups.
- To inform national guidelines regarding the indications for CAS.
Main Methods:
- Utilized the Vascular Quality Initiative (VQI) database from 2013-2016.
- Included patients undergoing CAS (with embolic protection) or CEA.
- Stratified patients into normal-risk (Nr) and high-risk (Hr) groups based on CMS criteria and used matching techniques for outcome comparison.
Main Results:
- A total of 51,942 patients were analyzed (CAS: 7030, CEA: 44,912).
- Crude analysis showed higher 30-day and 2-year stroke rates for CAS versus CEA in both Nr and Hr groups.
- After matching, stroke risk remained higher for CAS in the Hr group, but was similar between CAS and CEA in the Nr group.
Conclusions:
- The CMS criteria may overestimate the benefit of CAS in high-risk patients.
- The utility of CAS in normal-risk patients might be underestimated.
- Re-evaluation of CMS high-risk criteria and national guidelines for CAS indications is recommended.
Background:
The U.S. Centers for Medicare and Medicaid Services (CMS) has defined a set of high-risk criteria to help define patients who are appropriate for carotid artery stenting (CAS), but these criteria have never been validated. We aimed to validate the CMS high-risk criteria in a nationally representative cohort of patients undergoing CAS and carotid endarterectomy (CEA).
Methods:
All patients undergoing CAS (with embolic protection) or CEA in the Vascular Quality Initiative (VQI) database (2013-2016) were included. Patients were stratified as being at normal risk (Nr) or high risk (Hr) for undergoing CEA on the basis of CMS criteria. Thirty-day and 2-year stroke outcomes were compared for CAS vs CEA in both the Nr and Hr groups using 1:1 coarsened exact matching and multivariable Cox proportional hazards modeling.
Results:
A total of 51,942 patients (CAS, 7030; CEA, 44,912) underwent carotid revascularization during the study period. Thirty-day (Nr, 1.7% vs 1.0%; Hr, 2.5% vs 1.4%) and 2-year (Nr, 1.9% vs 1.0%; Hr, 2.4% vs 1.3%) stroke occurred more frequently after CAS vs CEA on crude analysis (P < .001). After matching 2920 pairs of patients on 18 preoperative variables, the risk of 30-day and 2-year stroke remained higher after CAS in the Hr group (30-day risk: hazard ratio [HR], 1.90; 95% confidence interval [CI], 1.26-2.85; 2-year risk: HR, 1.65; 95% CI, 1.05-2.60) but was similar for CAS vs CEA in the Nr group (30-day risk: HR, 0.97; 95% CI, 0.48-1.95; 2-year risk: HR, 1.49; 95% CI, 0.76-2.90).
Conclusions:
These data suggest that the utility of CAS in Nr patients may be underappreciated, whereas the potential benefit of CAS in Hr patients may be overestimated. Re-evaluation of the criteria for identifying patients at high risk for CEA and the national guidelines on the indications for CAS is strongly indicated.
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