Objective The Stenting with Angioplasty and Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial compared carotid endarterectomy (CEA) to carotid artery stenting (CAS) among high-risk patients using a model of risk that has not been validated by previous publications. The objective of our study was to determine the accuracy of this high-risk model and to determine the true risk factors that result in patients being at high risk for CEA. Methods Prospectively collected data for 3098 CEAs between 2003 and 2011 at 20 Vascular Surgery Group of New England (VSGNE) centers were used. SAPPHIRE general inclusion criteria and primary outcomes were assessed. Factors that were associated with the primary outcome by analysis of variance (P <.10) and not linearly dependent, as determined by a Pearson correlation analysis, were further assessed for an independent association by multivariate logistic regression. A risk index model was developed for these significant predictors to accurately define high-risk CEA. Results The average patient age was 69.9 ± 9.5 years, 60% were male, and 45.7% were asymptomatic. The 1-year composite outcome event rate, defined as postoperative myocardial infarction and stroke or death, was 14.2%. Multivariate analysis (P <.05) found the following independently significant risk factors: age in years (95% confidence interval [CI], 1.0-1.1; P <.001), preadmission living in a nursing home (95% CI, 1.2-6.6; P =.020), congestive heart failure (95% CI, 1.4-2.8; P <.001), diabetes mellitus (DM; 95% CI, 1.1-1.3; P <.001), chronic obstructive pulmonary disease (95% CI, 1.2-1.5; P <.001), any previous cerebrovascular disease (95% CI, 1.1-1.9; P =.003), and contralateral internal carotid artery stenosis (95% CI, 1.0-1.2; P =.001). Three of the SAPPHIRE high-risk criteria - abnormal stress test, recurrent stenosis after CEA, and previous radiotherapy to the neck - were not independently associated with an adverse outcome. Independently significant risk factors not included in the SAPPHIRE criteria are inclusion of ages <80 years, preadmission living in a nursing home, DM, contralateral carotid stenosis, and any previous cerebrovascular accident. The risk index predictors are age in years (40-49: 0 points; 50-59: 2 points; 60-69: 4 points; 70-79: 6 points; 80-89: 8 points), living in a nursing home (4 points), any cardiovascular disease (2 points), congestive heart failure (5 points), chronic obstructive pulmonary disease (3 points), DM (2 points), degree of contralateral stenosis (<50%: 0 points; 50%-69%: 1 point; 70%-near occlusion: 2 points; occlusion: 3 points). High-risk CEA is defined as >13 points, representing adverse outcome rate of 22.5%. Conclusions SAPPHIRE and other previously reported high-risk CAS inclusion criteria do not include all of the factors found to be independently associated with outcomes. Further studies are required to determine whether CAS is inferior to CEA in high-risk patients using a validated model of risk. In addition, this preoperative assessment includes novel criteria that can be used to stratify risks.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine