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 Criteria for Carotid Artery Stenting Overestimate Its Efficacy in Some Patients  

 Study shows symptomatic, high risk patients are most affected by current guidelines  

 JULY 1, 2013

​CHICAGO– A new study from Beth Israel Deaconess Medical Center (BIDMC) in Boston, Mass. indicates that current national criteria for carotid artery stenting (CAS) overestimate its efficacy in patients who are symptomatic and at high risk.
Marc L. Schemerhorn, MD, chief of the division of vascular and endovascular surgery at BIDMC, says that the validity of these high-risk criteria developed by The Centers for Medicare and Medicaid Services (CMS) are yet unproven. The CMS guidelines note that certain patients are considered at high risk for complications after carotid endarterectomy (CEA) for which (CAS) may provide benefit. 
“In our study we found physiologic high-risk status was associated with increased stroke/death, whereas  anatomic high-risk status showed a trend toward increased stroke/death in  symptomatic patients undergoing CAS  compared with  non- high-risk patients undergoing CAS or physiologically high-risk patients undergoing CEA,” added Dr. Schemerhorn.   
Dr. Schemerhorn and his co-researchers created a nonrandomized, retrospective cohort study that was performed by chart review of all patients at BIDMC undergoing CEA or CAS (as defined by CMS high-risk criteria) from January 1, 2005, to December 31, 2010. Demographic data and data pertaining to the presence or absence of high-risk factors were collected. Patients were stratified using symptom status and high-risk status as variables, and 30-day adverse  events  (stroke, death, myocardial infarction [MI]) were compared.
For the 271  patients who underwent CAS, the  30-day complication rates  of  stroke  (3.0 percent),  death (1.1 percent),  MI (1.5 percent),  stroke/death (3.7 percent),  and  stroke/death/MI (5.2 percent).  Of the  830   patients who underwent CEA, the 30-day complication rates  of  stroke   (2.0 percent),  death (0.1 percent),  MI  (0.6 percent),  stroke/death (1.9 percent),  and  stroke/death/MI (2.7 percent). 
Among symptomatic patients, physiologic high-risk status was associated with increased stroke/death (6 of 42 [14.3 percent] vs. 2 of 74 [2.7 percent];  P < .01), and  anatomic high-risk status was associated with  a trend toward increased stroke/death (5 of 31  [16.1 percent] vs. 0 of 20  [0.0 percent];  P =.14)  in patients who  underwent CAS vs. CEA. Analysis of asymptomatic patients showed no differences between the two groups overall, except for a trend toward a higher rate of MI after CAS than after CEA (3 of 71 [4.2 percent] vs. 0 of 108  [0.0 percent];  P =.06)  in those who were physiologically at high  risk. 
Among symptomatic patients who underwent CAS, patients with physiologic and anatomic high-risk factors,  had a higher rate of stroke/death than non-high-risk patients (6 of 42 [14.3 percent] vs. 0 of 24 [0.0 percent]  and 5 of 31 [16.1 percent] vs. 0 of 24 [0.0 percent] respectively; both less than or equal to .05. 
“We believe the current selection criteria for CAS vs. CEA may be inappropriate,” added Dr. Schemerhorn. “Physiologic high-risk, symptomatic patients, as defined by the current CMS criteria for CAS reimbursement, may be better suited for CEA than CAS. However, CAS may be a reasonable alternative to CEA in symptomatic patients who are not at high risk. Future comparative analyses of CEA vs. CAS should be stratified according to physiologic high-risk status and symptom status to overcome bias in patient selection. Further work and a greater number of patients are needed to identify appropriate patients for CAS, CEA, or medical management.”

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