Background & purpose: Embolic protection devices (EPD) may provide a mechanism to reduce peri-procedural strokes. They are advocated by consensus guidelines and mandated for Medicare reimbursement. However, outcomes data remain mixed. We aimed to characterize the population of patients undergoing unprotected carotid artery stenting (CAS) and assess the utility of distal filter EPD (F-EPD) in elective CAS.
Methods: We analyzed patients enrolled in the CARE Registry® undergoing CAS between May, 2005 and January, 2012. We assessed the relationship between distal F-EPD use versus no use (No-EPD) and the composite of in-hospital death or stroke (MAE) in unadjusted and 1:3 propensity-matched analyses.
Results: Embolic protection was not attempted in a total of 579 out of 13,263 cases performed (4.4%). Patients in the No-EPD group had worse preprocedure neurologic risk factors including higher rates of acute evolving stroke, prior TIA/stroke, symptomatic lesion status, spontaneous carotid artery dissection, and use of general anesthesia intraprocedurally (all Standardized Differences{sd} >10). After exclusion of nonelective cases there was no significant difference in MAE between the No-EPD and F-EPD groups (1.6% vs. 2.3%, sd = 4.72). Additionally, after propensity matching, rates of MAE did not differ between the No-EPD (n = 355) and F-EPD (n = 1065) groups (1.7% vs. 2.5%, sd = 5.87).
Conclusions: Patients selected to undergo unprotected CAS in contemporary practice have high rates of adverse preprocedure neurologic risk factors. Our propensity-matched analysis did not demonstrate evidence of significant benefit or harm associated with use of F-EPD in elective CAS patients.
Keywords: carotid artery stenosis; carotid artery stenting; embolic protection devices.
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