Abstract 9848: A Subgroup Analysis of Carotid Artery Stenting with Distal Protection in High Surgical Risk Patients in Routine Clinical Practice: Results of the CABANA Safety Surveillance Program

Abstract

INTRODUCTION: The multicenter, nonrandomized CABANA Study evaluated periprocedural outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System (Boston Scientific, Natick, MA) HYPOTHESIS: We assessed whether a patient's symptomatic status, high risk category and age (≤80 years vs >80 years) had an impact on the 30-day composite rate and individual event rates of major adverse events (MAE including stroke, death and myocardial infarction [MI]). METHODS: Of the 1,097 patients enrolled, 34.4% were at high risk for carotid endarterectomy due to prespecified anatomic criteria, while 65.6% had medical comorbidities. Approximately one-third of patients were symptomatic for carotid artery disease (≥50% carotid artery stenosis); the rest were asymptomatic (≥80% carotid stenosis). Follow-up at 30 days included clinical evaluation and independent neurologic and NIH stroke scale assessments. RESULTS: At 30 days postprocedure, the MAE rate in the overall population was 4.6% (47/1025). In asymptomatic and symptomatic patients, MAE rates were 4.2% (29/697) and 5.5% (18/328); respectively ( P =0.34); in the ≤80-year and >80-year cohort, MAE rates were 4.1% (34/836) and 6.9% (13/189), respectively ( P =0.10). Individual event rates are shown in Table 1. Patients with comorbid risk factors showed strong trends towards higher major stroke rates (2.5% vs 0.9%, P =0.07) versus those at anatomic high risk. No differences were seen in MAE (3.7%, anatomic vs 5.1%, comorbid, P=0.33), death, or MI rates between groups. CONCLUSIONS: Composite MAE and individual event rates at 30 days in all subgroups were low and similar to the outcomes in the overall CABANA dataset. A trend toward higher incidence of major stroke in the comorbid high risk group was observed. These results demonstrate the safety of the Carotid WALLSTENT plus FilterWire EZ in high surgical risk patients, regardless of their risk profile.