Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
L Nelson HopkinsDonald S Baim

Abstract

The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent plus FilterWire EX/EZ Emboli Protection System. For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography > or = 50% for symptomatic patients and > or = 60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31-365 days) ipsilateral stroke. Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1...Continue Reading

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