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

• Published in: Catheterization and cardiovascular interventions Vol. 71; no. 7; pp. 950 - 960
• Main Authors: Hopkins, L Nelson, Myla, Subbarao, Grube, Eberhard, Wehman, J Christopher, Levy, Elad I, Bersin, Robert M, Joye, James D, Allocco, Dominic J, Kelley, Lynne, Baim, Donald S
• Format: Journal Article
• Language: English
• Published: United States 01.06.2008
• Subjects: Aged; Aged, 80 and over; Angiography; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Argentina; Carotid Stenosis - mortality; Carotid Stenosis - pathology; Carotid Stenosis - surgery; Carotid Stenosis - therapy; Embolism - complications; Embolism - etiology; Embolism - mortality; Embolism - prevention & control; Endarterectomy, Carotid - adverse effects; Female; Filtration - instrumentation; Germany; Humans; Male; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Myocardial Infarction - prevention & control; Prospective Studies; Risk Assessment; Severity of Illness Index; Stents; Stroke - etiology; Stroke - mortality; Stroke - prevention & control; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; United States; Argentina; Germany
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.21564

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-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls.