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

Abstract

OBJECTIVE:

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.

BACKGROUND:

For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA).

METHODS:

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.

RESULTS:

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%.

CONCLUSIONS:

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.

• Authors: L Nelson Hopkins, Subbarao Myla, Eberhard Grube, J Christopher Wehman, Elad I Levy, Robert M Bersin, James D Joye, Dominic J Allocco, Lynne Kelley, Donald S Baim
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 71 Issue 7 Pg. 950-60 (Jun 01 2008) ISSN: 1522-726X [Electronic] United States
• PMID: 18412236 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: 2008 Wiley-Liss, Inc.

Topics

• Aged
• Aged, 80 and over
• Angiography
• Angioplasty, Balloon (adverse effects, instrumentation)
• Argentina
• Carotid Stenosis (mortality, pathology, surgery, therapy)
• Embolism (complications, etiology, mortality, prevention & control)
• Endarterectomy, Carotid (adverse effects)
• Female
• Filtration (instrumentation)
• Germany
• Humans
• Male
• Myocardial Infarction (etiology, mortality, prevention & control)
• Prospective Studies
• Risk Assessment
• Severity of Illness Index
• Stents
• Stroke (etiology, mortality, prevention & control)
• Time Factors
• Treatment Outcome
• Ultrasonography, Doppler, Duplex
• United States