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Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ
Author(s) -
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.
Publication year - 2008
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.21564
Subject(s) - medicine , carotid arteries , cardiology , revascularization , myocardial infarction
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 ≥50% for symptomatic patients and ≥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. © 2008 Wiley‐Liss, Inc.