Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial.
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.
Hopkins
L Nelson
LN
Department of Neurosurgery, University of Buffalo and Toshiba Stroke Center, Buffalo, New York 14209, USA. lnhbuffns@aol.com
Myla
Subbarao
S
Grube
Eberhard
E
Wehman
J Christopher
JC
Levy
Elad I
EI
Bersin
Robert M
RM
Joye
James D
JD
Allocco
Dominic J
DJ
Kelley
Lynne
L
Baim
Donald S
DS
D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001118:Argentina; D016893:Carotid Stenosis / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D004617:Embolism / Q000150:complications / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016894:Endarterectomy, Carotid / Q000009:adverse effects*; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D005858:Germany; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States