Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group.
OBJECTIVE
The multicenter, single-arm BEACH (Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients) evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EX/EZ Emboli Protection System (Boston Scientific, Natick, Massachusetts).


BACKGROUND
Carotid artery stent (CAS) placement offers a less invasive alternative for high-risk surgical carotid endarterectomy (CEA) patients.


METHODS
The trial enrolled 480 pivotal patients who were candidates for carotid revascularization but considered high surgical risk due to pre-specified anatomic criteria and/or medical comorbidities. The primary end point (all stroke, death, or Q-wave myocardial infarction [MI] through 30 days; non-Q-wave MI through 24 h; and ipsilateral stroke or neurologic death through 1 year) was compared with a proportionally weighted objective performance criterion (OPC) of 12.6% for published surgical endarterectomy results in similar patients, plus a pre-specified noninferiority margin of 4%.


RESULTS
Among pivotal patients, 41.2% were at high surgical risk due to comorbid risk factors, and 58.8% due to anatomic risk factors; 76.7% were asymptomatic with flow-limiting carotid stenosis >80%. At 1 year, the composite primary end point occurred in 8.9% (40 of 447), with a repeat revascularization rate of 4.7%. With an upper 95% confidence limit of 11.5% for the primary composite end point, the BEACH trial results met the pre-specified criteria for noninferiority relative to the calculated OPC plus noninferiority margin (16.6%) for historical surgical CEA outcomes in similar patients (p < 0.0001 for noninferiority).


CONCLUSIONS
The BEACH trial results demonstrate that CAS with the WALLSTENT plus FilterWire embolic protection is non-inferior (equivalent or better than) to CEA at 1-year in high-surgical-risk patients.
Iyer
Sriram S
SS
Lenox Hill Hospital, New York, New York 10021, USA. SRIUAB@aol.com
White
Christopher J
CJ
Hopkins
L Nelson
LN
Katzen
Barry T
BT
Safian
Robert
R
Wholey
Mark H
MH
Gray
William A
WA
Ciocca
Rocco
R
Bachinsky
William B
WB
Ansel
Gary
G
Joye
James D
JD
Russell
Mary E
ME
D000368:Aged; D001783:Blood Flow Velocity; D006348:Cardiac Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D016893:Carotid Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005374:Filtration / Q000295:instrumentation; D006801:Humans; D008297:Male; D011446:Prospective Studies; D018570:Risk Assessment; D015607:Stents; D016896:Treatment Outcome; D014463:Ultrasonography