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CLINICAL RESEARCH: CLINICAL TRIAL

Carotid Artery Revascularization in High-Surgical-Risk Patients Using the Carotid WALLSTENT and FilterWire EX/EZ

1-Year Outcomes in the BEACH Pivotal Group

Sriram S. Iyer, MD, FACC^_*,_*, Christopher J. White, MD, FACC, L. Nelson Hopkins, MD, Barry T. Katzen, MD, Robert Safian, MD, FACC^||, Mark H. Wholey, MD^¶, William A. Gray, MD, FACC^#, Rocco Ciocca, MD^_**, William B. Bachinsky, MD, FACC, Gary Ansel, MD, James D. Joye, DO, FACC, Mary E. Russell, MD, FACC^_** for the BEACH Investigators

^_* Lenox Hill Hospital, New York, New York
Ochsner Clinic Foundation, New Orleans, Louisiana
University of Buffalo, Buffalo, New York
Baptist Hospital, Miami, Florida
^|| William Beaumont Hospital, Royal Oak, Michigan
^¶ Pittsburgh Vascular Institute, Pittsburgh, Pennsylvania
^# Columbia University Medical Center, New York, New York
^_** Boston Scientific Corporation, Natick, Massachusetts
Pinnacle Health at Harrisburg Hospital, Harrisburg, Pennsylvania
Riverside Methodist Hospital, Columbus, Ohio
El Camino Hospital, Mountain View, California.

Manuscript received July 23, 2007; revised manuscript received September 4, 2007, accepted September 17, 2007.

^_* Reprint requests and correspondence: Dr. Sriram Iyer, Lenox Hill Hospital, 130 East 77th Street, Black Hall, 9th Floor, New York, New York 10021. (Email: SRIUAB{at}aol.com).

Objectives: 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 (Boston Scientific Embolic Protection, Inc. [EPI]: A Carotid Stenting Trial for High-Risk Surgical Patients [BEACH]; [ClinicalTrials.gov] &rank=1">http://clinicaltrials.gov/ct2/show/NCT00316108 [ClinicalTrials.gov] ?term=NCT00316108&rank=1; NCT00316108 [ClinicalTrials.gov] ).

Abbreviations and Acronyms   CAS = carotid artery stent/stenting   CCA = common carotid artery   CEA = carotid endarterectomy   CI = confidence interval   FDA = Food and Drug Administration   ICA = internal carotid artery   MI = myocardial infarction   NIHSS = National Institutes of Health Stroke Scale   OPC = objective performance criterion   PSV = peak systolic velocity