Carotid Artery Revascularization in High-Surgical-Risk Patients Using the Carotid WALLSTENT and FilterWire EX/EZ: 1-Year Outcomes in the BEACH Pivotal Group

Abstract

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, Christopher J. White, L. Nelson Hopkins, Barry T. Katzen, Robert Safian, Mark H. Wholey, William A. Gray, Rocco Ciocca, William B. Bachinsky, Gary Ansel, James D. Joye, Mary E. Russell, for the BEACH Investigators The multicenter, single-arm BEACH (Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients) trial (n = 480) evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the WALLSTENT plus FilterWire EX/EZ. Follow-up included duplex imaging and independent neurologic examination. The 1-year composite primary end point (30-day stroke, death, Q-wave myocardial infarction [MI]; 24-h non–Q-wave MI; 1-year ipsilateral stroke or neurologic death) occurred in 8.9% of patients (11.5% upper 95% confidence limit), well within the 16.6% calculated noninferiority margin (12.6% objective performance criterion for high-risk carotid endarterectomy [CEA] plus 4% margin). In high-surgical-risk patients, stenting with the WALLSTENT plus FilterWire EX/EZ is noninferior (equivalent or better, p < 0.0001) to CEA at 1 year. 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). Carotid artery stent (CAS) placement offers a less invasive alternative for high-risk surgical carotid endarterectomy (CEA) patients. 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%. 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). 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]; http://clinicaltrials.gov/ct2/show/NCT00316108?term=NCT00316108&rank=1 ; NCT00316108 ).