Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ
Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ
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DOI：
10.1016/j.jacc.2007.09.045
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发表时间：
2008-01-29
影响因子：
24
通讯作者：
Russell, Mary E.
中科院分区：
文献类型：
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作者：
Iyer, Sriram S.;White, Christopher J.;Russell, Mary E.
多中心、单臂BEACH （Boston Scientific EPI: A颈动脉支架置入高危手术患者试验）评估了颈动脉WALLSTENT + FilterWire EX/EZ栓塞保护系统（Boston Scientific, Natick, Massachusetts）治疗颈动脉狭窄的高危手术患者的结果。背景颈动脉支架（CAS）置入术为高风险颈动脉内膜切除术（CEA）患者提供了一种侵入性较小的选择。方法：该试验纳入了480例关键患者，他们是颈动脉血管重建术的候选人，但由于预先规定的解剖标准和/或医学合并症而被认为手术风险高。主要终点（30天内所有卒中、死亡或q波心肌梗死[MI]； 24小时内无q波心肌梗死；1年内同侧卒中或神经系统性死亡）与已公布的类似患者动脉内膜切除术结果的比例加权客观表现标准（OPC） 12.6%进行比较，加上预先指定的非效性界限为4%。结果关键患者中，41.2%因合并症危险因素手术风险高，58.8%因解剖危险因素手术风险高；76.7%无症状，颈动脉狭窄限流；1年后，复合主要终点发生率为8.9%（447例中的40例），重复血运重建率为4.7%。主要复合终点的95%置信上限为11.5%，BEACH试验结果符合预定的标准，相对于计算的OPC和类似患者历史手术CEA结果的非劣效性（16.6%）（非劣效性p < 0.0001）。结论：BEACH试验结果表明，在高危手术患者中，CAS联合WALLSTENT + FilterWire栓塞保护在1年内不逊于CEA（相当于或优于）(Boston Scientific embolic protection, Inc. [EPI]：一项针对高危手术患者的颈动脉支架置入术试验[BEACH]； http://clinicaltrials.gov/ct2/ show/NCT00316108？term = NCT00316108&rank = 1；NCT00316108)。
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 I 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 prespecified 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 noninferior (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).