Gray William A, Yadav Jay S, Verta Patrick, Scicli Andrea, Fairman Ronald, Wholey Mark, Hopkins L Nelson, Atkinson Richard, Raabe Rod, Barnwell Stanley, Green Richard
Columbia University Medical Center, 161 Ft. Washington Avenue, Fifth Floor, New York, NY 10032, USA.
Catheter Cardiovasc Interv. 2007 Dec 1;70(7):1025-33. doi: 10.1002/ccd.21359.
The use of carotid artery stenting with embolic protection has been practiced for over a decade in the United States, and increasingly so since carotid stenting received FDA approval in 2004. While there have been attempts at establishing predictors of outcomes in carotid artery stenting, they have generally been limited to single center experiences and/or multicenter retrospective surveys. This report examines predictors of outcomes in carotid stenting in the earliest and largest prospective multicenter neurologist-adjudicated experience in the United States post device approval.
The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry conducted to assess outcomes of carotid artery stenting (CAS) in the noninvestigational setting following device approval for high surgical risk patients (symptomatic with > or =50% stenosis; asymptomatic > or =80% stenosis). A neurologist examined the patients before the procedure, at 24 hr and 30-days post-procedure. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30-days post-procedure. Strokes and neurological events suspected to be strokes were adjudicated by an independent Clinical Events Adjudication Committee (CEAC) using prespecified definitions. Logistic regression analysis was performed to determine clinical, procedural, and anatomic predictors of endpoint outcomes.
Three thousand five hundred patients were enrolled at 144 sites by 353 physicians of varying specialty backgrounds and CAS experience. The 30-day primary endpoint event rate of death, stroke and MI was 6.3% [95% CI: 5.5-7.1%], and the rate of major stroke and death 2.9% [95% CI: 2.4-3.5]. Predictors of adverse outcomes included age, symptomatic patients, predilation prior to embolic protection device placement, time from symptoms to CAS procedure, and the use of multiple stents.
In general, carotid stenting is performed safely in patients with severe stenosis at high surgical risk, with best outcomes in younger asymptomatic patients. However, there are certain patient and procedural characteristics that are associated with poorer outcomes. In these patients, the risk of stenting should be considered vis-à-vis both the anticipated benefit as well as the alternative surgical and medical options.
在美国，使用带有栓子保护装置的颈动脉支架置入术已开展了十多年，自2004年颈动脉支架置入术获得美国食品药品监督管理局（FDA）批准后，其应用越来越广泛。虽然一直有人尝试确定颈动脉支架置入术预后的预测因素，但这些尝试通常局限于单中心经验和/或多中心回顾性调查。本报告在美国器械获批后最早且规模最大的前瞻性多中心神经病学专家判定的经验中，研究颈动脉支架置入术预后的预测因素。
颈动脉Acculink/Accunet获批后试验以发现意外或罕见事件（CAPTURE）是一项前瞻性多中心注册研究，旨在评估在器械获批后针对高手术风险患者（有症状且狭窄≥50%；无症状且狭窄≥80%）在非研究环境下进行颈动脉支架置入术（CAS）的预后。一名神经病学专家在手术前、术后24小时和30天对患者进行检查。主要终点是术后30天内死亡、任何卒中或心肌梗死的复合终点。卒中及疑似卒中的神经事件由独立的临床事件判定委员会（CEAC）根据预先设定的定义进行判定。进行逻辑回归分析以确定终点预后的临床、手术和解剖学预测因素。
353名具有不同专业背景和CAS经验的医生在144个地点纳入了3500名患者。术后30天死亡、卒中和心肌梗死的主要终点事件发生率为6.3%[95%可信区间（CI）：5.5 - 7.1%]，主要卒中和死亡发生率为2.9%[95%CI：2.4 - 3.5]。不良预后的预测因素包括年龄、有症状的患者、在放置栓子保护装置之前进行预扩张、从出现症状到进行CAS手术的时间以及使用多个支架。
总体而言，对于具有高手术风险的严重狭窄患者，颈动脉支架置入术实施安全，年轻无症状患者预后最佳。然而，存在某些与较差预后相关的患者和手术特征。对于这些患者，应权衡支架置入术的风险与预期获益以及替代的手术和药物选择。
