Center for Interventional Vascular Therapy, Columbia University, New York, NY 10032, USA.
Circ Cardiovasc Interv. 2009 Jun;2(3):159-66. doi: 10.1161/CIRCINTERVENTIONS.108.823013. Epub 2009 Mar 6.
The American Heart Association has established guidelines for acceptable 30-day death and stroke rates for patients with severe carotid disease undergoing standard-risk carotid endarterectomy: <3% for asymptomatic lesions and <6% for symptomatic lesions. To date, carotid artery stenting has not demonstrated these outcomes in multicenter, prospective assessments of high-surgical-risk patients.
Data from 2 prospective, multicenter (280 US sites, 672 operators), postmarket surveillance studies in high-surgical-risk patients were analyzed: 2145 patients from the Emboshield and Xact Post Approval Carotid Stent Trial (EX) and 4175 patients from the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (C2). Both studies had pre- and postprocedure neurological evaluation and independent adjudication of neurological events. The overall 30-day death and stroke rate was 4.1% (95% CI, 3.3% to 5.0%) for EX and 3.4% (95% CI, 2.9% to 4.0%) for C2. In the population comparable with American Heart Association guidelines (<80 years), the combined 30-day death and stroke rate was 5.3% (95% CI, 3.6% to 7.4%) for symptomatic patients and 2.9% (95% CI, 2.4% to 3.4%) for asymptomatic patients, independent of unfavorable risk factors (anatomic or physiologic); in patients >/=80 years, this rate was 10.5% (95% CI, 6.3% to 16.0%) and 4.4% (95% CI, 3.3% to 5.7%), respectively. In subjects with anatomic features unfavorable for surgery, the 30-day death and stroke rates were 1.7% (95% CI, 0.0% to 8.9%) and 2.7% (95% CI, 1.3% to 4.9%) for symptomatic and asymptomatic cohorts, respectively, independent of age.
Outcomes for carotid artery stenting in nonoctogenarian high-surgical-risk patients have improved since the pivotal Food and Drug Administration approval trials, and have achieved American Heart Association standards in both symptomatic and asymptomatic lesions.
美国心脏协会为接受标准风险颈动脉内膜切除术的严重颈动脉疾病患者制定了可接受的 30 天死亡和卒中发生率指南：无症状病变<3%，有症状病变<6%。迄今为止，多中心前瞻性评估高手术风险患者的颈动脉支架置入术并未显示出这些结果。
对高手术风险患者的 2 项前瞻性、多中心（280 个美国站点，672 名操作者）上市后监测研究的数据进行了分析：来自 Emboshield 和 Xact 术后批准颈动脉支架置入试验（EX）的 2145 例患者和来自颈动脉 ACCULINK/ACCUNET 术后批准试验以揭示罕见事件（C2）的 4175 例患者。两项研究均进行了术前和术后神经评估以及独立的神经事件裁决。EX 的总体 30 天死亡和卒中发生率为 4.1%（95%CI，3.3%至 5.0%），C2 为 3.4%（95%CI，2.9%至 4.0%）。在与美国心脏协会指南（<80 岁）可比的人群中，症状性患者的联合 30 天死亡和卒中发生率为 5.3%（95%CI，3.6%至 7.4%），无症状患者为 2.9%（95%CI，2.4%至 3.4%），独立于不利的危险因素（解剖或生理）；>/=80 岁的患者，这一比率分别为 10.5%（95%CI，6.3%至 16.0%）和 4.4%（95%CI，3.3%至 5.7%）。在解剖特征不利于手术的患者中，症状性和无症状队列的 30 天死亡和卒中发生率分别为 1.7%（95%CI，0.0%至 8.9%）和 2.7%（95%CI，1.3%至 4.9%），独立于年龄。
非 80 岁以上高手术风险患者的颈动脉支架置入术的结果自关键的食品和药物管理局批准试验以来有所改善，并且在有症状和无症状病变中均达到了美国心脏协会的标准。
