Illig Karl A, Zhang Renyu, Tanski William, Benesch Curt, Sternbach Yaron, Green Richard M
Division of Vascular Surgery, University of Rochester Medical Center, 601 Elmwood Avenue, Box 652, Rochester, NY 14642, USA.
J Vasc Surg. 2003 Mar;37(3):575-81. doi: 10.1067/mva.2003.79.
To compare outcome after carotid endarterectomy (CEA) in patients who would have been excluded from the North American Symptomatic Carotid Endarterectomy Trial (NASCET) or the Asymptomatic Carotid Atherosclerosis Study (ACAS) or would have been eligible for Acculink for Revascularization of Carotids in High Risk Patients (ARCHeR), a current high-risk stent registry, with outcome in a similar cohort at low risk.
Records of all CEAs performed at our institution from July 1993 to December 2000 were reviewed. Patients were assigned to groups either eligible or ineligible for NASCET and ACAS or ARCHeR, and criteria were stratified according to whether risk was defined by anatomic or medical problems or whether patients were ineligible according to nonmedical protocol exclusion criteria only.
Preoperative and postoperative data were sufficient to determine risk status according to various study criteria in 857 patients. Stroke or death within 30 days, the primary end point, occurred in 2.1% of patients. Rates were similar in patients excluded from (2.7%) or included in (1.6%) NASCET and ACAS and in patients eligible (3.1%) or ineligible (2.1%) for ARCHeR. Rates did not differ according to whether exclusion or inclusion was based on anatomic risk, medical risk, or protocol exclusion, although trends favored worse outcome in the ARCHeR medical risk subgroup. A higher rate of minor complications was found in the elderly; however, stroke and death rates were similar according to age, gender, repeat procedure, or the presence of contralateral occlusion.
No statistically or clinically significant differences were found in combined 30-day stroke or death rates after CEA in any group defined by previous surgical trials or current ongoing high-risk stent registry. While high-risk groups may exist, the premise that operative risk is higher in patients excluded from NASCET and ACAS or eligible for ARCHeR is not supported.
比较在北美症状性颈动脉内膜切除术试验（NASCET）或无症状性颈动脉粥样硬化研究（ACAS）中被排除或符合高危患者颈动脉血运重建Acculink（ARCHeR，一个当前的高危支架注册研究）标准的患者，与低风险的类似队列患者行颈动脉内膜切除术（CEA）后的结果。
回顾了1993年7月至2000年12月在我们机构进行的所有CEA记录。患者被分为符合或不符合NASCET、ACAS或ARCHeR标准的组，标准根据风险是由解剖学或医学问题定义，还是患者仅根据非医学方案排除标准不符合而分层。
术前和术后数据足以根据各种研究标准确定857例患者的风险状态。30天内的卒中或死亡这一主要终点在2.1%的患者中发生。在被NASCET和ACAS排除（2.7%）或纳入（1.6%）的患者以及符合ARCHeR标准（3.1%）或不符合标准（2.1%）的患者中发生率相似。根据排除或纳入是基于解剖学风险、医学风险还是方案排除，发生率没有差异，尽管趋势显示ARCHeR医学风险亚组的结果更差。在老年人中发现轻微并发症发生率较高；然而，根据年龄、性别、再次手术或对侧闭塞情况，卒中率和死亡率相似。
在由先前手术试验或当前正在进行的高危支架注册研究定义的任何组中，CEA后30天卒中或死亡率合并起来没有发现统计学或临床显著差异。虽然可能存在高危组，但不支持在被NASCET和ACAS排除或符合ARCHeR标准的患者中手术风险更高这一前提。
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