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目前的颈动脉支架置入术国家标准高估了其在有症状和高风险患者中的疗效。

The current national criteria for carotid artery stenting overestimate its efficacy in patients who are symptomatic and at high risk.

机构信息

Department of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.

出版信息

J Vasc Surg. 2013 Jul;58(1):120-7. doi: 10.1016/j.jvs.2012.12.075. Epub 2013 Apr 6.

Abstract

BACKGROUND

The Centers for Medicare and Medicaid Services (CMS) have established guidelines that outline patients who are considered "high risk" for complications after carotid endarterectomy (CEA) for which carotid artery stenting (CAS) may provide benefit. The validity of these high-risk criteria are yet unproven. In this study, we stratified patients who underwent CAS or CEA by CMS high-risk criteria and symptom status and examined their 30-day outcomes.

METHODS

A nonrandomized, retrospective cohort study was performed by chart review of all patients undergoing CEA or CAS from January 1, 2005, to December 31, 2010, at our institution. Demographic data and data pertaining to the presence or absence of high-risk factors were collected. Patients were stratified using symptom status and high-risk status as variables, and 30-day adverse events (stroke, death, myocardial infarction [MI]) were compared.

RESULTS

A total of 271 patients underwent CAS, with 30-day complication rates of stroke (3.0%), death (1.1%), MI (1.5%), stroke/death (3.7%), and stroke/death/MI (5.2%). A total of 830 patients underwent CEA with 30-day complication rates of stroke (2.0%), death (0.1%), MI (0.6%), stroke/death (1.9%), and stroke/death/MI (2.7%). Among symptomatic patients, physiologic high-risk status was associated with increased stroke/death (6 of 42 [14.3%] vs 2 of 74 [2.7%]; P < .01), and anatomic high-risk status was associated with a trend toward increased stroke/death (5 of 31 [16.1%] vs 0 of 20 [0.0%]; P = .14) in patients who underwent CAS vs CEA. Analysis of asymptomatic patients showed no differences between the two groups overall, except for a trend toward a higher rate of MI after CAS than after CEA (3 of 71 [4.2%] vs 0 of 108 [0.0%]; P = .06) in those who were physiologically at high risk. Among symptomatic patients who underwent CAS, patients with physiologic and anatomic high-risk factors had a higher rate of stroke/death than non-high-risk patients (6 of 42 [14.3%] vs 0 of 24 [0.0%] and 5 of 31 [16.1%] vs 0 of 24 [0.0%], respectively; both P ≤ .05).

CONCLUSIONS

Physiologic high-risk status was associated with increased stroke/death, whereas anatomic high-risk status showed a trend toward increased stroke/death in symptomatic patients undergoing CAS compared with non-high-risk patients undergoing CAS or physiologically high-risk patients undergoing CEA. Our results suggest that the current national criteria for CAS overestimate its efficacy in patients who are symptomatic and at high risk.

摘要

背景

医疗保险和医疗补助服务中心 (CMS) 制定了指南,概述了那些被认为在颈动脉内膜切除术 (CEA) 后有发生并发症高风险的患者,颈动脉支架置入术 (CAS) 可能对这些患者有益。这些高危标准的有效性尚未得到证实。在这项研究中,我们根据 CMS 的高危标准和症状状态对接受 CAS 或 CEA 的患者进行分层,并检查了他们的 30 天结果。

方法

对 2005 年 1 月 1 日至 2010 年 12 月 31 日期间在我院接受 CEA 或 CAS 的所有患者进行了非随机、回顾性队列研究。收集了人口统计学数据和存在或不存在高危因素的数据。患者按症状状态和高危状态进行分层,比较 30 天不良事件(卒、死亡、心肌梗死 [MI])。

结果

共有 271 例患者接受了 CAS,30 天并发症发生率为卒(3.0%)、死亡(1.1%)、MI(1.5%)、卒/死(3.7%)和卒/死/ MI(5.2%)。共有 830 例患者接受了 CEA,30 天并发症发生率为卒(2.0%)、死亡(0.1%)、MI(0.6%)、卒/死(1.9%)和卒/死/ MI(2.7%)。在有症状的患者中,生理高危状态与卒/死风险增加相关(42 例中的 6 例 [14.3%] vs 74 例中的 2 例 [2.7%];P <.01),解剖高危状态与卒/死风险增加呈趋势相关(31 例中的 5 例 [16.1%] vs 20 例中的 0 例 [0.0%];P =.14)在接受 CAS 与 CEA 的患者中。对无症状患者的分析显示,除了生理高危状态患者接受 CAS 后 MI 发生率高于 CEA(42 例中的 3 例 [4.2%] vs 108 例中的 0 例 [0.0%];P =.06)外,两组之间没有总体差异。在接受 CAS 的有症状患者中,有生理和解剖高危因素的患者卒/死风险高于非高危患者(42 例中的 6 例 [14.3%] vs 24 例中的 0 例 [0.0%]和 31 例中的 5 例 [16.1%] vs 24 例中的 0 例 [0.0%];均 P ≤.05)。

结论

生理高危状态与卒/死风险增加相关,而解剖高危状态在接受 CAS 的有症状患者中与非高危患者相比,卒/死风险呈增加趋势。我们的结果表明,目前用于 CAS 的国家标准高估了其在有症状和高危风险患者中的疗效。

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