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1、颈动脉成形术支架概述首都医科大学宣武医院朱凤水前 言卒中是目前三大死亡原因之一。5-12%初发卒中由可行血管重建的颈动脉闭塞性 疾病所致。颈动脉支架术是CEA合理的替代手段，特别是对 于CEA高危病人。EPD对减少CAS期间卒中危险是重要的。前 言颈动脉狭窄治疗方式的发展颈动脉狭窄和CAS相关试验的发展CAS器械的发展颈动脉狭窄治疗方式的发展介入治疗追述经皮腔内动脉成形术（PTA）颈动脉血管成形支架置入术（CAS） 经皮腔内动脉成形术（PTA）PTA最早于1977年被提议用于治疗颈动脉 疾病。 并在1980年由MULLAN实施了第1例颈动 脉PTA。单纯球囊扩张后可发生内膜撕裂、斑块移 位和栓
2、子脱落以及血管壁弹性回缩，引起 动脉夹层，甚至闭塞。脑栓塞以及再狭窄 成为影响其疗效的主要因素。据报道，单纯球囊扩张术导致颈动脉夹层 、闭塞的发生率分别为8%和5%，术后6个 月再狭窄率可达16%9。颈动脉血管成形支架置入术（CAS）1980-1982年国外处于锁骨下和椎基底 动脉的造影阶段1981年加拿大医生Bachman 通过介入 治疗subclavian steal syndrome 颈动脉血管成形支架置入术（CAS ）1989年首次在颈动脉中使用球囊扩张 支架，但此类支架容易受外力压迫， 术后30天，超过10%的患者发生了主 要不良事件。术中脑保护的应用CAS术中脑保护技术远端球囊阻断
3、，抽吸，冲洗技术。动脉滤器-保护伞远端球囊阻断，抽吸，冲洗技术temporary occlusion of the distal internal carotid or the vertebral artery 1984年世界上第一例保护装置术式由Jacques Thron在俄国Montreal 完成1984年Jiri Vitek 神经放射医生使用球囊完成五名 动脉的脑保护。颈动脉狭窄和CAS相关试验的发展q主要的治疗目的：预防中风！q主要的治疗手段： q药物治疗q颈动脉内膜剥脱术（CEA） 有症状性: NASCET, ECST, VA Trial 无症状性: ACAS, ACSTq颈动脉支架
4、术（CAS）高风险性外科患者行颈动脉支架术的对比 SAPPHIRE, ARCHeR, SECuRITY, CABERNET and CREATE市场后期监督试验 EXACT, CAPTURE, CASES 拓展CAS适应证的大规模试验 有症状：CREST(NIH), EVA-3S，SPACE 无症状：CREST(NIH), ACT1使用AVD颈动脉支架和保护伞CEA和CAS的发展CEACASNational Center for Health StatisticsNASCETACAS放射介入科神经外科心内科血管外科CAS: 多学科发展的局面神经内科EVA-3S试验在法国实施入选527名狭窄超过
5、70%症状性患者主要终点30天卒中或死亡率CAS9.6%,CEA3.9%质 疑 试验包括1183名狭窄超过50%症状性患者。 位于德国，奥地利，瑞士的35个研究中心参与。 30天同侧卒中或死亡率CAS术后9.6%,CEA术后 6.3%CREST试验由国立神经病学及卒中研究所（NINDS)发 起，随机选入1400名症状性患者和1100名无症 状性患者。症状性患者：血管造影发现颈动脉狭窄超过 50%或颈动脉超声发现狭窄超过70%无症状性患者：血管造影发现颈动脉狭窄超过 60%或颈动脉超声发现狭窄超过70%主要终点是30天心肌梗塞，卒中或死亡，以及1- 4年同侧卒中CEA-CASSource: Wi
6、lliam W Gray. Reading the Tea Leaves: Possible Outcomes from the CREST Trial and Effects on the Field. TCT, San Francisco, CA; 2009.Lal BK, Brott TG. The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: Lessons learned and anticipated results. J Vasc Surg 2009; 50
7、:1224-1231.CREST: Study OverviewCarotid Revascularization Endarterectomy vs. Stenting Trial First Lead-in patient1 year follow-up completedApr 2008Dec 2000 Jul 2008Oct 20092000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010Feb 2010Lead-in Phase completed N=1,564Randomization Phase completedNIH An
8、alysisStent/EPDRX Acculink / RX AccunetDesignProspective, Multicenter, Randomized 1:1 CEA to CASHypothesis1.Superiority Hazard Ratio for CAS vs CEA with multi-year follow-up (NIH Analysis) 2.Non-inferiority CAS is not worse than CEA at 1 year follow-up (FDA analysis)117 CREST sites in U.S. and Canad
9、a, 2522 patientsSource: Lal BK, Brott TG. The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: Lessons learned and anticipated results. J Vasc Surg 2009; 50:1224-1231.CREST is the largest RCTcomparing CAS vs CEALargest, most rigorous, prospective randomized trial
10、and shows the two therapies are safe and effective CREST is the standard by which these therapies should be measuredClinical Trial# of Patients# of Sites CREST2,502117 ICSS1,71053 SPACE*1,18335 EVA-3S*52030 SAPPHIRE*33429Patient Characteristics CAS (n=1262)CEA (n=1240) Age6969 Female - %3634 Asympto
11、matic - %4747 Hypertension - %8686 Diabetes - %3030 Dyslipidemia - %血脂异常8285 Current smoker - %2626 Cardiovascular disease - %4143 Systolic BP, mean mmHg142141 % stenosis 70%8587 Days from qualifying event (for symptomatic subjects)202547% Asymptomatic and53% Symptomatic47%53%Source: CREST Presentat
12、ion at International Stroke Conference on February 26, 2010Primary Endpoint : Both stenting and surgery are equally safe and effectiveCASCEAHazard RatioP-value 7.2%6.8%HR = 1.11; 95% CI: 0.81-1.510.51Any death, stroke or MI within the perioperative period plus ipsilateral stroke out to 4 years.Sourc
13、e: CREST Presentation at International Stroke Conference on February 26, 2010“ The CREST trial results show that we now have two safe and effective methods to treat carotid artery disease directly, the tried and true CEA, and the new kid on the block, CAS.”- Thomas G. Brott, M.D., National Principal
14、 Investigator for CREST, Professor of Neurology and Director for Research at the Mayo Clinic颈动脉支架注册研究汇总注册研究 N 支架 EPD 结 果ARCHeR 581 Acculink Accunet 30days I/stroke/D8.3%,1yrsstroke/D9.6% BEACH 480 Wallstent FilterWire 30days I/stroke/D5.8%,1yrs stroke/D9.1% CABERNET 454 NexStent FilterWire 30days I/stroke/D3.8%,1yrs stroke/D4.5% VCAPTURE 2500 RX Acculink Accunet 30days I/stroke/D5.7%, CaRESS 143 Wallstent Guardwire plus 30days I/stroke/D2.1%, CREATE P 419 protg spider OTW 30days I/stroke/D6.2%, CREATE S 125 Acculink spiderRX 30days I/stroke/D5.6%, CREST 749 RX Acculink RX Accunet
