CEA-----CAS
CREST: Study Overview
Carotid Revascularization Endarterectomy vs. Stenting Trial
Design Stent/EPD Prospective, Multicenter, Randomized 1:1 CEA to CAS RX Acculink® / RX Accunet®
Accunet 30days I/stroke/D8.3%,1yrsstroke/D9.6% FilterWire 30days I/stroke/D5.8%,1yrs stroke/D9.1% FilterWire 30days I/stroke/D3.8%,1yrs stroke/D4.5% Accunet 30days I/stroke/D5.7%, Guardwire plus 30days I/stroke/D2.1%, spider OTW 30days I/stroke/D6.2%, spiderRX 30days I/stroke/D5.6%, RX Accunet 30days I/stroke/D4.4%, Guardwire 30days I/stroke/D5.1%, Guardwire 30days I/stroke/D5.3%, MO.MA 30days I/stroke/D5.7%, MO.MA 30days I/stroke/D4.6%, Emboshield 30days I/stroke/D8.5%,
Apr 2008
2008
2009
2010
Dec 2000
Oct 2009 Jul 2008 Feb 2010
Source: William 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; 50:1224-1231.
117 CREST sites in U.S. and Canada, 2522 patients
Source: 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.
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
CEA和CAS的发展
210
U.S. Procedures ('000s)
180 150 120 90 60 30 0
CEA ACAS NASCET CAS
19 71 19 80 19 85 19 88 19 90 19 92 19 94 19 96 19 98 20 00 20 02 20 04 20 06
National Center for Health Statistics
CAS: 多学科发展的局面
放射介入科 神经外科
血管外科
神经内科
心内科
EVA-3S
试验在法国实施 入选527名狭窄超过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%
Any death, stroke or MI within the perioperative period plus ipsilateral stroke out to 4 years.
CAS 7.2%
CEA 6.8%
Hazard Ratio
HR = 1.11; 95% CI: 0.81-1.51
物治疗
颈动脉内膜剥脱术（CEA） • 有症状性: NASCET, ECST, VA Trial • 无症状性: ACAS, ACST 颈动脉支架术（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
1 year follow-up completed NIH Analysis
First Lead-in patient
Lead-in Phase completed N=1,564
Randomization Phase completed
2000
2001
2002
2003
2004
2005
2006
2007
47%
53%
Source: CREST Presentation at International Stroke Conference on February 26, 2010
Primary Endpoint :
Both stenting and surgery are equally safe and effective
ARCHeR BEACH CABERNET VCAPTURE CaRESS CREATE P CREATE S CREST MAVErIC I MAVErIC II MO.MA PRIAMUS SECuRITY
N
支架
EPD
结 果
581 Acculink 480 Wallstent 454 NexStent 2500 RX Acculink 143 Wallstent 419 proté gé 125 Acculink 749 RX Acculink 99 Exponet 399 Exponet 157 不限 416 不限 398 Xact
CREST is the largest RCT comparing CAS vs CEA
Largest, most rigorous, prospective randomized trial and
shows the two therapies are safe and effective CREST is the standard by which these therapies should be measured
- Thomas G. Brott, M.D., National Principal 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
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，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
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14年同侧卒中
or the vertebral artery 1984年世界上第一例保护装置术式由Jacques Thé ron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
主要的治疗目的：预防中风！ 主要的治疗手段：
Clinical Trial CREST ICSS SPACE* EVA-3S* SAPPHIRE*
# of Patients 2,502 1,710 1,183 520 334
# of Sites 117 53 35 30 29
Patient Characteristics
CAS (n=1262)
Cardiovascular disease %
Systolic BP, mean mmHg % stenosis ≥ 70% Days from qualifying event (for symptomatic subjects)
47% Asymptomatic and 53% Symptomatic
1.
Hypothesis