天坛医院培训课程宋立刚

1、注：2012年春，洛杉矶。第一页，共八十四页。The ARCHeR Trials Acculink for Revascularization of Carotids in High Risk Patients试验设计 IDE/ 登记研究目的 高危人群CAS登记时间 2000到2003年 （试验完成） （Accunet/Acculink于2004年8月获FDA批准）支架/保护装置 ARCHeR 1: OTW Acculink Carotid Stent System / 无栓子保护装置 ARCHeR 2: OTW Acculink / OTW Accunet EPD ARCHeR 3: 快速交

2、换RX Acculink / RX Accunet EPD入选标准 外科高危病例 症状性: 造影显示狭窄 50% 无症状：狭窄 80%独立的神经功能检查 是入选年龄80岁以上 是主要终点30天死亡、卒中、心梗事件/31到365天同侧卒中Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/092Company Confidential 2009 Abbott Laboratories第二页，共八十四页。The ARCHeR TrialsAcculink for Revascularization of Carotids in Hi

3、gh Risk Patients临床结局(n = 581)主要终点 30-day DSMI 8.30% 死亡, 所有卒中 6.90% 死亡，大卒中 2.90% 1-year DSMI 9.60%次要终点 1-year TLR 2.1% 2-year TLR 2.8% 3-year TLR 3.0%Data on file at Abbott VascularTarget lesion revascularizationCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/093Company Confidential 2009 A

4、bbott Laboratories第三页，共八十四页。SECuRITY试验设计 IDE / 登记研究目的 高危人群CAS登记时间 2002到 2003 (完成) (2005年9月FDA批准)支架/栓子保护装置 Xact Carotid Stent System / Emboshield Rapid Exchange EPS入选标准 外科高危病例 症状性: 造影显示狭窄 50% 无症状：狭窄 80% (独立的神经功能检查)入选80岁以上 是临床结果 n = 305 主要终点 30天死亡、卒中、心梗事件/31到365天同侧卒中 30-day DSMI 7.50%死亡，大卒中 3.60% 1-ye

5、ar DSMI 8.50%次要终点 1-year TLR 0.7%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/094Company Confidential 2009 Abbott Laboratories第四页，共八十四页。CAPTURECarotid RX Acculink/RX Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events试验设计 批准后 / 登记研究目的 高危人群CAS登记时间 2004 到 2006 (试验完成)支架/栓子

6、保护装置 RX Acculink and RX Accunet EPD入选标准 外科高危病例 症状性: 造影显示狭窄 50% 无症状：狭窄 80% (独立的神经功能检查)入选80岁以上 是 临床结果 n = 4225 主要终点 30天死亡、卒中、心梗事件 30-day DSMI 6.10% 死亡, 所有卒中 5.50% 死亡，大卒中 2.60%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/095Company Confidential 2009 Abbott Laboratories第五页，共八十四页。CAPTURE 2

7、RX Acculink/RX Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events试验设计 上市后 / 登记研究目的 高危人群CAS登记时间 2006至 2009(招募)支架/栓子保护装置 RX Acculink Carotid Stent System and RX Accunet EPD入选标准 外科高危病例 症状性: 造影显示狭窄 50% 无症状：狭窄 80% (独立的神经功能检查)入选80岁以上 Yes 临床结果 n = 4175 主要终点 30天死亡、卒中、心梗事件 30-day DSMI 3.70%

8、死亡, 所有卒中 3.40% 死亡，大卒中 1.40%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/096Company Confidential 2009 Abbott Laboratories第六页，共八十四页。EXACTEmboshield and Xact Post Approval Carotid Stent Trial试验设计 批准后 / 登记研究目的 高危人群CAS登记时间 2005 到 2006 (完成)支架/栓子保护装置 Xact Carotid Stent System / Emboshield Rap

9、id Exchange EPS入选标准 外科高危病例 症状性: 造影显示狭窄 50% 无症状：狭窄 80% (独立的神经功能检查)入选80岁以上 是 临床结果 n = 2145 主要终点 30天死亡、卒中、心梗事件 30-day DSMI 4.10% 死亡, 所有卒中 4.10% 死亡，大卒中 1.50%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/097Company Confidential 2009 Abbott Laboratories第七页，共八十四页。ACT I试验设计 IDE / 随机对照研究目的 一般危险人

10、群使用EPD的CAS (CAS:CEA 比率 = 3:1)时间 2005至 2009 (招募)支架/栓子保护装置 Xact Carotid Stent System / Emboshield and Emboshield PRO RX EPS入选标准 标准外科危险人群 症状性: not applicable 无症状: 超声或造影显示狭窄 70%， 99% (独立的神经功能检查)入选80岁以上 否 临床结果 n = 145 (仅限于先导研究) 主要终点 30天死亡、卒中、心梗事件加上31到365天同侧卒中 30-day DSMI 1.40%死亡，所有卒中 1.40% 31到365天同侧卒中 0.

11、00% (n = 106)Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/098Company Confidential 2009 Abbott Laboratories第八页，共八十四页。CHOICE试验设计 上市后 / 登记研究目的 高危人群CAS登记时间 2006至 2009(公开招募)支架/栓子保护装置 Xact Carotid Stent System / Emboshield RX EPS or RX Acculink Carotid Stent System / RX Accunet EPS入选标准 外科高危病

12、例 症状性: 造影显示狭窄 50% 无症状：狭窄 80% (独立的神经功能检查)入选80岁以上 Yes 临床结果 n = 1305 主要终点 30天死亡、卒中、心梗事件 30-day DSMI 4.40% 死亡, 所有卒中 4.20% 死亡，大卒中 2.70%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/099Company Confidential 2009 Abbott Laboratories第九页，共八十四页。PROTECT试验设计 批准后/登记研究及 IDE/Emboshield PRO登记研究目的 高危人群CA

13、S登记时间 2006 到 2008 (招募完成; 长期随访正进行)支架/栓子保护装置 Xact Carotid Stent System / Emboshield PRO RX EPS入选标准 外科高危病例 症状性: 造影显示狭窄 50% 无症状：狭窄 80% (独立的神经功能检查)入选80岁以上 Yes 临床结果 n = 274 主要终点 30天死亡、卒中、心梗事件加上31到365天同侧卒中 30-day DSMI 1.80% 死亡, 所有卒中 1.50% 死亡，大卒中 0.40%Carotid Certification TrainingModule 10 AP2929157 Rev. A

14、 2/0910Company Confidential 2009 Abbott Laboratories第十页，共八十四页。CREST试验设计 IDE / 随机对照研究目的 标准危险人群使用EPD的CAS同CEA比较 (CAS:CEA比率 = 1:1)时间 2000 到 2008 (招募完成; 长期随访进行中)支架/栓子保护装置 RX Acculink Carotid Stent System / RX Accunet EPS入选标准 标准外科危险人群 症状性: not applicable 无症状: 超声或造影显示狭窄 70%， 99% (独立的神经功能检查)入选80岁以上 是 (先导期排除

15、) 临床结果 n = 1303 (仅限于先导期) 主要终点 30天死亡、卒中、心梗事件加上31到365天同侧卒中 30-day DSMI 5.40%死亡, 所有卒中 4.60%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0911Company Confidential 2009 Abbott Laboratories第十一页，共八十四页。试验名称试验类型/设计试验目的纳入人数年限30 d DSMI死亡 所有卒中死亡 大卒中1 Y DSMI1 Y StrokeARCHeRIDE/ 登记研究 高危人群CAS登记5812000

16、-20038.30%6.90%2.90%9.60%SECuRITYIDE/ 登记研究 高危人群CAS登记3052000-20037.50%3.60%8.50%CAPTURE批准后 / 登记研究 高危人群CAS登记42252004-20066.10%5.50%2.00%CAPTURE 2上市后 / 登记研究 高危人群CAS登记41752006-20093.70%3.40%1.40%EXACT批准后 / 登记研究 高危人群CAS登记21452005-20064.10%4.10%1.50%ACT IIDE / 随机对照研究一般危险人群使用EPD的CAS (CAS:CEA 比率 = 3:1)14520

17、05-20091.40%1.40%0/106CHOICE上市后 / 登记研究 高危人群CAS登记13052006-20094.40%4.40%2.70%PROTECT批准后 / 登记研究 高危人群CAS登记2742006-20081.80%1.50%0.40%CRESTIDE / 随机对照研究标准危险人群使用EPD的CAS同CEA比较 (CAS:CEA比率 = 1:1)13032000-20085.40%4.60%第十二页，共八十四页。留下美好的瞬间！铸成永久的回忆！第十三页，共八十四页。全年800台颈内动脉300台椎动脉开口190台颅内支架200台Carotid Certification

18、TrainingModule 10 AP2929157 Rev. A 2/0914Company Confidential 2009 Abbott Laboratories第十四页，共八十四页。EXACT and CAPTURE 2CEA高危人群颈动脉支架术试验Data on file at Abbott VascularCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0915Company Confidential 2009 Abbott Laboratories第十五页，共八十四页。EXACT/CAPTURE 2: 设计

19、，实施及研究终点高危人群批准后/上市试验赞助商: Abbott Vascular 器材: RX Acculink Carotid Stent System and RX Accunet Embolic Protection System; RX Xact Carotid Stent System and Emboshield Embolic Protection System 概述:独立的神经科医生在入组前、术后24小时及30天进行神经功能检查神经系统事件由CEAC成员独立判断 主要终点:30天死亡、卒中、心梗事件Carotid Certification TrainingModule 10

20、AP2929157 Rev. A 2/0916Company Confidential 2009 Abbott Laboratories第十六页，共八十四页。颈动脉支架上市后的后续研究Oct 04Oct 06Oct 05Dec 06144 sitesCAPTURE招募完成第一代批准后研究随访完成128 sitesEXACT第二代批准后研究Nov 05Mar 06195 sitesCAPTURE 2招募进行上市后研究Apr 07Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0917Company Confidential 2

21、009 Abbott Laboratories第十七页，共八十四页。AHA 1998年CEA指南 无症状的颈动脉狭窄病人 手术风险低于3% ，并且预期寿命至少5年已获证实的适应证：狭窄超过60%，伴或不伴溃疡，用/不用抗血小板治疗，不管对侧颈动脉状况。A级推荐）Biller J, Feinberg WM, Castaldo JE, Whittemore AD, Harbaugh RE, Dempsey RJ, Caplan LR, Kresowik TF, Matchar DB, Toole JF, Easton JD, Adams HP Jr, Brass LM, Hobson RW 2nd

22、, Brott TG, Sternau L. Guidelines for carotid endarterectomy: a statement for healthcare professionals from a Special Writing Group of the Stroke Council, American Heart Association Circulation. 1998 Feb 10;97(5):501-9. 这些建议很大程度上是基于ACAS试验的结果，其表明75岁以内低手术风险病人CEA比药物治疗有更好的疗效，围术期卒中和死亡率为2.7Carotid Certifi

23、cation TrainingModule 10 AP2929157 Rev. A 2/0918Company Confidential 2009 Abbott Laboratories第十八页，共八十四页。病人一般资料特征EXACTN=2232CAPTURE 2N=4356平均年龄72.572.5Age 80 23.9%22.5%症状性比例10.3%13.2%男性比例63.2%61.7%糖尿病34.7%36.2%高血压89.5%89.7%高胆固醇血症 74.4%88.6%CHF 18.3%17.9%解剖因素10.6%20.5%是否现在吸烟19.6%23.3%PVD44.8%46.2%肾功能不

24、全7.2%3.0% Excluding co-morbiditiesCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0919Company Confidential 2009 Abbott Laboratories第十九页，共八十四页。30天复合终点：死亡与卒中Hierarchical- Includes only the most serious event for each patient and includes only each patient first occurrence of each event. *EX

25、ACT (N=2145)*CAPTURE 2 (N=4175)Combined (N=6320)EXACT (N=213)CAPTURE 2 (N=548)Combined (N=761)EXACT (N=1931)CAPTURE 2 (N=3627)Combined (N=5558)Clinical trial data presented may not be directly comparable and is presented for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev

26、. A 2/0920Company Confidential 2009 Abbott Laboratories第二十页，共八十四页。30天复合终点- 死亡与大卒中 Hierarchical- Includes only the most serious event for each patient and includes only each patient first occurrence of each event. * EXACT (N=2145)*CAPTURE 2 (N=4175)Combined (N=6320)EXACT (N=213)CAPTURE 2 (N=548)Combi

27、ned (N=761)EXACT (N=1931)CAPTURE 2 (N=3627)Combined (N=5558)Clinical trial data presented may not be directly comparable and is presented for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0921Company Confidential 2009 Abbott Laboratories第二十一页，共八十四页。合并EXACT/CAPTURE

28、2: 症状性病人30天严重不良事件 Hierarchical- Includes only the most serious event for each patient and includes only each patient first occurrence of each event.Symptomatic patients N=589 5.32.21.01.43.1012345678Death/StrokeDeath/Major StrokeDeathStroke Minor (3.1%)Stroke Major (1.4%)(%) Subjects6% AHA guideline

29、 Clinical trial data presented may not be directly comparable and is presented for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0922Company Confidential 2009 Abbott Laboratories第二十二页，共八十四页。Hierarchical- Includes only the most serious event for each patient and inc

30、ludes only each patient first occurrence of each event. N=4282 2.91.10.80.61.8012345678Death/StrokeDeath/Major StrokeDeathStroke Minor (1.8%)Stroke Major (0.6%)(%) Subjects3% AHA guideline 合并EXACT/CAPTURE 2: 无症状病人30天严重不良事件 Clinical trial data presented may not be directly comparable and is presented

31、 for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0923Company Confidential 2009 Abbott Laboratories第二十三页，共八十四页。Hierarchical- Includes only the most serious event for each patient and includes only each patient first occurrence of each event.N=60 1.71.71.7012345678

32、Death/StrokeDeath/Major StrokeDeathStroke Minor (0.0%)Stroke Major (1.7%)(%) Subjects合并EXACT/CAPTURE 2: 症状性患者解剖高危亚组30天严重不良事件6% AHA GuidelineClinical trial data presented may not be directly comparable and is presented for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev. A

33、 2/0924Company Confidential 2009 Abbott Laboratories第二十四页，共八十四页。Hierarchical- Includes only the most serious event for each patient and includes only each patient first occurrence of each event.合并EXACT/CAPTURE 2: 无症状患者解剖高危亚组30天严重不良事件6% AHA GuidelineN=371 2.70.80.30.51.9012345678Death/StrokeDeath/Maj

34、or StrokeDeathStroke Minor (1.9%)Stroke Major (0.5%)(%) Subjects3% AHA GuidelineClinical trial data presented may not be directly comparable and is presented for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0925Company Confidential 2009 Abbott Laboratories第二十五页，共八

35、十四页。结论两个针对CEA高危人群的上市后研究与AHA指南规定的CEA一般危险人群的死亡和卒中风险相当Clinical trial data presented may not be directly comparable and is presented for educational purposes. Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0926Company Confidential 2009 Abbott Laboratories第二十六页，共八十四页。CAPTURE 3500Data on file

36、at Abbott VascularCarotid RX ACCULINK/RX ACCUNET Post- Approval Trial to Uncover Unanticipated or Rare EventsCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0927Company Confidential 2009 Abbott Laboratories第二十七页，共八十四页。CAPTURE: 设计，实施与研究终点 FDA主导的批准后试验/针对外科高危人群的 赞助商: Abbott Vascular 器材: RX A

37、cculink Carotid Stent System and RX Accunet Embolic Protection System 概述:3500例病人144 家医院招募病人独立的神经科医生在入组前、术后24小时及30天进行神经功能检查神经系统事件由CEAC成员独立判断主要终点:30天死亡、卒中、心梗事件Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0928Company Confidential 2009 Abbott Laboratories第二十八页，共八十四页。CAPTURE 3500 vs ARCHeR

38、581: 病人一般资料CharacteristicCAPTURE N=3500ARCHeR N= 581平均年龄72.770.3Age 80 23.7%15.5%Age 65 80.4%72.5%症状性比例13.8%23.8%男性比例61.1%67.1%糖尿病34.7%37.9%高血压88.3%83.8%高胆固醇血症 77.8%72.6%CHF 16.5%33.6%解剖因素 10.7%19.3%是否现在吸烟20.9%19.3%PVD35.6%36.3% Denotes statistically significant difference at the 0.05 levelCarotid C

39、ertification TrainingModule 10 AP2929157 Rev. A 2/0929Company Confidential 2009 Abbott Laboratories第二十九页，共八十四页。CAPTURE 3500 vs. ARCHeR 581:30天结局事件CAPTURE N=3500ARCHeR N=581DIFFERENCE 95% CI死亡，卒中与心梗* 6.3%8.3%-1.98% -4.35%, 0.40%所有卒中与死亡*5.7%6.9%-1.20% -3.40%, 1.00%严重卒中与死亡*2.9%2.9%-0.04% -1.52%, 1.44%死

40、亡1.8%2.1%-0.29% -1.53%, 0.94%所有卒中4.8%5.5%-0.71% -2.69%, 1.28%严重卒中2.0%1.5%0.42% -0.68%, 1.53%轻微卒中2.9%4.0%-1.07% -2.75%, 0.61%心梗 0.9%2.4%-1.50% -2.78%, -0.21%* Hierarchical Includes only the most serious event for each patient and includes only each patients first occurrence of each event Denotes stat

41、istically significant difference at the 0.05 levelCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0930Company Confidential 2009 Abbott Laboratories第三十页，共八十四页。CAPTURE 3500: 术者经验对30天结局的影响CAPTURE (N=3500)High (n=282 pts)Medium (n=2377 pts)Low (n=841 pts)死亡，卒中与心梗* 5.3%6.0%7.4%所有卒中与死亡*4.6%5.4%

42、6.9%严重卒中与死亡*1.1%2.9%3.4%死亡0.0%1.8%2.3%所有卒中4.6%4.5%5.7%严重卒中1.1%2.0%2.3%轻微卒中3.5%2.6%3.6%心梗 0.7%1.0%0.8%* Hierarchical Includes only the most serious event for each patient and includes only each patients first occurrence of each eventCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0931Compa

43、ny Confidential 2009 Abbott Laboratories第三十一页，共八十四页。CAPTURE 3500: 有无症状对30天结局的影响 Denotes statistically significant difference at the 0.05 level *Hierarchical Events Includes only the most serious event for each patient and includes only each patient first occurrence of each event.% of all patientsCar

44、otid Certification TrainingModule 10 AP2929157 Rev. A 2/0932Company Confidential 2009 Abbott Laboratories第三十二页，共八十四页。CAPTURE 3500: 是否高龄对30天结局的影响% of all patients Denotes statistically significant difference at the 0.05 level* Hierarchical Events Includes only the most serious event for each patient

45、and includes only each patients first occurrence of each event24%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0933Company Confidential 2009 Abbott Laboratories第三十三页，共八十四页。CAPTURE 3500: 卒中部位 18% 卒中为非同侧卒中 非同侧卒中多为小卒中44%26%18%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0934C

46、ompany Confidential 2009 Abbott Laboratories第三十四页，共八十四页。CAPTURE 3500:症状、年龄与术者水平对卒中部位的影响同侧非同侧非同侧比例 症状状态症状性7.9%1.0%12%无症状患者3.3%0.9%20%年龄80 years6.2%1.1%15%80 (809) 80 (2611)2.462.193.093.154.972.211.842.002.531.721.661.752.422.442.172.93Odds RatioCarotid Certification TrainingModule 10 AP2929157 Rev.

47、A 2/0936Company Confidential 2009 Abbott Laboratories第三十六页，共八十四页。变量CHF 后扩 残余狭窄 80 (809) 80 (2611)1.652.391.671.67Odds RatioCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0937Company Confidential 2009 Abbott Laboratories第三十七页，共八十四页。CAPTURE 3500:不同专科的结局CAPTURE研究涉及到5个专科结局比较： IC, INR, IR, VS

48、, NS.对年龄、症状状态与术者水平等因素调整后，hoc分析显示不同专业之间没有显著差异Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0938Company Confidential 2009 Abbott Laboratories第三十八页，共八十四页。CAPTURE 3500: 结论同多个里程碑CAS试验比较，大规模前瞻性多中心上市后登记研究显示临床结局更好在本研究人群，年龄超过80岁以及症状性病变依然是更差结局的预测因素Carotid Certification TrainingModule 10 AP2929157

49、 Rev. A 2/0939Company Confidential 2009 Abbott Laboratories第三十九页，共八十四页。CAPTURE 3500: 结论3.本研究人群的其他预测指标有：最终狭窄 10%EPD前预扩张多个支架置入有症状所有病例(n=3307)80岁以上人群 (n=809)症状性患者 (n= 471)EPD前预扩张有症状Age 80多个支架置入75 Age 79EPD前预扩张Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0940Company Confidential 2009 Abbot

50、t Laboratories第四十页，共八十四页。CAPTURE 3500: 结论4. CAPTURE试验中几乎1/5卒中为非同侧的 不管亚组卒中率(症状状态，年龄，术者水平），非同侧卒中的发生率约1%约40%同侧卒中与入路有关联 5.调整症状状态，年龄，术者水平后，没有证据表明不同专业存在差异Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0941Company Confidential 2009 Abbott Laboratories第四十一页，共八十四页。Stenting and angioplasty with pr

51、otection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients.Massop D, Dave R, Metzger C, etal. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):129-36.METHODS: SAPPHIRE Worldwide is a multicenter, prospective, postapproval registry to evaluate CAS with distal p

52、rotection in patients at high-risk for surgery using the Cordis PRECISE Nitinol Stent and ANGIOGUARD XP/RX Emboli Capture Guidewire. Participating physicians are encouraged to treat patients according to their standard of practice and consistent with current Food and Drug Administration-approved lab

53、eling.RESULTS: Enrollment began in October 2006. Data are available on the first 2,001 patients enrolled and followed to 30 days. Of these patients, the mean age was 72.2 +/- 9.75 yr; 62% were male; and 27.7% were symptomatic. Entry criteria for surgical high-risk included anatomic (n = 716), physio

54、logic (n = 918), or both risk factors (n = 327). At 30-day follow-up, the MAE was 4.4% (death 1.1%, stroke 3.2%, MI 0.7%) for the overall population. Patients with anatomic risk had a significantly lower 30-day MAE than patients with physiologic risk (2.8% vs. 4.9%, P = 0.0306), respectively.第四十二页，共

55、八十四页。While the number of physicians performing CAS continues to increase, MAE rates seen in this registry (4.4%) are well within an acceptable range, as was first seen in the SAPPHIRE randomized trial (4.8%). A significant decrease in MAE was seen in patients with anatomic risk compared with physiol

56、ogic risk factors. The SAPPHIRE Worldwide Registry supports the use of CAS as an alternative to CEA in patients who are at high-risk for surgery due to anatomic risk factors.CONCLUSIONS:第四十三页，共八十四页。The ARCHeR TrialsData on file at Abbott VascularCarotid Certification TrainingModule 10 AP2929157 Rev.

57、 A 2/0944Company Confidential 2009 Abbott Laboratories第四十四页，共八十四页。ARCHeR 试验概述Acculink for Revascularization of Carotids in High Risk Patients目的 EPD+CAS同CEA在使用药物基础上治疗外科高危人群的疗效比较研究设计三个非随机对照前瞻性单一分组多中心试验，采用相同入选/排除标准，使用相同支架参加中心美国、欧洲与阿根廷48研究中心Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0945

58、Company Confidential 2009 Abbott Laboratories第四十五页，共八十四页。ARCHeR 入选及器材概述ARCHeR 1ARCHeR 2ARCHeR 3支架Acculink支架输送系统Acculink (OTW)RX Acculink栓子保护装置NoneAccunet (OTW)RX Accunet病人158 (+ 51 lead-ins)278 (+ 25 lead-ins)145总病例数 = 657先导期总例数 = 76登记病人总例数 = 581Carotid Certification TrainingModule 10 AP2929157 Rev.

59、 A 2/0946Company Confidential 2009 Abbott Laboratories第四十六页，共八十四页。ARCHeR 入选/排除标准入选标准血管造影标准 症状性: 造影显示狭窄 50% 无症状：狭窄 80%一个以上临床或解剖高危因素主要排除标准近期卒中 ( 7 days) 以前同侧严重卒中非卒中引起的神经功能缺陷Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0947Company Confidential 2009 Abbott Laboratories第四十七页，共八十四页。ARCHeR 高危

60、入选标准 内科/外科合并症高危因素入选需要1条以上标准EF 30% or NYHA 心功能分级 IIIFEV1 30% (预期)肾功能衰竭，需要透析未能控制的糖尿病既往CEA术后再狭窄入选需要2条以上标准30天内需要进行CABG或瓣膜手术2条以上冠脉狭窄超过 70%30天内心梗不稳定心绞痛对侧颈动脉闭塞Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0948Company Confidential 2009 Abbott Laboratories第四十八页，共八十四页。ARCHeR 高危入选标准解剖高危因素入选需要1条以上标