天壇醫(yī)院培訓(xùn)課程宋立剛

1、注：2012年春，洛杉磯。第一頁，共八十四頁。The ARCHeR Trials Acculink for Revascularization of Carotids in High Risk Patients試驗設(shè)計 IDE/ 登記研究目的 高危人群CAS登記時間 2000到2003年 （試驗完成） （Accunet/Acculink于2004年8月獲FDA批準(zhǔn)）支架/保護裝置 ARCHeR 1: OTW Acculink Carotid Stent System / 無栓子保護裝置 ARCHeR 2: OTW Acculink / OTW Accunet EPD ARCHeR 3: 快速交

2、換RX Acculink / RX Accunet EPD入選標(biāo)準(zhǔn) 外科高危病例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80%獨立的神經(jīng)功能檢查 是入選年齡80歲以上 是主要終點30天死亡、卒中、心梗事件/31到365天同側(cè)卒中Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/092Company Confidential 2009 Abbott Laboratories第二頁，共八十四頁。The ARCHeR TrialsAcculink for Revascularization of Carotids in Hi

3、gh Risk Patients臨床結(jié)局(n = 581)主要終點 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%次要終點 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第三頁，共八十四頁。SECuRITY試驗設(shè)計 IDE / 登記研究目的 高危人群CAS登記時間 2002到 2003 (完成) (2005年9月FDA批準(zhǔn))支架/栓子保護裝置 Xact Carotid Stent System / Emboshield Rapid Exchange EPS入選標(biāo)準(zhǔn) 外科高危病例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80% (獨立的神經(jīng)功能檢查)入選80歲以上 是臨床結(jié)果 n = 305 主要終點 30天死亡、卒中、心梗事件/31到365天同側(cè)卒中 30-day DSMI 7.50%死亡，大卒中 3.60% 1-ye

5、ar DSMI 8.50%次要終點 1-year TLR 0.7%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/094Company Confidential 2009 Abbott Laboratories第四頁，共八十四頁。CAPTURECarotid RX Acculink/RX Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events試驗設(shè)計 批準(zhǔn)后 / 登記研究目的 高危人群CAS登記時間 2004 到 2006 (試驗完成)支架/栓子

6、保護裝置 RX Acculink and RX Accunet EPD入選標(biāo)準(zhǔn) 外科高危病例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80% (獨立的神經(jīng)功能檢查)入選80歲以上 是 臨床結(jié)果 n = 4225 主要終點 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第五頁，共八十四頁。CAPTURE 2

7、RX Acculink/RX Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events試驗設(shè)計 上市后 / 登記研究目的 高危人群CAS登記時間 2006至 2009(招募)支架/栓子保護裝置 RX Acculink Carotid Stent System and RX Accunet EPD入選標(biāo)準(zhǔn) 外科高危病例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80% (獨立的神經(jīng)功能檢查)入選80歲以上 Yes 臨床結(jié)果 n = 4175 主要終點 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第六頁，共八十四頁。EXACTEmboshield and Xact Post Approval Carotid Stent Trial試驗設(shè)計 批準(zhǔn)后 / 登記研究目的 高危人群CAS登記時間 2005 到 2006 (完成)支架/栓子保護裝置 Xact Carotid Stent System / Emboshield Rap

9、id Exchange EPS入選標(biāo)準(zhǔn) 外科高危病例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80% (獨立的神經(jīng)功能檢查)入選80歲以上 是 臨床結(jié)果 n = 2145 主要終點 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第七頁，共八十四頁。ACT I試驗設(shè)計 IDE / 隨機對照研究目的 一般危險人

10、群使用EPD的CAS (CAS:CEA 比率 = 3:1)時間 2005至 2009 (招募)支架/栓子保護裝置 Xact Carotid Stent System / Emboshield and Emboshield PRO RX EPS入選標(biāo)準(zhǔn) 標(biāo)準(zhǔn)外科危險人群 癥狀性: not applicable 無癥狀: 超聲或造影顯示狹窄 70%， 99% (獨立的神經(jīng)功能檢查)入選80歲以上 否 臨床結(jié)果 n = 145 (僅限于先導(dǎo)研究) 主要終點 30天死亡、卒中、心梗事件加上31到365天同側(cè)卒中 30-day DSMI 1.40%死亡，所有卒中 1.40% 31到365天同側(cè)卒中 0.

11、00% (n = 106)Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/098Company Confidential 2009 Abbott Laboratories第八頁，共八十四頁。CHOICE試驗設(shè)計 上市后 / 登記研究目的 高危人群CAS登記時間 2006至 2009(公開招募)支架/栓子保護裝置 Xact Carotid Stent System / Emboshield RX EPS or RX Acculink Carotid Stent System / RX Accunet EPS入選標(biāo)準(zhǔn) 外科高危病

12、例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80% (獨立的神經(jīng)功能檢查)入選80歲以上 Yes 臨床結(jié)果 n = 1305 主要終點 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第九頁，共八十四頁。PROTECT試驗設(shè)計 批準(zhǔn)后/登記研究及 IDE/Emboshield PRO登記研究目的 高危人群CA

13、S登記時間 2006 到 2008 (招募完成; 長期隨訪正進(jìn)行)支架/栓子保護裝置 Xact Carotid Stent System / Emboshield PRO RX EPS入選標(biāo)準(zhǔn) 外科高危病例 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80% (獨立的神經(jīng)功能檢查)入選80歲以上 Yes 臨床結(jié)果 n = 274 主要終點 30天死亡、卒中、心梗事件加上31到365天同側(cè)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第十頁，共八十四頁。CREST試驗設(shè)計 IDE / 隨機對照研究目的 標(biāo)準(zhǔn)危險人群使用EPD的CAS同CEA比較 (CAS:CEA比率 = 1:1)時間 2000 到 2008 (招募完成; 長期隨訪進(jìn)行中)支架/栓子保護裝置 RX Acculink Carotid Stent System / RX Accunet EPS入選標(biāo)準(zhǔn) 標(biāo)準(zhǔn)外科危險人群 癥狀性: not applicable 無癥狀: 超聲或造影顯示狹窄 70%， 99% (獨立的神經(jīng)功能檢查)入選80歲以上 是 (先導(dǎo)期排除

15、) 臨床結(jié)果 n = 1303 (僅限于先導(dǎo)期) 主要終點 30天死亡、卒中、心梗事件加上31到365天同側(cè)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第十一頁，共八十四頁。試驗名稱試驗類型/設(shè)計試驗?zāi)康募{入人數(shù)年限30 d DSMI死亡 所有卒中死亡 大卒中1 Y DSMI1 Y StrokeARCHeRIDE/ 登記研究 高危人群CAS登記5812000

16、-20038.30%6.90%2.90%9.60%SECuRITYIDE/ 登記研究 高危人群CAS登記3052000-20037.50%3.60%8.50%CAPTURE批準(zhǔn)后 / 登記研究 高危人群CAS登記42252004-20066.10%5.50%2.00%CAPTURE 2上市后 / 登記研究 高危人群CAS登記41752006-20093.70%3.40%1.40%EXACT批準(zhǔn)后 / 登記研究 高危人群CAS登記21452005-20064.10%4.10%1.50%ACT IIDE / 隨機對照研究一般危險人群使用EPD的CAS (CAS:CEA 比率 = 3:1)14520

17、05-20091.40%1.40%0/106CHOICE上市后 / 登記研究 高危人群CAS登記13052006-20094.40%4.40%2.70%PROTECT批準(zhǔn)后 / 登記研究 高危人群CAS登記2742006-20081.80%1.50%0.40%CRESTIDE / 隨機對照研究標(biāo)準(zhǔn)危險人群使用EPD的CAS同CEA比較 (CAS:CEA比率 = 1:1)13032000-20085.40%4.60%第十二頁，共八十四頁。留下美好的瞬間！鑄成永久的回憶！第十三頁，共八十四頁。全年800臺頸內(nèi)動脈300臺椎動脈開口190臺顱內(nèi)支架200臺Carotid Certification

18、TrainingModule 10 AP2929157 Rev. A 2/0914Company Confidential 2009 Abbott Laboratories第十四頁，共八十四頁。EXACT and CAPTURE 2CEA高危人群頸動脈支架術(shù)試驗Data on file at Abbott VascularCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0915Company Confidential 2009 Abbott Laboratories第十五頁，共八十四頁。EXACT/CAPTURE 2: 設(shè)計

19、，實施及研究終點高危人群批準(zhǔn)后/上市試驗贊助商: 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:獨立的神經(jīng)科醫(yī)生在入組前、術(shù)后24小時及30天進(jìn)行神經(jīng)功能檢查神經(jīng)系統(tǒng)事件由CEAC成員獨立判斷 主要終點:30天死亡、卒中、心梗事件Carotid Certification TrainingModule 10

20、AP2929157 Rev. A 2/0916Company Confidential 2009 Abbott Laboratories第十六頁，共八十四頁。頸動脈支架上市后的后續(xù)研究Oct 04Oct 06Oct 05Dec 06144 sitesCAPTURE招募完成第一代批準(zhǔn)后研究隨訪完成128 sitesEXACT第二代批準(zhǔn)后研究Nov 05Mar 06195 sitesCAPTURE 2招募進(jìn)行上市后研究Apr 07Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0917Company Confidential 2

21、009 Abbott Laboratories第十七頁，共八十四頁。AHA 1998年CEA指南 無癥狀的頸動脈狹窄病人 手術(shù)風(fēng)險低于3% ，并且預(yù)期壽命至少5年已獲證實的適應(yīng)證：狹窄超過60%，伴或不伴潰瘍，用/不用抗血小板治療，不管對側(cè)頸動脈狀況。A級推薦）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. 這些建議很大程度上是基于ACAS試驗的結(jié)果，其表明75歲以內(nèi)低手術(shù)風(fēng)險病人CEA比藥物治療有更好的療效，圍術(shù)期卒中和死亡率為2.7Carotid Certifi

23、cation TrainingModule 10 AP2929157 Rev. A 2/0918Company Confidential 2009 Abbott Laboratories第十八頁，共八十四頁。病人一般資料特征EXACTN=2232CAPTURE 2N=4356平均年齡72.572.5Age 80 23.9%22.5%癥狀性比例10.3%13.2%男性比例63.2%61.7%糖尿病34.7%36.2%高血壓89.5%89.7%高膽固醇血癥 74.4%88.6%CHF 18.3%17.9%解剖因素10.6%20.5%是否現(xiàn)在吸煙19.6%23.3%PVD44.8%46.2%腎功能不

24、全7.2%3.0% Excluding co-morbiditiesCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0919Company Confidential 2009 Abbott Laboratories第十九頁，共八十四頁。30天復(fù)合終點：死亡與卒中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第二十頁，共八十四頁。30天復(fù)合終點- 死亡與大卒中 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第二十一頁，共八十四頁。合并EXACT/CAPTURE

28、2: 癥狀性病人30天嚴(yán)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第二十二頁，共八十四頁。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: 無癥狀病人30天嚴(yán)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第二十三頁，共八十四頁。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: 癥狀性患者解剖高危亞組30天嚴(yán)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第二十四頁，共八十四頁。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: 無癥狀患者解剖高危亞組30天嚴(yán)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第二十五頁，共八

35、十四頁。結(jié)論兩個針對CEA高危人群的上市后研究與AHA指南規(guī)定的CEA一般危險人群的死亡和卒中風(fēng)險相當(dāng)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第二十六頁，共八十四頁。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第二十七頁，共八十四頁。CAPTURE: 設(shè)計，實施與研究終點 FDA主導(dǎo)的批準(zhǔn)后試驗/針對外科高危人群的 贊助商: Abbott Vascular 器材: RX A

37、cculink Carotid Stent System and RX Accunet Embolic Protection System 概述:3500例病人144 家醫(yī)院招募病人獨立的神經(jīng)科醫(yī)生在入組前、術(shù)后24小時及30天進(jìn)行神經(jīng)功能檢查神經(jīng)系統(tǒng)事件由CEAC成員獨立判斷主要終點:30天死亡、卒中、心梗事件Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0928Company Confidential 2009 Abbott Laboratories第二十八頁，共八十四頁。CAPTURE 3500 vs ARCHeR

38、581: 病人一般資料CharacteristicCAPTURE N=3500ARCHeR N= 581平均年齡72.770.3Age 80 23.7%15.5%Age 65 80.4%72.5%癥狀性比例13.8%23.8%男性比例61.1%67.1%糖尿病34.7%37.9%高血壓88.3%83.8%高膽固醇血癥 77.8%72.6%CHF 16.5%33.6%解剖因素 10.7%19.3%是否現(xiàn)在吸煙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第二十九頁，共八十四頁。CAPTURE 3500 vs. ARCHeR 581:30天結(jié)局事件CAPTURE N=3500ARCHeR N=581DIFFERENCE 95% CI死亡，卒中與心梗* 6.3%8.3%-1.98% -4.35%, 0.40%所有卒中與死亡*5.7%6.9%-1.20% -3.40%, 1.00%嚴(yán)重卒中與死亡*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%嚴(yán)重卒中2.0%1.5%0.42% -0.68%, 1.53%輕微卒中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第三十頁，共八十四頁。CAPTURE 3500: 術(shù)者經(jīng)驗對30天結(jié)局的影響CAPTURE (N=3500)High (n=282 pts)Medium (n=2377 pts)Low (n=841 pts)死亡，卒中與心梗* 5.3%6.0%7.4%所有卒中與死亡*4.6%5.4%

42、6.9%嚴(yán)重卒中與死亡*1.1%2.9%3.4%死亡0.0%1.8%2.3%所有卒中4.6%4.5%5.7%嚴(yán)重卒中1.1%2.0%2.3%輕微卒中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第三十一頁，共八十四頁。CAPTURE 3500: 有無癥狀對30天結(jié)局的影響 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第三十二頁，共八十四頁。CAPTURE 3500: 是否高齡對30天結(jié)局的影響% 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第三十三頁，共八十四頁。CAPTURE 3500: 卒中部位 18% 卒中為非同側(cè)卒中 非同側(cè)卒中多為小卒中44%26%18%Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0934C

46、ompany Confidential 2009 Abbott Laboratories第三十四頁，共八十四頁。CAPTURE 3500:癥狀、年齡與術(shù)者水平對卒中部位的影響同側(cè)非同側(cè)非同側(cè)比例 癥狀狀態(tài)癥狀性7.9%1.0%12%無癥狀患者3.3%0.9%20%年齡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第三十六頁，共八十四頁。變量CHF 后擴 殘余狹窄 80 (809) 80 (2611)1.652.391.671.67Odds RatioCarotid Certification TrainingModule 10 AP2929157 Rev. A 2/0937Company Confidential 2009 Abbott Laboratories第三十七頁，共八十四頁。CAPTURE 3500:不同專科的結(jié)局CAPTURE研究涉及到5個專科結(jié)局比較： IC, INR, IR, VS

48、, NS.對年齡、癥狀狀態(tài)與術(shù)者水平等因素調(diào)整后，hoc分析顯示不同專業(yè)之間沒有顯著差異Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0938Company Confidential 2009 Abbott Laboratories第三十八頁，共八十四頁。CAPTURE 3500: 結(jié)論同多個里程碑CAS試驗比較，大規(guī)模前瞻性多中心上市后登記研究顯示臨床結(jié)局更好在本研究人群，年齡超過80歲以及癥狀性病變依然是更差結(jié)局的預(yù)測因素Carotid Certification TrainingModule 10 AP2929157

49、 Rev. A 2/0939Company Confidential 2009 Abbott Laboratories第三十九頁，共八十四頁。CAPTURE 3500: 結(jié)論3.本研究人群的其他預(yù)測指標(biāo)有：最終狹窄 10%EPD前預(yù)擴張多個支架置入有癥狀所有病例(n=3307)80歲以上人群 (n=809)癥狀性患者 (n= 471)EPD前預(yù)擴張有癥狀A(yù)ge 80多個支架置入75 Age 79EPD前預(yù)擴張Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0940Company Confidential 2009 Abbot

50、t Laboratories第四十頁，共八十四頁。CAPTURE 3500: 結(jié)論4. CAPTURE試驗中幾乎1/5卒中為非同側(cè)的 不管亞組卒中率(癥狀狀態(tài)，年齡，術(shù)者水平），非同側(cè)卒中的發(fā)生率約1%約40%同側(cè)卒中與入路有關(guān)聯(lián) 5.調(diào)整癥狀狀態(tài)，年齡，術(shù)者水平后，沒有證據(jù)表明不同專業(yè)存在差異Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0941Company Confidential 2009 Abbott Laboratories第四十一頁，共八十四頁。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.第四十二頁，共

55、八十四頁。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:第四十三頁，共八十四頁。The ARCHeR TrialsData on file at Abbott VascularCarotid Certification TrainingModule 10 AP2929157 Rev.

57、 A 2/0944Company Confidential 2009 Abbott Laboratories第四十四頁，共八十四頁。ARCHeR 試驗概述Acculink for Revascularization of Carotids in High Risk Patients目的 EPD+CAS同CEA在使用藥物基礎(chǔ)上治療外科高危人群的療效比較研究設(shè)計三個非隨機對照前瞻性單一分組多中心試驗，采用相同入選/排除標(biāo)準(zhǔn)，使用相同支架參加中心美國、歐洲與阿根廷48研究中心Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0945

58、Company Confidential 2009 Abbott Laboratories第四十五頁，共八十四頁。ARCHeR 入選及器材概述ARCHeR 1ARCHeR 2ARCHeR 3支架Acculink支架輸送系統(tǒng)Acculink (OTW)RX Acculink栓子保護裝置NoneAccunet (OTW)RX Accunet病人158 (+ 51 lead-ins)278 (+ 25 lead-ins)145總病例數(shù) = 657先導(dǎo)期總例數(shù) = 76登記病人總例數(shù) = 581Carotid Certification TrainingModule 10 AP2929157 Rev.

59、 A 2/0946Company Confidential 2009 Abbott Laboratories第四十六頁，共八十四頁。ARCHeR 入選/排除標(biāo)準(zhǔn)入選標(biāo)準(zhǔn)血管造影標(biāo)準(zhǔn) 癥狀性: 造影顯示狹窄 50% 無癥狀：狹窄 80%一個以上臨床或解剖高危因素主要排除標(biāo)準(zhǔn)近期卒中 ( 7 days) 以前同側(cè)嚴(yán)重卒中非卒中引起的神經(jīng)功能缺陷Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0947Company Confidential 2009 Abbott Laboratories第四十七頁，共八十四頁。ARCHeR 高危

60、入選標(biāo)準(zhǔn) 內(nèi)科/外科合并癥高危因素入選需要1條以上標(biāo)準(zhǔn)EF 30% or NYHA 心功能分級 IIIFEV1 30% (預(yù)期)腎功能衰竭，需要透析未能控制的糖尿病既往CEA術(shù)后再狹窄入選需要2條以上標(biāo)準(zhǔn)30天內(nèi)需要進(jìn)行CABG或瓣膜手術(shù)2條以上冠脈狹窄超過 70%30天內(nèi)心梗不穩(wěn)定心絞痛對側(cè)頸動脈閉塞Carotid Certification TrainingModule 10 AP2929157 Rev. A 2/0948Company Confidential 2009 Abbott Laboratories第四十八頁，共八十四頁。ARCHeR 高危入選標(biāo)準(zhǔn)解剖高危因素入選需要1條以上標(biāo)