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1、2009年中国PCI指南解读,浙江大学医学院附属第一医院陈君柱 教授,PCI的发展历史,1844Bernard coins the term“cardiac catheterization”,1929Forssmann peforms the 1st human cardiac catheterization,1958Sones discovers the diagnostic coronary angiogram,1962Ricketts and Abrams use the percutaneous approach in coronary arteries,1964Dotter intr
2、oduces transluminal angioplasty,1977Gruentzig peforms the 1st PTCA,1967Judkins perfects the transfemoral approach,1986Sigwart and Puel implant the 1st coronary stent,19941st coronary stent approved by the FDA,2003FDA approval of 1st DES,2006FDA panel on the safety of DES,2002CE Mark on 1st DES,背景,药物
3、洗脱支架（DES）的广泛应用，成为PCI技术发展的里程碑新技术的不断涌现辅助药物治疗的发展大量循证医学证据的出现规范化治疗，保证医疗质量和安全,对医疗机构的要求,应为三级医院，设有心内科、心胸外科、血管造影室和重症监护室；每年完成诊疗病例200例，治疗病例100例；术者需完成PCI每年50例；血管造影并发症0.5%，介入治疗死亡率0.5%；,血管重建策略的选择,药物治疗,介入治疗,CABG,慢性稳定性心绞痛的指征,有较大范围心肌缺血的客观证据；/A自体冠状动脉的原发病变常规置入支架；/A静脉旁路血管的原发病变常规置入支架；/A慢性完全闭塞病变；a/C外科手术高风险患者；a/B多支血管病变无糖尿
4、病，病变适合PCI；a/B多支病变合并糖尿病；b/C经选择的无保护左主干病变；b,PCI与药物治疗的比较,早期荟萃分析,包括11个随机试验的荟萃分析;N=2,950,Katritsis DG et al.Circulation.2005;111:2906-12.,0,1,2,Risk ratio,PCI优势,药物治疗优势,COURAGE试验-设计,多中心随机对照临床试验共筛选35,539个患者共2,287个患者完成随机化有心肌缺血证据稳定性心绞痛随机分组PCI+规范药物治疗 vs 单纯规范药物治疗随访2.5 to 7年(平均4.6年),Boden WE,NEJM 2007;356:1503-1
5、6,COURAGE试验-结果,No.at risk1,1381,017959834638408192301,1491,01395283363741720035,年份,单纯药物,PCI+药物,HR 1.0595%CI 0.87-1.27P=0.62,Boden WE,NEJM 2007;356:1503-16,Survival free of death from any cause and nonfatal myocardial infarction,COURAGE试验-结果,Boden WE,NEJM 2007;356:1503-16,Number at Risk,药物治疗组 1138 10
6、73 1029917 717 468 302 38PCI+药物组 1149 1094 1051929 733 488 312 44,Years,0,1,2,3,4,5,6,0.0,0.5,0.6,0.7,0.8,0.9,1.0,PCI+药物,单纯药物,7,Hazard ratio:0.8795%CI(0.65-1.16)P=0.38,Overall Survival,COURAGE试验-结果,The comparison between the PCI group and the medical-therapy group was significant at 1 year(P0.001)an
7、d 3 years(P=0.02)but not at baseline or 5 years.,Boden WE,NEJM 2007;356:1503-16,心绞痛发生率,25,50,75,100,88,87,34,42,28,33,28,26,Baseline 1 Year 3 Year 5 Year,P0.001,P=0.02,pNS,PCI+药物组单纯药物组,COURAGE试验-结果,Large preponderence of procedural MIsdeath and spontaneous MI actually less after PCI,30%of OMT patien
8、ts“crossed over”because of failure of OMT alone,Boden WE,NEJM 2007;356:1503-16,COURAGE核医学亚组分析,Shaw LJ et al:Circ 117:283,2008,PCI+药物治疗(n=159),单纯药物治疗(n=155),33.3%with 5%ischemia reduction(P=0.0004),18.9%with 5%ischemia reduction,Index,6-18 months,Mean=2.7%(95%CI=-1.7%to-3.8%),8.2%(7.2-9.3%)P=0.63,5.5
9、%(4.7-6.3%),Index,6-18 months,Mean=0.5%(95%CI=-1.6%to 0.6%),8.6%(7.5-9.8%),8.1%(6.9-9.4%)P0.0001,近期荟萃分析,Schomig et al:JACC 52:894,2008,PCI与药物治疗 指南推荐,对多数轻度心绞痛（CCS-级）患者可先选择药物治疗；对心绞痛症状较重或希望保持良好体能的患者可考虑PCI；有中、重度心肌缺血的稳定性心绞痛患者PCI可改善长期生存率；Blood is better than drugs for the ischemic myocardium-David Holmes,
10、MD,FACC,PCI与CABG的比较,缓解心绞痛不需要再次介入完全再血管化费用高创伤大,费用相对低 恢复快急性并发症减少再狭窄问题再次血管重建率高,裸支架时代CABG更占优势,PCI vs.CABG,Off pump技术微创手术动脉桥血管使用围手术期管理,技术的进步支架设计改进DES的问世,费用高创伤大恢复时间长,再狭窄再次血管重建,?,近年来随着介入技术的进展，PCI与CABG差距逐渐缩小,PCI vs.CABG,Sirolimus-eluting stent3.7 stents per patientAvg total length:73 mmn=607,ARTS-II研究,Histor
11、ical Controls from ARTS I:1202 patients with multivessel coronary lesions 18.2%diabetic28%3 vessel disease7.5%type C lesions,607 patients with multivessel coronary lesions26.2%diabetic54%3 vessel disease13.9%type C lesions,CABGn=602,Bare Metal Stent2.8 stents per patientAvg total length:48 mmn=600,E
12、ndpoints:Primary Major adverse cardiac and cerebrovascular events(MACCE),including death,cerebrovascular event,myocardial infarction,and revascularization,at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trialSecondary MAC
13、CE at 30 days,6 months,3 and 5 years.Total cost at 30 days Cost effectiveness,quality of life at 6 mo,and 1,3,and 5 years,ARTS II研究：存活率比较,p=0.001,p=0.003,p=0.46,1年不良事件比较,随访1年时，ARTS II DES组和ARTS I CABG组间不良事件率无明显差别；ARTS I BMS组的不良事件率较其它两组明显升高。,ARTS II研究：1年不良事件比较,p=NS,p=NS,p=NS,p=NS,ARTS II研究：结论,P0.01,L
14、eft Main Disease(isolated,+1,+2 or+3 vessels),3 Vessel Disease(revasc all 3 vascular territories),SYNTAX研究：入组条件,De novo disease,Limited Exclusion Criteria Previous interventions Acute MI with CPK2x Concomitant cardiac surgery,23 US Sites,62 EU Sites,+,SYNTAX研究设计,*TAXUS Express,Event Rate 1.5 SE.*Fis
15、hers Exact Test,ITT population,P=0.37*,4.3%,3.5%,1年后全因死亡比较,0.6%,2.2%,ITT population,P=0.003*,Event Rate 1.5 SE.*Fishers Exact Test,1年后脑血管事件比较,P=0.98*,ITT population,7.7%,7.6%,Event Rate 1.5 SE.*Fishers Exact Test,1年后全部心脑血管事件比较,5.9%,13.7%,ITT population,P0.0001*,Event Rate 1.5 SE.*Fishers Exact Test,
16、1年后再次血管重建比较,糖尿病N=452,非糖尿病N=1348,Death/CVA/MI,MACCE,Death/CVA/MI,MACCE,P=0.96,P=0.0025,P=0.08,P=0.97,糖尿病亚组分析,Patient 1,Patient 1,Patient 2,Patient 2,LCx 70-90%,RCA3 70-90%,LCx 100%,LAD 99%,RCA 100%,Syntax积分法：三支病变比较,13.5%,14.4%,P=0.71*,Syntax低分区亚组(0-22),P=0.19*,12,12,左主干病变,三支病变,Syntax低分区亚组(0-22),16.6%
17、,11.7%,P=0.10*,Syntax中分区亚组(23-32),P=0.02*,15.5%,12.6%,Mean baselineSYNTAX ScoreCABG27.2 3.0TAXUS27.0 2.7,左主干病变,三支病变,P=0.54*,Syntax中分区亚组(23-32),Syntax高分区亚组(33),23.3%,10.7%,P0.001*,21.5%,8.8%,P=0.002*,P=0.008*,25.3%,12.9%,Mean baselineSYNTAX ScoreCABG42.1 7.6TAXUS43.8 9.1,左主干病变,三支病变,Syntax高分区亚组(33),PC
18、I与CABG 指南推荐,适合PCI中等范围以上心肌缺血或有存活心肌，伴前降支受累的单支或双支病变能够进行完全血管重建的病变有外科手术禁忌证、要接受非心脏手术者ACS，尤其是急性心肌梗死的患者,适合CABG左主干病变多支血管病变伴EF50%伴有前降支近端明显狭窄的双支病变病变不适合PCI或其效果不理想者前降支闭塞而无前壁MI者PCI不成功或不能进行完全血管重建的患者,慢性稳定性心绞痛的指征,有较大范围心肌缺血的客观证据；/A自体冠状动脉的原发病变常规置入支架；/A静脉旁路血管的原发病变常规置入支架；/A慢性完全闭塞病变；a/C外科手术高风险患者；a/B多支血管病变无糖尿病，病变适合PCI；a/B
19、多支病变合并糖尿病；b/C经选择的无保护左主干病变；b,非ST抬高ACS的指征,对不稳定性心绞痛和非ST段抬高心梗应进行危险分层（TIMI、GRACE）；对极高危患者行紧急PCI（2h内）；a/B对中高危患者行早期PCI（72h内）；/A对低危患者不推荐常规PCI；/C对PCI患者常规支架置入；/C对中高危患者围手术期应强化抗血小板、抗凝治疗；,STEMI的处理流程,PCI方法的选择,BMS,晚期血栓事件极少不需长期使用双重抗血小板治疗费用相对较低支架内再狭窄和再次血管重建问题,DES,支架内再狭窄率明显降低再次血管重建率减少晚期血栓问题需长期使用双重抗血小板治疗费用较高,DES vs BMS
20、,支架内晚期血栓形成的原因,抗血小板药物强度和疗程不足,内皮化延迟,复杂PCI,支架聚合物过敏/炎症,支架内血栓,DES和BMS死亡率的比较,In the BASKET LATE Trial,cardiac death trended higher in the DES group than in the BMS group during the year following clopidogrel discontinuation(1.2%vs 0%,P=.09).Data from the PREMIER registry looked exclusively at AMI patients
21、 who received DES and suggested that patients who discontinued thienopyridine therapy early within 30 days in this instance were significantly more likely to die over the next 11 months(P.0001).,BASKET LATE Trial:Cardiac death in DES vs BMS(%),PREMIER Registry Data:All cause death according to minim
22、um 30 day thienopyridine therapy duration(%),7.5,0.7,0,2,4,6,8,Stoppedthienopyridines,Stayed onthienopyridines,%Patients,1.2,0.0,0,1,2,DES,BMS,%Patients,P.0001,P=.09,Pfisterer ME.Presented at ACC 2006;Spertus JA,et al.Circulation.2006;113:2803-2809.,Adverse Events(%),TAXUS II,IV,V,VI*(N=3,445),Stent
23、 Thrombosis,All Death,CardiacDeath,Q-WaveMI,Death or QWMI,TLR,TAXUS VI荟萃分析,0.9,1.3,7.0,6.4,3.1,2.6,1.2,1.5,8.1,7.6,20.4,10.5,p=0.55,p=0.53,p=0.40,p=0.80,p0.0001,p=0.29,4.3,4.6,2.0,2.1,1.1,5.3,5.7,19.8,9.3,Bare Metal Stent N=1,727,TAXUS Express Stent N=1,718,BMS,DES,DES vs BMS,DES vs BMS 指南推荐,能耐受至少1年
24、的双重抗血小板治疗患者，特别是易发生再狭窄的病变，首选DES对所有置入DES者，术后双重抗血小板治疗均应至少1年对支架内血栓高风险病变，术后双重抗血小板治疗可延长至1年以上对双重抗血小板治疗难以坚持1年或有较高出血风险者，应选择BMS对预期行非心脏手术的患者，选择BMS,其它PCI技术,单纯球囊扩张冠状动脉斑块旋磨术定向性冠状动脉斑块旋切术支架内再狭窄放射疗法切割球囊远端保护装置血栓抽吸装置,MajpjMVcyzj21HLfrvy96dv02lPPfYgxUS7IYmZkyEmZ0kGeYZS3bpLCkYH1lt4EK7CxmUX3ijoYSOer7ZuaVWYgz4EpZrUirVpMzz
25、vNtf1XZw5oswSXOtFaejnOcmfE1lZgnN1RSXg8wLCG8CVQ3XPJMvodPFWcpiYJgZazNSEPNIaklYSu7qSd1UpaxmZDlpN9zW7kljfsLCLi26Yv109ffbnDH8LbUN1G6ACURQ39eG12KHL9tXsZ1jzgoCK8g1kuNOh5eFvcmVT5ZYVQt9zk3rp3qLnf02FovEXxVRxjCcFRNppiJljNiOuk6fONnyX7fyGg7sXZ49BmCN5oy9VesHpKzdjTKwjrkCEQCFDehVmGax3lrOEbw63VscA3YSijtUKoCyiLzAlVRp
26、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,
