支架内血栓李建平.ppt

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,支架内血栓,In-Stent Thrombosis,北京大学第一医院 李建平,Definite/Confirmed,（肯定的）,Acute coronary syndrome AND,Angiographic confirmation of thrombus or occlusion OR,Pathologic confirmation of acute thrombosis,Probable,（可能的）,Unexplained death within 30 days,Target vessel MI without angiographic confirmation of thrombosis or other identified culprit lesion,Possible,（不能排除的）,Unexplained death after 30 days,ARC,支架内血栓定义,支架内血栓的预后,SES(N=13),BMS(N=15),Death,4,5,Myocardial Infarction,13,13,Fatal MI,4,4,Q Wave MI,8,5,Non-Q Wave MI,5,8,Similar mortality observed for SES and BMS thrombosis,Pooled Data from RAVEL,SIRIUS,C-SIRIUS,E-SIRIUS,支架内血栓发生时间,ST=stent thrombosis;SAT=subacute stent thrombosis;,LST=late stent thrombosis;VLST=very late stent thrombosis.,Adapted from Bhatt.,J Invasive Cardiol,.2003;15(suppl B):3B.,Stent Thrombosis(%),支架内血栓与抗凝、抗血小板治疗,ASA und Ticlopidine,ASA und Anticoagulation,ASA und Clopidogrel,DES,ASA=Acetylsalicylic acid,DES:Drug-eluting stent,Bare Metal Stent,Prasugrel?,0,1,2,3,4,Time since PCI in years,0,1,2,3,4,5,Cumulative incidence,%,Months,1,12,24,36,48,Cumulative incidence,%,1.2,1.6,2.1,2.7,3.3,Patients at risk,7538,7210,5164,2790,1051,Incidence density,1.0/100 pt years,3.3%,3.5,0.53%(95%CI=0.44-0.64)/year,192 definite ST cases,DES,肯定的,ST,发生率,:Bern-Rotterdam Cohort Study 4 Years,Wenaweser P et al.,J Am Coll Cardiol,2008,52,1134-,0.52%(95%CI=0.42-0.62)/year between 30 days and 5 years,DES,肯定的支架内血栓发生率,:Bern-Cohort Study 5 Years,Wenaweser P et al.ESC 2008,Favours,DES,Favours BMS,180 days,31-180 days,0-30 days,Time after PCI,.1,.2,.5,1,2,5,10,20,50,100,Odds Ratio,Favors DES,Favors BMS,.1,.2,.5,1,2,5,10,20,50,100,Odds Ratio,Adjusted Resultswith interaction terms,for time since PCI,Early period:0-30 days,OR 0.59,95%CI.35-1.01,Late period31-180 days,OR 0.52,95%CI.16 1.75,Very late period:180 days,OR 9.4,95%CI 2.56 34.70,Wenaweser et al.ACC 2007,DES vs BMS,A,cohort of 9,175 patients treated with either BMS or DES(SES or PES),all patients with angiographically documented ST were identified as cases,Early Stent Thrombosis,RR=0.76,95%CI=0.30-1.80,P=0.55,RR=0.80,95%CI=0.32-2.03,P=0.79,Meta-analysis,SES vs BMS,Bavry A et al.,Am J Card,2005,Meta-analysis,PES vs BMS,Stone G et al.,NEJM,2007,%,%,Very Late ST 1 Year(Per Protocol),P=0.75,P=0.02,%,P=0.30,P=0.03,%,Stone G et al.,NEJM,2007;356:998-1008,Kastrati A et al.,NEJM,2007;356:1030-9,Sirolimus-Eluting Stent,Paclitaxel-Eluting Stent,SIRTAX Definite ST 4 Years,Windecker S et al ESC 2008,2.0%,1.8%,2.8%,2.4%,3.7%,3.4%,1-year HR,1.12 0.46,2.76,P=0.01,2-year HR,0.86 0.40,1.87,P=0.71,3-year HR,0.90 0.47,1.73,P=0.75,4-year HR,1.06 0.57,1.95,P=0.86,SES 4.2%,PES 3.9%,Cumulative Incidence of Definite STin LEADERS(BES vs.SES),Windecker et al.Lancet,2008,372,1163-,Early:1.6%,2.0%SES,1.9%BES,Overall Incidence of ST with DES,CYPHER,TAXUS,ENDEAVOR,XIENCE,BIOMATRIX,0.4,0.3,0.7,0.5,1.6,1.4,0.8,TAXUS II,TAXUS IV,TAXUS V,TAXUS VI,REALITY,SIRTAX,ISAR-DM,1,0.5,0.8,1.9,Endeavor I,Endeavor II,Spirit III,Leaders,0.2,1.1,2,0.6,1.8,0.8,0,0,1,2,3,SIRIUS,E-SIRIUS,C-SIRIUS,REALITY,SIRTAX,ARTS II,ISAR-DM,%,High Risk of ST in All-Comer Patient Population and STEMI Patients,%,支架内血栓的病因,STENT THROMBOSIS,Stent,Design/Length,Polymer,Surface,Drugs,Lesion,Vessel Size,Thrombus,Intervention,Residual Dissection,Incomplete Stent Apposition,Antithromobotic Medication,Patient,Genetic Polymorphism,Reduced LV-EF,Acute Coronary Syndrome,Hematology Disorder,Drugs,Resistance,Drug-drug Interaction,Duration of Antiplatelet,Treatement,Vessel Reaction,Vessel Remodeling,Hypersensitivity Reaction,Delayed Healing,早期支架内血栓的预测因素,:,残留夹层,/,撕裂,Bare Metal Stents,MACE 30 days,Schhlen H et al.,Circulation,1998,N=2,894,Drug-Eluting Stents,MACE 30 days,Biondi-Zoccai G et al.,EHJ,2006,N=2,418,%,P=0.01,P=0.01,Residual Dissection:Independent Predictor of MACE(OR=2.9),早期支架内血栓,IVUS,预测因素,With the Use of Sirolimus-Eluting Stents,Fujii K et al.,J Am Coll Cardiol,2005;45:995-8,Minimal Stent CSA,P0.001,mm,2,Stent Expansion,Residual Stenosis,%,P0.001,Stent Underexpansion and Residual Reference Segment Stenosis:,Independent Predictors of Early Stent Thrombosis!,P0.001,支架内血栓预测因素药物反应异常,Wenaweser P et al.,JACC,2005;45(11):1748-52,服药后血小板活性与,DES ST,的关系,Buonamici P et al JACC 2007,p0.001,p0.001,p1 yr)stent thrombosis associated with current DES,2-4 per 1000 pts per year(?continous hazard,?patient and lesion predictors),Data from multiple sources indicate thatDES are associated with delayed healingresponses and increased inflammation,The causes of late DES thrombosis are multi-factorial;device,procedural,and patientfactors(often multiple=perfect storm),专家共识,FDA DES Panel Meeting,There may be a link between post-DES reduced neo-intimal hyperplasia(late loss)and delayed late healing responses which contributes to late stent thrombosis,DES stent thrombosis is highly definition dependent;need for revised standardizeddefinitions and adjudication methods(ARC)to facilitate inter-study comparisons,专家共识,“Off-label DES use increased incidence of late DES thrombosis and death/MI cw“on-label”,butinadequate controls;results inconsistent!,Few RCTs(underpowered);FDA sanctioned registries=insufficient sample size and FU,represents major data gap and source of concern,Large population studies(SCAAR)fraught with methodologic flaws(e.g.risk adjustment issues),专家共识,Duration of dual anti-platelet therapy should extend beyond the present product labels,O,ne year is reasonable compromise(esp.for“off-label”DES use),Must balance against the increased risk ofbleeding with dual anti-platelet therapy,Additional studies immediately required tobetter clarify optimal anti-platelet therapy,专家共识,Assess patient and lesion characteristics to establish restenosis risk profile,Determine relative value of DES vs.BMS inevery patient (no more“unrestricted”use),Consider both on-label and off-label situations(ironically,off-label use scenarios may be more compelling),Increased restenosis risk=favor DES,Increased safety concerns=favor No DES,专家共识,Assess patient factors which may preclude long-term(at least one year)dual AP therapy,Planned or possible intercurrent surgery,Bleeding Hx or tendencies,Other concomitant medications(e.g.coumadin),Socio-economic factors which may affect Plavix compliance,专家共识,Consider alternatives to DES,if risk-benefit assessments prove unfavorable,CABG unprotected LM disease,complex MVD(esp.diabetics),recurrent ISR(esp.VBT),BMS Plavix dependence concerns,large(4mm diameter)vessels,?AMI pts,?low restenosis risk lesions,Balloon PCI sidebranch in bifurcations (provisional stent only),small vessels in distal locations,专家共识,Optimize DES implantation techniques,Adequate lesion preparation(pre-dilatation),High pressure implantation methodologies(like previous BMS strategies),Avoid undersizing and inflow/outflow obstruction(mod stenoses or dissections),Implant stent edges into normal references segments,Consider IVUS guidance(esp.LAD),专家共识,Careful explanations and open communication with patients and families,Careful pre-treatment history,Discussion with EVERY pt re:risks and benefits of DES vs.alternative therapies,Ongoing(post-Rx)communication and careful FU re:dual AP compliance(instructions=NO Plavix discontinuation without MD approval)!,DES,风险,&,获益,治疗,1000,个病人可以预防,100,个再狭窄,同时可以预防,10,个再狭窄相关的心肌梗死,可能会因为晚期支架内血栓增加,5,个心肌梗死,获益,风险,