高润霖冠心病介入治疗的热点

高润霖冠心病介入治疗的热点第1页/共82页

DES的安全性和长期疗效

新一代DES第2页/共82页FromTCT2006第3页/共82页FromTCT2006第4页/共82页TimeafterInitialProcedure(years)01234TimeafterInitialProcedure(years)TAXUSI,II,IV,V,VI(n=3,513)RAVEL,SIRIUS,E-SIRIUS,andC-SIRIUS(n=1,748)CYPHERstent(n=870)Baremetalstent(n=878)StoneGWetal.NEJM2007;356:998-100801234TAXUSstent(n=1,755)Baremetalstent(n=1,758)9Prospective,Double-Blind,RandomizedTrials

FreedomFrom(Protocol)StentThrombosisP=0.2099.4%(5)98.8%(10)P=0.3099.1%(14)98.7%(20)第5页/共82页TimeafterInitialProcedure(years)01234TimeafterInitialProcedure(years)TAXUSI,II,IV,V,VI(n=3,513)RAVEL,SIRIUS,E-SIRIUS,andC-SIRIUS(n=1,748)CYPHERstent(n=870)Baremetalstent(n=878)StoneGWetal.NEJM2007;356:998-100801234TAXUSstent(n=1,755)Baremetalstent(n=1,758)9Prospective,Double-Blind,RandomizedTrials

FreedomFrom(Protocol)StentThrombosisP=0.2099.4%(5)98.8%(10)P=0.3099.1%(14)98.7%(20)5

vs.0,P=0.025After1year9

vs.2,P=0.028After1year第6页/共82页TimeafterInitialProcedure(years)01234TimeafterInitialProcedure(years)TAXUSI,II,IV,V,VI(n=3,513)RAVEL,SIRIUS,E-SIRIUS,C-SIRIUS(n=1,748)P=0.2394.7%(45)93.3%(57)CYPHERstent(n=870)Baremetalstent(n=878)StoneGWetal.NEJM2007;356:998-100801234P=0.6893.4%(92)93.9%(86)TAXUSstent(n=1,755)Baremetalstent(n=1,758)9Prospective,Double-Blind,RandomizedTrials

FreedomFromAllCauseDeath第7页/共82页TimeafterInitialProcedure(years)01234TimeafterInitialProcedure(years)TAXUSI,II,IV,V,VI(n=3,513)RAVEL,SIRIUS,E-SIRIUS,C-SIRIUS(n=1,748)P=0.8693.8%(53)93.6%(55)CYPHERstent(n=870)Baremetalstent(n=878)StoneGWetal.NEJM2007;356:998-100801234P=0.6693.7%(105)93.0%(115)TAXUSstent(n=1,718)Baremetalstent(n=1,727)9Prospective,Double-Blind,RandomizedTrials

FreedomFromMyocardialInfarction第8页/共82页TimeafterInitialProcedure(years)01234TimeafterInitialProcedure(years)TAXUSI,II,IV,V,VI(n=3,513)RAVEL,SIRIUS,E-SIRIUS,C-SIRIUS(n=1,748)P<0.000176.4%(202)92.2%(66)CYPHERstent(n=870)Baremetalstent(n=878)StoneGWetal.NEJM2007;356:998-100801234P<0.000180.0%(338)89.9%(166)TAXUSstent(n=1,755)Baremetalstent(n=1,758)9Prospective,Double-Blind,RandomizedTrials

FreedomFromIschemicTLR第9页/共82页ARCProposedStandardDefinitionsDefinite/ConfirmedAcutecoronarysyndromeAND[Angiographicconfirmationofthrombusorocclusion ORPathologicconfirmationofacutethrombosis]ProbableUnexplaineddeathwithin30daysTargetvesselMIwithoutangiographicconfirmationofthrombosisorotheridentifiedculpritlesionPossibleUnexplaineddeathafter30daysNOTE:PatientswhohaveaTLRpriortoathrombosisareincludedbythissetofdefinitions,asopposedtothe“PerProtocol”definition第10页/共82页StentThrombosis:FDAAdvisoryPanel,8RCTMauri,L.NEnglJMed2007;356:1020-9.definiteandprobabledefiniteandprobable1.2%0.6%1.7%1.5%1.3%0.8%1.8%1.4%第11页/共82页WhenDESareusedfortheirapprovedindications,theriskofthrombosisdoesnotoutweightheiradvantagesoverBMSinreducingTLRAscomparedwithon-labeluse,off-labeluseisassociatedwithincreasedrisksofbothearlyandlatestentthrombosis,aswellasdeathorMI第12页/共82页第13页/共82页第14页/共82页第15页/共82页第16页/共82页第17页/共82页第18页/共82页第19页/共82页第20页/共82页第21页/共82页第22页/共82页第23页/共82页第24页/共82页RCT荟萃分析显示,死亡、MI,不论on-label或off-label应用,在DES与BMS组均无显著差别;TVR则不论on-label或off-label应用DES均明显低于BMS30项研究174,302患者真实世界注册研究则显示,全因死亡、MI在DES组均明显低于BMSDES的长期安全性及有效性已得到临床试验及真实世界研究证实第25页/共82页Conclusions(1)In22RCTsinwhich9,470ptswererandomizedtoDESorBMSandfollowedfor≥1yr,DESresultedin:Nonsignificant3%and6%reductionsinmortalityandMIrespectivelyAhighlysignificant55%reductioninTVRIn30registriesinwhich174,302ptsweretreatedwitheitherDESorBMSandfollowedfor≥1yr,DESresultedin:Ahighlysignificant20%reductioninmortalityAsignificant11%reductioninMIAhighlysignificant47%reductioninTVR第26页/共82页Conclusions(2)ThefavorableresultsofDESfromtheRCTandregistryanalysispopulationswererobustandconsistentforbothon-labelandoff-labeluse,andforclinicalf/uextendingto3-4yearsThesefindings,derivedfrommorethan180,000ptstreatedin52studies,stronglysuggestthatDESaresafeforbothon-labelandoff-labeluse,andhavecomparableefficacyinbothRCTsandinthe“real-world”第27页/共82页A65-yearoldmalewithCAD,hypertension,MI,Statuspostx2stents,RCA,proximalBxVelocityandCypherdistal-15monthspriortodeath(traumaticbraininjury)BxVelocityNeointimaStrutFibrinCypherFibrinNoendothelializationFromDr.R.Vermani第28页/共82页DiscontinuationofAnti-plateletTherapyandRiskforSTIncidence(%)Iakovouetal.JAMA.2005;293:2126.Overallstentthrombosis=1.3%(P=0.09,N=2229)UnstableanginaThrombusDiabetesUnprotectedleftmainBifurcationRenalfailurePriorbrachyRxPrematureantiplateletdiscont’dHowlongshoulddualantiplatelettherapycontinue??第29页/共82页双重抗血小板治疗至少一年不适宜DES置入的情况计划中的非心脏手术不适宜长期双重抗血小板治疗

置入DES后必须行非心脏手术者尽量不停阿斯匹林术后尽早恢复氯吡格雷治疗教育病人家属，与相关医师沟通、必要时咨询心脏科医生第30页/共82页不适宜长期双重抗血小板治疗的情况计划中的非心脏手术支架血栓形成的高危患者出血并发症风险增加高龄，贫血，肾功能衰竭，消化道出血后，低体重需长期服口服抗凝剂者房颤、肺栓塞、机械瓣置换术后不愿意或不能长期按医嘱服药者第31页/共82页SummaryLong-termefficacyofDESispersistentandthesafetyofDESisconfirmedbymeta-analysisbasedonpatientslevelLatestentthrombosisafterDESimplantationhasemergedasaconcerningentityIndicationforDESstentingProperdualantiplatelettherapy,atleast1yearTechnicalimprovementofDESandnewtypeofDESareemergingandpromising第32页/共82页第33页/共82页第34页/共82页第35页/共82页第36页/共82页第37页/共82页第38页/共82页第39页/共82页第40页/共82页第41页/共82页第42页/共82页第43页/共82页第44页/共82页010300jt-os.ppt-On-screen45第45页/共82页AcuteMyocardialInfarctionEmergingroleofaspirationthrombectomyinalargetrialfromEurope第46页/共82页TAPASTrial:1071STEMIpatientsrandomized535wereassignedtothrombusaspiration33 didnotundergoPCI502underwentprimaryPCI295 underwentTAfollowedby directstenting153underwentTAwithadditionalballoondilation54 hadcrossovertoconventional PCI536wereassignedtoconventionalPCI33didnotundergoPCI503underwentprimaryPCI485 underwentballoondilation followedbystenting12 underwentconventionalPCIwithadditionalTA6 hadcrossovertoTA530completefollow-upat1year530completefollow-upat1yearZiljstraetal,NEJM2008第47页/共82页

TAPASPrimary

endpoint

MyocardialblushgradeP<0.001Patients(%)ThrombusaspirationConventionalPCIZiljstraetal,NEJM2008第48页/共82页TAPAS:Mortalityat1yearLog-Rankp=0.040*UnpublishedresultsZiljstraetal,NEJM2008第49页/共82页TAPAS:Mortalityornon-fatalReMIat1yearLog-Rankp=0.016*UnpublishedresultsZiljstraetal,NEJM2008第50页/共82页TakeHomeMessageUnlikeearlierstudieswithaggressiverheolyticthrombecomy,themildaspirationthrombectomyhadsignificantangiographicandclinicalbenefitinpatientswithSTEMIhavingPCI第51页/共82页在稳定性CAD患者中，

哪些患者更能从PCI获益?第52页/共82页AMI:PathophysiologyRupturedplaquewith

occlusivethrombus第53页/共82页23RandomizedTrialsofPCIvs.LysisP<0.0001N=7,739Keeley,Grines.Lancet2003;361:13-20P<0.0001p=0.0002p=0.0002第54页/共82页ACS:PathophysiologyRupturedplaquewithsubocclusivethrombus第55页/共82页MehtaSRetal.JAMA2005;293:2908-2917CompositeofDeathorMyocardialInfarctionNo./Total(%)SourceRoutineinvasiveSelectiveinvasiveTIMIIIIB86/740(11.6)101/733(13.8)VANQWISH152/462(32.9)139/458(30.3)MATE16/111(14.4)11/90(12.2)FRISCII127/1222(10.4)174/1235(14.1)TACTICS81/1114(7.3)105/1106(9.5)VINO4/64(6.3)15/67(22.4)RITA95/895(10.6)118/915(12.9)Total561/4608(12.2)663/4604(14.4)OddsRatio(95%Cl)FavorsRoutineInvasiveFavorsSelectiveInvasiveOR,0.82[0.72-0.93]P<0.0010.11.010Meta-analysisofConservativevs.InvasiveStrategiesinACS9,212randomizedptsin7trialsCompositedeathorMIfromrandtolatestFU18%第56页/共82页SourceRoutineNo./Total(%)SelectiveNo./Total(%)TIMIIIIB218/740(29.5)265/733(36.2)VANQWISH275/462(59.5)287/458(62.7)MATE25/111(22.5)20/90(22.2)FRISCII451/1222(36.9)704/1235(57.0)TACTICS123/1114(11.0)152/1106(13.7)VINO16/64(25.0)25/67(37.3)RITA379/863(43.9)436/882(49.4)

Total1487/4576(32.5)1669/4571(41.3)Meta-analysisofConservativevs.InvasiveStrategiesinACSMehtaSRetal.JAMA2005;293:2908-2917SourceRoutineNo./Total(%)SelectiveNo./Total(%)TIMIIIIB106/740(14.3)123/733(16.8)VANQWISH68/462(14.7)69/458(15.1)MATE6/111(5.4)0/90(0)FRISCII32/1170(2.7)81/1170(6.9)TACTICS80/1114(7.2)73/1106(6.6)VINO9/64(14.1)12/67(17.9)RITA206/862(23.9)275/883(31.1)Total507/4525(11.2)633/4507(14.0)CCSClassIII-IVAnginaRehospitalizationOddsRatio(95%Cl)OR,0.77[0.68-0.87]P<0.0010.11.0100.11.010OR,0.66[0.60-0.72],P<0.001FavorsRoutineInvasiveFavorsSelectiveInvasive23%34%第57页/共82页StableCoronaryArteryDiseaseFibroticplaque第58页/共82页COURAGE:StudydesignBodenWEetal.AmHeartJ.2006;151:1173-9.BodenWEetal.NEnglJMed.2007;356:1503-16.Optimalmedicaltherapy*+PCI(n=1149)Optimalmedicaltherapy

(n=1138)AHA/ACCClassI/IIindicationsforPCI,suitablecoronaryarteryanatomy+

≥70%stenosisin≥1proximalepicardialvessel+objectiveevidenceofischemia

(or≥80%stenosis+CCSclassIIIanginawithoutprovocationtesting)Primaryoutcomes:All-causemortality,nonfatalMIFollow-up:Median4.6yearsRandomized*Intensivepharmacologictherapy+lifestyleintervention

CCS=CanadianCardiovascularSocietySecondaryoutcomes:Death,MI,stroke;ACShospitalization第59页/共82页NumberatRiskMedicalTherapy11381017959 834 638 408 192 30PCI 11491013952 833 637 417 200 35Years01234560.00.50.60.70.80.91.0PCI+OMTOptimalMedicalTherapy(OMT)Hazardratio:1.0595%CI(0.87-1.27)P=0.627SurvivalFreefromDeathandMI

(medianFU4.6yrs)BodenWEetal.NEJM2007;356:1503-16FreedomfromDeathorMI(%)Death/MIat4.6yrs19.0%18.5%第60页/共82页COURAGE:TreatmenteffectonprimaryoutcomeHR1.05(0.87-1.27)P=0.62*BodenWEetal.NEnglJMed.2007;356:1503-16.All-causedeath,MI(timetofirstevent)*UnadjustedNo.atriskMedicaltherapy 1138 1017 959 834 638 408 192 30PCI 1149 1013 952 833 637 417 200 35MedicaltherapyPCI+medicaltherapySurvivalfreeofprimaryoutcome024700.50.60.70.81.00.9Years6531第61页/共82页No.atriskMedicaltherapyPCI38443023124684887177339179291029105110731094113811491201341922004094186386378348339629541019101511381149COURAGE:TreatmenteffectsBodenWEetal.NEnglJMed.2007;356:1503-16.*UnadjustedAll-causedeathMyocardialinfarctionOverallsurvivalSurvivalfreeofMIPCI+medicaltherapy1.00.90.70.8Medicaltherapy1.00.90.70.8012345670YearsYears012345670HR0.87(0.65-1.16)P=0.38*HR1.13(0.89-1.43)P=0.33*第62页/共82页COURAGE:TreatmenteffectonhospitalizationforACSBodenWEetal.NEnglJMed.2007;356:1503-16.*UnadjustedHR1.07(0.84-1.37)P=0.56*No.atriskMedicaltherapyPCI1271342362464184316626678338359569571025102711381149SurvivalfreeofACSYears0012345671.00.90.70.8PCI+medicaltherapyMedicaltherapy第63页/共82页COURAGE:TreatmenteffectonanginaBodenWEetal.NEnglJMed.2007;356:1503-16.P<0.001P=0.02NSAngina-free

(%)NS第64页/共82页BodenWEetal.NEnglJMed.2007;356:1503-16.TreatmenteffectinCVanddiabetessubgroups0.250.501.002.001.751.50MedicaltherapybetterPCIbetterMyocardialinfarctionYesNoExtentofCADMultivesseldiseaseSingle-vesseldiseaseDiabetesYesNoAnginaCCS0-ICCSII-IIIEjectionfraction>50%PreviousCABGNoYes≤50%BaselinecharacteristicsHazardratio(95%CI)第65页/共82页PCI+OMTcomparedtoOMTresultedin:Significantlylessuseofnitratesat-1year(53%vs.67%)-3years(47%vs.61%)-5years(40%vs.57%)SignificantlylessuseofCa+2channelblockersat-1year(40%vs.49%)-3years(43%vs.50%)-5years(42%vs.52%)FreedomfromAnti-anginalMedsDuringLong-termFollow-upDespiteamuchhigherthananticipatedXOtoPCIintheOMTgroupBodenWEetal.NEJM2007;356:1503-16第66页/共82页Follow-upPCI+OMTOMTPValueBaseline51+2551+250.833months73+2268+23<0.00016months73+2370+230.000512months75+2171+220.000624months76+2174+220.1136months77+2175+220.05SAQDomain

QualityofLifeBodenandWeintraub,ACC2007.第67页/共82页NeedforSubsequentRevascularizationAtamedian4.6yearfollow-up,21.1%ofthePCIpatientsrequiredanadditionalrevascularization,comparedto32.6%oftheOMTgroupwhorequireda1strevascularization77patientsinthePCIgroupand81patientsintheOMTgrouprequiredsubsequentCABGsurgeryMediantimetosubsequentrevascularizationwas10.0mointhePCIgroupand10.8mointheOMTgroupBodenWEetal.NEnglJMed.2007;356:1503-16.第68页/共82页

COURAGE研究是一项重要研究，例数多，几乎全部病人均置入支架PCI对SAP可以有效缓解心绞痛、提高生活质量，但与标准药物治疗相比，不能减少死亡和心肌梗死的发生约2/3SAP患者经过标准药物治疗，控制各种危险因素以后，在相当一段时间内可能可以避免PCI第69页/共82页010300jt-os.ppt-On-screen70本研究的局限性1、COURAGE研究在35539名患者中仅筛选出3071名符合入选标准。2、符合入选标准的病例784例（25%）未进入随机，其中450例为医生不同意分组，原文中未指出这些病人的治疗方式…2、标准内科治疗组32.6%交叉到PCI组，是否可能影响终点的判定…第70页/共82页CompleterevascularizationPeri-PCIMIsPCIOutcomes1149patientstotal46(4%)procedurenotattempted27(2%)nolesionscrossed1077patients(94%)hadPCIattempted1577/1688lesionshadPCIsuccess(93%)FewPCIptsreceivedGPIIb/IIIaoradequateclopidogrelpre-loading,andnonereceivedbival787patients(69%)had2or3vesselds.590pts(59%)received1stent416pts(41%)received≥2stentsAtleast371of787pts(47%)withmultivesseldiseasehadincompleterevascularization14%PTCAonly86%stents97%BMS3%DESReally~85%PCIsuccess第71页/共82页OddsRatio(95%ConfidenceInterval)OverallTrialSieversetal.Dakiketal.ACIPACME-1TIMEALKKAVERTBechetal.MASSACME-2RITA-2Yearof

Publication19931998199719972004200319992001199919972003271/3675PCI0/441/212/19216/11545/1536/1491/1772/906/729/5143/504335/3838Medical1/441/2320/36615/11240/14817/1511/1644/916/7210/5043/514Deaths/TotalSWISSIIIDANAMICOURAGEINSPIREHambrechtetal.MASSII2007200620072006200420066/9619/50385/11492/10428/20522/10524/50595/11381/10135/2030/500/511.110RandomeffectsmodelFixedeffectsmodelPheterogeneity=0.263;I2=17%PCIvs.MedicalRx–17RCTs,7513pts

PrimaryEndPoint:All-CauseDeath

Kastratietal;TCT20070.80(0.64to0.99)0.80(0.68to0.95)第72页/共82页NuclearSubstudy(n=314/2,287)Hypothesis:ReductioninIschemiawillbegreaterforpatientsRandomizedtoPCI+OMTthanforthoseRandomizedtoOMTSerialRest/StressMyocardialPerfusionSPECT(MPS)ToComparePatientManagementStrategyforIschemiaReductionPre-Rx=OffMeds6-18m=OnMeds*TimingChosento OccurBeyond WindowofIn-Stent Restenosis& Delayedto