高潤霖冠心病介入治療的熱點(diǎn)第1頁/共82頁

DES的安全性和長期療效

新一代DES第2頁/共82頁FromTCT2006第3頁/共82頁FromTCT2006第4頁/共82頁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頁/共82頁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頁/共82頁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頁/共82頁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頁/共82頁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頁/共82頁ARCProposedStandardDefinitionsDefinite/ConfirmedAcutecoronarysyndromeAND[Angiographicconfirmationofthrombusorocclusion ORPathologicconfirmationofacutethrombosis]ProbableUnexplaineddeathwithin30daysTargetvesselMIwithoutangiographicconfirmationofthrombosisorotheridentifiedculpritlesionPossibleUnexplaineddeathafter30daysNOTE:PatientswhohaveaTLRpriortoathrombosisareincludedbythissetofdefinitions,asopposedtothe“PerProtocol”definition第10頁/共82頁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頁/共82頁WhenDESareusedfortheirapprovedindications,theriskofthrombosisdoesnotoutweightheiradvantagesoverBMSinreducingTLRAscomparedwithon-labeluse,off-labeluseisassociatedwithincreasedrisksofbothearlyandlatestentthrombosis,aswellasdeathorMI第12頁/共82頁第13頁/共82頁第14頁/共82頁第15頁/共82頁第16頁/共82頁第17頁/共82頁第18頁/共82頁第19頁/共82頁第20頁/共82頁第21頁/共82頁第22頁/共82頁第23頁/共82頁第24頁/共82頁RCT薈萃分析顯示,死亡、MI,不論on-label或off-label應(yīng)用,在DES與BMS組均無顯著差別;TVR則不論on-label或off-label應(yīng)用DES均明顯低于BMS30項(xiàng)研究174,302患者真實(shí)世界注冊(cè)研究則顯示,全因死亡、MI在DES組均明顯低于BMSDES的長期安全性及有效性已得到臨床試驗(yàn)及真實(shí)世界研究證實(shí)第25頁/共82頁Conclusions(1)In22RCTsinwhich9,470ptswererandomizedtoDESorBMSandfollowedfor≥1yr,DESresultedin:Nonsignificant3%and6%reductionsinmortalityandMIrespectivelyAhighlysignificant55%reductioninTVRIn30registriesinwhich174,302ptsweretreatedwitheitherDESorBMSandfollowedfor≥1yr,DESresultedin:Ahighlysignificant20%reductioninmortalityAsignificant11%reductioninMIAhighlysignificant47%reductioninTVR第26頁/共82頁Conclusions(2)ThefavorableresultsofDESfromtheRCTandregistryanalysispopulationswererobustandconsistentforbothon-labelandoff-labeluse,andforclinicalf/uextendingto3-4yearsThesefindings,derivedfrommorethan180,000ptstreatedin52studies,stronglysuggestthatDESaresafeforbothon-labelandoff-labeluse,andhavecomparableefficacyinbothRCTsandinthe“real-world”第27頁/共82頁A65-yearoldmalewithCAD,hypertension,MI,Statuspostx2stents,RCA,proximalBxVelocityandCypherdistal-15monthspriortodeath(traumaticbraininjury)BxVelocityNeointimaStrutFibrinCypherFibrinNoendothelializationFromDr.R.Vermani第28頁/共82頁DiscontinuationofAnti-plateletTherapyandRiskforSTIncidence(%)Iakovouetal.JAMA.2005;293:2126.Overallstentthrombosis=1.3%(P=0.09,N=2229)UnstableanginaThrombusDiabetesUnprotectedleftmainBifurcationRenalfailurePriorbrachyRxPrematureantiplateletdiscont’dHowlongshoulddualantiplatelettherapycontinue??第29頁/共82頁雙重抗血小板治療至少一年不適宜DES置入的情況計(jì)劃中的非心臟手術(shù)不適宜長期雙重抗血小板治療

置入DES后必須行非心臟手術(shù)者盡量不停阿斯匹林術(shù)后盡早恢復(fù)氯吡格雷治療教育病人家屬，與相關(guān)醫(yī)師溝通、必要時(shí)咨詢心臟科醫(yī)生第30頁/共82頁不適宜長期雙重抗血小板治療的情況計(jì)劃中的非心臟手術(shù)支架血栓形成的高?；颊叱鲅l(fā)癥風(fēng)險(xiǎn)增加高齡，貧血，腎功能衰竭，消化道出血后，低體重需長期服口服抗凝劑者房顫、肺栓塞、機(jī)械瓣置換術(shù)后不愿意或不能長期按醫(yī)囑服藥者第31頁/共82頁SummaryLong-termefficacyofDESispersistentandthesafetyofDESisconfirmedbymeta-analysisbasedonpatientslevelLatestentthrombosisafterDESimplantationhasemergedasaconcerningentityIndicationforDESstentingProperdualantiplatelettherapy,atleast1yearTechnicalimprovementofDESandnewtypeofDESareemergingandpromising第32頁/共82頁第33頁/共82頁第34頁/共82頁第35頁/共82頁第36頁/共82頁第37頁/共82頁第38頁/共82頁第39頁/共82頁第40頁/共82頁第41頁/共82頁第42頁/共82頁第43頁/共82頁第44頁/共82頁010300jt-os.ppt-On-screen45第45頁/共82頁AcuteMyocardialInfarctionEmergingroleofaspirationthrombectomyinalargetrialfromEurope第46頁/共82頁TAPASTrial:1071STEMIpatientsrandomized535wereassignedtothrombusaspiration33 didnotundergoPCI502underwentprimaryPCI295 underwentTAfollowedby directstenting153underwentTAwithadditionalballoondilation54 hadcrossovertoconventional PCI536wereassignedtoconventionalPCI33didnotundergoPCI503underwentprimaryPCI485 underwentballoondilation followedbystenting12 underwentconventionalPCIwithadditionalTA6 hadcrossovertoTA530completefollow-upat1year530completefollow-upat1yearZiljstraetal,NEJM2008第47頁/共82頁

TAPASPrimary

endpoint

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

哪些患者更能從PCI獲益?第52頁/共82頁AMI:PathophysiologyRupturedplaquewith

occlusivethrombus第53頁/共82頁23RandomizedTrialsofPCIvs.LysisP<0.0001N=7,739Keeley,Grines.Lancet2003;361:13-20P<0.0001p=0.0002p=0.0002第54頁/共82頁ACS:PathophysiologyRupturedplaquewithsubocclusivethrombus第55頁/共82頁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頁/共82頁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頁/共82頁StableCoronaryArteryDiseaseFibroticplaque第58頁/共82頁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頁/共82頁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頁/共82頁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頁/共82頁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頁/共82頁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頁/共82頁COURAGE:TreatmenteffectonanginaBodenWEetal.NEnglJMed.2007;356:1503-16.P<0.001P=0.02NSAngina-free

(%)NS第64頁/共82頁BodenWEetal.NEnglJMed.2007;356:1503-16.TreatmenteffectinCVanddiabetessubgroups0.250.501.002.001.751.50MedicaltherapybetterPCIbetterMyocardialinfarctionYesNoExtentofCADMultivesseldiseaseSingle-vesseldiseaseDiabetesYesNoAnginaCCS0-ICCSII-IIIEjectionfraction>50%PreviousCABGNoYes≤50%BaselinecharacteristicsHazardratio(95%CI)第65頁/共82頁P(yáng)CI+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頁/共82頁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頁/共82頁NeedforSubsequentRevascularizationAtamedian4.6yearfollow-up,21.1%ofthePCIpatientsrequiredanadditionalrevascularization,comparedto32.6%oftheOMTgroupwhorequireda1strevascularization77patientsinthePCIgroupand81patientsintheOMTgrouprequiredsubsequentCABGsurgeryMediantimetosubsequentrevascularizationwas10.0mointhePCIgroupand10.8mointheOMTgroupBodenWEetal.NEnglJMed.2007;356:1503-16.第68頁/共82頁

COURAGE研究是一項(xiàng)重要研究，例數(shù)多，幾乎全部病人均置入支架PCI對(duì)SAP可以有效緩解心絞痛、提高生活質(zhì)量，但與標(biāo)準(zhǔn)藥物治療相比，不能減少死亡和心肌梗死的發(fā)生約2/3SAP患者經(jīng)過標(biāo)準(zhǔn)藥物治療，控制各種危險(xiǎn)因素以后，在相當(dāng)一段時(shí)間內(nèi)可能可以避免PCI第69頁/共82頁010300jt-os.ppt-On-screen70本研究的局限性1、COURAGE研究在35539名患者中僅篩選出3071名符合入選標(biāo)準(zhǔn)。2、符合入選標(biāo)準(zhǔn)的病例784例（25%）未進(jìn)入隨機(jī)，其中450例為醫(yī)生不同意分組，原文中未指出這些病人的治療方式…2、標(biāo)準(zhǔn)內(nèi)科治療組32.6%交叉到PCI組，是否可能影響終點(diǎn)的判定…第70頁/共82頁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頁/共82頁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頁/共82頁NuclearSubstudy(n=314/2,287)Hypothesis:ReductioninIschemiawillbegreaterforpatientsRandomizedtoPCI+OMTthanforthoseRandomizedtoOMTSerialRest/StressMyocardialPerfusionSPECT(MPS)ToComparePatientManagementStrategyforIschemiaReductionPre-Rx=OffMeds6-18m=OnMeds*TimingChosento OccurBeyond WindowofIn-Stent Restenosis& Delayedto