ami介入治療時支架選擇策略陳紀(jì)林

精選課件精選課件StudyNo.ofpatientsMeanage(years)Type

ofDESPrimaryendpointLengthofthienopyridinetherapy(months)Meanlengthoffollow-up(months)BASKET-AMI221662.2PES

SESCardiacdeath,myocardialinfarction,orreintervention618.0DiLorenzo327064.0PES

SESDeath,myocardialinfarction,orreintervention612.0HAAMU-STENT416463.0PESAngiographiclatelumenloss1216.7MISSION531059.2SESAngiographiclatelumenloss1212.0PASSION661960.8PESCardiacdeath,myocardialinfarction,orreintervention612.0SESAMI732061.6SESAngiographicbinaryrestenosis1212.3STRATEGY817562.6SESDeath,myocardialinfarction,stroke,orangiographicbinaryrestenosis324.2TYPHOON971259.3SESCardiacdeath,myocardialinfarction,orreintervention612.11.KastratiA,etal.EurHeartJ.2007;28:2706-2713.2.PittlC,etal.EurHeartJ.2006;27:650(abstractsuppl).3.DiLorenzoE,etal.ACCScientificSessions2005.Presentation2303.4.HAAMU-STENTtrial.Availableatwwwcardiosourcecom/pops/trialSumasp?trialID=1492.Accessed5March2007.5.vanderHoevenBL,etal.JAmCollCardiol.2008;51(6):618-26.6.LaarmanGJetal.NEnglJMed.2006;355:1105-13.

7.MenichelliM,etal.JAmCollCardiol.2007;49(19):1924-30.8.ValgimigliM,etal.JAMA.2005;293(17):2109-17.9.SpauldingC,etal.NEnglJMed.2006;355(11):1093-104.精選課件20105Probabilityofreintervention(%)1501112Monthsafterrandomization1098765432102786patientsDESBMSHR:0.38(95%CI,0.29–0.50)p<0.001*Trialsincludedwere:

BASKET;diLorenzo;HAAMU-STENT;MISSION;PASSION;SESAMI;STRATEGY;TYPHOONKastratiA,etal.EurHeartJ.2007;28:2706-2713.精選課件10Probabilityofdeath(%)84620HR:0.76(95%CI,0.53-1.10)

p=0.14Monthsafterrandomisation01234567891011121084620HR:0.72(95%CI,0.48-1.08)

p=0.11Monthsafterrandomisation0123456789101112Probabilityofrecurrent

myocardialinfarction(%)*Trialsincludedwere:

BASKET;diLorenzo;HAAMU-STENT;MISSION;PASSION;SESAMI;STRATEGY;TYPHOONDESBMSDESBMSKastratiA,etal.EurHeartJ.2007;28:2706-2713.精選課件54210Probabilityofstentthrombosis(%)3012481112MonthsafterrandomisationDESBMS10697532786patients*Trialsincludedwere:

BASKET;diLorenzo;HAAMU-STENT;MISSION;PASSION;SESAMI;STRATEGY;TYPHOONHR:0.80(95%CI,0.46-1.39)

p=0.43KastratiA,etal.EurHeartJ2007;28:2706-2713.精選課件精選課件Randomisation1:1BMS(n=310)TaxusExpress2orLiberteStent(n=309)STEMIpatientswithchestpain>20mnandST-elevationin≥2contiguousleads;infarctrelatedarterywithadenovolesionPrimaryEndpoint:Compositeofdeath,recurrentMI,ortargetlesion

(within5mmofstentedges)revascularization(TLR)atoneyearLaarman,GJetal.NEnglJMed.2006;355:1105-13.精選課件MACE(%)10012024036050TaxusBMSLaarman,GJetal.NEnglJMed.2006;355:1105-13.DaysPRIMARYENDPOINTNOTACHIEVEDHR=0.68(0.41-1.10)

p=0.128.712.6Noprespecified

angiographicF/UDualAPTrecommendedfor≥6months

(Clopidogrel:MedianDurationof9months)*CardiacDeath,MI,orTLR精選課件p=0.12p=0.32p=0.09OR0.70

(95%CI:0.45-1.09)OR0.78

(95%CI:0.41-1.44)OR0.60

(95%CI:0.34-1.09)DirksenMT.PresentedatESC2009.905101520MACECardiacDeathTLR%ofPatientsTaxusBMSSESinAMITyphoonTrialToAssessTheUseoftheCYPHER?Sirolimus-elutingStent(SES)inAcuteMyocardialInfarctionPatientsTreatedWithBalloonAngioplastyChristianSpaulding

fortheTYPHOONInvestigatorsPCR2009精選課件SESinAMITyphoonstudydesign715名首次發(fā)生AMI后12小時內(nèi)行急診PCI手術(shù)的患者1:1隨機(jī)化CYPHER?orCYPHERSelect?(356patients)裸金屬支架(359patients)SpauldingC.,etal.,NewEnglJMed2006;355:1093-104.1withdrew

consentpost-PCI2withdrew

consentpost-PCICYPHER?orCYPHERSelect?(355patients)研究終點(diǎn):1年的TVF,

TVF確定標(biāo)準(zhǔn):缺血癥狀引起的TVR,再發(fā)心梗,靶血管相關(guān)的心源性死亡裸金屬支架(3597patients)精選課件%占患者總數(shù)的百分比P<0.001P<0.0001P=NSP<0.001P=0.004P=NSMACE:majoradversecardiaceventsdefinedasall-causedeath,re-MIorTLR.

TLR:targetlesionrevascularization. TVR:targetvesselrevascularization.

TVF:targetvesselfailuredefinedasischemia-drivenTVR,recurrentMI,ortargetvessel-relatedcardiacdeathMI:myocardialinfarction(all).ST:stentthrombosis(perprotocol)P=NS主要終點(diǎn)TVFMACETLRTVRMISTDEATH精選課件HORIZON2年和TYPHOON4年結(jié)果精選課件AProspective,RandomizedComparisonofPaclitaxel-elutingTAXUSStentsvs.BareMetalStentsDuringPrimaryAngioplastyinAcuteMyocardialInfarctionGreggW.StoneMDFortheHORIZONS-AMIInvestigators精選課件3602ptswithSTEMIwithsymptomonset≤12hoursEmergentangiography,followedbytriageto…PrimaryPCICABG–MedicalRx–UFH+GPIIb/IIIainhibitor(abciximaboreptifibatide)Bivalirudinmonotherapy(±provisionalGPIIb/IIIa)Aspirin,thienopyridine（噻吩吡啶）

R1:13000ptseligibleforstentrandomization

R3:1BaremetalEXPRESSstentPaclitaxel-elutingTAXUSstentClinicalFUat30days,6months,1year,andthenyearlythrough5years;angioFUat13months精選課件1)Ischemia-drivenTLR*2)CompositeSafetyMACE=Allcausedeath,re-infarction,stentthrombosis(ARCdefiniteorprobable)**,orstrokeand*Relatedtorandomizedstentlesions(whetherstudyornonstudystentswereimplanted);MajorSecondaryEndpoint(at13Months)Binaryangiographicrestenosis **Inrandomizedstentlesionswith≥1stentimplanted(whetherstudyornonstudystents)精選課件1年結(jié)果：TAXUSPES與ExpressBMS減少臨床和造影再狹窄率，而死亡、再發(fā)心結(jié)梗死和支架內(nèi)血栓形成發(fā)生率相似。MACE：死亡、心肌梗死、卒中或支架內(nèi)血栓形成心源性死亡

全因死亡

缺血所致TVR次要終點(diǎn)

MACE

缺血所致TLR再次心肌梗死主要終點(diǎn)

支架內(nèi)血栓（肯定和極可能的）2-yearoutcomes%ofPatientsP=0.005P=0.23P=0.013P=0.83MI:myocardialinfarction,TLR:targetlesionrevascularization,TVR:targetvesselrevascularisation,Non-hierarchicaleventsP=0.3710/25116/2508/25112/25012/25110/25018/25138/25024/25143/250AcademicResearchConsortium/Dublin-DefinedEvents53%44%精選課件13

(5.2%)9

(3.6%)9

(3.6%)6

(2.4%)3

(1.2%)6

(2.4%)1

(0.4%)21

(8.4%)StentThrombosis(%)P=0.16ARC/Dublindefinitions.Hierarchicalevents精選課件Typhoon研究小結(jié)TYPHOON4yrFUTYPHOON研究表明:同BMS相比Cypher支架明顯的降低了TVF,TVR,TLR的發(fā)生率在全因死亡率,心源性死亡率,心梗發(fā)生率和支架內(nèi)血栓發(fā)生率方面,二者沒有差別在心肌梗死患者中應(yīng)用,Cypher支架降低了再次血運(yùn)重建的幾率,并且沒有晚期追趕的現(xiàn)象;長期的隨訪同時表明,Cypher支架的安全性同樣持久保持精選課件ARandomized，Multi-Center，Single-Blind

ComparisonofNEVO?

Sirolimus-ElutingCoronaryStentversustheTAXUS?Liberté?Paclitaxel-ElutingCoronaryStentSysteminDeNovoNativeCoronaryArteryLesionsPI:Drs.ChristianSpaulding,AlexandreAbizaidandJohnOrmiston22精選課件NEVO是Cordis的下一代的藥物涂層支架,藥物沿用經(jīng)典的雷帕霉素，支架平臺設(shè)計(jì)采用獨(dú)特的RES(藥物釋放槽)技術(shù),將藥物/聚合物同血管壁的接觸降低到更小;迄今真正的可吸收聚合物支架,其藥物釋放槽中的聚合物可在3-4個月后完全降解.RES技術(shù)：全新的設(shè)計(jì)(Reservoir,藥物釋放槽)Minimizetissue/polymercontactwhileprotectingthedrug/polymerfrommechanicaldamageCompleteelutionofthedrugandresorbtionofthepolymerfromthereservoirsovertimeleavebehindabaremetalstentAmatrixofdrugandpolymerisloadedonthereservoirs23精選課件Objective:

Todemonstratenon-inferiority(and,ifpositive,superiority)oftheNEVO?

StentcomparedwiththeTAXUS?Liberté?stentfortheprimaryendpointof6-monthsin-stentlatelossMajorInclusionCriteria:SingleDenovelesionsinnativecoronaryarteriesLesionLength≤28mm2.5mm-3.5mmindiameterMajorExclusionCriteria:AcutemyocardialinfarctionOstiallesionsUnprotectedleftmainstemlesions精選課件SingleDeNovoNativeCoronaryArteryLesion<28mmina2.5-3.5mmdiametervessel388patients@40sitesinEurope,SouthAmerica,Australia,&NewZealandNEVO?Sirolimus-ElutingStent(N=202)TAXUS?Liberté?Paclitaxel-ElutingStent(N=192)1:1RandomizationPrimaryEndpoint:6-MonthIn-StentLateLossIVUSinasubsetofpatients30Day6Mo.1Yr.2Yr.3Yr.4Yr.Clinical/MACEAngio/IVUS5Yr.9Mo.3Mo.FirstPatientEnrolledMarch19,2008EnrollmentCompletedOctober17,2008精選課件PrimaryEndpoint:6-monthsin-stentlatelumenloss(Angiographic)SecondaryEndpoints:In-stent/in-segmentbinaryrestenosis,%diameterstenosisandMLDDevice,Lesion,andproceduresuccessStentThrombosis(ARCandprotocoldefinition)in