ami介入治疗时支架选择策略-陈纪林-课件幻灯

中国医学科学院阜外心血管病医院陈纪林教授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):1093-104.20105Probabilityofreintervention(%)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;28:2706-2713.10Probabilityofdeath(%)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;28:2706-2713.54210Probabilityofstentthrombosis(%)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.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.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,orTLRp=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.PresentedatESC2007.15.47.29.911.15.66.005101520MACECardiacDeathTLR%ofPatientsTaxusBMSSESinAMITyphoonTrialToAssessTheUseoftheCYPHER®Sirolimus-elutingStent(SES)inAcuteMyocardialInfarctionPatientsTreatedWithBalloonAngioplastyChristianSpaulding

fortheTYPHOONInvestigatorsPCR2009SESinAMITyphoonstudydesign1:1随机化CYPHER®orCYPHERSelect®(356patients)裸金属支架(359patients)SpauldingC.,etal.,NewEnglJMed2006;355:1093-104.1withdrew

consentpost-PCI2withdrew

consentpost-PCICYPHER®orCYPHERSelect®(355patients)研究终点:1年的TVF,

TVF确定标准:缺血症状引起的TVR,再发心梗,靶血管相关的心源性死亡裸金属支架(3597patients)%占患者总数的百分比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主要终点TVFMACETLRTVRMISTDEATHHORIZON2年和TYPHOON4年结果AProspective,RandomizedComparisonofPaclitaxel-elutingTAXUSStentsvs.BareMetalStentsDuringPrimaryAngioplastyinAcuteMyocardialInfarctionGreggW.StoneMDFortheHORIZONS-AMIInvestigators3602ptswithSTEMIwithsymptomonset≤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;angioFUat13months1)Ischemia-drivenTLR*2)CompositeSafetyMACE=Allcausedeath,re-infarction,stentthrombosis(ARCdefiniteorprobable)**,orstrokeand*Relatedtorandomizedstentlesions(whetherstudyornonstudystentswereimplanted);MajorSecondaryEndpoint(at13Months)Binaryangiographicrestenosis **Inrandomizedstentlesionswith≥1stentimplanted(whetherstudyornonstudystents)1年结果：TAXUSPES与ExpressBMS减少临床和造影再狭窄率，而死亡、再发心结梗死和支架内血栓形成发生率相似。MACE：死亡、心肌梗死、卒中或支架内血栓形成心源性死亡

全因死亡

缺血所致TVR次要终点

MACE

缺血所致TLR再次心肌梗死主要终点

支架内血栓（肯定和极可能的）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%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.HierarchicaleventsTyphoon研究小结TYPHOON4yrFUTYPHOON研究表明:同BMS相比

Cypher支架明显的降低了TVF,TVR,TLR的发生率在全因死亡率,心源性死亡率,心梗发生率和支架内血栓发生率方面,二者没有差别在心肌梗死患者中应用,Cypher支架降低了再次血运重建的几率,并且没有晚期追赶的现象;长期的随访同时表明,Cypher支架的安全性同样持久保持©CordisCorporation200822ARandomized，Multi-Center，Single-Blind

ComparisonofNEVO™

Sirolimus-ElutingCoronaryStentversustheTAXUS®Liberté™Paclitaxel-ElutingCoronaryStentSysteminDeNovoNativeCoronaryArteryLesionsPI:Drs.ChristianSpaulding,AlexandreAbizaidandJohnOrmiston©CordisCorporation200823Minimizetissue/polymercontactwhileprotectingthedrug/polymerfrommechanicaldamageCompleteelutionofthedrugandresorbtionofthepolymerfromthereservoirsovertimeleavebehindabaremetalstentAmatrixofdrugandpolymerisloadedonthereservoirsObjective:

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

StentcomparedwiththeTAXUS®

Liberté™stentfortheprimaryendpointof6-monthsin-stentlatelossMajorInclusionCriteria:SingleDenovelesionsinnativecoronaryarteriesLesionLength≤28mm2.5mm-3.5mmindiameterMajorExclusionCriteria:Acutemyocardialinfarction

OstiallesionsUnprotectedleftmainstemlesionsSingleDeNovoNativeCoronaryArteryLesion<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.FirstPatientEnrolledMarch19,2008EnrollmentCompletedOctober17,2008PrimaryEndpoint:6-monthsin-stentlatelumenloss(Angiographic)SecondaryEndpoints:In-stent/in-segmentbinaryrestenosis,%diameterstenosisandMLDDevice,Lesion,andproceduresuccess

StentThrombosis(ARCandprotocoldefinition)including