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StudyNo.ofpatientsMeanage(years)TypeofDESPrimaryendpointLengthofthienopyridinetherapy(months)Meanlen
gthoffollow-up(months)BASKET-AMI221662.2PESSESCardiacdeath,myocardialinfarction,orreintervention618.0DiLorenzo327064.0PESSESDeath,m
yocardialinfarction,orreintervention612.0HAAMU-STENT416463.0PESAngiographiclatelumenloss1216.7MISSION5310
59.2SESAngiographiclatelumenloss1212.0PASSION661960.8PESCardiacdeath,myocardialinfarction,orreintervention612
.0SESAMI732061.6SESAngiographicbinaryrestenosis1212.3STRATEGY817562.6SESDeath,myocardialinfarction,stroke,orangiographicbina
ryrestenosis324.2TYPHOON971259.3SESCardiacdeath,myocardialinfarction,orreintervention612.11.KastratiA,etal.EurHeartJ.2007;28:2706-271
3.2.PittlC,etal.EurHeartJ.2006;27:650(abstractsuppl).3.DiLorenzoE,etal.ACCScientificSessions2005.Presentation2303.4.HAAMU-S
TENTtrial.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.JAmCollC
ardiol.2007;49(19):1924-30.8.ValgimigliM,etal.JAMA.2005;293(17):2109-17.9.SpauldingC,etal.NEnglJMed.2006;355(11):1093-104.20105Pro
babilityofreintervention(%)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;28:2706-2713.10P
robabilityofdeath(%)84620HR:0.76(95%CI,0.53-1.10)p=0.14Monthsafterrandomisation01234567891011121084620HR:0.72(95%CI,
0.48-1.08)p=0.11Monthsafterrandomisation0123456789101112Probabilityofrecurrentmyocardialinfarction(%)*Trialsincludedwere
:BASKET;diLorenzo;HAAMU-STENT;MISSION;PASSION;SESAMI;STRATEGY;TYPHOONDESBMSDESBMSKastratiA,etal.EurHeartJ.2007;28:2706-2713.54210Probabilit
yofstentthrombosis(%)3012481112MonthsafterrandomisationDESBMS10697532786patients*Trialsincludedwere:BASKET;diLorenzo;HAAMU-STENT;MISS
ION;PASSION;SESAMI;STRATEGY;TYPHOONHR:0.80(95%CI,0.46-1.39)p=0.43KastratiA,etal.EurHeartJ2007;28:2706-2713.Randomisat
ion1:1BMS(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.DaysPRIMARYEND
POINTNOTACHIEVEDHR=0.68(0.41-1.10)p=0.128.712.6NoprespecifiedangiographicF/UDualAPTrecommendedfor≥6mont
hs(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:0.34-1.0
9)DirksenMT.PresentedatESC2007.15.47.29.911.15.66.005101520MACECardiacDeathTLR%ofPatientsTaxusBMSSESinAMITyphoonTrialToAssessTheUseofth
eCYPHER®Sirolimus-elutingStent(SES)inAcuteMyocardialInfarctionPatientsTreatedWithBalloonAngioplastyChristianSpauld
ingfortheTYPHOONInvestigatorsPCR2009SESinAMITyphoonstudydesign715名首次发生AMI后12小时内行急诊PCI手术的患者1:1随机化CYPHER®orCYPHERSelect
®(356patients)裸金属支架(359patients)SpauldingC.,etal.,NewEnglJMed2006;355:1093-104.1withdrewconsentpost-
PCI2withdrewconsentpost-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-rel
atedcardiacdeathMI:myocardialinfarction(all).ST:stentthrombosis(perprotocol)P=NS主要终点TVFMACETLRTVRMISTDEATHAProspective,RandomizedCom
parisonofPaclitaxel-elutingTAXUSStentsvs.BareMetalStentsDuringPrimaryAngioplastyinAcuteMyocardialInfarctionGreggW.StoneMDFortheHORI
ZONS-AMIInvestigators3602ptswithSTEMIwithsymptomonset≤12hoursEmergentangiography,followedbytriageto…PrimaryPCICABG–MedicalRx–U
FH+GPIIb/IIIainhibitor(abciximaboreptifibatide)Bivalirudinmonotherapy(±provisionalGPIIb/IIIa)Aspirin,thienopy
ridine(噻吩吡啶)R1:13000ptseligibleforstentrandomizationR3:1BaremetalEXPRESSstentPaclitaxel-elutingTAXUSstentClinicalF
Uat30days,6months,1year,andthenyearlythrough5years;angioFUat13months1)Ischemia-drivenTLR*2)CompositeSafetyMAC
E=Allcausedeath,re-infarction,stentthrombosis(ARCdefiniteorprobable)**,orstrokeand*Relatedtorandomizedstentlesions(whetherstudyo
rnonstudystentswereimplanted);MajorSecondaryEndpoint(at13Months)Binaryangiographicrestenosis**Inrandomizedstentlesionswit
h≥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-yearoutcomes4.03.24.87.29.66.44.84.015.217.2010203040DeathCardiacDea
thMITLRTVRCYPHERBareMetalStent%ofPatientsP=0.005P=0.23P=0.013P=0.83MI:myocardialinfarction,TLR:targetlesionreva
scularization,TVR:targetvesselrevascularisation,Non-hierarchicaleventsP=0.3710/25116/2508/25112/25012
/25110/25018/25138/25024/25143/250AcademicResearchConsortium/Dublin-DefinedEvents53%44%0.02.04.06.08.010.0CYPHER(n=251)BMS(
n=250Early(0to30d)Late(>30dto1yr)VeryLate(>1yr)13(5.2%)9(3.6%)9(3.6%)6(2.4%)3(1.2%)6(2.4%)1(0.4%)21(8.4%)Ste
ntThrombosis(%)P=0.16ARC/Dublindefinitions.HierarchicaleventsTyphoon研究小结TYPHOON4yrFU•TYPHOON研究表明:•同BMS相比Cypher支架明显的降低了T
VF,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-BlindComparisonofNEVO™Sirolimus-ElutingCoronaryStentversustheTAXU
S®Liberté™Paclitaxel-ElutingCoronaryStentSysteminDeNovoNativeCoronaryArteryLesionsPI:Drs.ChristianSpaulding,AlexandreAbizaidand
JohnOrmiston©CordisCorporation200823NEVO是Cordis的下一代的药物涂层支架,药物沿用经典的雷帕霉素,支架平台设计采用独特的RES(药物释放槽)技术,将药物/聚合物同血管壁的接触降低到更小;迄今真正的可吸收聚合物支架
,其药物释放槽中的聚合物可在3-4个月后完全降解.RES技术:全新的设计(Reservoir,药物释放槽)•Minimizetissue/polymercontactwhileprotectingthedrug/poly
merfrommechanicaldamage•Completeelutionofthedrugandresorbtionofthepolymerfromthereservoirsovertimeleavebehindabar
emetalstentAmatrixofdrugandpolymerisloadedonthereservoirsObjective:•Todemonstratenon-inferiority(and,ifpositive,superiority)oftheNEVO™S
tentcomparedwiththeTAXUS®Liberté™stentfortheprimaryendpointof6-monthsin-stentlatelossMajorInclusionCriteria:•
SingleDenovelesionsinnativecoronaryarteries•LesionLength≤28mm•2.5mm-3.5mmindiameterMajorExclusionCriteria:•Acutemyocardi
alinfarction•Ostiallesions•UnprotectedleftmainstemlesionsSingleDeNovoNativeCoronaryArteryLesion<28mmina2.5-3.5mmdiametervessel388p
atients@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.•FirstPatientEnrolledMarch19,2008•EnrollmentCompletedOctober17,2008PrimaryEndpoint:•6-monthsi
n-stentlatelumenloss(Angiographic)SecondaryEndpoints:•In-stent/in-segmentbinaryrestenosis,%diameterstenosisandMLD•Device,Lesion,andproceduresuccess•
StentThrombosis(ARCandprotocoldefinition)includingfollowupto5years•TLF/TVF/MACEandindividualcomponentsinc
ludingfollowupto5years•Stentmalappositionand%volumeobstruction(IVUS)•Qualityoflifeatbaseline,30days,
6monthsand1yearSpecifiedsubgroupanalyses:•Patientswithdiabetesmellitus±0.31±0.46N=180N=16264%P=0.0752/18013
/1627/18014/16286%55%•SuperiorityoftheNEVO™stentovertheTAXUS®Liberté™stentswasreachedwithahighlysignificantdifference(P<0.001)betweenste
nts(6-monthlateloss0.13±0.31vs.0.36±0.46mm)•NostentthrombosiswereobservedintheNEVO™groupwhile2latethrombosesdespite
dualAPToccurredintheTAXUS®Liberté™group•Whilenotpoweredforclinicalendpoints,inthisstudytheratesofdeath,MI,andrevascularizatio
naswellasthecompositeendpointsofTLF,TVF,andMACEallfavoredNEVO™overTAXUS®Liberté™