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 1 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 20 10 5 Probabilityofreintervention 15 11 12 Monthsafterrandomization 10 9 8 7 6 5 4 3 2 1 0 2786patients HR 0 38 95 CI 0 29 0 50 p 0 001 Trialsincludedwere BASKET diLorenzo HAAMU STENT MISSION PASSION SESAMI STRATEGY TYPHOON KastratiA etal EurHeartJ 2007 28 2706 2713 10 Probabilityofdeath 8 4 6 2 0 HR 0 76 95 CI 0 53 1 10 p 0 14 Monthsafterrandomisation 10 8 4 6 2 0 HR 0 72 95 CI 0 48 1 08 p 0 11 Monthsafterrandomisation Probabilityofrecurrentmyocardialinfarction Trialsincludedwere BASKET diLorenzo HAAMU STENT MISSION PASSION SESAMI STRATEGY TYPHOON KastratiA etal EurHeartJ 2007 28 2706 2713 5 4 2 1 0 Probabilityofstentthrombosis 3 0 1 2 4 8 11 12 Monthsafterrandomisation 10 6 9 7 5 3 2786patients Trialsincludedwere BASKET diLorenzo HAAMU STENT MISSION PASSION SESAMI STRATEGY TYPHOON HR 0 80 95 CI 0 46 1 39 p 0 43 KastratiA etal EurHeartJ2007 28 2706 2713 Randomisation1 1 BMS n 310 TaxusExpress2orLiberteStent n 309 STEMIpatientswithchestpain 20mnandST elevationin 2contiguousleads infarctrelatedarterywithadenovolesion PrimaryEndpoint Compositeofdeath recurrentMI ortargetlesion within5mmofstentedges revascularization TLR atoneyear Laarman GJetal NEnglJMed 2006 355 1105 13 MACE 10 0 120 240 360 5 BMS Laarman GJetal NEnglJMed 2006 355 1105 13 Days PRIMARYENDPOINTNOTACHIEVEDHR 0 68 0 41 1 10 p 0 12 8 7 12 6 NoprespecifiedangiographicF U DualAPTrecommendedfor 6months Clopidogrel MedianDurationof9months CardiacDeath MI orTLR p 0 12 p 0 32 p 0 09 OR0 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 4 7 2 9 9 11 1 5 6 6 0 0 5 10 15 20 MACE CardiacDeath TLR ofPatients BMS SESinAMITyphoonTrialToAssessTheUseoftheCYPHER Sirolimus elutingStent SES inAcuteMyocardialInfarctionPatientsTreatedWithBalloonAngioplasty ChristianSpauldingfortheTYPHOONInvestigatorsPCR2009 SESinAMITyphoonstudydesign 715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 SpauldingC etal NewEnglJMed2006 355 1093 104 1withdrewconsentpost PCI 2withdrewconsentpost PCI CYPHER 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 0 001 P 0 0001 P NS P 0 001 P 0 004 P NS MACE 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TVF MACE TLR TVR MI ST DEATH HORIZON2年和TYPHOON4年结果 AProspective RandomizedComparisonofPaclitaxel elutingTAXUSStentsvs BareMetalStentsDuringPrimaryAngioplastyinAcuteMyocardialInfarctionGreggW StoneMDFortheHORIZONS AMIInvestigators 3602ptswithSTEMIwithsymptomonset 12hours ClinicalFUat30days 6months 1year andthenyearlythrough5years angioFUat13months 1 Ischemia drivenTLR 2 CompositeSafetyMACE Allcausedeath re infarction stentthrombosis ARCdefiniteorprobable orstroke and 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 ofPatients P 0 005 P 0 23 P 0 013 P 0 83 MI myocardialinfarction TLR targetlesionrevascularization TVR targetvesselrevascularisation Non hierarchicalevents P 0 37 10 251 16 250 8 251 12 250 12 251 10 250 18 251 38 250 24 251 43 250 AcademicResearchConsortium Dublin DefinedEvents 53 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 16 ARC Dublindefinitions Hierarchicalevents Typhoon研究小结 TYPHOON4yrFU TYPHOON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 CordisCorporation2008 22 ARandomized Multi Center Single BlindComparisonofNEVO Sirolimus ElutingCoronaryStentversustheTAXUS Libert Paclitaxel ElutingCoronaryStentSysteminDeNovoNativeCoronaryArteryLesions PI Drs ChristianSpaulding AlexandreAbizaidandJohnOrmiston CordisCorporation2008 23 NEVO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 polymerfrommechanicaldamage Completeelutionofthedrugandresorbtionofthepolymerfromthereservoirsovertimeleavebehindabaremetalstent Amatrixofdrugandpolymerisloadedonthereservoirs Objective Todemonstratenon inferiority and ifpositive superiority oftheNEVO StentcomparedwiththeTAXUS Libert stentfortheprimaryendpointof6 monthsin stentlateloss MajorInclusionCriteria SingleDenovelesionsinnativecoronaryarteriesLesionLength 28mm2 5mm 3 5mmindiameter MajorExclusionCriteria AcutemyocardialinfarctionOstiallesionsUnprotectedleftmainstemlesions SingleDeNovoNativeCoronaryArteryLesion 28mmina2 5 3 5mmdiametervessel 388patients 40sitesinEurope SouthAmerica Australia NewZealand NEVO Sirolimus ElutingStent N 202 TAXUS Libert Paclitaxel ElutingStent N 192 1 1Randomization PrimaryEndpoint 6 MonthIn StentLateLossIVUSinasubsetofpatients 30Day 6Mo 1Yr 2Yr 3Yr 4Yr Clinical MACE Angio IVUS 5Yr 9Mo 3Mo FirstPatientEnrolledMarch19 2008EnrollmentCompletedOctober17 2008 PrimaryEndpoint 6 monthsin stentlatelumenloss Angiographic SecondaryEndpoints In stent in segmentbinaryrestenosis diameterstenosisandMLDDevice Lesion andproceduresuccessStentThrombosis ARCandprotocoldefinition includingfollowupto5yearsTLF TVF MACEandindividualc