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中国医学科学院 阜外心血管病医院陈纪林 教授StudyBASKET-AMI2Di Lorenzo3HAAMU-STENT4MISSION5PASSION6SESAMI7STRATEGY8TYPHOON9No.of patients216270164310619320175712Mean age(years)62.264.063.059.260.861.662.659.3Typeof DESPESSESPESSESPESSESPESSESSESSESPrimary endpointCardiac death,myocardial infarction,or reinterventionDeath,myocardial infarction,or reinterventionAngiographic late lumen lossAngiographic late lumen lossCardiac death,myocardial infarction,or reinterventionAngiographic binary restenosisDeath,myocardial infarction,stroke,or angiographic binary restenosisCardiac death,myocardial infarction,or reinterventionLength of thienopyridine therapy(months)66121261236Mean length of follow-up(months)18.012.016.712.012.012.324.212.11.Kastrati A,et al.Eur Heart J.2007;28:2706-2713.2.Pittl C,et al.Eur Heart J.2006;27:650(abstract suppl).3.Di Lorenzo E,et al.ACC Scientific Sessions 2005.Presentation 2303.4.HAAMU-STENT trial.Available at wwwcardiosourcecom/pops/trialSumasp?trialID=1492.Accessed 5 March 2007.5.van der Hoeven BL,et al.J Am Coll Cardiol.2008;51(6):618-26.6.Laarman GJ et al.N Engl J Med.2006;355:1105-13.7.Menichelli M,et al.J Am Coll Cardiol.2007;49(19):1924-30.8.Valgimigli M,et al.JAMA.2005;293(17):2109-17.9.Spaulding C,et al.N Engl J Med.2006;355(11):1093-104.20105Probability of reintervention(%)1501112Months after randomization1098765432102786 patientsDESBMSHR:0.38(95%CI,0.290.50)p 20mn and ST-elevation in 2 contiguous leads;infarct related artery with a de novo lesion Primary Endpoint:Composite of death,recurrent MI,or target lesion(within 5 mm of stent edges)revascularization(TLR)at one yearLaarman,GJ et al.N Engl J Med.2006;355:1105-13.MACE(%)10012024036050TaxusBMSLaarman,GJ et al.N Engl J Med.2006;355:1105-13.DaysPRIMARY ENDPOINT NOT ACHIEVEDHR=0.68(0.41-1.10)p=0.128.712.6No prespecified angiographic F/UDual APT recommended for 6 months(Clopidogrel:Median Duration of 9 months)*Cardiac Death,MI,or TLRp=0.12p=0.32p=0.09OR 0.70(95%CI:0.45-1.09)OR 0.78(95%CI:0.41-1.44)OR 0.60(95%CI:0.34-1.09)Dirksen MT.Presented at ESC 2007.15.47.29.911.15.66.005101520MACECardiac DeathTLR%of PatientsTaxusBMSSES in AMITyphoonTrial To Assess The Use of the CYPHER Sirolimus-eluting Stent(SES)in Acute Myocardial Infarction Patients Treated With Balloon AngioplastyChristian Spauldingfor the TYPHOON InvestigatorsPCR 2009 SES in AMITyphoon study design715 715 名首次发生名首次发生AMIAMI后后1212小时内行急诊小时内行急诊PCIPCI手术的患者手术的患者CYPHER or CYPHER Select(356 patients)裸金属支架裸金属支架(359 patients)Spaulding C.,et al.,New Engl J Med 2006;355:1093-104.1 withdrew consent post-PCI2 withdrew consent post-PCICYPHER or CYPHER Select(355 patients)研究终点研究终点:1年的年的TVF,TVF确定标准确定标准:缺血症状引起的缺血症状引起的TVR,再发心梗再发心梗,靶血管相关的心源性死亡靶血管相关的心源性死亡裸金属支架裸金属支架(3597patients)MACE:major adverse cardiac events defined as all-cause death,re-MI or TLR.TLR:target lesion revascularization.TVR:target vessel revascularization.TVF:target vessel failure defined as ischemia-driven TVR,recurrent MI,or target vessel-related cardiac deathMI:myocardial infarction(all).ST:stent thrombosis(per protocol)主要终点主要终点TVFMACETLRTVRMISTDEATHHORIZON 2HORIZON 2年和年和TYPHOON 4TYPHOON 4年结果年结果3602 pts with STEMI with symptom onset 12 hoursPrimary PCICABGMedical RxAspirin,thienopyridine（噻吩吡啶）（噻吩吡啶）Clinical FU at 30 days,6 months,1 year,and thenyearly through 5 years;angio FU at 13 monthsand1 1年结果：年结果：TAXUS PESTAXUS PES与与Express BMSExpress BMS减少临床和造影再狭窄率，而死亡、再发心结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。梗死和支架内血栓形成发生率相似。MACEMACE：死亡、心肌梗死、卒中或支架内血栓形成：死亡、心肌梗死、卒中或支架内血栓形成心源性死亡心源性死亡 全因死亡全因死亡 缺血所致缺血所致TVRTVR次要终点次要终点 MACE MACE 缺血所致缺血所致TLRTLR再次心肌梗死再次心肌梗死主要终点主要终点 支架内血栓支架内血栓（肯定和极可能的）（肯定和极可能的）2-year outcomes MI:myocardial infarction,TLR:target lesion revascularization,TVR:target vessel revascularisation,Non-hierarchical events 10/25116/2508/25112/25012/25110/25018/25138/25024/25143/250Academic Research Consortium/Dublin-Defined Events53%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%)Stent Thrombosis(%)P=0.16ARC/Dublin definitions.Hierarchical eventsTyphoon 研究小结研究小结 4 yr FUTYPHOON 研究表明研究表明:同同BMS相比相比 Cypher支架明显的降低了支架明显的降低了TVF,TVR,TLR的发生率的发生率在全因死亡率在全因死亡率,心源性死亡率心源性死亡率,心梗发生率和支架内血栓发生率心梗发生率和支架内血栓发生率方面方面,二者没有差别二者没有差别在心肌梗死患者中应用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并且没有晚期追赶的现象;长期的随访同时表明长期的随访同时表明,Cypher支架的安支架的安全性同样持久保持全性同样持久保持 Cordis Corporation 200822A Randomized，Multi-Center，Single-Blind Comparison of NEVO Sirolimus-Eluting Coronary Stent versus the TAXUS Libert Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery LesionsPI:Drs.Christian Spaulding,Alexandre Abizaid and John Ormiston Cordis Corporation 200823 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3-43-4个月个月后完全降解.RES技术：全新的设计 (Reservoir,药物释放槽)Minimize tissue/polymer contact while protecting the drug/polymer from mechanical damage Complete elution of the drug and resorbtion of the polymer from the reservoirs over time leave behind a bare metal stentA matrix of drug and polymer is loaded on the reservoirsObjective:To demonstrate non-inferiority(and,if positive,superiority)of the NEVO Stent compared with the TAXUS Libert stent for the primary endpoint of 6-months in-stent late lossMajor Inclusion Criteria:Single De nove lesions in native coronary arteries Lesion Length 28mm 2.5mm-3.5mm in diameterMajor Exclusion Criteria:Acute myocardial infarction Ostial lesions Unprotected left main stem lesionsSingle De Novo Native Coronary Artery Lesion28 mm in a 2.5-3.5mm diameter vessel388 patients 40 sites in Europe,South America,Australia,&New ZealandNEVO Sirolimus-Eluting Stent(N=202)TAXUS LibertPaclitaxel-Eluting Stent(N=192)1:1 RandomizationPrimary Endpoint:6-Month In-Stent Late LossIVUS in a subset of patients30Day6Mo.1Yr.2Yr.3Yr.4Yr.Clinical/MACEAngio/IVUS5Yr.9Mo.3Mo.First Patient Enrolled March 19,2008Enrollment Completed October 17,2008Primary Endpoint:6-months in-stent late lumen loss(Angiographic)Secondary Endpoints:In-stent/in-segment binary restenosis,%diameter stenosis and MLD Device,Lesion,and procedure success Stent Thrombosis (ARC and protocol definition)including follow up to 5 years TLF/TVF/MACE and individual components including follow up to 5 years Stent malapposition and%volume obstruction(IVUS)Quality of life at baseline,30 days,6months and 1 yearSpecified subgroup analyses:Patients with diabetes mellitus0.310.46N=180N=16264%P=0.0752/18013/1627/18014/16286%55%Superiority of the NEVO stent over the TAXUS Libert stents was reached with a highly significant difference(P0.001)between stents(6-month late loss 0.13 0.31 vs.0.36 0.46mm)No stent thrombosis were observed in the NEVO group while 2 late thromboses despite dual APT occurred in the TAXUS Libert group While not powered for clinical endpoints,in this study the rates of death,MI,and revascularization as well as the composite endpoints of TLF,TVF,and MACE all favored NEVO over TAXUS Libert
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