循證醫(yī)學(xué)數(shù)據(jù)與病例分享

PLATINUMWorkhorse,SmallVessel,LongLesion12個月TLF非劣效性單組30(全球)102長病變12個月TLF來自SPIRIT系列試驗中Xience支架歷史數(shù)據(jù)以及TAXUSExpress2歷史數(shù)據(jù)非劣效性單組23(全球)94小血管12個月TLFXineceVStentPROMUSElement鉑鉻合金EES非劣效性1:1隨機，前瞻性，單盲132(全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天心臟事件主要研究終點N/A對照組N/A成功標準PROMUSElement鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)——PLATINUMTrial鉑金試驗

PROMUS

Element?支架治療denovo病變PLATINUMQCA研究循證醫(yī)學(xué)數(shù)據(jù)與病例分享第1頁PLATINUMWorkhorse,SmallVessel,LongLesion12個月TLF非劣效性單組30(全球)102長病變12個月TLF來自SPIRIT系列試驗中Xience支架歷史數(shù)據(jù)以及TAXUSExpress2歷史數(shù)據(jù)非劣效性單組23(全球)94小血管12個月TLFXineceVStentPROMUSElement鉑鉻合金EES非劣效性1:1隨機，前瞻性，單盲132(全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天心臟事件主要研究終點N/A對照組N/A成功標準PROMUSElement鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)——PLATINUMTrial鉑金試驗

PROMUS

Element?支架治療denovo病變PLATINUMQCA研究循證醫(yī)學(xué)數(shù)據(jù)與病例分享第2頁PLATINUMQCATrial同類研究一覽晚期管腔丟失(mm)SPIRITFirstSPIRITFirstPLATINUMQCASPIRITIISPIRITIII隨訪時間延長N=23N=237N=301N=73N=206mths6mths8mths9mths12mthsPromusElementStentXienceVStentEuroInterv(inpress)循證醫(yī)學(xué)數(shù)據(jù)與病例分享第3頁PLATINUMQCATrial(IVUS)

支架貼壁不良(ISA)參考目標(SPIRITIII:XienceV)術(shù)后即刻ISA晚期取得性ISA晚期ISA支架貼壁不良(ISA)(%)p<0.001PromusElementStentXienceVStentEuroInterv(inpress)循證醫(yī)學(xué)數(shù)據(jù)與病例分享第4頁AllDeath,MI,TVR1.0%(1)1.0%(1) AllDeath0.0%(0)0.0%(0) MyocardialInfarction0.0%(0)0.0%(0) Q-wave0.0%(0)0.0%(0) Non–Q-wave0.0%(0)0.0%(0) TargetVesselRevascularization1.0%(1)1.0%(1)TargetLesionRevascularization1.0%(1)1.0%(1)TargetLesionFailure*1.0%(1)1.0%(1)StentThrombosis(ARCDef/Prob)1.0%(1)1.0%(1)30天12個月PLATINUMQCATrial

臨床結(jié)果(N=100)*Ischemia-drivenTLR,orMI/cardiacdeathrelatedtothetargetvessel(Alleventsoccurredinthesamepatient)EuroInterv(inpress)循證醫(yī)學(xué)數(shù)據(jù)與病例分享第5頁PLATINUMWorkhorse,SmallVessel,LongLesion12個月TLF非劣效性單組30(全球)102長病變12個月TLF來自SPIRIT系列試驗中Xience支架歷史數(shù)據(jù)以及TAXUSExpress2歷史數(shù)據(jù)非劣效性單組23(全球)94小血管12個月TLFXineceVStentPROMUSElement鉑鉻合金EES非劣效性1:1隨機，前瞻性，單盲132(全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天心臟事件主要研究終點N/A對照組N/A成功標準PROMUSElement鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)——PLATINUMTrial鉑金試驗

PROMUS

Element?支架治療denovo病變PLATINUMQCA研究循證醫(yī)學(xué)數(shù)據(jù)與病例分享第6頁依維莫司洗脫冠狀動脈藥品支架試驗組：PROMUSElementPBMA=poly(n?butylmethacrylate)(基底層);PVDF-HFP=poly(vinylidenefluoride?co?hexafluoropropylene)(一個生物相容性非常好氟化共聚物載藥層)依維莫司藥品濃度:1ug/mm2聚合物涂層:PBMA&PVDF?HFP(厚度7

m，不可降解)對照組：XIENCEV鐵65%鎳14%鉻18%316L不銹鋼TAXUS,Cypher鉻20%鎳35%鉬10%鈷33%MP35N鈷鎳合金L605鈷鉻合金EES鉻20%鎳10%鎢15%鈷51%Endeavor,Resolute37%3%9%18%33%鐵鉬鎳鉻鉑PtCr鉑鉻合金EES3%鉬循證醫(yī)學(xué)數(shù)據(jù)與病例分享第7頁CoCrEES(XienceV)N=762PtCrEES(PROMUSElement)N=7681530Patientswith1or2denovonativecoronaryarterytargetlesionsRVD

2.5

to≤4.25;Lesionlength≤24mmPeri-proc:ASA≥300mg,clopidogrel≥300mgloadunlessonchronicRxRandomized1:1Stratifiedbydiabetes,intentiontotreat1vs.2targetlesions,&studysiteClinicalf/uonly:1,6,12,18monthsthenyearlyfor2-5yearsASAindefinitely,thienopyridine≥6mos(≥12mosifnothighriskforbleeding)PLATINUMWorkhorse研究設(shè)計循證醫(yī)學(xué)數(shù)據(jù)與病例分享第8頁PLATINUMWorkhorse研究終點主要終點12個月靶病變失敗(TLF)

-靶血管相關(guān)心因性死亡，或者-靶血管相關(guān)心肌梗死，或者-缺血驅(qū)動靶病變血運重建符合研究方案數(shù)據(jù)集*次要終點TLF包含各原因支架血栓(ARCdefinite/probable)技術(shù)成功?臨床治療操作成功?

* Patientswhoreceived≥1assignedstudystent? Successfuldelivery&deploymentofstudystenttothetargetvessel,withoutballoonruptureorstentembolization? LesionDS<30%withvisuallyassessedTIMI3flowandwithouttheoccurrenceofin-hospitalcardiacdeath,MI,orTVR循證醫(yī)學(xué)數(shù)據(jù)與病例分享第9頁534120-1-3-2-5-4主要研究終點—12個月TLF12個月靶病變失敗(TLF)非劣效性檢驗達標UCB=upperconfidencebound3.5%上邊界

非劣效性界限3.2%(23/737)3.5%(26/742)0.3%[-1.5%,2.2%]2.9%(21/714)3.4%(25/731)0.5%[-1.3%,2.3%]0.0010.600.00090.72P值(非劣效性檢驗)(優(yōu)效性檢驗)CoCr-

EES

(N=762)PtCr-EES

(N=768)Difference

[2-sided

95%CI]Difference[2-sided95%CI](1-sidedUCB)PopulationPerprotocol(1o終點)Intent-

to-treat意向治療PROMUSElementPtCr-EES

betterXienceVCoCr-EES

better2.01%1-sidedUCB2.13%1-sidedUCBFromACC循證醫(yī)學(xué)數(shù)據(jù)與病例分享第10頁靶病變失敗TLFMonthsSinceIndexProcedureCoCr-EESPtCr-EESNo.atrisk鉑金試驗Workhorse研究4年隨訪結(jié)果TargetLesionFailure=cardiacdeathorMIrelatedtothetargetvesselorischemia-driventargetlesionrevascularization749738735715701683656473758747745727715702687480XienceVCoCr-EES(N=749)PROMUSElementPtCr-EES(N=758)TLFPatients(%)8.5%7.4%HR[95%CI]=0.86[0.60,1.24]P=0.43PrimaryEndpointACCNew！循證醫(yī)學(xué)數(shù)據(jù)與病例分享第11頁缺血驅(qū)動TLRXienceVCoCr-EES(N=749)PROMUSElementPtCr-EES(N=758)HR[95%CI]=0.76[0.48,1.20]P=0.24MonthsSinceIndexProcedureTVRPatients(%)CoCr-EESPtCr-EESNo.atrisk7497427387187056876614767587517487317207106934875.9%4.6%鉑金試驗Workhorse研究4年隨訪結(jié)果ACCNew！循證醫(yī)學(xué)數(shù)據(jù)與病例分享第12頁3年靶病變血運重建(TLR)FDA關(guān)鍵性試驗結(jié)果一覽

PLATINUMClinicalTrialProgramstudiedthePROMUSElement?Stent(PromusPtCrEESStent)1PLATINUM3-YearresultspresentedbyIanT.Meredith,MD,ACC;2SPIRITIII3-YearresultspresentedbyGreggW.Stone,MDatTCT;3RESOLUTEUSStudy3-YearresultspresentedbyPaulTeirstein,MDatACC.Resultsfromdifferentstudiesarenotdirectlycomparable.Informationprovidedforeducationalpurposesonly.SPIRITIII23-Yearn=669n=1,064n=758RESOLUTEUS33-YearTLR(%)PromusElement?在FDA同意藥品支架注冊臨床中擁有最低TLRPromusElementPtCrEESXience?CoCrEESResolute?CoNiZESPLATINUMWorkhorseTrial13-Year循證醫(yī)學(xué)數(shù)據(jù)與病例分享第13頁03691202641080.4%0.4%安全性指標—支架內(nèi)血栓ARCStentThrombosisDefinite/Probable(%)*Months762755752745728768761758752741CoCr-EESPtCr-EESNo.atriskXienceVCoCr-EES(N=762)PROMUSElementPtCr-EES(N=768)HR[95%CI]=0.99[0.20,4.91]P=0.99鉑金試驗Workhorse研究1年隨訪結(jié)果*AllweredefiniteSTFromACC循證醫(yī)學(xué)數(shù)據(jù)與病例分享第14頁次要終點—支架內(nèi)血栓等

鉑金試驗Workhorse研究4年隨訪結(jié)果XienceV(CoCrEES)(N=749)PROMUSElement(PtCrEES)(N=758)EventRate(%)P=0.44P=0.09P=0.82P=0.19P=0.98Cardiac

DeathAllDeathARCST(Def/Prob)MIQ-waveMITimetoeventratesn=1n=2n=3n=2n=2PtCr-

EESCoCr-

EESARCSTbyTimePeriod0-30d1-4y0-30d1-4y31-364dACCNew！循證醫(yī)學(xué)數(shù)據(jù)與病例分享第15頁PLATINUMWorkhorse,SmallVessel,LongLesion12個月TLF非劣效性單組30(全球)102長病變12個月TLF來自SPIRIT系列試驗中Xience支架歷史數(shù)據(jù)以及TAXUSExpress2歷史數(shù)據(jù)非劣效性單組23(全球)94小血管12個月TLFXineceVStentPROMUSElement鉑鉻合金EES非劣效性1:1隨機，前瞻性，單盲132(全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天心臟事件主要研究終點N/A對照組N/A成功標準PROMUSElement鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)——PLATINUMTrial鉑金試驗

PROMUS

Element?支架治療denovo病變PLATINUMQCA研究循證醫(yī)學(xué)數(shù)據(jù)與病例分享第16頁PLATINUMSmallVesselTrial1,3PromusPtCrEES(n=89)RVD=2.04mmLesionLength=14.15mmRESOLUTEUSTrial2ResoluteCoNiZES(n=146)RVD=2.15mmLesionLength=12.40mm無ARC定義支架血栓(def/prob)無心肌梗死1.4%靶血管相關(guān)心梗1.4%ARC定義支架血栓(def/prob)IncidenceRate(%)IncidenceRate(%)PROMUSElement鉑金支架

小血管研究12年隨訪結(jié)果一覽PLATINUMClinicalTrialProgramstudiedthePROMUSElement?Stent(PromusPtCrEES).PLATINUMSmallVesselTrial,PresentedbyDominicAlloccoMD,PCR.IanT.Meredith,AM,MBBS,PhDisthePI.TherewerenoMIsinthePLATINUMSmallVesselTrial.PresentedbyLauraMauriMD,MSc,ACC.RESOLUTEUSTrialstudiedtheResoluteStent.Resultsfromdifferentstudiesarenotdirectlycomparable.Informationprovidedforeducationalpurposesonly.PROMUSElementStenthasadedicatedsmallvessel2.25mmstentmodel.循證醫(yī)學(xué)數(shù)據(jù)與病例分享第17頁無ARC定義支架血栓(def/prob)無心肌梗死PLATINUMLongLesionTrial1PromusPtCrEES(n=100)RVD=2.56mmLesionLength=24.38mmPROMUSElement鉑金支架

長病變研究12年隨訪結(jié)果一覽IncidenceRate(%)IncidenceRate(%)PLATINUMClinicalTrialProgramstudiedthePROMUSElement?Stent(PromusPtCrEES).PLATINUMLongLesionTrial,PresentedbyTeirstein,P,MD.TCT.SPIRITPrimeTrial,PresentedbyCosta,Metal.TCT.SPIRITPRIMETrialstudiedtheXiencePrimeStent.Resultsfromdifferentstudiesarenotdirectlycomparable.Informationprovidedforeducationalpurposesonly.Deathsduetounknowncauseswereadjudicatedascardiacdeath.SPIRITPRIMELongLesionReg