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STEEPLE分析课件

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STEEPLE分析课件SafetyandEfficacyofIntravenousEnoxaparininElectivePercutaneousCoronaryIntervention:anInternationalRandomizedEvaluation(STEEPLE)STEEPLETrialIVenoxaparin0.5mg/kgn=1070STEEPLETrialPresentedatESC2005IVenoxaparin0.75mg/kgn=12283528patientsage>18yearsundergoingno...

STEEPLE分析课件
SafetyandEfficacyofIntravenousEnoxaparininElectivePercutaneousCoronaryIntervention:anInternationalRandomizedEvaluation(STEEPLE)STEEPLETrialIVenoxaparin0.5mg/kgn=1070STEEPLETrialPresentedatESC2005IVenoxaparin0.75mg/kgn=12283528patientsage>18yearsundergoingnon-emergentsingleormulti-vesselPCI(performedwithafemoralapproach)Randomized25%female,meanage64years,meanfollow-up30daysGPIIb/IIIainhibitorswereusedin41%ofpatients,andaspirinin85%Drug-elutingstentswereusedin57%ofpatientsandmultivesselPCIwasperformedin16%ofpatients PrimaryEndpoint:Non-CABGrelatedmajorandminorbleedingby48hrspost-PCI SecondaryEndpoint:Percentofpatientsreachingtargetanticoagulationlevelsatthestartandendoftheprocedure;compositeofnon-CABGmajorbleedthrough48hrs;all-causemortality;myocardialinfarction;urgenttargetvesselrevascularizationat30daysActivatedclottingtime(ACT)–adjustedIVunfractionatedheparin(UFH)regimenWithGPIIb/IIIa(50-70IUdose):targetACT200-300WithoutGPIIb/IIIa(70-100IUdose):targetACT300-350n=1230STEEPLETrial:PrimaryEndpointat48hoursAnalysisofnon-CABGmajororminorbleeding(%)PresentedatESC2005 Theprimaryendpointofnon-CABGmajororminorbleedingwaslowerinthosegroupstreatedwithenoxaparin ThelowerbleedingrateassociatedwithenoxaparinwasobservedbothinthesubgroupofpatientsintendedtobetreatedwithGPIIb/IIIainhibitors,aswellasinaperprotocolanalysisp=0.014vsUFHp=0.052vsUFHSTEEPLETrial:PrimaryEndpointat48hoursAnalysisofmajorbleeding(%)PresentedatESC2005Majorbleedingoccurredin1.2%ofeachoftheenoxaparingroupsand2.8%intheUFHgroupTheprimaryendpointofmajorbleedingwas57%lowerintheenoxaparingroupscomparedwiththeUFHgroupp=0.005vsUFHp=0.007vsUFHSTEEPLETrial:PrimaryEndpointat48hoursAnalysisofminorbleeding(%)PresentedatESC2005Minorbleedingoccurredin4.9%(0.5mg/kg)and5.4%(0.75mg/kg)ineachofthetwoenoxaparingroupsand5.9%intheUFHgroupP=0.315vsUFHP=0.530vsUFHSTEEPLETrial:SecondaryEndpointAnalysisofpatientsreachingtargetanticoagulationlevelsatthestartandendofprocedure(%)PresentedatESC2005 ThepercentofpatientsreachingtargetanticoagulationlevelsatthestartandendoftheprocedurewassignificantlyloweramongtheUFHtreatmentgroupcomparedwiththetwoenoxaparintreatmentgroups(78.8%,91.7%vs19.7%)p<0.001vsUFHp<0.001vsUFHSTEEPLETrial:SecondaryEndpointCompositeendpointofnon-CABGmajorbleedthrough48hours,all-causemortality,MI,orurgenttargetvesselrevascularizationat30days(%)p=NSPresentedatESC2005 ThecompositesecondaryendpointwasnumericallyloweramongthetwoenoxaparintreatmentgroupscomparedwiththeUFHtreatmentgroup(7.2%,7.9%vs8.4%) TherewasnodifferenceindeathorMIindividuallySTEEPLETrialSummary Amongpatientsundergoingnon-emergentPCI,treatmentwithreduceddoseenoxaparinwasassociatedwithlowerratesofmajororminorbleedingby48hourspost-PCIcomparedwithtreatmentwithACT-drivenUFH. Patientenrollmentintheenoxaparin0.5mg/kgtreatmentgroupwasdiscontinuedbythedatasafetymonitoringcommitteeneartheendofthetrialattheobjectionofthesteeringcommittee,duetoadifferenceinmortalitybetweenthethreegroups(p=0.02). Withfull30daydata,neithermortality,MI,norurgenttargetvesselrevascularizationdifferedbetweenthethreegroups. Furtherinvestigationisstillnecessary,buttheresultsfromthistrialshowthattheuseofenoxaparinatlowerdosesinthecatheterizationlaboratorymayofferapotentialsafetyadvantagewithlowerbleedingeventsrelativetoACTguidedUFH.PresentedatESC2005
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