SYNERGY研究PPT课件.ppt

《SYNERGY研究PPT课件.ppt》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、Presenters’DisclosureInformation:RelationshipsRelatedtothisPresentationResearchGrantsand/orConsultantfees:Mahaffey:Aventis,AstraZeneca,Berlex,Lilly,Daiichi,Millennium,Merck,Schering-Plough,TheMedicinesCompanyFerguson:Aventis,AstraZeneca,BristolMyersSquibb,Guidant,Merck,Sanofi,Schering-Plough,TheM

2、edicinesCompanyKennethW.Mahaffey,M.D.JamesJ.Ferguson,M.D.OnbehalfoftheSYNERGYInvestigatorsTheSYNERGYTrialSuperiorYieldoftheNewstrategyofEnoxaparin,Revascularization&GlYcoproteinIIb/IIIaInhibitorsTheSYNERGYTrialKeyPriorTrialsESSENCE/TIMI11b:SuperiorityofenoxaparinvsUFHinconservativemanagementstrate

3、gyNICERegistries:ComparablesafetyandefficacytohistoricalcontrolsinPCIACUTE2/INTERACT/AtoZContemporarytrialsinhigherriskpatientsKeyQuestionsWhatistheroleofenoxaparininhigh-riskNSTEMIACSpatientsmanagedwithanearlyinvasivetreatmentstrategy?Canwesafelybringpatientsonenoxaparinrapidlyforwardtothecathete

4、rizationlaboratory?StudyDesignAtleast2of3required:Age60ST(transient)or(+)CK-MBorTroponinEnoxaparinIVHeparinPrimaryendpoint:DeathorMIat30daysHigh-RiskACSPatientsRandomize(n=10,000)EarlyinvasivestrategyOthertherapyperAHA/ACCGuidelines(ASA,-blocker,ACE,clopidogrel,GPIIb/IIIa)60U/kg12U/kg/hr(aPT

5、T50-70sec)1mg/kgSCQ12HStatisticalAssumptionsControlgroup15%death/MI17%reductionprimaryendpointTypeIerrorof5%(2-sided)90%powerSamplesize~10,000patientsSamplesize:800010,000ptsForcrossoverandinterimeventrate1.1zoneofnoninferiorityEurope:5163Australia:253NewZealand:160Brazil:289Argentina:192Canada:1

6、616USA:5702Belgium355Germany456Italy72Poland381Spain412Turkey13912Countries.467Sites.10,027Patients.InclusionCriteriaAge(+)ECG(+)Biomarkers20%16%20%44%EnoxaparinUFH(n=4993)(n=4985)Medianage(years)6868Femalesex(%)3434Hypertension(%)6868Diabetes(%)2930Hypercholesterolemia(%)5859FamilyhistoryofCAD(%)

7、4645Myocardialinfarction(%)2928CHF(%)99Stroke(%)55PVD(%)1010CABG(%)1617PCI(%)2119BaselineCharacteristicsConcomitantMedicationsEnoxaparinUFH(n=4993)(n=4985)Aspirin(%)9595Betablocker(%)8686Aceinhibitor(%)6462Statin