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1、SamsungMedicalCenterSungkyunkwanUniversitySchoolofMedicineACC2011LBCTTheRandomizedComparisonof6-monthvs.12-monthDurationofDualAntiplateletTherapyaftertheImplantationofDrugElutingStentHyeon-CheolGwon,JooYongHahn,YoungBinSong,KyungWooPark,YangSooJang,Hyo-SooKim,O
2、nbehalfoftheEXCELLENTTrialInvestigatorsSamsungMedicalCenter,SungkyunkwanUniversitySchoolofMedicineBackground:Thecurrentguidelinerecommends12monthsorlongerdurationaftertheimplantationofdrug-elutingstent(DES),notbasedonanyprospectivelyrandomizeddata..Prolongeddua
3、lantiplatelettherapyhasbeenoneofthemajormorbiditiesaftertheprocedure.Inthisprospectiverandomizedtrial,wecomparedtheefficacyandsafetyof6-monthversus12-monthdualantiplatelettherapy.Methods:Thisstudyisaprospective,randomized,openlabel,multi-centertrialwitha2×2fact
4、orialdesignaccordingtothetypeofstent(everolimuselutingstentvs.sirolimuselutingstent)andthedurationofdualantiplatelettherapy(DAT:6vs.12months).Aspirinwasusedindefinitely.Theprimaryendpointwas12-monthtargetvesselfailure(TVF),acompositeofcardiovasculardeath,myocar
5、dialinfarction,andtargetvesselrevascularization.Thetrialdesignhasbeenpublishedpreviouslyandthetrialisregisteredatclinicaltrials.gov(NCT00698607).Results:Atotalof1443patientsfrom19Koreancenterswererandomized1:1eitherto6-month(6-monthgroup,N=722)orto12-monthdurat
6、ionofdualantiplatelettherapy(12-monthgroup,N=721).Therewerenosignificantdifferencesinbaselinecharacteristicsbetween2groups.Twelve-monthTVFratewasnotsignificantlydifferentbetween2groups(6-monthgroup4.7%,12-monthgroup4.4%,p=0.721).Six-monthgroupwassignificantlyno
7、n-inferiorto12-monthgroupwithregardtotheriskofTVF(pfornon-inferiority=0.0031,predefinednon-inferioritymargin4.0%).Non-inferioritywasshowntobesignificantineverolimus-elutingstentsubgroup(p=0.0029)Conclusions:Six-monthDATisnon-inferiorto12-monthDATwithregardtothe
8、riskofTVFat12monthsafterDESimplantation.Alarger-scalerandomizedcontrolledtrialisrequiredtotesttheimpactofshorterdurationofclopidogreltherapyonthehardendpointsofdeath,MI,orst
