InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.AXIENCE支架最新临床数据分享InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A2XIENCE支架最新临床数据分享•最新安全性数据汇总•坚实的DAPT数据•临床数据的设计基础InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.AXIENCE:最新安全性数据汇总InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A4XIENCE在术后30天显示出比BMS及其他药物洗脱支架都低的支架血栓发生率在术后30天,与XIENCE相比不同支架发生确定的支架血栓的可能性BMS**CypherTaxusEndeavorResolute5xMoreLikely*2xMoreLikely*4xMoreLikely*5xMoreLikely*14xMoreLikely*不同支架30天确定的支架血栓发生率与XIENCE的比值比†*Numbercalculatedfromsourcedata.**TheBMScomparatorisacompositeofseveralbaremetalstents.†Amethodofcomparingtheoddsofaneventbetweentwogroups.Source:Palmerinietal.TheLancet.379:9824,14-20April2012,pp.1393-1402.InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A5只有XIENCE在不同的研究中持续保持最低的支架血栓发生率Sources:1.SmitsP.COMPARETrial:2-YearResultsPresentation,TCT2010.2.Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.3.RäberL.LESSON1:3-YearPresentation,ESC2010.4.ByrneRA.ISARTEST4:2-YearDataPresentation,TCT2010.5.StoneG.SPIRITIV:1-YearResultsPresentation,TCT2009.6.Fajadet,PLATINUMPLUS,TCT2012.早期确定的支架血栓(0-30天)XIENCECompetitor0.201.000.100.800.300.800.300.460.120.57COMPARE1XIENCE–TaxusLibertéRESOLUTEAC2XIENCE–ResoluteLESSON3XIENCE–CypherISARTEST44XIENCE–CypherSPIRITIV1XIENCE–TaxusARCDefiniteStentThrombosis(%)0.000.200.400.600.801.001.201.400.200.00PLATINUMPLUS6XIENCE–PromusElementDatafromdifferenttrialspresentedforeducationalpurposesandarenotdirectlycomparableInformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A6在头对头研究中,XIENCE的30天支架血栓发生率显著低于对照组6RESOLUTEAllComers11Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.2FajadetJ.PLATINUMPLUS30-DayPoster,TCT2012.PLATINUMPLUS2XIENCEvs.ResoluteXIENCEvs.PromusElementARCDef/ProbStentThrombosis(%)ARCDef/ProbStentThrombosis(%)InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A7在真实世界RCT研究中,XIENCE与PromusElement相比有更低的事件发生率PLATINUMPLUS30天研究结果Source:Fajadet,J,etal.PLATINUMPLUS30-dayPoster,TCT2012.PromusElement(n=1,955)XIENCEPRIME(n=1,030)p-value靶血管失败21(1.07%)8(0.78%)0.43心源性死亡9(0.46%)4(0.39%)1.00与靶血管相关的MI11(0.56%)3(0.29%)0.40靶病变血运重建4(0.20%)0(0.00%)0.31靶血管血运重建6(0.31%)2(0.19%)0.72InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A8远期结果:XIENCE在真实世界研究至术后3年有持续一致的低支架血栓发生率XIENCEARC确定的支架血栓Sources:1.Natsuaki,M,et.al.,NEXT1-YearResults,ACC2013.2.vonBirgelen,C,etal.,TWENTE2-YearResults,TCT2012.3.Kozuma,Ketal.,RESET2-YearResults,TCT2012.4.Kaiser,C.,et.al.,BASKET-PROVE2-YearResults,AHA2010.5.Jensen,LO,et.al.,SORTOUTIV3-YearResults,ACC2013.6.Räber,L.,et.al.,LESSON13-YearResults,ESC2010.7.Byrne,RA,et.al.,3-YearResultsoftheISAR-TEST4Trial,JACC.2011;58(13):1325-1331.8.Windecker,S.,et.al.,RESOLUTEAllComers3-YearResults,EuroPCR2012.InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A9RCT网络荟萃分析(NMAs):3个不同的RCTNMA均显示XIENCE表现出色RCT网络荟萃分析:•根据ESC指南,这一研究设计拥有最高的证据等级•3个研究全部由国际知名专家独立进行•比较超过两个产品的方式有直接及间接的比较–通过这种方式,以往从未在头对头研究中比较过的产品可以获得统计学相关结果InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A10RCT网络荟萃分析研究设计TAXUSCYPHERPromusElementResoluteEndeavorInformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A113个在2012年已经发表的RCT网络荟萃分析(NMA)概览RCTNMA2012年3月发表于Lancet上RCTNMA2012年6月发表于CirculationRCTNMA2012年8月发表于BMJ入选的RCT数量497742患者数量50,494117,76210,714患者群所有入组患者所有入组患者糖尿病患者主要终点1年安全性:确定的支架血栓所有时段有效性:TVR和TLR所有时段安全性:Death,MI,ST所有时段有效性(TVR)和安全性(死亡,MI,ST)入组标准至少在2个关于BMS和/或DES的RCT中研究过至少包括100例患者且长于6月随访时间的RCT至少50名糖尿病患者和6个月以上随访时间的RCT研究统计学方法带P值的比值比带可能性%的比值比带可能性%的比值比结论“XIENCE相比于BMS和其余DES是最安全的”“XIENCE相比于BMS和其余DES最安全而且最有效”“在糖尿病患者中XIENCE相比于BMS和其余DES最安全而且最有效”Sources:1.PalmeriniTetal.Lancet.March2012.379:9824,14-20April2012,pp.1393-1402.2.BangaloreS,etal.CirculationJune2012.DOI:10.1161/CIRCULATIONAHA.112.097014.3.BangaloreS,etal.BritishMedicalJournal,Aug2012.345:e5170doi:10.1136/bmj.e5170.InformationcontainedhereinisnotintendedforphysiciansfromFranceortheU.S.©2013Abbott.Allrightsreserved.AP2938300-OUSRev.A12LancetRCTNMA:XIENCE是唯一在1年和2年时支架血栓发生率均低于BMS的DES1年和2年确定的支架血栓发生率汇总比值比*Source:Palmerini,etal.TheLancet.379:9824,14-20April2012,pp.1393-1402.*Anoddsratioisamethodofcomparingtheoddsofaneventbetweentwogroups.BMSisacompositeofbaremetalstents.**TheBMScomparatorisacompositeofseveralbaremetalstents“Meta-analysesshouldberegardedashypothesis-generatingandthefindingsofPalmeriniandcolleaguessuggestthatarandomizedtrialofCoCrEESand