雅培XIENCE安全性證據(jù)課件

雅培XIENCE安全性證據(jù)2022/12/17雅培XIENCE安全性證據(jù)雅培XIENCE安全性證據(jù)2022/12/14雅培XIENC1XIENCE支架最新臨床數(shù)據(jù)分享最新安全性數(shù)據(jù)匯總堅(jiān)實(shí)的DAPT數(shù)據(jù)臨床數(shù)據(jù)的設(shè)計(jì)基礎(chǔ)雅培XIENCE安全性證據(jù)XIENCE支架最新臨床數(shù)據(jù)分享最新安全性數(shù)據(jù)匯總雅培XI2XIENCE:最新安全性數(shù)據(jù)匯總雅培XIENCE安全性證據(jù)XIENCE:最新安全性數(shù)據(jù)匯總雅培XIENCE安全性證據(jù)3XIENCE在術(shù)后30天顯示出比BMS及其他藥物洗脫支架都低的支架血栓發(fā)生率在術(shù)后30天，與XIENCE相比不同支架發(fā)生確定的支架血栓的可能性BMS**CypherTaxusEndeavorResolute5xMoreLikely*2xMoreLikely*4xMoreLikely*5xMoreLikely*14xMoreLikely*不同支架30天確定的支架血栓發(fā)生率與XIENCE的比值比?*Numbercalculatedfromsourcedata.**TheBMScomparatorisacompositeofseveralbaremetalstents.?Amethodofcomparingtheoddsofaneventbetweentwogroups.Source:Palmerinietal.TheLancet.379:9824,14-20April2012,pp.1393-1402.雅培XIENCE安全性證據(jù)XIENCE在術(shù)后30天顯示出比BMS及其他藥物洗脫支架都低4只有XIENCE在不同的研究中持續(xù)保持最低的支架血栓發(fā)生率Sources:1.SmitsP.COMPARETrial:2-YearResultsPresentation,TCT2010.2.Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.3.R?berL.LESSON1:3-YearPresentation,ESC2010.4.ByrneRA.ISARTEST4:2-YearDataPresentation,TCT2010.5.StoneG.SPIRITIV:1-YearResultsPresentation,TCT2009.6.Fajadet,PLATINUMPLUS,TCT2012.早期確定的支架血栓(0-30天)XIENCECompetitor0.201.000.100.800.300.800.300.460.120.57COMPARE1

XIENCE–TaxusLibertéRESOLUTEAC2

XIENCE–ResoluteLESSON3

XIENCE–CypherISARTEST44

XIENCE–CypherSPIRITIV1

XIENCE–TaxusARCDefiniteStentThrombosis(%)0.000.200.400.600.801.001.201.400.200.00PLATINUMPLUS6XIENCE–PromusElementDatafromdifferenttrialspresentedforeducationalpurposesandarenotdirectlycomparable雅培XIENCE安全性證據(jù)只有XIENCE在不同的研究中持續(xù)保持最低的支架血栓發(fā)生率S5在頭對(duì)頭研究中，XIENCE的30天支架血栓發(fā)生率顯著低于對(duì)照組6RESOLUTEAllComers11Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.2FajadetJ.PLATINUMPLUS30-DayPoster,TCT2012.PLATINUMPLUS2XIENCEvs.ResoluteXIENCEvs.PromusElementARCDef/ProbStentThrombosis(%)ARCDef/ProbStentThrombosis(%)雅培XIENCE安全性證據(jù)在頭對(duì)頭研究中，XIENCE的30天支架血栓發(fā)生率顯著低于對(duì)6在真實(shí)世界RCT研究中，XIENCE與PromusElement相比有更低的事件發(fā)生率PLATINUMPLUS30天研究結(jié)果Source:Fajadet,J,etal.PLATINUMPLUS30-dayPoster,TCT2012.PromusElement(n=1,955)XIENCEPRIME(n=1,030)p-value靶血管失敗21(1.07%)8(0.78%)0.43心源性死亡9(0.46%)4(0.39%)1.00與靶血管相關(guān)的MI11(0.56%)3(0.29%)0.40靶病變血運(yùn)重建4(0.20%)0(0.00%)0.31靶血管血運(yùn)重建6(0.31%)2(0.19%)0.72雅培XIENCE安全性證據(jù)在真實(shí)世界RCT研究中，XIENCE與PromusElem7遠(yuǎn)期結(jié)果:

XIENCE在真實(shí)世界研究至術(shù)后3年有持續(xù)一致的低支架血栓發(fā)生率XIENCEARC確定的支架血栓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.R?ber,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.雅培XIENCE安全性證據(jù)遠(yuǎn)期結(jié)果:

XIENCE在真實(shí)世界研究至術(shù)后3年有持續(xù)一致8RCT網(wǎng)絡(luò)薈萃分析(NMAs):3個(gè)不同的RCTNMA均顯示XIENCE表現(xiàn)出色RCT網(wǎng)絡(luò)薈萃分析:根據(jù)ESC指南，這一研究設(shè)計(jì)擁有最高的證據(jù)等級(jí)3個(gè)研究全部由國(guó)際知名專家獨(dú)立進(jìn)行比較超過兩個(gè)產(chǎn)品的方式有直接及間接的比較通過這種方式，以往從未在頭對(duì)頭研究中比較過的產(chǎn)品可以獲得統(tǒng)計(jì)學(xué)相關(guān)結(jié)果雅培XIENCE安全性證據(jù)RCT網(wǎng)絡(luò)薈萃分析(NMAs):RCT網(wǎng)絡(luò)薈萃分析:雅培9RCT網(wǎng)絡(luò)薈萃分析研究設(shè)計(jì)TAXUSCYPHERPromusElementResoluteEndeavor雅培XIENCE安全性證據(jù)RCT網(wǎng)絡(luò)薈萃分析研究設(shè)計(jì)TAXUSCYPHERPromus103個(gè)在2012年已經(jīng)發(fā)表的RCT網(wǎng)絡(luò)薈萃分析(NMA)概覽RCTNMA2012年3月發(fā)表于Lancet上RCTNMA2012年6月發(fā)表于CirculationRCTNMA2012年8月發(fā)表于BMJ入選的RCT數(shù)量497742患者數(shù)量50,494117,76210，714患者群所有入組患者所有入組患者糖尿病患者主要終點(diǎn)1年安全性:確定的支架血栓所有時(shí)段有效性:TVR和TLR所有時(shí)段安全性:Death,MI,ST所有時(shí)段有效性(TVR)和安全性(死亡,MI,ST)入組標(biāo)準(zhǔn)至少在2個(gè)關(guān)于BMS和/或DES的RCT中研究過至少包括100例患者且長(zhǎng)于6月隨訪時(shí)間的RCT至少50名糖尿病患者和6個(gè)月以上隨訪時(shí)間的RCT研究統(tǒng)計(jì)學(xué)方法帶P值的比值比帶可能性%的比值比帶可能性%的比值比結(jié)論“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.雅培XIENCE安全性證據(jù)3個(gè)在2012年已經(jīng)發(fā)表的RCT網(wǎng)絡(luò)薈萃分析(NMA)概覽R11LancetRCTNMA:XIENCE是唯一在1年和2年時(shí)支架血栓發(fā)生率均低于BMS的DES1年和2年確定的支架血栓發(fā)生率匯總比值比*Source:Palmerini,etal.TheLancet.379:9824,14-20April2012,pp.1393-1402.*Anoddsratioisamethodofcomparingtheoddsofaneventbetweentwogroups.BMSisacompositeofbaremetalstents.**TheBMScomparatorisacompositeofseveralbaremetalstents“Meta-analysesshouldberegardedashypothesis-generatingandthefindingsofPalmeriniandcolleaguessuggestthatarandomizedtrialofCoCrEESandBMSisdesirable.”O(jiān)rmiston,TheLancet,April2012.XIENCE更佳對(duì)比產(chǎn)品更佳雅培XIENCE安全性證據(jù)LancetRCTNMA:XIENCE是唯一在1年和212*Numbercalculatedfromsourcedata.**TheBMScomparatorisacompositeofseveralbaremetalstents.?Amethodofcomparingtheoddsofaneventbetweentwogroups.

TheXIENCEproductwasdesignedasanoverallsystem,witheachsystemcomponentcontributingtoitsclinicaloutcomes.Thesystemincludes:thethin-strutCoCr,multi-generationMULTI-LINK,withitsflexibleringand3-linkstentdesign;advanceddeliverysystem,noveleverolimuscompound;themulti-layercoatingtechnologies,utilizingaprimerandco-polymer,previouslyknownforcardiovascularimplants,andhavingexcellentmechanicalproperties.VersusallFDAapprovedDES:EndeavorResolute,Endeavor,PromusElement,Cypher,TaxusExpressandTaxusLiberte.相比于XIENCE1年時(shí)確定的支架血栓發(fā)生率增高倍數(shù)相比于XIENCE1年時(shí)確定的支架血栓發(fā)生率比值比4.3x2.4x3.6x4.8x7.1x*******Source:Palmerini,etal.TheLancet.379:9824,14-20April2012,pp.1393-1402.LancetRCTNMA:XIENCE1是唯一在1年及2年時(shí)支架血栓發(fā)生率均低于BMS的DES2雅培XIENCE安全性證據(jù)*Numbercalculatedfromsourc13CirculationRCTNMA:XIENCE相比于BMS和其余DES是最安全的*TheBMScomparatorisacompositeofseveralbaremetalstents.Source:BangaloreS,etal.CirculationJune2012.DOI:10.1161/CIRCULATIONAHA.112.097014.相比于XIENCE確定的/可能的支架血栓發(fā)生率增高倍數(shù)相比于XIENCE支架血栓發(fā)生率比值比2.7xMoreLikelyMoreLikelyMoreLikely2x3xBMS*CypherTaxusEndeavor1.8xMoreLikelyResolute1.4xMoreLikely雅培XIENCE安全性證據(jù)CirculationRCTNMA:XIENCE相比于14CirculationRCTNMA:XIENCE相比于BMS和其余DES是最有效的支架*TheBMScomparatorisacompositeofseveralbaremetalstents.Source:BangaloreS,etal.CirculationJune2012.DOI:10.1161/CIRCULATIONAHA.112.097014.相比于XIENCETVR比值比1.6xMoreLikelyMoreLikelyMoreLikely1.0x2.6xBMS*CypherTaxusEndeavor1.6xMoreLikelyResolute1.1xMoreLikely相比于XIENCETVR增高倍數(shù)雅培XIENCE安全性證據(jù)CirculationRCTNMA:XIENCE相比于15XIENCE:堅(jiān)實(shí)的DAPT數(shù)據(jù)雅培XIENCE安全性證據(jù)XIENCE:堅(jiān)實(shí)的DAPT數(shù)據(jù)雅培XIENCE安全性證據(jù)16來(lái)自真實(shí)世界的挑戰(zhàn)PCI手術(shù)后12個(gè)月內(nèi)，每6個(gè)接受支架植入的患者中就有1個(gè)會(huì)中斷或停用DAPT*S.S.Naiduet.al.ContemporaryIncidence&PredictorsofSTandOtherMACEintheYearAfterXIENCEVImplantation.JACC,June2012.Patientsshouldfollowphysicians’guidanceforutilizationofdualanti-platelettherapyfollowingstentimplantation.雅培XIENCE安全性證據(jù)來(lái)自真實(shí)世界的挑戰(zhàn)PCI手術(shù)后12個(gè)月內(nèi)，每6個(gè)接受支架植入17XIENCEDAPT數(shù)據(jù)XIENCE:首個(gè)進(jìn)行DAPT研究–

擁有最多的DPAT數(shù)據(jù)超過14,000名患者,包括11,500名真實(shí)世界患者DataonfileatAbbottVascular.SPIRITII

(n=223)SPIRITIII

(n=669)SPIRITIV

(n=2,458)SPIRITV

(n=1,662)SPIRITWomen

(n=1,506)XIENCEVUSA

(n=6,516)XIENCEVIndia

(n=931)COMPARE

(n=897)雅培XIENCE安全性證據(jù)XIENCEDAPT數(shù)據(jù)XIENCE:首個(gè)進(jìn)行DAPT18XIENCEDAPT中斷分析基于真實(shí)世界患者群3個(gè)月DAPT中斷數(shù)據(jù)1個(gè)月DAPT中斷數(shù)據(jù)XIENCEDAPT數(shù)據(jù):匯總分析四個(gè)來(lái)自真實(shí)世界的研究，共10,615位患者919位患者在3-12個(gè)月期間中斷DAPT1,047位患者在1-12個(gè)月期間中斷DAPTDAPT中斷包括暫時(shí)性或永久性中斷DAPT使用XIENCEDAPT分析:基于真實(shí)世界研究:SPIRITWomen

(n=1,506)SPIRITV

(n=1,662)XIENCEVUSA

(n=6,516)XIENCEVIndia

(n=931)Sources:1.Palmerini,T.StentThrombosisandDAPTInterruptioninXIENCEVReal-WorldPatients.PCR2012.2.Généreux,P.Stentthrombosis:insightsonoutcomes,predictorsandimpactofdualantiplatelettherapyinterruptionfromtheEverolimusStentFamilytrials.TCT2012.Patientsshouldfollowphysicians’guidanceforutilizationofdualanti-platelettherapyfollowingstentimplantation.雅培XIENCE安全性證據(jù)XIENCEDAPT中斷分析基于真實(shí)世界患者群3個(gè)月D19在3-12個(gè)月內(nèi)中斷DAPT，XIENCE的支架血栓發(fā)生率是0%12個(gè)月內(nèi)首次中斷DAPT的時(shí)程與支架血栓的關(guān)系*IncludingpatientswithnoDAPTInterruptionexceptpossiblyafterStentThrombosisthough365days.中斷DAPT后發(fā)生的支架血栓ARC定義確定的/可能的(%)0.68%1.64%0.21%0.00%從未中斷*DAPT中斷0-3個(gè)月3-12個(gè)月60/8,99611/70018/8,9960/919Source:Palmerini,T.StentThrombosisandDAPTInterruptioninXIENCEV?Real-WorldPatients.PCR2012.雅培XIENCE安全性證據(jù)在3-12個(gè)月內(nèi)中斷DAPT，XIENCE的支架血栓發(fā)生率是20在1-12個(gè)月內(nèi)中斷DAPT，XIENCE顯示出低支架血栓發(fā)生率Source:Genereaux,P.Stentthrombosis:insightsonoutcomes,predictorsandimpactofdualantiplatelettherapyinterruptionfromtheEverolimusStentFamilytrials.TCT2012.1.63%0.29%0.20%0.68%1.00-1Month1-12Months從未中斷*DAPT中斷隨后發(fā)生的支架血栓ARC定義確定的/可能的(%)12個(gè)月內(nèi)首次中斷DAPT的時(shí)程與支架血栓的關(guān)系*IncludingpatientswithnoDAPTInterruptionexceptpossiblyafterStentThrombosisthough365days.60/8,9969/57225/8,9962/1,047雅培XIENCE安全性證據(jù)在1-12個(gè)月內(nèi)中斷DAPT，XIENCE顯示出低支架血栓發(fā)21使用XIENCE，在術(shù)后6-24個(gè)月永久性中斷DAPT沒有顯示出支架血栓增高的風(fēng)險(xiǎn)*永久性中斷DAPT確定的/可能的支架血栓發(fā)生率*DerivedfromE.KedhiSPIRIT-COMPAREMetaDAPTDiscontinuation,ACC2012Patientsshouldfollowphysicians’guidanceforutilizationofdualanti-platelettherapyfollowingstentimplantation.15/1,9699/1,73024個(gè)月沒有DPAT中斷6-24個(gè)月永久性中斷DAPT雅培XIENCE安全性證據(jù)使用XIENCE，在術(shù)后6-24個(gè)月永久性中斷DAPT沒有顯22XIENCE:為最佳的結(jié)果而設(shè)計(jì)雅培XIENCE安全性證據(jù)XIENCE:為最佳的結(jié)果而設(shè)計(jì)雅培XIENCE安全性證據(jù)23XIENCE:優(yōu)異結(jié)果與其任何一部分支架組成有關(guān)“一個(gè)藥物洗脫支架由3個(gè)部分組成，這幾部分同等重要:金屬支架平臺(tái)，聚合物和藥物，這3部分共同影響其即刻和長(zhǎng)期的安全性和有效性.”–Dr.Fajadet1

1.Fajadet,J.,etal.PLATINUMPLUS30-dayPoster,TCT2012.依維莫司最低劑量有效控釋含氟聚合物涂層處理設(shè)計(jì)穩(wěn)定及更好的生物相容性MULTI-LINK

設(shè)計(jì)傳承8代，有證可循的設(shè)計(jì)雅培XIENCE安全性證據(jù)XIENCE:優(yōu)異結(jié)果與其任何一部分支架組成有關(guān)“一個(gè)藥物洗24涂層技術(shù)

涂層完整性1?含氟共聚物應(yīng)用了多層處理技術(shù)?有良好的柔軟度及彈性，及長(zhǎng)時(shí)間的韌性1?藥物控釋覆蓋整個(gè)再狹窄的病理過程2,3,4XIENCEt=0t=7dt=56d1LoEsetal.USPatent3,178,9992DataonfileatAbbottVascular3ForresterJetal.JACC1991:17(3)758-7694Simon,D.InflammationSummit,TCT2003雅培XIENCE安全性證據(jù)涂層技術(shù)

涂層完整性1?含氟共聚物應(yīng)用了多層處理技術(shù)XIE25涂層技術(shù)

減少血栓形成1? 更好的生物相容性獲得更好的臨床結(jié)果，包括減少血栓的形成1? 氟化物的臨床優(yōu)勢(shì)已經(jīng)有超過20年的充分研究? 建議在心血管植入物上使用含氟涂層已經(jīng)有很長(zhǎng)時(shí)間2,3? 含氟涂層使血小板激活降到最低，同時(shí)優(yōu)化蛋白吸附和保留4,5,這些可以帶來(lái):–更快的再內(nèi)皮化1–減少炎癥1–減少血栓形成11Patonetal.USPatent5,356,668.2LilenfieldRetal.USPatent4,564,0133TuRHetal.USPatent4,816,3394GarfinkleAetal.TAmSocArtIntOrg1984:30,432-439.5Kiaeietal,JBiomatSci-PolymE.1993;4(1)35-44雅培XIENCE安全性證據(jù)涂層技術(shù)

減少血栓形成1? 更好的生物相容性獲得更好的臨26結(jié)論最新數(shù)據(jù)顯示，XIENCE有比其他二代支架及BMS更低的支架血栓發(fā)生率（包括早期及長(zhǎng)期隨訪）XIENCE擁有最大數(shù)量堅(jiān)實(shí)的DAPT數(shù)據(jù)XIENCE的安全性表現(xiàn)源于安全性設(shè)計(jì)雅培XIENCE安全性證據(jù)結(jié)論最新數(shù)據(jù)顯示，XIENCE有比其他二代支架及BMS更低的27演講完畢，謝謝聽講!再見，seeyouagain3rew2022/12/17雅培XIENCE安全性證據(jù)演講完畢，謝謝聽講!再見，seeyouagain3rew28雅培XIENCE安全性證據(jù)2022/12/17雅培XIENCE安全性證據(jù)雅培XIENCE安全性證據(jù)2022/12/14雅培XIENC29XIENCE支架最新臨床數(shù)據(jù)分享最新安全性數(shù)據(jù)匯總堅(jiān)實(shí)的DAPT數(shù)據(jù)臨床數(shù)據(jù)的設(shè)計(jì)基礎(chǔ)雅培XIENCE安全性證據(jù)XIENCE支架最新臨床數(shù)據(jù)分享最新安全性數(shù)據(jù)匯總雅培XI30XIENCE:最新安全性數(shù)據(jù)匯總雅培XIENCE安全性證據(jù)XIENCE:最新安全性數(shù)據(jù)匯總雅培XIENCE安全性證據(jù)31XIENCE在術(shù)后30天顯示出比BMS及其他藥物洗脫支架都低的支架血栓發(fā)生率在術(shù)后30天，與XIENCE相比不同支架發(fā)生確定的支架血栓的可能性BMS**CypherTaxusEndeavorResolute5xMoreLikely*2xMoreLikely*4xMoreLikely*5xMoreLikely*14xMoreLikely*不同支架30天確定的支架血栓發(fā)生率與XIENCE的比值比?*Numbercalculatedfromsourcedata.**TheBMScomparatorisacompositeofseveralbaremetalstents.?Amethodofcomparingtheoddsofaneventbetweentwogroups.Source:Palmerinietal.TheLancet.379:9824,14-20April2012,pp.1393-1402.雅培XIENCE安全性證據(jù)XIENCE在術(shù)后30天顯示出比BMS及其他藥物洗脫支架都低32只有XIENCE在不同的研究中持續(xù)保持最低的支架血栓發(fā)生率Sources:1.SmitsP.COMPARETrial:2-YearResultsPresentation,TCT2010.2.Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.3.R?berL.LESSON1:3-YearPresentation,ESC2010.4.ByrneRA.ISARTEST4:2-YearDataPresentation,TCT2010.5.StoneG.SPIRITIV:1-YearResultsPresentation,TCT2009.6.Fajadet,PLATINUMPLUS,TCT2012.早期確定的支架血栓(0-30天)XIENCECompetitor0.201.000.100.800.300.800.300.460.120.57COMPARE1

XIENCE–TaxusLibertéRESOLUTEAC2

XIENCE–ResoluteLESSON3

XIENCE–CypherISARTEST44

XIENCE–CypherSPIRITIV1

XIENCE–TaxusARCDefiniteStentThrombosis(%)0.000.200.400.600.801.001.201.400.200.00PLATINUMPLUS6XIENCE–PromusElementDatafromdifferenttrialspresentedforeducationalpurposesandarenotdirectlycomparable雅培XIENCE安全性證據(jù)只有XIENCE在不同的研究中持續(xù)保持最低的支架血栓發(fā)生率S33在頭對(duì)頭研究中，XIENCE的30天支架血栓發(fā)生率顯著低于對(duì)照組34RESOLUTEAllComers11Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.2FajadetJ.PLATINUMPLUS30-DayPoster,TCT2012.PLATINUMPLUS2XIENCEvs.ResoluteXIENCEvs.PromusElementARCDef/ProbStentThrombosis(%)ARCDef/ProbStentThrombosis(%)雅培XIENCE安全性證據(jù)在頭對(duì)頭研究中，XIENCE的30天支架血栓發(fā)生率顯著低于對(duì)34在真實(shí)世界RCT研究中，XIENCE與PromusElement相比有更低的事件發(fā)生率PLATINUMPLUS30天研究結(jié)果Source:Fajadet,J,etal.PLATINUMPLUS30-dayPoster,TCT2012.PromusElement(n=1,955)XIENCEPRIME(n=1,030)p-value靶血管失敗21(1.07%)8(0.78%)0.43心源性死亡9(0.46%)4(0.39%)1.00與靶血管相關(guān)的MI11(0.56%)3(0.29%)0.40靶病變血運(yùn)重建4(0.20%)0(0.00%)0.31靶血管血運(yùn)重建6(0.31%)2(0.19%)0.72雅培XIENCE安全性證據(jù)在真實(shí)世界RCT研究中，XIENCE與PromusElem35遠(yuǎn)期結(jié)果:

XIENCE在真實(shí)世界研究至術(shù)后3年有持續(xù)一致的低支架血栓發(fā)生率XIENCEARC確定的支架血栓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.R?ber,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.雅培XIENCE安全性證據(jù)遠(yuǎn)期結(jié)果:

XIENCE在真實(shí)世界研究至術(shù)后3年有持續(xù)一致36RCT網(wǎng)絡(luò)薈萃分析(NMAs):3個(gè)不同的RCTNMA均顯示XIENCE表現(xiàn)出色RCT網(wǎng)絡(luò)薈萃分析:根據(jù)ESC指南，這一研究設(shè)計(jì)擁有最高的證據(jù)等級(jí)3個(gè)研究全部由國(guó)際知名專家獨(dú)立進(jìn)行比較超過兩個(gè)產(chǎn)品的方式有直接及間接的比較通過這種方式，以往從未在頭對(duì)頭研究中比較過的產(chǎn)品可以獲得統(tǒng)計(jì)學(xué)相關(guān)結(jié)果雅培XIENCE安全性證據(jù)RCT網(wǎng)絡(luò)薈萃分析(NMAs):RCT網(wǎng)絡(luò)薈萃分析:雅培37RCT網(wǎng)絡(luò)薈萃分析研究設(shè)計(jì)TAXUSCYPHERPromusElementResoluteEndeavor雅培XIENCE安全性證據(jù)RCT網(wǎng)絡(luò)薈萃分析研究設(shè)計(jì)TAXUSCYPHERPromus383個(gè)在2012年已經(jīng)發(fā)表的RCT網(wǎng)絡(luò)薈萃分析(NMA)概覽RCTNMA2012年3月發(fā)表于Lancet上RCTNMA2012年6月發(fā)表于CirculationRCTNMA2012年8月發(fā)表于BMJ入選的RCT數(shù)量497742患者數(shù)量50,494117,76210，714患者群所有入組患者所有入組患者糖尿病患者主要終點(diǎn)1年安全性:確定的支架血栓所有時(shí)段有效性:TVR和TLR所有時(shí)段安全性:Death,MI,ST所有時(shí)段有效性(TVR)和安全性(死亡,MI,ST)入組標(biāo)準(zhǔn)至少在2個(gè)關(guān)于BMS和/或DES的RCT中研究過至少包括100例患者且長(zhǎng)于6月隨訪時(shí)間的RCT至少50名糖尿病患者和6個(gè)月以上隨訪時(shí)間的RCT研究統(tǒng)計(jì)學(xué)方法帶P值的比值比帶可能性%的比值比帶可能性%的比值比結(jié)論“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.雅培XIENCE安全性證據(jù)3個(gè)在2012年已經(jīng)發(fā)表的RCT網(wǎng)絡(luò)薈萃分析(NMA)概覽R39LancetRCTNMA:XIENCE是唯一在1年和2年時(shí)支架血栓發(fā)生率均低于BMS的DES1年和2年確定的支架血栓發(fā)生率匯總比值比*Source:Palmerini,etal.TheLancet.379:9824,14-20April2012,pp.1393-1402.*Anoddsratioisamethodofcomparingtheoddsofaneventbetweentwogroups.BMSisacompositeofbaremetalstents.**TheBMScomparatorisacompositeofseveralbaremetalstents“Meta-analysesshouldberegardedashypothesis-generatingandthefindingsofPalmeriniandcolleaguessuggestthatarandomizedtrialofCoCrEESandBMSisdesirable.”O(jiān)rmiston,TheLancet,April2012.XIENCE更佳對(duì)比產(chǎn)品更佳雅培XIENCE安全性證據(jù)LancetRCTNMA:XIENCE是唯一在1年和240*Numbercalculatedfromsourcedata.**TheBMScomparatorisacompositeofseveralbaremetalstents.?Amethodofcomparingtheoddsofaneventbetweentwogroups.

TheXIENCEproductwasdesignedasanoverallsystem,witheachsystemcomponentcontributingtoitsclinicaloutcomes.Thesystemincludes:thethin-strutCoCr,multi-generationMULTI-LINK,withitsflexibleringand3-linkstentdesign;advanceddeliverysystem,noveleverolimuscompound;themulti-layercoatingtechnologies,utilizingaprimerandco-polymer,previouslyknownforcardiovascularimplants,andhavingexcellentmechanicalproperties.VersusallFDAapprovedDES:EndeavorResolute,Endeavor,PromusElement,Cypher,TaxusExpressandTaxusLiberte.相比于XIENCE1年時(shí)確定的支架血栓發(fā)生率增高倍數(shù)相比于XIENCE1年時(shí)確定的支架血栓發(fā)生率比值比4.3x2.4x3.6x4.8x7.1x*******Source:Palmerini,etal.TheLancet.379:9824,14-20April2012,pp.1393-1402.LancetRCTNMA:XIENCE1是唯一在1年及2年時(shí)支架血栓發(fā)生率均低于BMS的DES2雅培XIENCE安全性證據(jù)*Numbercalculatedfromsourc41CirculationRCTNMA:XIENCE相比于BMS和其余DES是最安全的*TheBMScomparatorisacompositeofseveralbaremetalstents.Source:BangaloreS,etal.CirculationJune2012.DOI:10.1161/CIRCULATIONAHA.112.097014.相比于XIENCE確定的/可能的支架血栓發(fā)生率增高倍數(shù)相比于XIENCE支架血栓發(fā)生率比值比2.7xMoreLikelyMoreLikelyMoreLikely2x3xBMS*CypherTaxusEndeavor1.8xMoreLikelyResolute1.4xMoreLikely雅培XIENCE安全性證據(jù)CirculationRCTNMA:XIENCE相比于42CirculationRCTNMA:XIENCE相比于BMS和其余DES是最有效的支架*TheBMScomparatorisacompositeofseveralbaremetalstents.Source:BangaloreS,etal.CirculationJune2012.DOI:10.1161/CIRCULATIONAHA.112.097014.相比于XIENCETVR比值比1.6xMoreLikelyMoreLikelyMoreLikely1.0x2.6xBMS*CypherTaxusEndeavor1.6xMoreLikelyResolute1.1xMoreLikely相比于XIENCETVR增高倍數(shù)雅培XIENCE安全性證據(jù)CirculationRCTNMA:XIENCE相比于43XIENCE:堅(jiān)實(shí)的DAPT數(shù)據(jù)雅培XIENCE安全性證據(jù)XIENCE:堅(jiān)實(shí)的DAPT數(shù)據(jù)雅培XIENCE安全性證據(jù)44來(lái)自真實(shí)世界的挑戰(zhàn)PCI手術(shù)后12個(gè)月內(nèi)，每6個(gè)接受支架植入的患者中就有1個(gè)會(huì)中斷或停用DAPT*S.S.Naiduet.al.ContemporaryIncidence&PredictorsofSTandOtherMACEintheYearAfterXIENCEVImplantation.JACC,June2012.Patientsshouldfollowphysicians’guidanceforutilizationofdualanti-platelettherapyfollowingstentimplantation.雅培XIENCE安全性證據(jù)來(lái)自真實(shí)世界的挑戰(zhàn)PCI手術(shù)后12個(gè)月內(nèi)，每6個(gè)接受支架植入45XIENCEDAPT數(shù)據(jù)XIENCE:首個(gè)進(jìn)行DAPT研究–

擁有最多的DPAT數(shù)據(jù)超過14,000名患者,包括11,500名真實(shí)世界患者DataonfileatAbbottVascular.SPIRITII

(n=223)SPIRITIII

(n=669)SPIRITIV

(n=2,458)SPIRITV

(n=1,662)SPIRITWomen

(n=1,506)XIENCEVUSA

(n=6,516)XIENCEVIndia

(n=931)COMPARE

(n=897)雅培XIENCE安全性證據(jù)XIENCEDAPT數(shù)據(jù)XIENCE:首個(gè)進(jìn)行DAPT46XIENCEDAPT中斷分析基于真實(shí)世界患者群3個(gè)月DAPT中斷數(shù)據(jù)1個(gè)月DAPT中斷數(shù)據(jù)XIENCEDAPT數(shù)據(jù):匯總分析四個(gè)來(lái)自真實(shí)世界的研究，共10,615位患者919位患者在3-12個(gè)月期間中斷DAPT1,047位患者在1-12個(gè)月期間中斷DAPTDAPT中斷包括暫時(shí)性或永久性中斷DAPT使用XIENCEDAPT分析:基于真實(shí)世界研究:SPIRITWomen

(n=1,506)SPIRITV

(n=1,662)XIENCEVUSA

(n=6,516)XIENCEVIndia

(n=931)Sources:1.Palmerini,T.StentThrombosisandDAPTInterruptioninXIENCEVReal-WorldPatients.PCR2012.2.Généreux,P.Stentthrombosis:insightsonoutcomes,predictorsandimpactofdualantiplatelettherapyinterruptionfromtheEverolimusStentFamilytrials.TCT2012.Patientsshouldfollowphysicians’guidanceforutilizationofdualanti-platelettherapyfollowingstentimplantation.雅培XIENCE安全性證據(jù)XIENCEDAPT中斷分析基于真實(shí)世界患者群3個(gè)月D47在3-12個(gè)月內(nèi)中斷DAPT，XIENCE的支架血栓發(fā)生率是0%12個(gè)月內(nèi)首次中斷DAPT的時(shí)程與支架血栓的關(guān)系*IncludingpatientswithnoDAPTInterruptionexceptpossiblyafterStentThrombosisthough365days.中斷DAPT后發(fā)生的支架血栓ARC定義確定的/可能的(%)0.68%1.64%0.21%0.00%從未中斷*DAPT中斷0-3個(gè)月3-12個(gè)月60/8,99611/70018/8,9960/919Source:Palmerini,T.StentThrombosisandDAPTInterruptioninXIENCEV?Real-WorldPatients.PCR2012.雅培XIENCE安全性證據(jù)在3-12個(gè)月內(nèi)中斷DAPT，XIENCE的支架血栓發(fā)生率是48在1-12個(gè)月內(nèi)中斷DAPT，XIENCE顯示出低支架血栓發(fā)生率Source:Genereaux,P.Stentthrombosis:insightsonoutcomes,pre