雅培XIENCE安全性證據(jù)(終稿)

XIENCE支架最新臨床數(shù)據(jù)分享XIENCE支架最新臨床數(shù)據(jù)分享最新安全性數(shù)據(jù)匯總堅實的DAPT數(shù)據(jù)臨床數(shù)據(jù)的設計基礎XIENCE:最新安全性數(shù)據(jù)匯總XIENCE在術后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.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在頭對頭研究中，XIENCE的30天支架血栓發(fā)生率顯著低于對照組6RESOLUTEAllComers11Serruys,PWetal.RESOLUTEAllComersTrial,NEJM2010.PublishedonlineJune16,2010.2FajadetJ.PLATINUMPLUS30-DayPoster,TCT2012.PLATINUMPLUS2XIENCEvs.ResoluteXIENCEvs.PromusElementARCDef/ProbStentThrombosis(%)ARCDef/ProbStentThrombosis(%)在真實世界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與靶血管相關的MI11(0.56%)3(0.29%)0.40靶病變血運重建4(0.20%)0(0.00%)0.31靶血管血運重建6(0.31%)2(0.19%)0.72遠期結(jié)果:

XIENCE在真實世界研究至術后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.RCT網(wǎng)絡薈萃分析(NMAs):3個不同的RCTNMA均顯示XIENCE表現(xiàn)出色RCT網(wǎng)絡薈萃分析:根據(jù)ESC指南，這一研究設計擁有最高的證據(jù)等級3個研究全部由國際知名專家獨立進行比較超過兩個產(chǎn)品的方式有直接及間接的比較通過這種方式，以往從未在頭對頭研究中比較過的產(chǎn)品可以獲得統(tǒng)計學相關結(jié)果RCT網(wǎng)絡薈萃分析研究設計TAXUSCYPHERPromusElementResoluteEndeavor3個在2012年已經(jīng)發(fā)表的RCT網(wǎng)絡薈萃分析(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1年安全性:確定的支架血栓所有時段有效性:TVR和TLR所有時段安全性:Death,MI,ST所有時段有效性(TVR)和安全性(死亡,MI,ST)入組標準至少在2個關于BMS和/或DES的RCT中研究過至少包括100例患者且長于6月隨訪時間的RCT至少50名糖尿病患者和6個月以上隨訪時間的RCT研究統(tǒng)計學方法帶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.LancetRCTNMA:XIENCE是唯一在1年和2年時支架血栓發(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更佳對比產(chǎn)品更佳*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年時確定的支架血栓發(fā)生率增高倍數(shù)相比于XIENCE1年時確定的支架血栓發(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年時支架血栓發(fā)生率均低于BMS的DES2CirculationRCTNMA: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*CypherTaxusEndeavor1.8xMoreLikelyResolute1.4xMoreLikelyCirculationRCTNMA: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)XIENCE:堅實的DAPT數(shù)據(jù)來自真實世界的挑戰(zhàn)PCI手術后12個月內(nèi)，每6個接受支架植入的患者中就有1個會中斷或停用DAPT*S.S.Naiduet.al.ContemporaryIncidence&PredictorsofSTandOtherMACEintheYearAfterXIENCEVImplantation.JACC,June2012.Patientsshouldfollowphysicians’guidanceforutilizationofdualanti-platelettherapyfollowingstentimplantation.XIENCEDAPT數(shù)據(jù)

XIENCE:首個進行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)XIENCEDAPT中斷分析基于真實世界患者群3個月DAPT中斷數(shù)據(jù)1個月DAPT中斷數(shù)據(jù)XIENCEDAPT數(shù)據(jù):匯總分析四個來自真實世界的研究，共10,615位患者

919位患者在3-12個月期間中斷DAPT1,047位患者在1-12個月期間中斷DAPTDAPT中斷包括暫時性或永久性中斷DAPT使用XIENCEDAPT分析:基于真實世界研究: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.在3-12個月內(nèi)中斷DAPT，XIENCE的支架血栓發(fā)生率是0%12個月內(nèi)首次中斷DAPT的時程與支架血栓的關系*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個月3-12個月60/8,99611/70018/8,9960/919Source:Palmerini,T.StentThrombosisandDAPTInterruptioninXIENCEV?Real-WorldPatients.PCR2012.在1-12個月內(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個月內(nèi)首次中斷DAPT的時程與支架血栓的關系*IncludingpatientswithnoDAPTInterruptionexceptpossiblyafterStentThrombosisthough365days.60/8,9969/57225/8,9962/1,047使用XIENCE，在術后6-24個月永久性中斷DAPT沒有顯示出支架血栓增高的風險*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個月沒有DPAT中斷6-24個月永久性中斷DAPTXIENCE:為最佳的結(jié)果而設計XIENCE:優(yōu)異結(jié)果與其任何一部分支架組成有關“一個藥物洗脫支架由3個部分組成，這幾部分同等重要:金屬支架平臺，聚合物和藥物，這3部分共同影響其即刻和長期的安全性和有效性.”–Dr.Fajadet1

1.Fajadet,J.,et