1、2023-1-8雅培XIENCE安全性证据雅培雅培XIENCE安全性证据安全性证据雅培XIENCE安全性证据XIENCE 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雅培XIENCE安全性证据XIENCE:最新安全性数据最新安全性数据汇总汇总雅培XIENCE安全性证据XIENCE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在术术后后30天,与天,与XIENCE相比不同支架相比不同支架发发生确定的支架血栓生确定的支架血栓的可能性的可能性BMS*CypherTaxusEndeavorResolute5xMoreLikely*2x MoreL
2、ikely*4xMoreLikely*5xMoreLikely*14xMoreLikely*不同支架不同支架30天确定的支架血栓天确定的支架血栓发发生率与生率与XIENCE的比的比值值比比*Number calculated from source data.*The BMS comparator is a composite of several bare metal stents.A method of comparing the odds of an event between two groups.Source:Palmerini et al.The Lancet.379:9824,1
3、4-20 April 2012,pp.1393-1402.雅培XIENCE安全性证据只有XIENCE在不同的研究中持续保持最低的支架血栓发生率Sources:1.Smits P.COMPARE Trial:2-Year Results Presentation,TCT 2010.2.Serruys,PW et al.RESOLUTE All Comers Trial,NEJM 2010.Published online June 16,2010.3.Rber L.LESSON 1:3-Year Presentation,ESC 2010.4.Byrne RA.ISAR TEST 4:2-Yea
4、r Data Presentation,TCT 2010.5.Stone G.SPIRIT IV:1-Year Results Presentation,TCT 2009.6.Fajadet,PLATINUM PLUS,TCT 2012.早期确定的支架血栓早期确定的支架血栓(0-30 天天)XIENCECompetitor0.201.000.100.800.300.800.300.460.120.57COMPARE1 XIENCE Taxus LibertRESOLUTE AC2 XIENCE ResoluteLESSON3 XIENCE CypherISAR TEST44 XIENCE Cy
5、pherSPIRIT IV1 XIENCE Taxus ARC Definite Stent Thrombosis(%)0.000.200.400.600.801.001.201.400.200.00PLATINUM PLUS6XIENCE Promus ElementData from different trials presented for educational purposes and are not directly comparable雅培XIENCE安全性证据在头对头研究中,XIENCE的30天支架血栓发生率显著低于对照组6RESOLUTE All Comers11 Serr
6、uys,PW et al.RESOLUTE All Comers Trial,NEJM 2010.Published online June 16,2010.2 Fajadet J.PLATINUM PLUS 30-Day Poster,TCT 2012.PLATINUM PLUS2XIENCE vs.ResoluteXIENCE vs.Promus ElementARC Def/Prob Stent Thrombosis(%)ARC Def/Prob Stent Thrombosis(%)雅培XIENCE安全性证据在真实世界RCT研究中,XIENCE与Promus Element相比有更低的
7、事件发生率PLATINUM PLUS 30天研究天研究结结果果Source:Fajadet,J,et al.PLATINUM PLUS 30-day Poster,TCT 2012.Promus Element(n=1,955)XIENCE PRIME(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%)0.72雅培XIENCE安全性证据远期结果:XIENC
8、E 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XIENCE ARC 确定的支架血栓确定的支架血栓Sources:1.Natsuaki,M,et.al.,NEXT 1-Year Results,ACC 2013.2.von Birgelen,C,et al.,TWENTE 2-Year Results,TCT 2012.3.Kozuma,K et al.,RESET 2-Year Results,TCT 2012.4.Kaiser,C.,et.al.,BASKET-PROVE 2-Year Results,AHA 2010.5.Jensen,LO,et.al.,SORT OUT IV
9、3-Year Results,ACC 2013.6.Rber,L.,et.al.,LESSON 1 3-Year Results,ESC 2010.7.Byrne,RA,et.al.,3-Year Results of the ISAR-TEST 4 Trial,JACC.2011;58(13):1325-1331.8.Windecker,S.,et.al.,RESOLUTE All Comers 3-Year Results,EuroPCR 2012.雅培XIENCE安全性证据RCT 网络荟萃分析(NMAs):3个不同的RCT NMA均显示XIENCE表现出色RCT 网络荟萃分析:根据ESC
10、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雅培XIENCE安全性证据RCT网络荟萃分析研究设计TAXUSCYPHERPromus ElementResoluteEndeavor雅培XIENCE安全性证据3个在2012年已经发表的RCT网络荟萃分析(NMA)概览RCT NMA2012年3月发表于Lancet上RCT NMA2012年6月发表于CirculationRCT NMA 2012年8月发表于BMJ入选的RCT数量497742患者数量50,494117
11、,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相比于相比于BMS和其余和其余DES是最安全的是最安全的”“XIENCE相比于相比于BMS和其余和其余DES最安全而且最有效最安全而且最有效”“在糖
12、尿病患者中在糖尿病患者中XIENCE相比于相比于BMS和其余和其余DES最最安全而且最有效安全而且最有效”Sources:1.Palmerini T et al.Lancet.March 2012.379:9824,14-20 April 2012,pp.1393-1402.2.Bangalore S,et al.Circulation June 2012.DOI:10.1161/CIRCULATIONAHA.112.097014.3.Bangalore S,et al.British Medical Journal,Aug 2012.345:e5170 doi:10.1136/bmj.e51
13、70.雅培XIENCE安全性证据Lancet RCT NMA:XIENCE是唯一在1年和2年时支架血栓发生率均低于BMS的DES1 年和年和2年确定的支架血栓年确定的支架血栓发发生率生率汇总汇总比比值值比比*Source:Palmerini,et al.The Lancet.379:9824,14-20 April 2012,pp.1393-1402.*An odds ratio is a method of comparing the odds of an event between two groups.BMS is a composite of bare metal stents.*Th
14、e BMS comparator is a composite of several bare metal stents“Meta-analyses should be regarded as hypothesis-generating and the findings of Palmerini and colleagues suggest that a randomized trial of CoCr EES and BMS is desirable.”Ormiston,The Lancet,April 2012.XIENCE更佳更佳对对比比产产品更佳品更佳雅培XIENCE安全性证据*Num
15、ber calculated from source data.*The BMS comparator is a composite of several bare metal stents.A method of comparing the odds of an event between two groups.The XIENCE product was designed as an overall system,with each system component contributing to its clinical outcomes.The system includes:the
16、thin-strut CoCr,multi-generation MULTI-LINK,with its flexible ring and 3-link stent design;advanced delivery system,novel everolimus compound;the multi-layer coating technologies,utilizing a primer and co-polymer,previously known for cardiovascular implants,and having excellent mechanical properties
17、.1.Versus all FDA approved DES:Endeavor Resolute,Endeavor,Promus Element,Cypher,Taxus Express and Taxus Liberte.相比于相比于XIENCE 1年年时时确定的支架血栓确定的支架血栓发发生率增高倍数生率增高倍数相比于相比于XIENCE 1年年时时确定的支架血栓确定的支架血栓发发生率比生率比值值比比4.3x2.4x3.6x4.8x7.1x*Source:Palmerini,et al.The Lancet.379:9824,14-20 April 2012,pp.1393-1402.Lanc
18、et RCT NMA:XIENCE1是唯一在1年及2年时支架血栓发生率均低于BMS的DES2雅培XIENCE安全性证据Circulation RCT NMA:XIENCE相比于BMS和其余DES是最安全的*The BMS comparator is a composite of several bare metal stents.Source:Bangalore S,et al.Circulation June 2012.DOI:10.1161/CIRCULATIONAHA.112.097014.相比于相比于XIENCE确定的确定的/可能的支架血栓可能的支架血栓发发生率增高倍数生率增高倍数相比
19、于相比于XIENCE支架血栓支架血栓发发生率比生率比值值比比2.7xMore LikelyMore LikelyMore Likely2x3xBMS*CypherTaxusEndeavor1.8xMore LikelyResolute1.4xMore Likely雅培XIENCE安全性证据Circulation RCT NMA:XIENCE相比于BMS和其余DES是最有效的支架*The BMS comparator is a composite of several bare metal stents.Source:Bangalore S,et al.Circulation June 2012
20、.DOI:10.1161/CIRCULATIONAHA.112.097014.相比于相比于XIENCE TVR比比值值比比1.6xMore LikelyMore LikelyMore Likely1.0 x2.6xBMS*CypherTaxusEndeavor1.6xMore LikelyResolute1.1xMore Likely相比于相比于XIENCE TVR增高倍数增高倍数雅培XIENCE安全性证据XIENCE:坚实坚实的的DAPT数据数据雅培XIENCE安全性证据来自真实世界的挑战PCI手术后12个月内,每6个接受支架植入的患者中就有1个会中断或停用DAPT*S.S.Naidu et
21、.al.Contemporary Incidence&Predictors of ST and Other MACE in the Year After XIENCE V Implantation.JACC,June 2012.Patients should follow physicians guidance for utilization of dual anti-platelet therapy following stent implantation.雅培XIENCE安全性证据XIENCE DAPT数据 XIENCE:首个进行DAPT研究拥有最多的DPAT数据超过14,000名患者,包
22、括11,500名真实世界患者Data on file at Abbott Vascular.SPIRIT II(n=223)SPIRIT III(n=669)SPIRIT IV(n=2,458)SPIRIT V(n=1,662)SPIRIT Women(n=1,506)XIENCE V USA(n=6,516)XIENCE V India(n=931)COMPARE(n=897)雅培XIENCE安全性证据XIENCE DAPT 中断分析基于真实世界患者群 3 个月DAPT中断数据 1 个月DAPT中断数据XIENCE DAPT 数据:汇总分析四个来自真实世界的研究,共10,615位患者 919
23、 位患者在3-12个月期间中断DAPT 1,047位患者在1-12个月期间中断DAPT DAPT中断包括暂时性或永久性中断DAPT使用XIENCE DAPT 分析分析:基于真基于真实实世界研究世界研究:SPIRIT Women(n=1,506)SPIRIT V(n=1,662)XIENCE V USA(n=6,516)XIENCE V India(n=931)Sources:1.Palmerini,T.Stent Thrombosis and DAPT Interruption in XIENCE V Real-World Patients.PCR 2012.2.Gnreux,P.Stent
24、thrombosis:insights on outcomes,predictors and impact of dual antiplatelet therapy interruption from the Everolimus Stent Family trials.TCT 2012.Patients should follow physicians guidance for utilization of dual anti-platelet therapy following stent implantation.雅培XIENCE安全性证据在3-12个月内中断DAPT,XIENCE的支架
25、血栓发生率是0%12个月内首次中断个月内首次中断DAPT的的时时程与支架血栓的关系程与支架血栓的关系*Including patients with no DAPT Interruption except possibly after Stent Thrombosis though 365 days.中断中断DAPT后后发发生的支架血栓生的支架血栓ARC 定定义义确定的确定的/可能的可能的(%)0.68%1.64%0.21%0.00%从未中断从未中断*DAPT中断中断0-3 个月个月3-12 个月个月60/8,99611/70018/8,9960/919Source:Palmerini,T.S
26、tent Thrombosis and DAPT Interruption in XIENCE V Real-World Patients.PCR 2012.雅培XIENCE安全性证据在1-12个月内中断DAPT,XIENCE显示出低支架血栓发生率Source:Genereaux,P.Stent thrombosis:insights on outcomes,predictors and impact of dual antiplatelet therapy interruption from the Everolimus Stent Family trials.TCT 2012.1.63%0
27、.29%0.20%0.68%1.00.51.52.00-1 Month1-12 Months从未中断从未中断*DAPT中断中断随后随后发发生的支架血栓生的支架血栓 ARC定定义义确定的确定的/可能的可能的 (%)12个月内首次中断个月内首次中断DAPT的的时时程与支架血栓的关系程与支架血栓的关系*Including patients with no DAPT Interruption except possibly after Stent Thrombosis though 365 days.60/8,9969/57225/8,9962/1,047雅培XIENCE安全性证据使用XIENCE,在
28、术后6-24个月永久性中断DAPT没有显示出支架血栓增高的风险*永久性中断永久性中断 DAPT确定的确定的/可能的支架血栓可能的支架血栓发发生率生率*Derived from E.Kedhi SPIRIT-COMPARE Meta DAPT Discontinuation,ACC 2012Patients should follow physicians guidance for utilization of dual anti-platelet therapy following stent implantation.15/1,9699/1,73024个月没有个月没有DPAT中断中断6-24
29、个月永久性中个月永久性中断断 DAPT雅培XIENCE安全性证据XIENCE:为为最佳的最佳的结结果而果而设计设计雅培XIENCE安全性证据XIENCE:优异结果与其任何一部分支架组成有关“一个药物洗脱支架由3个部分组成,这几部分同等重要:金属支架平台,聚合物和药物,这3部分共同影响其即刻和长期的安全性和有效性.”Dr.Fajadet1 1.Fajadet,J.,et al.PLATINUM PLUS 30-day Poster,TCT 2012.依依维维莫司莫司最低最低剂剂量量有效控有效控释释含氟聚合物涂含氟聚合物涂层处层处理理设设计计稳稳定及更好的生物相定及更好的生物相容性容性MULTI-
30、LINK设计设计传传承承8代,代,有有证证可循的可循的设计设计雅培XIENCE安全性证据涂层技术涂层完整性1 含氟共聚物应用了多层处理技术 有良好的柔软度及弹性,及长时间的韧性1 药物控释覆盖整个再狭窄的病理过程2,3,4t=0t=7 dt=56 d1Lo Es et al.US Patent 3,178,999 2Data on file at Abbott Vascular 3Forrester J et al.JACC 1991:17(3)758-769 4Simon,D.Inflammation Summit,TCT 2003雅培XIENCE安全性证据涂层技术减少血栓形成1 更好的生物
31、相容性获得更好的临床结果,包括减少血栓的形成1 氟化物的临床优势已经有超过20年的充分研究 建议在心血管植入物上使用含氟涂层已经有很长时间 2,3 含氟涂层使血小板激活降到最低,同时优化蛋白吸附和保留4,5,这些可以带来:更快的再内皮化1 减少炎症1 减少血栓形成11Paton et al.US Patent 5,356,668.2Lilenfield R et al.US Patent 4,564,013 3Tu RH et al.US Patent 4,816,339 4Garfinkle A et al.T Am Soc Art Int Org 1984:30,432-439.5Kiaei et al,J Biomat Sci-Polym E.1993;4(1)35-44雅培XIENCE安全性证据结论 最新数据显示,XIENCE有比其他二代支架及BMS更低的支架血栓发生率(包括早期及长期随访)XIENCE拥有最大数量坚实的DAPT数据 XIENCE的安全性表现源于安全性设计2023-1-8雅培XIENCE安全性证据