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Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,信心来自循证,PROMUS Element 循证医学数据与病例分享,曹丰,中国人民解放军总医院心血管内科,PLATINUM W,orkhorse,S,mall Vessel,L,ong Lesion,12个月的 TLF,非劣效性,单组,30(全球),102,长病变,12个月的 TLF,来自SPIRIT 系列试验中 Xience 支架的,历史数据以及 TAXUS Express,2,历史数据,非劣效性,单组,23(全球),94,小血管,12个月的 TLF,Xinece V Stent,PROMUS Element 铂铬合金EES,非劣效性,1:1 随机，前瞻性，单盲,132(全球),1,532,Workhorse,1,4(澳洲和东南亚),中心数量,100,样本量,30天的心脏事件,主要研究终点,N/A,对照组,N/A,成功标准,PROMUS Element,铂铬合金EES,研究对象,单组,试验设计,研究名称,循证医学PLATINUM Trial 铂金试验,PROMUS,Element,支架 治疗,de novo,病变,PLATINUM,QCA,研究,PLATINUM W,orkhorse,S,mall Vessel,L,ong Lesion,12个月的 TLF,非劣效性,单组,30(全球),102,长病变,12个月的 TLF,来自SPIRIT 系列试验中 Xience 支架的,历史数据以及 TAXUS Express,2,历史数据,非劣效性,单组,23(全球),94,小血管,12个月的 TLF,Xinece V Stent,PROMUS Element 铂铬合金EES,非劣效性,1:1 随机，前瞻性，单盲,132(全球),1,532,Workhorse,1,4(澳洲和东南亚),中心数量,100,样本量,30天的心脏事件,主要研究终点,N/A,对照组,N/A,成功标准,PROMUS Element,铂铬合金EES,研究对象,单组,试验设计,研究名称,循证医学PLATINUM Trial 铂金试验,PROMUS,Element,支架 治疗,de novo,病变,PLATINUM,QCA,研究,PLATINUM QCA Trial 同类研究一览,晚期管腔丢失(mm),SPIRIT,First,SPIRIT,First,PLATINUM,QCA,SPIRIT,II,SPIRIT,III,随访时间延长,N=23,N=237,N=301,N=73,N=20,6mths,6mths,8mths,9mths,12mths,Promus Element Stent,Xience V Stent,EuroInterv 2010(in press),PLATINUM QCA Trial(IVUS),支架贴壁不良(ISA),参照目标(SPIRIT III:Xience V),术后即刻 ISA,晚期获得性ISA,晚期ISA,支架贴壁不良(ISA)(%),p0.001,Promus Element Stent,Xience V Stent,EuroInterv 2010(in press),All Death,MI,TVR,1.0%(1),1.0%(1),All Death,0.0%(0),0.0%(0),Myocardial Infarction,0.0%(0),0.0%(0),Q-wave,0.0%(0),0.0%(0),NonQ-wave,0.0%(0),0.0%(0),Target Vessel Revascularization,1.0%(1),1.0%(1),Target Lesion Revascularization,1.0%(1),1.0%(1),Target Lesion Failure,*,1.0%(1),1.0%(1),Stent Thrombosis,(ARC Def/Prob),1.0%(1),1.0%(1),30 天,12 个月,PLATINUM QCA Trial,临床结果(N=100),*,Ischemia-driven TLR,or MI/cardiac death related to the target vessel,(All events occurred in the same patient),EuroInterv 2010(in press),PLATINUM W,orkhorse,S,mall Vessel,L,ong Lesion,12个月的 TLF,非劣效性,单组,30(全球),102,长病变,12个月的 TLF,来自SPIRIT 系列试验中 Xience 支架的,历史数据以及 TAXUS Express,2,历史数据,非劣效性,单组,23(全球),94,小血管,12个月的 TLF,Xinece V Stent,PROMUS Element 铂铬合金EES,非劣效性,1:1 随机，前瞻性，单盲,132(全球),1,532,Workhorse,1,4(澳洲和东南亚),中心数量,100,样本量,30天的心脏事件,主要研究终点,N/A,对照组,N/A,成功标准,PROMUS Element,铂铬合金EES,研究对象,单组,试验设计,研究名称,循证医学PLATINUM Trial 铂金试验,PROMUS,Element,支架 治疗,de novo,病变,PLATINUM,QCA,研究,依维莫司洗脱冠状动脉药物支架,试验组：PROMUS,Element,PBMA=poly(nbutyl methacrylate)(,基底层,);,PVDF-HFP=poly(vinylidene fluoridecohexafluoropropylene)(,一种生物相容性非常好的氟化共聚物载药层,),依维莫司药物浓度:1 ug/mm,2,聚合物涂层:PBMA&PVDFHFP(厚度7,m，不可降解),对照组：XIENCE V,铁,65%,镍,14%,铬,18%,316L 不锈钢,TAXUS,Cypher,铬,20%,镍,35%,钼,10%,钴,33%,MP35N 钴镍合金,L605 钴铬合金 EES,铬,20%,镍,10%,钨,15%,钴,51%,Endeavor,Resolute,37%,3%,9%,18%,33%,铁,钼,镍,铬,铂,PtCr 铂铬合金 EES,3%,钼,CoCr EES,(Xience V),N=762,PtCr EES,(PROMUS Element),N=768,1530 Patients with 1 or 2,de novo,native coronary artery target lesions,RVD,2.5to 4.25;Lesion length 24 mm,Peri-proc:,ASA 300 mg,clopidogrel 300 mg load unless on chronic Rx,Randomized 1:1,Stratified by diabetes,intention to treat 1 vs.2 target lesions,&study site,Clinical f/u only,:1,6,12,18 months then yearly for 2-5 years,ASA indefinitely,thienopyridine 6 mos(12 mos if not high risk for bleeding),PLATINUM Workhorse 研究设计,PLATINUM Workhorse 研究终点,主要终点,12,个月的靶病变失败(TLF),-靶血管相关的心因性死亡，或者,-靶血管相关的心肌梗死，或者,-缺血驱动的靶病变血运重建,符合研究方案的数据集,*,次要终点,TLF,包括的各因素,支架血栓(ARC definite/probable),技术成功,临床治疗操作成功,*Patients who received 1 assigned study stent,Successful delivery&deployment of study stent to the target vessel,without balloon rupture or stent embolization,Lesion DS30%with visually assessed TIMI 3 flow and without the occurrence of in-hospital cardiac death,MI,or TVR,5,3,4,1,2,0,-1,-3,-2,-5,-4,主要研究终点12个月的TLF,12个月的靶病变失败(TLF)非劣效性检验达标,UCB=upper confidence bound,3.5%上,边,界,非,劣,效,性,界,限,3.2%,(23/737),3.5%,(26/742),0.3%,-1.5%,2.2%,2.9%,(21/714),3.4%,(25/731),0.5%,-1.3%,2.3%,0.001,0.60,0.0009,0.72,P,值,(,非劣效性检验,),(,优效性检验,),CoCr-,EES,(N=762),PtCr-EES,(N=768),Difference,2-sided 95%CI,Difference,2-sided 95%CI,(1-sided UCB),Population,Per,protocol,(1 终点),Intent-to-treat,意向治疗,PROMUS Element,PtCr-EES better,Xience V,CoCr-EES better,2.01%,1-sided UCB,2.13%,1-sided UCB,From,ACC 2011,靶病变失败 TLF,Months Since Index Procedure,CoCr-EES,PtCr-EES,No.at risk,铂金试验Workhorse研究 4年随访结果,Target Lesion Failure=cardiac death or MI related to the target vessel or ischemia-driven tar
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