信心来自循证PROMUSElement循证医学数据与病例分享PPT学习教案课件

,#,单击此处编辑母版标题样式,会计学,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,会计学,1,信心来自循证,PROMUSElement,循证医学数据与病例分享,会计学1信心来自循证PROMUSElement循证医学数据与,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,第1页/共29页,PLATINUM Workhorse,Small Ves,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,第2页/共29页,PLATINUM Workhorse,Small Ves,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),第3页/共29页,PLATINUM QCA Trial 同类研究一览晚期管腔丢,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),第4页/共29页,PLATINUM QCA Trial(IVUS)支架贴壁,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),第5页/共29页,All Death,MI,TVR1.0%(1)1.0%,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,第6页/共29页,PLATINUM Workhorse,Small Ves,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,第7页/共29页,依维莫司洗脱冠状动脉药物支架试验组：PROMUS PBMA=,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,第8页/共29页,CoCr EESPtCr EES 1530 Patients,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,第9页/共29页,PLATINUM Workhorse 研究终点主要终点*P,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,第10页/共29页,534120-1-3-2-5-4主要研究终点12个月的TL,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 target lesion revascularization,749,738,735,715,701,683,656,473,758,747,745,727,715,702,687,480,Xience V CoCr-EES(N=749),PROMUS Element PtCr-EES(N=758),TLF Patients(%),8.5%,7.4%,HR 95%CI=,0.86 0.60,1.24,P,=0.43,Primary Endpoint,ACC 2014,New！,第11页/共29页,靶病变失败 TLF Months Since Index P,缺血驱动的 TLR,Xience