信心来自循证PROMUSElement循证医学数据与病例分享学习教案课件

1、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 Workhorse, Small Vessel, Long Lesion12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 Express2 历史数据非劣效性单组23 (全球)94小血管12个月的 TLFXinece V StentPROMUS Element 铂铬合金EES非劣效性1:1 随机，前瞻性，单盲132 (全球)1,532Workhorse1

2、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PLATINUMQCA 研究第1页/共29页PLATINUM Workhorse, Small VesPLATINUM Workhorse, Small Vessel, Long Lesion12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 T

3、AXUS Express2 历史数据非劣效性单组23 (全球)94小血管12个月的 TLFXinece V StentPROMUS Element 铂铬合金EES非劣效性1:1 随机，前瞻性，单盲132 (全球)1,532Workhorse14(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PLATINUMQCA 研究第2页/共29页PLATINUM Workhorse, Sma

4、ll VesPLATINUM QCA Trial 同类研究一览晚期管腔丢失 (mm)SPIRITFirstSPIRITFirstPLATINUMQCASPIRITIISPIRITIII随访时间延长N=23N=237N=301N=73N=206mths6mths8mths9mths12mthsPromus Element StentXience V StentEuroInterv 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: X

5、ience V)术后即刻 ISA晚期获得性ISA晚期ISA支架贴壁不良 (ISA) (%)p0.001Promus Element StentXience V StentEuroInterv 2010 (in press)第4页/共29页PLATINUM QCA Trial (IVUS)支架贴壁All Death, MI, TVR1.0% (1)1.0% (1)All Death0.0% (0)0.0% (0)Myocardial Infarction0.0% (0)0.0% (0)Q-wave0.0% (0)0.0% (0)NonQ-wave0.0% (0)0.0% (0)Target Ve

6、ssel Revascularization1.0% (1)1.0% (1) Target Lesion Revascularization1.0% (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 occurre

7、d in the same patient)EuroInterv 2010 (in press)第5页/共29页All Death, MI, TVR1.0% (1)1.0%PLATINUM Workhorse, Small Vessel, Long Lesion12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 Express2 历史数据非劣效性单组23 (全球)94小血管12个月的 TLFXinece V StentPROMUS Element 铂铬合金EES非劣效性1:1 随机，前瞻性，单盲1

8、32 (全球)1,532Workhorse14(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PLATINUMQCA 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 ElementPBMA=poly (nbutyl methacrylate) (基底层); PVDF-HFP=poly (vinylid

9、ene 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/mm2聚合物涂层: PBMA & PVDFHFP (厚度7m，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, Resolute37%3%9%18%33%铁钼镍铬铂PtCr 铂铬合金 EES3%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=C

10、oCr EES( Xience V )N=762PtCr EES ( PROMUS Element )N=7681530 Patients with 1 or 2 de novo native coronary artery target lesions RVD 2.5to 4.25; Lesion length 24 mmPeri-proc: ASA 300 mg, clopidogrel 300 mg load unless on chronic RxRandomized 1:1Stratified by diabetes, intention to treat 1 vs. 2 targe

11、t lesions, & study siteClinical f/u only: 1, 6, 12, 18 months then yearly for 2-5 yearsASA 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 PatientsPLATINUM 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

12、- 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 stentSuccessful delivery & deployment of study stent to the target vessel, without balloon rupture or stent embolizationLesion DS30% with visually assessed TIMI 3 flow and without

13、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*P534120-1-3-2-5-4主要研究终点12个月的TLF12个月的靶病变失败(TLF)非劣效性检验达标UCB=upper confidence bound3.5% 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%0.0010.600.00090.72P值(非劣效性检验)(优效性检验)

14、CoCr- EES(N=762)PtCr- EES(N=768)Difference2-sided 95% CIDifference2-sided 95% CI(1-sided UCB)PopulationPer protocol(1 终点)Intent-to-treat意向治疗PROMUS ElementPtCr-EES betterXience VCoCr-EES better2.01%1-sided UCB2.13%1-sided UCBFromACC 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 Ind

15、ex ProcedureCoCr-EESPtCr-EESNo. 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 revascularization749738735715701683656473758747745727715702687480Xience V CoCr-EES (N=749)PROMUS Element PtCr-EES (N=758)TLF Patients

16、(%)8.5%7.4%HR 95% CI =0.86 0.60, 1.24P = 0.43Primary EndpointACC 2014New！第11页/共29页靶病变失败 TLF Months Since Index P缺血驱动的 TLRXience V CoCr-EES (N=749)PROMUS Element PtCr-EES (N=758)HR 95% CI =0.76 0.48, 1.20P = 0.24Months Since Index ProcedureTVR Patients (%)CoCr-EESPtCr-EESNo. at risk749742738718705687

17、6614767587517487317207106934875.9%4.6%铂金试验Workhorse研究 4年随访结果ACC 2014New！第12页/共29页缺血驱动的 TLRXience V CoCr-EES (N=3年的靶病变血运重建 (TLR) FDA 关键性试验结果一览 PLATINUM Clinical Trial Program studied the PROMUS Element Stent (Promus PtCr EES Stent ) 1 PLATINUM 3-Year results presented by Ian T. Meredith, MD, ACC 2013

18、; 2 SPIRIT III 3-Year results presented by Gregg W. Stone, MD at TCT 2009; 3 RESOLUTE US Study 3-Year results presented by Paul Teirstein, MD at ACC 2013. Results from different studies are not directly comparable. Information provided for educational purposes only.SPIRIT III 23-Yearn=669n=1,064n=75

19、8RESOLUTE US 33-YearTLR (%) Promus Element 在FDA批准的药物支架 注册临床中拥有最低的TLR Promus Element PtCr EES Xience CoCr EES Resolute CoNi ZESPLATINUM Workhorse Trial 1 3-Year第13页/共29页3年的靶病变血运重建 (TLR) PLATINUM Cl03691202641080.4%0.4%安全性指标 支架内血栓ARC Stent Thrombosis Definite/Probable (%)*Months76275575274572876876175

20、8752741CoCr-EESPtCr-EESNo. at riskXience V CoCr-EES (N=762)PROMUS Element PtCr-EES (N=768)HR 95% CI =0.99 0.20, 4.91P = 0.99铂金试验Workhorse研究 1年随访结果* All were definite STFromACC 2011第14页/共29页03691202641080.4%0.4%安全性指标 支次要终点 支架内血栓等铂金试验Workhorse研究 4年随访结果Xience V (CoCr EES) (N=749)PROMUS Element (PtCr EE

21、S) (N=758)Event Rate (%)P=0.44P=0.09P=0.82P=0.19P=0.98CardiacDeathAll DeathARC ST (Def/Prob)MIQ-wave MITime to event ratesn=1n=2n=3n=2n=2PtCr-EESCoCr-EESARC ST by Time Period0-30d1-4y0-30d1-4y31-364dACC 2014New！第15页/共29页次要终点 支架内血栓等铂金试验Workhorse研究 PLATINUM Workhorse, Small Vessel, Long Lesion12个月的 TL

22、F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 Express2 历史数据非劣效性单组23 (全球)94小血管12个月的 TLFXinece V StentPROMUS Element 铂铬合金EES非劣效性1:1 随机，前瞻性，单盲132 (全球)1,532Workhorse14(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 Eleme

23、nt支架 治疗de novo 病变PLATINUMQCA 研究第16页/共29页PLATINUM Workhorse, Small VesPLATINUM Small Vessel Trial1,3Promus PtCr EES(n = 89)RVD = 2.04 mmLesion Length = 14.15 mmRESOLUTE US Trial2Resolute CoNi ZES(n = 146)RVD = 2.15 mmLesion Length = 12.40 mm无 ARC 定义的支架血栓(def/prob)无心肌梗死1.4% 靶血管相关的心梗1.4% ARC定义的支架血栓 (de

24、f/prob)Incidence Rate (%)Incidence Rate (%)PROMUS Element 铂金支架小血管研究1 2年随访结果一览PLATINUM Clinical Trial Program studied the PROMUS Element Stent (Promus PtCr EES). PLATINUM Small Vessel Trial, Presented by Dominic Allocco MD, PCR 2012. Ian T. Meredith, AM, MBBS, PhD is the PI. There were no MIs in the

25、PLATINUM Small Vessel Trial. Presented by Laura Mauri MD, MSc, ACC 2012. RESOLUTE US Trial studied the Resolute Stent. Results from different studies are not directly comparable. Information provided for educational purposes only.PROMUS Element Stent has a dedicated small vessel 2.25 mm stent model.

26、 第17页/共29页PLATINUM Small Vessel Trial1,3无 ARC 定义的支架血栓(def/prob)无心肌梗死PLATINUM Long Lesion Trial1Promus PtCr EES(n = 100)RVD = 2.56 mm Lesion Length = 24.38 mm PROMUS Element 铂金支架长病变研究1 2年随访结果一览Incidence Rate (%)Incidence Rate (%)PLATINUM Clinical Trial Program studied the PROMUS Element Stent (Promus

27、 PtCr EES). PLATINUM Long Lesion Trial, Presented by Teirstein, P, MD. TCT 2012. SPIRIT Prime Trial, Presented by Costa, M et al. TCT 2012. SPIRIT PRIME Trial studied the Xience Prime Stent. Results from different studies are not directly comparable. Information provided for educational purposes onl

28、y.Deaths due to unknown causes were adjudicated as cardiac death.SPIRIT PRIME Long Lesion Registry2 Xience CoCr EES(n = 104)RVD = 2.8 mmLesion Length = 26.1 mm4.8% 靶血管相关的心梗第18页/共29页无 ARC 定义的支架血栓(def/prob)PLATINU主要终点：9个月的支架内管腔丢失 PROMUS Element PtCr EES 优于 TAXUS Liberte PES（0.11mm : 0.40mm, P0.001）12 个月随访时的靶病变失败与再次血运重