信心來自循證PROMUSElement循證醫(yī)學(xué)數(shù)據(jù)與病例分享學(xué)習(xí)教案課件

1、會計學(xué)1信心來自循證PROMUSElement循證醫(yī)學(xué)數(shù)據(jù)與病例分享會計學(xué)1信心來自循證PROMUSElement循證醫(yī)學(xué)數(shù)據(jù)與PLATINUM Workhorse, Small Vessel, Long Lesion12個月的 TLF非劣效性單組30 (全球)102長病變12個月的 TLF來自SPIRIT 系列試驗中 Xience 支架的歷史數(shù)據(jù)以及 TAXUS Express2 歷史數(shù)據(jù)非劣效性單組23 (全球)94小血管12個月的 TLFXinece V StentPROMUS Element 鉑鉻合金EES非劣效性1:1 隨機(jī)，前瞻性，單盲132 (全球)1,532Workhorse1

2、4(澳洲和東南亞)中心數(shù)量100樣本量30天的心臟事件主要研究終點(diǎn)N/A對照組N/A成功標(biāo)準(zhǔn)PROMUS Element 鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)PLATINUM Trial 鉑金試驗PROMUS Element支架 治療de novo 病變PLATINUMQCA 研究第1頁/共29頁P(yáng)LATINUM Workhorse, Small VesPLATINUM Workhorse, Small Vessel, Long Lesion12個月的 TLF非劣效性單組30 (全球)102長病變12個月的 TLF來自SPIRIT 系列試驗中 Xience 支架的歷史數(shù)據(jù)以及 T

3、AXUS Express2 歷史數(shù)據(jù)非劣效性單組23 (全球)94小血管12個月的 TLFXinece V StentPROMUS Element 鉑鉻合金EES非劣效性1:1 隨機(jī)，前瞻性，單盲132 (全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天的心臟事件主要研究終點(diǎn)N/A對照組N/A成功標(biāo)準(zhǔn)PROMUS Element 鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)PLATINUM Trial 鉑金試驗PROMUS Element支架 治療de novo 病變PLATINUMQCA 研究第2頁/共29頁P(yáng)LATINUM Workhorse, Sma

4、ll VesPLATINUM QCA Trial 同類研究一覽晚期管腔丟失 (mm)SPIRITFirstSPIRITFirstPLATINUMQCASPIRITIISPIRITIII隨訪時間延長N=23N=237N=301N=73N=206mths6mths8mths9mths12mthsPromus Element StentXience V StentEuroInterv 2010 (in press)第3頁/共29頁P(yáng)LATINUM QCA Trial 同類研究一覽晚期管腔丟PLATINUM QCA Trial (IVUS)支架貼壁不良 (ISA)參照目標(biāo) (SPIRIT III: X

5、ience V)術(shù)后即刻 ISA晚期獲得性ISA晚期ISA支架貼壁不良 (ISA) (%)p0.001Promus Element StentXience V StentEuroInterv 2010 (in press)第4頁/共29頁P(yáng)LATINUM QCA Trial (IVUS)支架貼壁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 個月PLATINUM QCA Trial臨床結(jié)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頁/共29頁All Death, MI, TVR1.0% (1)1.0%PLATINUM Workhorse, Small Vessel, Long Lesion12個月的 TLF非劣效性單組30 (全球)102長病變12個月的 TLF來自SPIRIT 系列試驗中 Xience 支架的歷史數(shù)據(jù)以及 TAXUS Express2 歷史數(shù)據(jù)非劣效性單組23 (全球)94小血管12個月的 TLFXinece V StentPROMUS Element 鉑鉻合金EES非劣效性1:1 隨機(jī)，前瞻性，單盲1

8、32 (全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天的心臟事件主要研究終點(diǎn)N/A對照組N/A成功標(biāo)準(zhǔn)PROMUS Element 鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)PLATINUM Trial 鉑金試驗PROMUS Element支架 治療de novo 病變PLATINUMQCA 研究第6頁/共29頁P(yáng)LATINUM Workhorse, Small Ves依維莫司洗脫冠狀動脈藥物支架試驗組：PROMUS ElementPBMA=poly (nbutyl methacrylate) (基底層); PVDF-HFP=poly (vinylid

9、ene fluoridecohexafluoropropylene) (一種生物相容性非常好的氟化共聚物載藥層) 依維莫司藥物濃度: 1 ug/mm2聚合物涂層: PBMA & PVDFHFP (厚度7m，不可降解) 對照組：XIENCE V鐵65%鎳14%鉻18%316L 不銹鋼TAXUS, Cypher鉻20%鎳35%鉬10%鈷33%MP35N 鈷鎳合金L605 鈷鉻合金 EES鉻20%鎳10%鎢15%鈷51%Endeavor, Resolute37%3%9%18%33%鐵鉬鎳鉻鉑PtCr 鉑鉻合金 EES3%鉬第7頁/共29頁依維莫司洗脫冠狀動脈藥物支架試驗組：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 研究設(shè)計第8頁/共29頁CoCr EESPtCr EES 1530 PatientsPLATINUM Workhorse 研究終點(diǎn)主要終點(diǎn)12個月的靶病變失敗 (TLF) - 靶血管相關(guān)的心因性死亡，或者- 靶血管相關(guān)的心肌梗死，或者

12、- 缺血驅(qū)動的靶病變血運(yùn)重建符合研究方案的數(shù)據(jù)集*次要終點(diǎn)TLF包括的各因素 支架血栓 (ARC definite/probable)技術(shù)成功臨床治療操作成功 *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頁/共29頁P(yáng)LATINUM Workhorse 研究終點(diǎn)主要終點(diǎn)*P534120-1-3-2-5-4主要研究終點(diǎn)12個月的TLF12個月的靶病變失敗(TLF)非劣效性檢驗達(dá)標(biāo)UCB=upper confidence bound3.5% 上邊界非劣效性界限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(非劣效性檢驗)(優(yōu)效性檢驗)

14、CoCr- EES(N=762)PtCr- EES(N=768)Difference2-sided 95% CIDifference2-sided 95% CI(1-sided UCB)PopulationPer protocol(1 終點(diǎn))Intent-to-treat意向治療PROMUS ElementPtCr-EES betterXience VCoCr-EES better2.01%1-sided UCB2.13%1-sided UCBFromACC 2011第10頁/共29頁534120-1-3-2-5-4主要研究終點(diǎn)12個月的TL靶病變失敗 TLF Months Since Ind

15、ex ProcedureCoCr-EESPtCr-EESNo. at risk鉑金試驗Workhorse研究 4年隨訪結(jié)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頁/共29頁靶病變失敗 TLF Months Since Index P缺血驅(qū)動的 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%鉑金試驗Workhorse研究 4年隨訪結(jié)果ACC 2014New！第12頁/共29頁缺血驅(qū)動的 TLRXience V CoCr-EES (N=3年的靶病變血運(yùn)重建 (TLR) FDA 關(guān)鍵性試驗結(jié)果一覽 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批準(zhǔn)的藥物支架 注冊臨床中擁有最低的TLR Promus Element PtCr EES Xience CoCr EES Resolute CoNi ZESPLATINUM Workhorse Trial 1 3-Year第13頁/共29頁3年的靶病變血運(yùn)重建 (TLR) PLATINUM Cl03691202641080.4%0.4%安全性指標(biāo) 支架內(nèi)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鉑金試驗Workhorse研究 1年隨訪結(jié)果* All were definite STFromACC 2011第14頁/共29頁03691202641080.4%0.4%安全性指標(biāo) 支次要終點(diǎn) 支架內(nèi)血栓等鉑金試驗Workhorse研究 4年隨訪結(jié)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頁/共29頁次要終點(diǎn) 支架內(nèi)血栓等鉑金試驗Workhorse研究 PLATINUM Workhorse, Small Vessel, Long Lesion12個月的 TL

22、F非劣效性單組30 (全球)102長病變12個月的 TLF來自SPIRIT 系列試驗中 Xience 支架的歷史數(shù)據(jù)以及 TAXUS Express2 歷史數(shù)據(jù)非劣效性單組23 (全球)94小血管12個月的 TLFXinece V StentPROMUS Element 鉑鉻合金EES非劣效性1:1 隨機(jī)，前瞻性，單盲132 (全球)1,532Workhorse14(澳洲和東南亞)中心數(shù)量100樣本量30天的心臟事件主要研究終點(diǎn)N/A對照組N/A成功標(biāo)準(zhǔn)PROMUS Element 鉑鉻合金EES研究對象單組試驗設(shè)計研究名稱循證醫(yī)學(xué)PLATINUM Trial 鉑金試驗PROMUS Eleme

23、nt支架 治療de novo 病變PLATINUMQCA 研究第16頁/共29頁P(yáng)LATINUM 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無 ARC 定義的支架血栓(def/prob)無心肌梗死1.4% 靶血管相關(guān)的心梗1.4% ARC定義的支架血栓 (de

24、f/prob)Incidence Rate (%)Incidence Rate (%)PROMUS Element 鉑金支架小血管研究1 2年隨訪結(jié)果一覽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頁/共29頁P(yáng)LATINUM Small Vessel Trial1,3無 ARC 定義的支架血栓(def/prob)無心肌梗死PLATINUM Long Lesion Trial1Promus PtCr EES(n = 100)RVD = 2.56 mm Lesion Length = 24.38 mm PROMUS Element 鉑金支架長病變研究1 2年隨訪結(jié)果一覽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% 靶血管相關(guān)的心梗第18頁/共29頁無 ARC 定義的支架血栓(def/prob)PLATINU主要終點(diǎn)：9個月的支架內(nèi)管腔丟失 PROMUS Element PtCr EES 優(yōu)于 TAXUS Liberte PES（0.11mm : 0.40mm, P0.001）12 個月隨訪時的靶病變失敗與再次血運(yùn)重