信心來(lái)自循證PROMUSElement循證醫(yī)學(xué)數(shù)據(jù)與病例分享

1、信心來(lái)自循證信心來(lái)自循證promuselement循證醫(yī)學(xué)數(shù)據(jù)與病例分享循證醫(yī)學(xué)數(shù)據(jù)與病例分享曹豐曹豐中國(guó)人民解放軍總醫(yī)院心血管內(nèi)科中國(guó)人民解放軍總醫(yī)院心血管內(nèi)科platinumworkhorse,smallvessel,longlesion12個(gè)月的個(gè)月的tlf非劣效性非劣效性單組單組30(全球全球)102長(zhǎng)長(zhǎng)病病變變12個(gè)月的個(gè)月的tlf來(lái)自來(lái)自spirit系列系列試驗(yàn)試驗(yàn)中中xience支架的支架的歷歷史數(shù)據(jù)以及史數(shù)據(jù)以及taxusexpress2歷歷史數(shù)據(jù)史數(shù)據(jù)非劣效性非劣效性單組單組23(全球全球)94小血管小血管12個(gè)月的個(gè)月的tlfxinecevstentpromuselemen

2、t鉑鉻鉑鉻合金合金ees非劣效性非劣效性1:1隨機(jī)，前瞻性，隨機(jī)，前瞻性，單單盲盲132(全球全球)1,532workhorse14(澳洲和澳洲和東東南南亞亞)中心數(shù)量中心數(shù)量100樣樣本量本量30天的心天的心臟臟事件事件主要研究主要研究終終點(diǎn)點(diǎn)n/a對(duì)對(duì)照照組組n/a成功成功標(biāo)標(biāo)準(zhǔn)準(zhǔn)promuselement鉑鉻鉑鉻合金合金ees研究研究對(duì)對(duì)象象單組單組試驗(yàn)設(shè)計(jì)試驗(yàn)設(shè)計(jì)研究名稱(chēng)研究名稱(chēng)platinumqca研究研究platinumworkhorse,smallvessel,longlesion12個(gè)月的個(gè)月的tlf非劣效性非劣效性單組單組30(全球全球)102長(zhǎng)長(zhǎng)病病變變12個(gè)月的個(gè)月的tl

3、f來(lái)自來(lái)自spirit系列系列試驗(yàn)試驗(yàn)中中xience支架的支架的歷歷史數(shù)據(jù)以及史數(shù)據(jù)以及taxusexpress2歷歷史數(shù)據(jù)史數(shù)據(jù)非劣效性非劣效性單組單組23(全球全球)94小血管小血管12個(gè)月的個(gè)月的tlfxinecevstentpromuselement鉑鉻鉑鉻合金合金ees非劣效性非劣效性1:1隨機(jī)，前瞻性，隨機(jī)，前瞻性，單單盲盲132(全球全球)1,532workhorse14(澳洲和澳洲和東東南南亞亞)中心數(shù)量中心數(shù)量100樣樣本量本量30天的心天的心臟臟事件事件主要研究主要研究終終點(diǎn)點(diǎn)n/a對(duì)對(duì)照照組組n/a成功成功標(biāo)標(biāo)準(zhǔn)準(zhǔn)promuselement鉑鉻鉑鉻合金合金ees研究研究

4、對(duì)對(duì)象象單組單組試驗(yàn)設(shè)計(jì)試驗(yàn)設(shè)計(jì)研究名稱(chēng)研究名稱(chēng)platinumqca研究研究promus element stentxience v stentpromus element stentxience v stentplatinumworkhorse,smallvessel,longlesion12個(gè)月的個(gè)月的tlf非劣效性非劣效性單組單組30(全球全球)102長(zhǎng)長(zhǎng)病病變變12個(gè)月的個(gè)月的tlf來(lái)自來(lái)自spirit系列系列試驗(yàn)試驗(yàn)中中xience支架的支架的歷歷史數(shù)據(jù)以及史數(shù)據(jù)以及taxusexpress2歷歷史數(shù)據(jù)史數(shù)據(jù)非劣效性非劣效性單組單組23(全球全球)94小血管小血管12個(gè)月的個(gè)月的t

5、lfxinecevstentpromuselement鉑鉻鉑鉻合金合金ees非劣效性非劣效性1:1隨機(jī)，前瞻性，隨機(jī)，前瞻性，單單盲盲132(全球全球)1,532workhorse14(澳洲和澳洲和東東南南亞亞)中心數(shù)量中心數(shù)量100樣樣本量本量30天的心天的心臟臟事件事件主要研究主要研究終終點(diǎn)點(diǎn)n/a對(duì)對(duì)照照組組n/a成功成功標(biāo)標(biāo)準(zhǔn)準(zhǔn)promuselement鉑鉻鉑鉻合金合金ees研究研究對(duì)對(duì)象象單組單組試驗(yàn)設(shè)計(jì)試驗(yàn)設(shè)計(jì)研究名稱(chēng)研究名稱(chēng)platinumqca研究研究鎳鎳14%鉻鉻18%鉻鉻20%鎳鎳35%鉬鉬10%l605鈷鉻合金鈷鉻合金ees鉻鉻20%鎳鎳10%鎢鎢15%ptcr鉑鉻合金鉑

6、鉻合金eesclinical 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)u主要終點(diǎn)u12個(gè)月的靶病變失敗 (tlf) u - 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- 缺血驅(qū)動(dòng)的靶病變血運(yùn)重建u符合研究方案的數(shù)據(jù)集*u次要終點(diǎn)utlf包括的各因素 u技術(shù)成功u臨床治療操作成功 主要研究終點(diǎn)12個(gè)月的tlf12個(gè)月的靶病變失敗(tlf)非劣效性檢驗(yàn)達(dá)標(biāo)3.5

7、%上上邊邊界界非非劣劣效效性性界界限限2.01%1-sideducb2.13%1-sideducbfromacc2011靶病變失敗 tlf months since index procedurecocr-eesptcr-eesno. at risk鉑金試驗(yàn)workhorse研究 4年隨訪(fǎng)結(jié)果target lesion failure = cardiac death or mi related to the target vessel or ischemia-driven target lesion revascularizationxience v cocr-ees (n=749)promu

8、s element ptcr-ees (n=758)treatment grouppromus element 0-4ypromus 0-4ytlf patients(%)primaryendpointacc2014new！缺血驅(qū)動(dòng)的 tlrxience v cocr-ees (n=749)promus element ptcr-ees (n=758)months since index proceduretvr patients (%)cocr-eesptcr-eesno. at risktreatment grouppromus element 0-4ypromus 0-4y鉑金試驗(yàn)wor

9、khorse研究 4年隨訪(fǎng)結(jié)果acc2014new！3年的靶病變血運(yùn)重建 (tlr) fda 關(guān)鍵性試驗(yàn)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; 2 spirit iii 3-year results presented by gregg w. stone, md at tct 2009; 3 resolute

10、 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.spiritiii23-yearn=669n=1,064n=758resoluteus33-yeartlr(%)promuselement在在fda批準(zhǔn)的藥物支架批準(zhǔn)的藥物支架注冊(cè)注冊(cè)臨床中擁有最低的臨床中擁有最低的tlrpromusel

11、ementptcreesxiencecocreesresoluteconizesplatinumworkhorsetrial13-year03691202641080.4%0.4%arc stent thrombosis definite/probable (%)*cocr-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(yàn)workhorse研究 1年隨訪(fǎng)結(jié)果* all were definite stfromac

12、c2011鉑金試驗(yàn)workhorse研究 4年隨訪(fǎng)結(jié)果xience v (cocr ees) (n=749)promus element (ptcr ees) (n=758)event rate (%)p=0.44p=0.09p=0.82p=0.19p=0.98time to event ratesn=1n=2n=3n=2n=2ptcr-eescocr-eesarc st by time period0-30d1-4y0-30d1-4y31-364dacc2014new！platinumworkhorse,smallvessel,longlesion12個(gè)月的個(gè)月的tlf非劣效性非劣效性單組單

13、組30(全球全球)102長(zhǎng)長(zhǎng)病病變變12個(gè)月的個(gè)月的tlf來(lái)自來(lái)自spirit系列系列試驗(yàn)試驗(yàn)中中xience支架的支架的歷歷史數(shù)據(jù)以及史數(shù)據(jù)以及taxusexpress2歷歷史數(shù)據(jù)史數(shù)據(jù)非劣效性非劣效性單組單組23(全球全球)94小血管小血管12個(gè)月的個(gè)月的tlfxinecevstentpromuselement鉑鉻鉑鉻合金合金ees非劣效性非劣效性1:1隨機(jī)，前瞻性，隨機(jī)，前瞻性，單單盲盲132(全球全球)1,532workhorse14(澳洲和澳洲和東東南南亞亞)中心數(shù)量中心數(shù)量100樣樣本量本量30天的心天的心臟臟事件事件主要研究主要研究終終點(diǎn)點(diǎn)n/a對(duì)對(duì)照照組組n/a成功成功標(biāo)標(biāo)準(zhǔn)準(zhǔn)

14、promuselement鉑鉻鉑鉻合金合金ees研究研究對(duì)對(duì)象象單組單組試驗(yàn)設(shè)計(jì)試驗(yàn)設(shè)計(jì)研究名稱(chēng)研究名稱(chēng)platinumqca研究研究platinum 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 mmincidence rate (%)incidence rate (%)1.platinum clinical trial

15、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 platinum small vessel trial. 2.presented by laura mauri md, msc, acc 2012. resolute us trial studied

16、the resolute stent. results from different studies are not directly comparable. information provided for educational purposes only.3.promus element stent has a dedicated small vessel 2.25 mm stent model. platinum long lesion trial1promus ptcr ees(n = 100)rvd = 2.56 mm lesion length = 24.38 mm incide

17、nce rate (%)incidence rate (%)1.platinum clinical trial program studied the promus element stent (promus ptcr ees). platinum long lesion trial, presented by teirstein, p, md. tct 2012. 2.spirit prime trial, presented by costa, m et al. tct 2012. spirit prime trial studied the xience prime stent. res

18、ults from different studies are not directly comparable. information provided for educational purposes only.3.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 mmfromcit2013&occ2014lad 100%, 中間支25%rca 中-遠(yuǎn)段90%狹窄mc+ pliot50 失敗mc+ ms 失敗mc+ conquest pro runthrough ns d1 1.5mmx20mm legend -d1 1.5mmx20mm/ 2.5m