使用生物可降解聚合物技術(shù)的BioMatrix支架的結(jié)果課件

NewerGenerationDES_LEADERS中使用生物可降解聚合物技術(shù)的

BioMatrix支架的最新結(jié)果

從LEADERS研究中

我們學(xué)到了什么?NewerGenerationDES_LEADERS中靶病變血運(yùn)重建DESvsBMS

StettlerCetal.Lancet2007;370:937-48

N=18,023

58%

70%SESvsBMS:HR=0.30(0.24-0.37),p<0.0001PESvsBMS:HR=0.42(0.33-0.53),p<0.0001SESvsPES:HR=0.70(0.56-0.84),p<0.0021NewerGenerationDES_LEADERS中第一代DES的局限性極晚期支架血栓內(nèi)皮化功能的影響支架貼壁不良NewerGenerationDES_LEADERS中01234TimesincePCIinyears012345Cumulativeincidence,%Months112243648Cumulativeincidence,%1.21.62.12.73.3Patientsatrisk75387210516427901051Incidencedensity1.0/100ptyears3.3%3.5使用DES的明確定義的支架血栓:

Bern-RotterdamCohort研究WenaweserPetal.JAmCollCardiol2008192STcasesinacohortof8.146patients0.53%(95%CI0.44%-0.64%)

4年隨訪結(jié)果NewerGenerationDES_LEADERS中生物可降解聚合物涂層StentwithbiodegradablecoatingabluminalonlyAfterreleaseofbiodegradablecoatingPolylactideAcid(PLA)-Biosensors-Terumo-Devax-XtentPolylactide-co-glycolicacid(PLGA)-Conor/Cordis-BostonScientifcPoly-L-lactideAcid(PLLA)

-BiotronikHeparinizedpolymerblendofPLLA,PLGA,polyvinylpyrrolidine-SahajanandStentStrutStentStrut聚合物NewerGenerationDES_LEADERS中Biolimus-A9?ElutingStentBiolimus是一種半人工合成的雷帕霉素衍生物，它的親脂性比雷帕霉素高10倍。生物可降解聚合物中Biolimus的濃度為15.6

g/mm，藥物和聚合物涂層是單面涂層，僅面向血管壁。聚乳酸隨著B(niǎo)iolimus藥物一起釋放，在植入后6－9個(gè)月完全分解為水和二氧化碳。不銹鋼支架平臺(tái)軸桿厚度為112m。.NewerGenerationDES_LEADERS中DES的使用－On-Labelvs.Off-Label%DES

的Off-Label使用

復(fù)雜的適應(yīng)癥小血管及長(zhǎng)病變慢性完全閉塞分叉病變左主干病變支架內(nèi)再狹窄多支病變急性心梗隱靜脈橋BeoharJAMA2007N=5,541WinJAMA2007N=3,323MarroquinNEJM2008N=6,551NewerGenerationDES_LEADERS中BiolimusStentBioMatrixFlexN=850SirolimusStentCypherSelectN=850試驗(yàn)設(shè)計(jì)適合進(jìn)行PCI手術(shù)的穩(wěn)定性心絞痛及ACS病人N=17001:3Randomisation主要終點(diǎn): 心血管性死亡，心梗，具有臨床指癥的TVR次要終點(diǎn): 死亡,心血管性死亡，心梗,TLR,TVR

根據(jù)ARC定義的支架血栓

造影研究: 支架內(nèi)直徑狹窄%，晚期丟失，二元再狹窄ClinicalF/UN=640AngioF/UN=210ClinicalF/UN=640AngioF/UN=210評(píng)估者單盲1:1隨機(jī)入選NewerGenerationDES_LEADERS中病人入選資格入選標(biāo)準(zhǔn)冠心病

-穩(wěn)定性心絞痛-隱匿性缺血

急性冠脈綜合癥，包括不穩(wěn)定性心絞痛，NSTEMI和STEMI至少有一處病變符合-直徑狹窄>50%-RVD:2.25-3.5mm-病變數(shù):不限定-血管數(shù):不限定

病變長(zhǎng)度:不限定簽署知情同意書(shū)排除標(biāo)準(zhǔn)已知對(duì)以下之一過(guò)敏

阿司匹林，氯吡格雷，肝素，不銹鋼，雷帕霉素，biolimus，造影劑在PCI術(shù)后6個(gè)月內(nèi)進(jìn)行計(jì)劃，選擇性手術(shù)

可以維持雙聯(lián)的APT治療懷孕婦女同時(shí)參加其他臨床試驗(yàn)NewerGenerationDES_LEADERS中LEADERS–

病人基線特征

BiolimusStent

SirolimusStent

857Patients

850Patients急性冠脈綜合癥

55%

56%-不穩(wěn)定心絞痛 22%

21%-非ST段抬高性MI 17%

18%-ST段抬高性MI 16%

17%左心室射血分?jǐn)?shù) 5611%

5512%每個(gè)病人的病變數(shù)量

1.50.7

1.40.7病變數(shù) -1處病變

63% 69% -2處病變

29% 22% -3處病變

7% 8% ->4處病變

1% 2%Denovo病變

92% 91%病變程度(>20mm)

31% 27%小血管(RVD<2.75mm)

68% 69%Offlabel使用

81% 78%NewerGenerationDES_LEADERS中051015850791786784781777771758751746857806798796792784779777771761No.atrisk0123456789MonthsofFollow-upSESBESCumulativeIncidence(%)主要終點(diǎn)

心性死亡,MI,或TVR@9months

WindeckerSetal.Lancet2008;372:1163-73SirolimusStent10.5%BiolimusStent9.2%RiskDifference-1.3%,UpperLimit95%CI1.1%Pnon-inferiority=0.003RateRatio=0.88,95%CI0.64-1.19NewerGenerationDES_LEADERS中安全性終點(diǎn)@12MonthsP=0.86*%P=0.15*P=0.35*P=0.95*P=0.25*P=0.42**PvaluesforsuperiorityNewerGenerationDES_LEADERS中有效性終點(diǎn)@12MonthsP=0.56*%P=0.13*P=0.09*P=0.29*P=0.47**PvaluesforsuperiorityNewerGenerationDES_LEADERS中RR=0.90(0.52-1.55)P=0.71*RR=0.80(0.38-1.72)P=0.57*靶病變血運(yùn)重建

造影隨訪

WindeckerSetal.Lancet2008;372:1163-73TargetLesionRevascularisation(%)僅臨床隨訪同時(shí)進(jìn)行造影隨訪TargetLesionRevascularisation(%)*PvaluesforsuperiorityNewerGenerationDES_LEADERS中造影隨訪結(jié)果BiolimusStent255lesionsSirolimusStent233lesionsP*MLDin-stent(mm)2.23±0.642.11±0.700.08in-segment(mm)2.01±0.591.87±0.640.03Diameterstenosisin-stent(%)20.9±17.523.3±19.60.26in-segment(%)27.1±16.429.9±18.50.14Latelumenlossin-stent(mm)0.13±0.460.19±0.500.34in-segment(mm)0.08±0.450.15±0.460.12Binaryrestenosisin-stent(%)5.58.70.20in-segment(%)6.710.80.15*PvaluesforsuperiorityNewerGenerationDES_LEADERS中對(duì)主要終點(diǎn)的滿意度分析

WindeckerSetal.Lancet2008;372:1163-73BiolimusSirolimusPValueRiskRatio(95%CI)NewerGenerationDES_LEADERS中LateLossmmRestenosis%%TLRN=223N=191P=0.15P=0.64P=0.18RVD=2.56mm,Lesionlength:14.4mm,StentLength:33mmLEADERS研究亞組分析–

糖尿病N=223N=191N=223N=191NewerGenerationDES_LEADERS中LateLossmmRestenosis%%TLRN=223N=191P=0.28RVD=2.56mm,Lesionlength:14.4mm,StentLength:33mmLEADERS研究亞組分析–

小血管N=223N=191N=223N=191P=nsP=nsNewerGenerationDES_LEADERS中明確定義支架血栓@9Month

WindeckerSetal.Lancet2008;372:1163-73SirolimusStent2.0%BiolimusStent1.9%RateRatio=0.93,95%CI0.47-1.850123CumulativeIncidence(%)8508228188168158158138068037998578338268258248218188178168080123456789MonthsofFollow-upDefinitestentthrombosisNumberatriskBESSESNewerGenerationDES_LEADERS中支架血栓@12MonthsBiolimusStent857PatientsSirolimusStent850PatientsPDefiniteST

0-30days1.6%1.6%0.99

>30days–9mo0.4%0.5%0.70

0days–9mo2.0%2.0%*0.99ProbableST

0-30days0.6%0.2%0.28

>30days–9mo0.2%0.0%-

0days–9mo0.8%0.2%0.12PossibleST

0-30days0.0%0.0%-

>30days–9mo0.8%1.1%0.60

0days–9mo0.8%1.1%0.60*Excludesonesecondary,definiteSToccurringat60daysinapatientwhohadearlySTat3daysNewerGenerationDES_LEADERS中從支架血栓角度看%明確定義支架血栓@12MonthsAllComerTrialsACSTrialSTEMITrialN=1,700N=1,012N=903N=2,878N=744N=2,238N=3,224NewerGenerationDES_LEADERS中LEADERS–OCT亞組研究CDiMario,PWSerruys,submitted隨機(jī)入選349個(gè)病人175個(gè)病人植入biolimus藥物洗脫支架174個(gè)病人植入雷帕霉素藥物洗脫支架43個(gè)病人進(jìn)行造影隨訪45個(gè)病人進(jìn)行造影隨訪28個(gè)病人入選OCT亞組分析(42lesions)32個(gè)病人入選OCT亞組分析(46lesions)15個(gè)病人沒(méi)有進(jìn)行造影隨訪13個(gè)病人沒(méi)有進(jìn)行造影隨訪26個(gè)病人進(jìn)行了OCT30個(gè)病人進(jìn)行了OCT1個(gè)病人拒絕(1處病變)

1個(gè)病人沒(méi)有進(jìn)行OCT1個(gè)病人拒絕(1處病變)

1個(gè)病人沒(méi)有進(jìn)行OCT對(duì)20個(gè)進(jìn)行OCT的病人分析(29出病變;4592處軸桿)*對(duì)26個(gè)進(jìn)行OCT的病人進(jìn)行分析(35處病變