q1aop訓(xùn)練營材料綜合3.poa支架血栓科室會版

支架血栓的影響因素：

Resolute支架安全性數(shù)據(jù)解讀目錄支架血栓的發(fā)生率及危害性支架血栓的影響因素:患者，操作，支架Resolute血栓發(fā)生率的最新數(shù)據(jù)：

真實世界的患者：RAC和薈萃分析

糖尿病患者：糖尿病亞組薈萃分析

分叉病變及長病變患者：重疊支架薈萃分析血栓與出血的平衡ResoluteDAPT中斷薈萃分析最新數(shù)據(jù)支架內(nèi)血栓近期死亡率20-25%大面積心肌梗死發(fā)生率60-70%Circulation2003;108盡管DES支架內(nèi)血栓發(fā)生率較低，但其后果卻是災(zāi)難性的目前支架內(nèi)血栓仍然是PCI治療中最主要的死亡原因之一支架血栓的高死亡率156肯定的/極可能的血栓事件DangasGetal,JACC2012死亡率HORIZONS-AMIN=54N=102支架血栓的高死亡率晚期和遲發(fā)晚期支架血栓DAPT依從性炎癥反應(yīng)

超敏反應(yīng)內(nèi)皮化延遲急性和早期支架血栓抗血小板治療機械因素和/或技術(shù)因素操作Procedure

支架血栓殘余夾層,完全覆蓋病變支架擴張/后擴張/IVUS病人Patient高危因素病變特性抗血小板治療依從性產(chǎn)品Product支架設(shè)計/材質(zhì)

涂層類型載藥類型/劑量/釋放Honda,Fitzgerald.Circulation,2003,108:2.KereiakesD,etal.RevCardiovascMed.2004,5(1):9-15.支架血栓的影響因素金屬材質(zhì)支架幾何外形涂層材質(zhì)藥物延遲內(nèi)皮化藥物釋放動力學(xué)支架血栓的影響因素:支架因素支架骨梁厚度涂層厚度載藥量形狀TaxusExpress132μm16μm1μg/mm2楔形TaxusLiberte97μm16μm1μg/mm2楔形PromusElement81μm7.0μm1μg/mm2方形XienceV81μm7.8μm1μg/mm2方形Resolute91μm5.6μm1.6μg/mm2卵圓形支架絲/涂層/載藥量的比較ResoluteXienceV/PE截面面積(μm2)68089809截面周長(μm)292405ResoluteXienceV/PE80.4Micron93.1Micron94.4Micron122Micron支架絲的形狀Conclusion:“Astreamlinedstentwithahigherstrutthicknesseswillresultinfasterhealingofthevesselandlessprobabilityofstentthrombosis,thanathinner,non-streamlinedstrutdesign.”11HemodynamicallyDrivenStentStrutDesign,byJuanM.Jimenez&PeterF.Davis:AnnalsofBiomedicalEngineering,Vol.37,No.8,August2009pp.1483-1494圓形支架絲更易修復(fù)外層：親水高度生物相容性支架安全性保證：低血栓快速、完整、功能良好的內(nèi)皮細胞覆蓋內(nèi)層：親脂

有效結(jié)合藥物，嚴(yán)格控制藥物釋放支架有效性保證：低TLR

多聚物Resolute專為DES研發(fā)的BioLinx多聚物多聚物越親水越少單核細胞粘附越少炎癥反應(yīng)生物相容越好多聚物：低致炎性28天小血管安全性研究1

180天安全性研究2

365天安全性研究3

電鏡掃描分析多聚物：出色的內(nèi)皮修復(fù)（BenchTest）豬冠狀動脈的benchtest試驗128daySmallVesselSafetyStudyinporcinemodel(FS144).2180daySafetyStudyinporcinemodel(FS129).3365daysinporcinemodel(FS142).多聚物：出色的內(nèi)皮修復(fù)（臨床試驗）OCT代表性結(jié)果Patients

with

coronary

artery

disease(multi-vessel

lesion)1st-PCI

(elective

PCI)33patients(44stents)Withdenovolesions2nd-PCI(stagedPCI)1st-PCIlesioncheck2nd-PCI(stagedPCI)1st-PCIlesioncheckR-ZESgroup(1,2,3month)18patients22stentsEESgroup(1,2,3month)15patients22stentsNeointimalcoverageevaluatedbyOCT:ResoluteZotarolimus-elutingstentversusEverolimus-elutingstentTakehiro

Hashikata1,

etal.1kitasato

University

Graduate

School

of

Medical

Sciences,試驗設(shè)計多聚物：出色的內(nèi)皮修復(fù)（臨床試驗）Resolute在3個月時支架絲覆蓋率超過85%1,2,3個月時，Resolute新生內(nèi)膜覆蓋支架絲的百分比要高于XienceV*neointimal

coverage:covered

struts/

total

struts

x

100*malapposition:>

strut

+

abluminal

polymer

thickness*%NIH(NIH:neointimal

hyperplasia):[(stent

area-lumen

area)

/

stent

area]

x

1001

month2

months3

monthsR-ZESEESPR-ZESEESPR-ZESEESPNo.

of

total

struts,

n162016601880118224271081Thrombus11NS01NS10NSWell-apposedWith

neointima,

%88.4±6.339.1±16.0<0.0195.5±5.545.5±11.1<0.0194.7±2.361.2±7.4<0.01Without

neointima,

%7.2±4.859.6±13.0<0.012.6±3.853.5±11.1<0.013.2±1.938.7±7.4<0.01MalapposedWith

neointima,

%2.3±2.60

NS1.7±1.60.1±1.0NS2.8±2.00.1±0.3NSWithout

neointima,

%1.3±2.20.4±0.9NS0.2±0.50.9±1.3NS0.3±0.30NSMean

NIH

thickness,um38.9±8.140.0±8.4NS70.6±18.843.5±5.8<0.0154.2±6.251.6±15.3NSMean

%

NIH,

%5.2±1.05.9±1.8NS9.6±1.85.6±0.8<0.017.4±3.87.3±3.8NSNeointimal

coverago(%)88.439.195.545.594.761.2P<0.01P<0.01P<0.01真實世界患者ResoluteAllComers研究設(shè)計開放、非劣效性研究所有需要采用DES治療的有癥狀的冠狀動脈疾病（沒有病變/血管限制）ResoluteDESn=1150XienceVDESn=1150主要終點:TLF(ARC-defined),包括心源性死亡、靶血管心梗、12個月TLR次要終點:Clinical:Patientcompositeofanydeath,anyMI,&anyrepeatrevascularisationQCA(powered):13-monthin-stent%diameterstenosisQCA:%diameterstenosis,lateloss,andbinaryrestenosis藥物治療:6個月以上的阿司匹林和氯砒格雷(依據(jù)指南)2300patients,17sitesinEurope100%monitoringCo-PIs:Profs.Serruys,Silber,Windecker30d6mo4yr3yr2yr12mo13mo5yrClinicalAngio/OCT460(20%)QCAsubset50(2%)OCTsubsetSerruysPW,etal.,NEnglJMed.2010;363(2):136-46RESOLUTEAllComers研究設(shè)計Randomized1:1Resolute?(R-ZES)N=1140n=113299.3%n=112898.9%PatientsEnrolledN=2292XienceV?(EES)N=1152n=114299.1%n=113998.9%n=112898.9%n=113798.7%1YrFollow-up2YrFollow-up3YrFollow-upn=112798.9%4YrFollow-upn=113598.5%n=112398.5%5YrFollow-upn=113398.4%真實世界患者ResoluteAllComers患者隨訪ResoluteZES(N=1140)XienceVEES(N=1152)PvalueAge(yr)64.4±10.964.2±10.80.70Men(%)76.777.20.80Diabetesmellitus(%)23.523.41.00IDDM8.47.10.28ACS(%)48.347.70.80AMI(within12hr)(%)15.417.80.13AMI(within72hr)(%)28.928.80.96Multivesseldisease(%)58.459.20.73Smallvessel(RVD≤2.75mm)67.867.40.88Longlesion(length>18mm)18.221.20.11Bifurcation/trifurcation(%)16.917.70.62Totalocclusion(%)16.317.20.61In-stentrestenosis(%)8.18.00.94ComplexPatients1(%)67.065.60.51真實世界患者ResoluteAllComers患者基線1Complexpatientdefinition:bifurcation,bypassgrafts,ISR,AMI<72hr,LVEF<30%,unprotectedLM,>2vesselsstented,renalinsufficiencyorfailure(creatinine>140μmol/L),lesionlength>27mm,>1lesionpervessel,lesionwiththrombusorTO(preprocedureTIMI=0).SerruysPW,etal.,NEnglJMed.2010;363(2):136-46.真實世界患者ResoluteAllComers手術(shù)基線SerruysPW,etal.,NEnglJMed.2010;363(2):136-46.ResoluteZESN=1140patients,1661lesionsXienceVEESN=1152patients,1705lesionsPvalueLesionstreatedperpatient1.5±0.71.5±

0.80.46Lesionlength(mm)11.9±7.512.2±7.90.38No.ofstentsperpatient1.9±1.22.0±1.30.02Stentlengthperpatient(mm)34±2437±260.02Pre-stent

balloon

dilatation69.5%70.2%0.75Deploymentpressure14.9±3.115.1±3.20.01Implantationofstudystentonly98.0%96.9%0.11Lesionsuccess98.9%99.1%0.62Devicesuccess97.0%96.6%0.52Proceduresuccess94.6%94.2%0.78真實世界患者ResoluteAllComers5年極晚期支架內(nèi)血栓（確定/可能）TimeAfterInitialProcedure(years)132CumulativeIncidenceofVeryLateARCDefinite/ProbableST(%)031.03%0.84%541254LogrankP=0.66Resolute?ZES(N=1140)XienceV?EES(N=1152)No.atriskResolute11111111108510571018XienceV11081108108710551025StephanWindecker.FinalFive-yearOutcomesfromtheRandomizedComparisonofZotarolimus-elutingStentsWithEverolimus-elutingStentsintheRESOLUTEAllComersTrialEuroPCR.2014.真實世界患者Resolute薈萃分析5年數(shù)據(jù)Enrolling真實世界患者Resolute薈萃分析患者由5130名增加到7618名TrialDesignRESOLUTE1Non-RCTFirst-in-Human(R=139)5yrRESOLUTEAC2,31:1RCTvs.XienceV?

EES(R=1140;X=1152)5yrNon-RCTObservational(R=2349)3yr2.25–4.0mmNon-RCTvs.HxControl(R=1402)4yrRESOLUTEUS62.5–3.5mmNon-RCTvs.HxControl(R=100)RESOLUTEJapan4yrRESOLUTEAsia7Non-RCTObservational(R=311)1yrRESOLUTEInt4,5R-ChinaRegistry9Non-RCTObservational(R=1800)1yrR-JapanSVS2.25mmNon-RCTvs.PG(R=65)2yrSub-studyNon-RCTvs.PG(R=114)1yrR-US38mm71:1RCTvs.Taxus?

PES(R=200;T=200)R-ChinaRCT82yrLatestFollow-up1MeredithIT,etal.EuroIntervention.2010;5:692-7.2SerruysPW,etal.NEnglJMed.2010;363:136-46.3SilberS,etal.Lancet.2011;377:1241-47.4NeumannFJ,etal.EuroIntervention.2012;7(10):1181-8.5BelardiJA,etal.JIntervCardiol.2013;26(5):515-23.6YeungAC,etal.JACC.2011;57:1778-83.7XuB,etal.JACCCardiovascInterv.2013;6(7):664-70.8LeeM,etal.AmJCardiol.2013;112(9):1335-41.9QiaoS,etal.AmJCardiol.2013.doi:10.1016/j.amjcard.2013.10.042.[Epubaheadofprint]RI-USRegistryPost-approvalstudy(RI≈230)PROPELPost-approvalstudyvs.HxControl(RI=1200)%N=7618PtsAge(yr)63.0±11.0Male75.4Diabetesmellitus30.4IDDM6.8Hypertension71.0Hyperlipidemia62.3Currentsmoker26.6Familyhistory29.1PriorMI29.2PriorPCI25.8PriorCABG6.3CardiacStatus:Stableangina33.0 Unstableangina38.1 MI25.9真實世界患者Resolute薈萃分析患者基線DiMarioC.Safetyupdateandlong-termclinicaloutcomesfromallstudiesintheRESOLUTEGlobalClinicalProgramEuroPCR.2014.

Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS真實世界患者Resolute薈萃分析病變及手術(shù)基線%N=7618Pts,10186LesionsLAD53.2LCx29.0RCA34.4LeftMain1.8Bypassgraft1.2B2/Clesion67.5ReferenceVesselDiameter(mm)2.83±0.52MinimumLumenDiameter(mm)0.64±0.49PercentDiameterStenosis77.1±16.9Lesionlength(mm)18.22±11.28No.oflesionstreatedperpatient1.35±0.64No.ofstentsperpatient1.61±0.96Totalstentlengthperpatient(mm)33.10±22.59Multi-vesseltreament(%)20.5Complexpatient146.71Complexpatientdefinition:bifurcation,bypassgrafts,ISR,AMI<72hr,LVEF<30%,unprotectedLM,>2vesselsstented,renalinsufficiencyorfailure(creatinine>140μmol/L),lesionlength>27mm,>1lesionpervessel,lesionwiththrombusortotalocclusion(preprocedureTIMI=0).DiMarioC.Safetyupdateandlong-termclinicaloutcomesfromallstudiesintheRESOLUTEGlobalClinicalProgramEuroPCR.2014.

Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVSNo.atrisk761876106908542542442087%CI0.080.670.840.961.081.1702531.1740.6701245TimeAfterInitialProcedure(years)ResoluteZESPooled(N=7618)13CumulativeIncidenceof

ARCDefinite/ProbableST(%)真實世界患者Resolute薈萃分析5年低血栓發(fā)生率DiMarioC.Safetyupdateandlong-termclinicaloutcomesfromallstudiesintheRESOLUTEGlobalClinicalProgramEuroPCR.2014.

Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS糖尿病患者Resolute薈萃研究DM亞組分析糖尿病患者Resolute薈萃研究DM亞組患者基線%Non-DiabeticsN=5301Non-IDDMN=1801IDDMN=516Age(yr)62.4±11.264.2±10.3*65.0±9.9Female22.027.7*40.1**Diabetesmellitus0100.0100.0IDDM00100.0Hypertension65.780.9*90.3**Hyperlipidemia59.067.2*79.8**Currentsmoker28.923.1*15.4**Familyhistory29.825.4*35.6**PriorMI28.930.129.4PriorPCI24.426.637.4**PriorCABG5.47.7*10.7**Clinicalstatus:*** Stableangina32.133.442.0 Unstableangina37.541.233.5 Myocardialinfarction27.822.019.9*p-value<0.05Non-IDDMvs.Non-Diabetics

**p-value<0.05IDDMvs.Non-IDDM%Non-DiabeticsN=5301Non-IDDMN=1801IDDMN=516Lesionlocation:LAD54.052.945.5**LCx28.530.129.5RCA33.635.738.0LeftMain1.81.72.3RVD(mm)2.86±0.532.81±0.51*2.71±0.49**MLD(mm)0.64±0.500.63±0.480.67±0.43**Lesionlength(mm)18.13±10.9918.86±12.22*16.87±10.50**Totalstentlengthperpatient(mm)32.77±22.2134.87±24.29*30.23±19.64***p-value<0.05Non-IDDMvs.Non-Diabetics

**p-value<0.05IDDMvs.Non-IDDM糖尿病患者Resolute薈萃研究DM亞組病變基線MohdAliR.OutcomesinMoreThan7000PatientsWithDiabetesAfterImplantationoftheResoluteZotarolimus-elutingStent.EuroPCR.2014.

Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS246120.59%54321.36%0.72%0CumulativeIncidenceof

ARCDef/ProbST(%)TimeAfterInitialProcedure(months)0LogrankP=0.0818101Non-IDDM(N=1801)Non-Diabetics(N=5301)IDDM(N=516)No.atriskNon-Diabetics5301529652235165Non-IDDM1801179917761745IDDM516515502493到目前為止Resolute是唯一獲得美國FDA糖尿病適應(yīng)癥的DESMohdAliR.OutcomesinMoreThan7000PatientsWithDiabetesAfterImplantationoftheResoluteZotarolimus-elutingStent.EuroPCR.2014.

Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.P-valueadjustedfordifferencesinbaselinevariables.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS糖尿病患者Resolute薈萃研究DM亞組低血栓發(fā)生率Overlapping支架Overlapping支架Resolute全球臨床試驗7618名患者TrialDesign1MeredithIT,etal.EuroIntervention.2010;5:692-7.2SerruysPW,etal.NEnglJMed.2010;363:136-46.3SilberS,etal.Lancet.2011;377:1241-47.4NeumannFJ,etal.EuroIntervention.2012;7(10):1181-8.5BelardiJA,etal.JIntervCardiol.2013;26(5):515-23.6YeungAC,etal.JACC.2011;57:1778-83.7XuB,etal.JACCCardiovascInterv.2013;6(7):664-70.8LeeM,etal.AmJCardiol.2013;112(9):1335-41.9QiaoS,etal.AmJCardiol.2013.doi:10.1016/j.amjcard.2013.10.042.[Epubaheadofprint]RESOLUTE1Non-RCTFirst-in-Human(R=139)5yrRESOLUTEAC2,31:1RCTvs.XienceV?

EES(R=1140;X=1152)5yrNon-RCTObservational(R=2349)3yr2.25–4.0mmNon-RCTvs.HxControl(R=1402)4yrRESOLUTEUS62.5–3.5mmNon-RCT(R=100)vs.HxControlRESOLUTEJapan4yrRESOLUTEAsia7Non-RCTObservational(R=311)1yrRESOLUTEInt4,5R-ChinaRegistry9Non-RCTObservational(R=1800)1yrR-JapanSVS2.25mmNon-RCTvs.PG(R=65)2yrSub-studyNon-RCTvs.PG(R=114)1yrR-US38mm71:1RCTvs.Taxus?

PES(R=200;T=200)R-ChinaRCT82yrLatestFollow-up1089PatientsWithOverlappingStentsResolute薈萃分析Overlapping支架亞組分析患者基線%NoOverlappingN=6529PtsOverlappingN=1089PtsP-valueAge(yr)63.0±11.063.1±10.80.63Male75.277.00.22Diabetesmellitus30.430.30.94IDDM6.95.90.22Hypertension71.070.80.91Hyperlipidemia63.356.4<0.001Currentsmoker26.030.40.003Familyhistory29.725.80.018PriorMI29.030.10.49PriorPCI26.621.0<0.001PriorCABG6.36.20.89CardiacStatus: ACS51.855.30.045 STEMI7.47.90.61Resolute薈萃分析Overlapping支架亞組分析病變基線%NoOverlappingN=6529Pts,8520LesionsOverlappingN=1089Pts,1666LesionsP-valueVessellocation: LAD52.457.60.002

LCx29.128.00.47 RCA33.539.9<0.001 LeftMain1.72.30.18 Bypassgraft1.21.0B2/Clesion65.577.5<0.001Moderate/severecalcification26.633.7<0.001Bend>45degrees18.223.1<0.001TIMI3flow78.170.3<0.001Complexpatient141.776.9<0.0011Complexpatientdefinition:bifurcation,bypassgrafts,ISR,AMI<72hr,LVEF<30%,unprotectedLM,>2vesselsstented,renalinsufficiencyorfailure(creatinine>140μmol/L),lesionlength>27mm,>1lesionpervessel,lesionwiththrombusortotalocclusion(preprocedureTIMI=0).Resolute薈萃分析Overlapping支架亞組分析手術(shù)基線NoOverlappingN=6529Pts,8520LesionsOverlappingN=1089Pts,1666LesionsP-valueReferenceVesselDiameter(mm)2.83±0.522.85±0.530.13MinimumLumenDiameter(mm)0.65±0.480.57±0.54<0.001PercentDiameterStenosis76.6±16.579.5±18.8<0.001Lesionlength(mm)16.34±8.2728.32

±17.97<0.001No.oflesionstreatedperpatient1.32±0.601.52±0.79<0.001No.ofstentsperpatient1.40±0.742.85±1.14<0.001Totalstentlengthperpatient(mm)28.78±17.9258.94

±29.41<0.001Multi-vesseltreament(%)19.128.7<0.001123554210CumulativeIncidenceof

Def/ProbST(%)TimeAfterInitialProcedure(years)043No.atriskNooverlappingstents652965225970473637221873%CI0.080.620.750.891.031.13Overlappingstents10891088938689522214%CI0.091.011.381.381.381.38P=0.76ResolutePatientsWithOverlappingStentsResolutePatientsWithoutOverlappingStents1.13%1.38%Resolute薈萃分析Overlapping支架亞組分析低血栓發(fā)生率DiMarioC.OverlappingImplantationofResoluteZotarolimus-elutingStents:Long-termOutcomesFromtheRESOLUTEGlobalClinicalProgram.EuroPCR.2014.

Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.P-valueisadjustedbyusingCoxregressionfordifferencesinbaselinecharacteristics.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS出血抗栓抗栓強度增加，時間延長出血風(fēng)險增加DAPT治療：成功PCI的重要保障出血：減?？寡“逅幬颮esoluteDAPT中斷薈萃分析(最新文獻)ResoluteDAPT中斷薈萃分析

在ACC2014上公布了在最新的數(shù)據(jù)EnrollmentComplete-InFollowUpRESOLUTE1Non-RCTFirst-in-Human(R=139)5yrRESOLUTEAC2,31:1RCTvs.XienceV?

EES(R=1140;X=1152)4yrNon-RCTObservational(R=2349)3yr2.25–4.0mmNon-RCTvs.HxControl(R=1402)4yrRESOLUTEUS62.5–3.5mmNon-RCT(R=100)vs.HxControlRESOLUTEJapan3yrRESOLUTEAsia7Non-RCTObservational(R=312)1yrRI-USRegistryPost-approvalstudy(RI≈230)enrollingEnrolling/Planning1:1RCTvs.Taxus?

PES(R=200;T=200)R-ChinaRCT81yrRESOLUTEInt4,5R-ChinaRegistry9Non-RCTObservational(R=1800)1yrR-JapanSVS2.25Non-RCTvs.PG(R=65)2yr38mmsub-studyNon-RCTvs.PG(R=114)1yrRESOLUTEUS7PROPELPost-approvalstudy(RI=1200)vs.HxControlenrolling薈萃分析包含所有Resolute全球臨床試驗>7000名患者，含2個中國的臨床試驗，數(shù)據(jù)更貼近中國的臨床實踐從Resolute全球臨床試驗中納入7277患者1

185(15%)0-1個月第一次中斷1059(85%)1-12個月第一次中斷146名患者沒有納入分析99名患者數(shù)據(jù)不全47名患者手術(shù)1天后才開始DAPT治療5887(83%)1年內(nèi)無DAPT中斷2（DAPT中斷3天以內(nèi)或無中斷）

1244(17%)1年內(nèi)DAPT中斷3（DAPT中斷至少3天以上）

7131名患者納入DAPT中斷薈萃分析1AlltrialswithintheRESOLUTEPooledProgramwereincludedinthisanalysis(withtheexceptionofRESOLUTEFIMwhichutilizedadifferentDAPTdatacollectionmethodology):R-AC(N=1140),R-INT(N=2349),R-Japan(N=100),R-US(N=1402),R-ChinaRCT(N=198),R-JapanSVS(N=65),R-38mm(N=223),R-ChinaRegistry(N=1800).2

NoInterruptionisdefinedasallpatientswhodidnotinterrupt(onDAPT)foratleast3daysuntilthe12-monthsfollow-up.3InterruptionisdefinedasallpatientswhodidnottakeDAPTforatleast3days,includingtemporaryinterruptionsorpermanentdiscontinuations.入組患者以中斷時間3天為截點，因為DAPT中斷后血小板開始恢復(fù)功能至少需要3天。%NoInterruption1N=5887PtsInterruption2

N=1244PtsP-valueAge(years)Mean±SD62.6±10.965.3±11.1<0.001DiabetesMellitus29.732.10.09InsulinDependent6.39.2<0.001HistoryofSmoking50.952.8<0.001PriorPCI25.430.1<0.001PriorMI28.828.90.96ACS50.144.9<0.001STEMI7.46.70.40NSTEMI6.37.90.04UnstableAngina36.430.3<0.001LesionClassACC/AHAB2/C66.869.90.03RVD(mm)Mean±SD2.78±0.512.75±0.530.04LesionLength(mm)Mean±SD16.38±9.7615.48±9.300.002No.ofstentsperpatientMean±SD1.61±0.961.58±0.980.41TotalStentLength(mm)Mean±SD33.32±22.7731.11±22.730.0021NoInterruptionisdefinedasallpatientswhodidnotinterrupt(onDAPT)foratleast3daysuntilthe12-monthsfollow-up,2InterruptionisdefinedasallpatientswhodidnottakeDAPTforatleast3days,includingtemporaryinterruptionsorpermanentdiscontinuations.患者基線%NoInterruption1N=5887PtsTemporaryInterr.2N=402PtsPermanentDisc.3N=842PtsP-valueAge(years)Mean±SD62.6±10.965.5±11.065.2±11.1<0.001DiabetesMellitus29.736.629.90.01InsulinDependent6.39.59.1<0.001HistoryofSmoking50.957.250.7<0.001PriorPCI25.434.328.0<0.001PriorMI28.827.929.30.87ACS50.137.848.3<0.001STEMI7.44.08.00.03NSTEMI6.34.89.30.001UnstableAngina36.429.030.9<0.001LesionClassACC/AHAB2/C66.873.868.10.01RVD(mm)Mean±SD2.78±0.512.67±0.522.79±0.53<0.001LesionLength(mm)Mean±SD16.38±9.7615.26±8.8115.59±9.530.01No.ofstentsperpatientMean±SD1.61±0.961.45±0.891.64±1.020.003TotalStentLength(mm)Mean±SD33.32±22.7728.46±20.4632.38±23.64<0.0011NoInterruptionisdefinedasallpatientswhodidnotinterrupt(onDAPT)foratleast3daysuntilthe12-monthsfollow-up,2TemporaryInterruptionisdefinedasanypatientwhostoppedDAPTtemporarilyforatleast3days,andrestarted.3PermanentDiscontinuationisdefinedasanypatientwhostoppedDAPT(ASA,thienopyridineorboth)anddidnotrestartatanytimeuntilthe12-monthsfollow-up.患者基線DAPT中斷和終止的具體原因DAPT1年內(nèi)中斷的1244名患者暫時中斷（N=402）永久終止（N=842）手術(shù)相關(guān)=外科手術(shù)，牙科手術(shù)等的篩查和診斷檢驗測試臨床相關(guān)=臨床上表現(xiàn)，如過敏或者出血患者相關(guān)=沒有按時服藥或者更改服藥的劑量雙聯(lián)抗血小板藥物的中斷情況1年內(nèi)中斷DAPT的1244名患者噻吩并吡啶和阿司匹林的中斷情況噻吩并吡啶和阿司匹林中斷的患者數(shù)和比例患者中斷時間的分布暫時中斷或永久終止的時間分布(1244名患者)DAPT中斷的患者比例

(%)暫時中斷的持續(xù)時間中位數(shù)28天33天10天20天21天1年內(nèi)首次中斷DAPT的時間與支架內(nèi)血栓的關(guān)系從未中斷0-1個月首次中斷1-12個月首次中斷SubsequentST(ARCDef/Prob)(%)所有DAPT暫時中斷與永久終止（中斷持續(xù)時間≥3天）0-1個月首次中斷1-12個月首次中斷DAPT暫時中斷（中斷持續(xù)時間≥3天）患者基數(shù)5887185105987315事件發(fā)生數(shù)量437020首次中斷時間的中位數(shù)NA42424195DavidKandzari,ACC2014.以中斷時間3天為截點，因為DAPT中斷后血小板開始恢復(fù)功能至少需要3天。1個月后中斷/永久終止DAPT，不會增加1年的累計血栓發(fā)生率ResoluteDAPT中斷薈萃分析（1年）ResoluteDAPT中斷薈萃分析：1年隨訪結(jié)果ResoluteDAPT

3年隨訪研究結(jié)果長期的安全性？ResoluteDAPT中斷薈萃分析（3年）4991名患者在評估后認(rèn)定符合入選條件涵蓋臨床項目：RAC:1140名患者；RINTL:2349名患者；RJ:10