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支架血栓的影响因素:
Resolute支架安全性数据解读目录支架血栓的发生率及危害性支架血栓的影响因素:患者,操作,支架Resolute血栓发生率的最新数据:
真实世界的患者:RAC和荟萃分析
糖尿病患者:糖尿病亚组荟萃分析
分叉病变及长病变患者:重叠支架荟萃分析血栓与出血的平衡ResoluteDAPT中断荟萃分析最新数据支架内血栓近期死亡率20-25%大面积心肌梗死发生率60-70%Circulation2003;108尽管DES支架内血栓发生率较低,但其后果却是灾难性的目前支架内血栓仍然是PCI治疗中最主要的死亡原因之一支架血栓的高死亡率156肯定的/极可能的血栓事件DangasGetal,JACC2012死亡率HORIZONS-AMIN=54N=102支架血栓的高死亡率晚期和迟发晚期支架血栓DAPT依从性炎症反应
超敏反应内皮化延迟急性和早期支架血栓抗血小板治疗机械因素和/或技术因素操作Procedure
支架血栓残余夹层,完全覆盖病变支架扩张/后扩张/IVUS病人Patient高危因素病变特性抗血小板治疗依从性产品Product支架设计/材质
涂层类型载药类型/剂量/释放Honda,Fitzgerald.Circulation,2003,108:2.KereiakesD,etal.RevCardiovascMed.2004,5(1):9-15.支架血栓的影响因素金属材质支架几何外形涂层材质药物延迟内皮化药物释放动力学支架血栓的影响因素:支架因素支架骨梁厚度涂层厚度载药量形状TaxusExpress132μm16μm1μg/mm2楔形TaxusLiberte97μm16μm1μg/mm2楔形PromusElement81μm7.0μm1μg/mm2方形XienceV81μm7.8μm1μg/mm2方形Resolute91μm5.6μm1.6μg/mm2卵圆形支架丝/涂层/载药量的比较ResoluteXienceV/PE截面面积(µm2)68089809截面周长(µm)292405ResoluteXienceV/PE80.4Micron93.1Micron94.4Micron122Micron支架丝的形状Conclusion:“Astreamlinedstentwithahigherstrutthicknesseswillresultinfasterhealingofthevesselandlessprobabilityofstentthrombosis,thanathinner,non-streamlinedstrutdesign.”11HemodynamicallyDrivenStentStrutDesign,byJuanM.Jimenez&PeterF.Davis:AnnalsofBiomedicalEngineering,Vol.37,No.8,August2009pp.1483-1494圆形支架丝更易修复外层:亲水高度生物相容性支架安全性保证:低血栓快速、完整、功能良好的内皮细胞覆盖内层:亲脂
有效结合药物,严格控制药物释放支架有效性保证:低TLR
多聚物Resolute专为DES研发的BioLinx多聚物多聚物越亲水越少单核细胞粘附越少炎症反应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
电镜扫描分析多聚物:出色的内皮修复(BenchTest)猪冠状动脉的benchtest试验128daySmallVesselSafetyStudyinporcinemodel(FS144).2180daySafetyStudyinporcinemodel(FS129).3365daysinporcinemodel(FS142).多聚物:出色的内皮修复(临床试验)OCT代表性结果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,试验设计多聚物:出色的内皮修复(临床试验)Resolute在3个月时支架丝覆盖率超过85%1,2,3个月时,Resolute新生内膜覆盖支架丝的百分比要高于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真实世界患者ResoluteAllComers研究设计开放、非劣效性研究所有需要采用DES治疗的有症状的冠状动脉疾病(没有病变/血管限制)ResoluteDESn=1150XienceVDESn=1150主要终点:TLF(ARC-defined),包括心源性死亡、靶血管心梗、12个月TLR次要终点:Clinical:Patientcompositeofanydeath,anyMI,&anyrepeatrevascularisationQCA(powered):13-monthin-stent%diameterstenosisQCA:%diameterstenosis,lateloss,andbinaryrestenosis药物治疗:6个月以上的阿司匹林和氯砒格雷(依据指南)2300patients,17sitesinEurope100%monitoringCo-PIs:Profs.Serruys,Silber,Windecker30d6mo4yr3yr2yr12mo13mo5yrClinicalAngio/OCT460(20%)QCAsubset50(2%)OCTsubsetSerruysPW,etal.,NEnglJMed.2010;363(2):136-46RESOLUTEAllComers研究设计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%真实世界患者ResoluteAllComers患者随访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真实世界患者ResoluteAllComers患者基线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.真实世界患者ResoluteAllComers手术基线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真实世界患者ResoluteAllComers5年极晚期支架内血栓(确定/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.真实世界患者Resolute荟萃分析5年数据Enrolling真实世界患者Resolute荟萃分析患者由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真实世界患者Resolute荟萃分析患者基线DiMarioC.Safetyupdateandlong-termclinicaloutcomesfromallstudiesintheRESOLUTEGlobalClinicalProgramEuroPCR.2014.
Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS真实世界患者Resolute荟萃分析病变及手术基线%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(%)真实世界患者Resolute荟萃分析5年低血栓发生率DiMarioC.Safetyupdateandlong-termclinicaloutcomesfromallstudiesintheRESOLUTEGlobalClinicalProgramEuroPCR.2014.
Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS糖尿病患者Resolute荟萃研究DM亚组分析糖尿病患者Resolute荟萃研究DM亚组患者基线%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荟萃研究DM亚组病变基线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到目前为止Resolute是唯一获得美国FDA糖尿病适应症的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荟萃研究DM亚组低血栓发生率Overlapping支架Overlapping支架Resolute全球临床试验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荟萃分析Overlapping支架亚组分析患者基线%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荟萃分析Overlapping支架亚组分析病变基线%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荟萃分析Overlapping支架亚组分析手术基线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荟萃分析Overlapping支架亚组分析低血栓发生率DiMarioC.OverlappingImplantationofResoluteZotarolimus-elutingStents:Long-termOutcomesFromtheRESOLUTEGlobalClinicalProgram.EuroPCR.2014.
Post-hocRESOLUTEPooledanalysiswasnotpoweredfortheanalysisshown.P-valueisadjustedbyusingCoxregressionfordifferencesinbaselinecharacteristics.*RESOLUTEFIM,RESOLUTEAll-Comers,RESOLUTEInternational,RESOLUTEUS,RESOLUTEUS38mm,RESOLUTEJapan,RESOLUTEChinaRCT,RESOLUTEChinaRegistry,ResoluteAsia,RESOLUTEJapanSVS出血抗栓抗栓强度增加,时间延长出血风险增加DAPT治疗:成功PCI的重要保障出血:减停抗血小板药物ResoluteDAPT中断荟萃分析(最新文献)ResoluteDAPT中断荟萃分析
在ACC2014上公布了在最新的数据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荟萃分析包含所有Resolute全球临床试验>7000名患者,含2个中国的临床试验,数据更贴近中国的临床实践从Resolute全球临床试验中纳入7277患者1
185(15%)0-1个月第一次中断1059(85%)1-12个月第一次中断146名患者没有纳入分析99名患者数据不全47名患者手术1天后才开始DAPT治疗5887(83%)1年内无DAPT中断2(DAPT中断3天以内或无中断)
1244(17%)1年内DAPT中断3(DAPT中断至少3天以上)
7131名患者纳入DAPT中断荟萃分析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.入组患者以中断时间3天为截点,因为DAPT中断后血小板开始恢复功能至少需要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.患者基线%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.患者基线DAPT中断和终止的具体原因DAPT1年内中断的1244名患者暂时中断(N=402)永久终止(N=842)手术相关=外科手术,牙科手术等的筛查和诊断检验测试临床相关=临床上表现,如过敏或者出血患者相关=没有按时服药或者更改服药的剂量双联抗血小板药物的中断情况1年内中断DAPT的1244名患者噻吩并吡啶和阿司匹林的中断情况噻吩并吡啶和阿司匹林中断的患者数和比例患者中断时间的分布暂时中断或永久终止的时间分布(1244名患者)DAPT中断的患者比例
(%)暂时中断的持续时间中位数28天33天10天20天21天1年内首次中断DAPT的时间与支架内血栓的关系从未中断0-1个月首次中断1-12个月首次中断SubsequentST(ARCDef/Prob)(%)所有DAPT暂时中断与永久终止(中断持续时间≥3天)0-1个月首次中断1-12个月首次中断DAPT暂时中断(中断持续时间≥3天)患者基数5887185105987315事件发生数量437020首次中断时间的中位数NA42424195DavidKandzari,ACC2014.以中断时间3天为截点,因为DAPT中断后血小板开始恢复功能至少需要3天。1个月后中断/永久终止DAPT,不会增加1年的累计血栓发生率ResoluteDAPT中断荟萃分析(1年)ResoluteDAPT中断荟萃分析:1年随访结果ResoluteDAPT
3年随访研究结果长期的安全性?ResoluteDAPT中断荟萃分析(3年)4991名患者在评估后认定符合入选条件涵盖临床项目:RAC:1140名患者;RINTL:2349名患者;RJ:10
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