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药物洗脱冠脉支架现状和发展趋势目录•药物支架的现状•存在的安全性问题•解决的可能途径•降低高分子载体的安全性风险•发展完全可降解支架•优化血小板治疗•发展趋势国产药物支架•微创:•乐普:•吉威:•垠亿:FirebirdFirebirdⅡPartn
erNano(R&D)Excel紫杉醇支架Background:breakthroughtechnologiesDriverofrestenosisrecoilneointimaformationimplantati
ontechniquemechanicalstabilizationofacuteresultlocaldeliveryofanti-proliferativeagents5%BMSPTCADESNeedforrevascularization40%20%‘fool-pro
of’deliverysystem?药物支架的现状基本解决了再狭窄的问题结束了二十年来介入器械与再狭窄作斗争的历史存在远期血栓的安全性风险技术变革解决临床问题安全性问题再狭窄问题BMSvsDESBMSPESSES
BMSConclusions:•BMSshowedfargreaterendothelializationthanDES•Lackofcoveragehighlightedinareasofoverlap•Lesssu
rfacecoveragebyendothelialcellsinPESthanSESDelayedendothelializationFinnetal.Circulation.2005;112:270-278.内皮化延迟是问题的核心•缺乏系统性
的基础研究:•未明确延迟内皮化的关键因素(药物、载体、交互作用)•促进内皮化的可能途径•减少与药物支架相关的安全因素和促进内皮化的途径如何接合解决远期血栓的途径•支架设计•药物:有效成分•高分子载体:非绝对有效成分•支架平台:无直接关联新一代药物支架的发展方向•减少高分
子载体的有害作用•发展完全可降解支架DirectionalDrugDelivery(ablumenalpreference)•Selectivecoatingontheoutsidesurfaceofthe
stent•Reduceddrug/polymer•LumenalsurfaceBMS•Drugonlywhereneeded™BiodegradableDrug/Carrier:•BiolimusA9®/Poly(LacticAcid
)50:50mix•abluminalsurfaceonly(contactsvesselwall)•15µmetercoatingthickness•degradesin9monthsreleasingCO2+water™BioMatrix®IIStentPlatform
DesignBIOFLEX™IBioFlexIstent*DataperNHLBIsponsoredstudy,availablefromBSIConorDrugReleaseTechnologyACompletelyPolymer-FreeStrategyTransluminaY
UKON®ChoiceDES•Polymer-freecoating•Uniqueroughenedsurface•Adjustabledosageforindividualizedtreatment•FreechoiceofdrugsMIVPolymer-freeDES乐普公司Nano无载体药
物洗脱支架纳米微孔载药载药后,支架表面均匀一致ResultsfromNanoFIMclinicalstudy:LLat6-8MonthsNanoTMPartnerTM⚫与裸金属支架相同的安全性,与药物支架相同的有
效性0.370.260.340.30DesignPrincipleofEPCCapturingandDrugElutingCombinationStent•EPCCapturingandDrugElutingC
ombinationStent外表面已喷涂雷帕霉素Innersurface-CD34antibodyOutersurface-RapamycinRAPAMYCIN•AdsorptionprincipalofCD34antibodyonthestent’ssurfacePor
ousadsorptionChargeadsorption++++++++YYYYYYYCD34antibodycoatingPatents:PCT/CN2007/002964•TheactivityofCD34antibodyoftheinnersur
faceTheinnersurfaceofBMSImmerseinKG-1acellsuspensionstainedbyDAPI(CD34+Cell,ATCC)BMSCombinationstentTheinnersurf
aceofCombinationstent•EndotheliumAppraisementEMMorphologyonthe7thdayBMSCD34stentCombinationstent•AnimalExperimentalResultsinporcine-QCA00.050.10.150.
20.250.30.35BMSCD34stentCombinationstentLateLOss(mm)LateLossat28DayP<0.05•REVABioresorbableCoronaryStent发展趋势新一代药物支架将在保证有效性的基础上着重解决安全性问题。
减少高分子的有害作用是目前的研究方向。无载体药物支架彻底消除了高分子的有害作用,是目前安全性最好的药物支架。完全可降解支架是未来的发展方向。THANKYOU!DES现状展望视频资料,欢迎大家登陆优酷网
www.youku.com后,搜索“药物支架现状”或“蒲忠杰”