可降解药物涂层支架临床研究现状王宁夫PPT课件.ppt

可降解药物涂层支架临床研究现状_王宁夫•Polymer(Degradable)forDrugExcel Sirolimus JWMedicalBioMatrix BiolimusA9 Biosensors-Infinnium Paclitaxel/Sirolimus SMT(印度)Nobori BiolimusA9 Terumo-Champion Everolimus Guidant•Polymer(Degradable)PlusHolesforDrug-CoStar Paclitaxel Conor/Biotronik(Cordis)•NoPolymerButHolesforDrug-Janus Tacrolimus Sorin-Taxcor Paclitaxel Eurocor(Germany)•NoPolymerButSpecialStentSurfaceforDrug-Axxion Paclitaxel BiosensorsYukon Sirolimus Translumina(Germany)-ALA Abciximab KoreanAMPYinyi Paclitaxel Yinyi•Polymer(Nondegradable)forDrug(ConventionalDES)-CypherSelect Sirolimus Cordis/Johnson&Johnson-TaxusLiberté Paclitaxel BostonScientific-Endeavor Zotarolimus MedtronicXience Everolimus Abbott/GuidantFirebird Sirolimus MicroportPartner Sirolimus LepuActive(Drug-Eluting)Stents与其他聚合物相比,生物可降解聚合物DES是安全有效的作为ISAR-TEST-3试验的一部分,由德国国家心脏中心的AdnanKastrati教授带领的研究组,随机入选了605例原发冠脉病变患者,分组使用三种西罗莫司洗脱支架:永久聚合物支架,生物可降解聚合物支架及无聚合物支架June2008TCTMD基线资料共入选605例,%,%为复杂病变。492例(%)再次造影,两治疗组随访率没有明显差别。随机分配到各组,其中生物可降解聚合物组(202例),永久性聚合物组(202例),无聚合物组(201例)死亡、非致死性心梗和支架血栓的发生率生物可降解聚合物(N=202)永久性聚合物(N=202)无聚合物(N=201)晚期管腔丢(6-8月)±±±(1年)12例16例26例明确的血栓012很可能的血栓100可能的血栓131总计243结论在造影结果和临床结果方面,生物可吸收聚合物支架可完全达到甚至超过永久性聚合物支架。生物可降解聚合物支架BioMatrix(Biosensors)Nobori(Terumo)Excel(JWMedical)Infinnium(SMT)BEACONRegistry(PI:THKoh)DeNovo/ativeCoronaryArteryLesionsMulti-lesion/Multi-vessel VesselDiameters:≥–≤ StentDiameters:– LesionLength:≥10mm–≤28mm StentLengths:8-28mm8and12mmLengthsforBailoutOnlyPre-Dilatationperferred30d 6mo 9mo 12moClinicalFollow-UpPrimaryEndpoint: TVRat6monthsKeySecondaryEndpoints: MACEat30days,6months,12months ClinicallydrivenTLR,TVRat9&12mos Device,essAnti-PlateletTherapyatInvestigatorsDiscretionBioMatrixIN=292Evaluable10SitesinAsiaProspective,Multi-Center,ElectronicRegistry(2007)BEACONRegistry–PatientCharacteristicsBioMatrixI 292PatientsAge 57(26-83) Diabetes(%) 38 Hypertension(%) 68Hypercholesterolemia(%) 67Smokinghistory(%) 42Familyhist