可降解药物涂层支架临床研究现状王宁夫

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,可降解药物涂层支架临床研究现状,杭州市第一人民医院,王宁夫,Polymer(Degradable)for Drug,Excel,Sirolimus,JW Medical,BioMatrixBiolimus,A9Biosensors,-,Infinnium,Paclitaxel,/,Sirolimus,SMT(,印度),Nobor,i,Biolimus,A9Terumo,-Champion,Everolimus,Guidant,Polymer(Degradable)Plus Holes for Drug,-CoStarPaclitaxelConor/BiotronikCordis,No Polymer But Holes for Drug,-JanusTacrolimus Sorin,-TaxcorPaclitaxel Eurocor(Germany),No Polymer But Special Stent Surface for Drug,-Axxion,PaclitaxelBiosensors,Yukon,SirolimusTranslumina,(Germany),-,ALA,Abciximab,Korean AMP,Yinyi,PaclitaxelYinyi,Polymer(Nondegradable)for Drug(Conventional DES),-Cypher SelectSirolimusCordis/Johnson&Johnson,-Taxus LibertPaclitaxelBoston Scientific,-Endeavor ZotarolimusMedtronic,XienceEverolimus,Abbott,/,Guidant,Firebird,SirolimusMicroport,Partner,SirolimusLepu,Active,(Drug-Eluting)Stents,与其他聚合物相比，生物可降解聚合物DES是平安有效的,作为ISAR-TEST-3试验的一局部，由德国国家心脏中心的Adnan Kastrati 教授带着的研究组，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,June 2021 TCTMD,基线资料,共入选605例，其中糖尿病患者占27.4%，712处病变中74.1%为复杂病变。492例81.3%再次造影，两治疗组随访率没有明显差异。,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,（N202）,永久性聚合物,（N202）,无聚合物,（N201）,晚期管腔丢(6-8月),0.170.45mm,0.230.46mm,0.470.56mm,TLR（1年）,12例,16例,26例,明确的血栓,0,1,2,很可能的血栓,1,0,0,可能的血栓,1,3,1,总计,2,4,3,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到达甚至超过永久性聚合物支架。,生物可降解聚合物支架,BioMatrixBiosensors,NoboriTerumo,ExcelJW Medical,Infinnium(SMT),BEACON Registry,(PI:TH Koh),De Novo/Restenotic Native Coronary Artery Lesions,Multi-lesion/Multi-vessel,Vessel Diameters:,2.5,4.0 mm,Stent Diameters:2.5 4.0 mm,Lesion Length:,10 mm 28 mm,Stent Lengths:8-28 mm,8 and 12 mm Lengths for Bailout Only,Pre-Dilatation perferred,30 d 6 mo 9 mo 12 mo,Clinical Follow-Up,Primary Endpoint:TVR at 6 months,Key Secondary Endpoints:MACE at 30 days,6 months,12 months,Clinically driven TLR,TVR at 9&12 mos,Device,Lesion and Procedure Success,Anti-Platelet Therapy at Investigators Discretion,BioMatrix I,N=292,Evaluable,10 Sites in Asia,Prospective,Multi-Center,Electronic Registry(2007),BEACON Registry Patient Characteristics,BioMatrix I,292 Patients,Age,57(26-83),Diabetes(%)38,Hypertension(%)68,Hypercholesterolemia(%)67,Smoking history(%)42,Family history of CAD(%)25,Prior MI(%)41,Previous PCI(%)19,Previous CABG(%)2,Unstable Angina(%)29,LVEF(%)56,BEACON Registry Target Lesion Characteristics,ACC/AHA Lesion,Classification,Lesion,Localization,Bifurcation lesions,Moderate/Severe calcification,Lesions,24mm,Small vessel,2.5mm,CTO*,De novo lesions,Restenotic lesions,Count,56,22,51,137,22,387,6,14.2,5.6,13.0,34.9,5.6,98.5,1.5,%,*,CTO and any other 100%occluded lesions were not recommended as target lesion(as per protocol-treatment strategy).,n=393 Target Lesions,BEACON Registry Lesion Characteristics,BEACON Registry Lesion Characteristics,BioMatrix I,393 Lesions,Lesion length(mm),16.2,Vessel size(mm),2.89,Diameter stenosis(%),82,Stent length(mm)21,Stents per lesion1.1,Stents per patient1.4,Device Success(%)99.7,Lesion Success(%)98.8,Procedure Success(%)95.9,BEACON Registry Clinical Events,%,MACE at 30 Days,2 patients(0.7%)with early stent thrombosis day 5 and day 6,Study Primary Endpoint*-180 Day TVR,0-30 Day,31-180 Day,181 360 Day,180 Days,360 Days,TVR Rates,CABG,PTCA,3(1.0%),0(0.0%),3(1.0%),3(1.0%)*,0(0.0%),3(1.0%),2(0.7%),0(0.0%),2(0.7%),6(2.1%)*,0(0.0%),6(2.1%),8(2.8%),0(0.0%),8(2.8%),*One patient had two TVRs.,Cumulative,BEACON Registry Clinical Events,BEACON Registry Clinical Events,%,MACE at 12 Months,No stent thrombosis between 30 days and 12 months,M,edistra,E,xcel,D,rug-Elut,I,ng,S,tent,TR,i,A,l,Predilatation,is encouraged,even though direct,stenting,is allowed in simple lesion,Stent,selection:,Try to always use,EXCEL,If appropriate size/length not available,use other DES,(,Cypher,or,Taxus,),If other DES is not available(logistic problem),use,BMS,Antiplatelet,regimen:,ASA 160 mg indefinitely(unless contraindicated),Clopidogrel,300 mg(loading),then 75 mg for,6 months,Methods,All comers,N=359,2 stent dislodgement*(“prototype stent),357 eligible pts,DES-stenting as default strategy,(N=993 stents),except if there is logistic problem(BMS will be used),*1 case when negotiating mildly stenotic,acutely angulated LCX to fix mid-LCX stenosis,1 case with diffuse,calcified mid-RCA stenosis,during attempted direct stenting,EXCEL,N=607,CYPHER,N=178,TAXUS,N=111,BMS,N=49,BIOMATRIX,N=41,ENDEAVOUR,N=7,Demographics&CV Risk Factors,N patients357,Age(yrs)58.8,+,9.7,Male/female297/60,Family history108(30.2%),Hypertension192(53.8%),Dyslipidemia,212(59.4%),Diabetes mellitus126(35.3%),Smoking162(45.4%),Prior MI163(45.7%),Prior CABG19 (5.3%),Prior PCI101(28.3%),Clinical Presentation,No.patients357,No.lesions812,No.,stents,993,Clinical presentation,Stable angina153(42.8%),Unstable angina/ACS42(11.8%),Acute MI17(4.8%),Recent MI(50%),In-segment7/52(13.5%)3/42(7.1%)9/186(,4.8%),2/19(10.5%),In-stent6/52(11.5%)2/42(4.8%)7/186(,3.8%),2/19(10.5%),CYPHERTAXUS,EXCEL,BMS,QCA analysis at 6 months*,*,Biomatr