2018年可降解药物涂层支架临床研究现状_王宁夫-文档资料.ppt
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1、 Polymer (Degradable) for Drug Excel Sirolimus JW Medical BioMatrix Biolimus A9 Biosensors - Infinnium Paclitaxel/Sirolimus SMT(印度) Nobori Biolimus A9 Terumo - Champion Everolimus Guidant, Polymer (Degradable) Plus Holes for Drug - CoStar Paclitaxel Conor / Biotronik(Cordis), No Polymer But Holes fo
2、r Drug - Janus Tacrolimus Sorin - Taxcor Paclitaxel Eurocor(Germany), No Polymer But Special Stent Surface for Drug - Axxion Paclitaxel Biosensors Yukon Sirolimus Translumina(Germany) - ALA Abciximab Korean AMP Yinyi Paclitaxel Yinyi, Polymer (Nondegradable) for Drug (Conventional DES) - Cypher Sele
3、ct Sirolimus Cordis / Johnson & Johnson - Taxus Libert Paclitaxel Boston Scientific - Endeavor Zotarolimus Medtronic Xience Everolimus Abbott / Guidant Firebird Sirolimus Microport Partner Sirolimus Lepu,Active (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Adnan Kast
4、rati 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 June 2008 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,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,BioMatri
5、x(Biosensors) Nobori(Terumo) Excel(JW 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
6、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 Discr
7、etion,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 (%) 2
8、5 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,Count,%,* CTO and any other 100% occluded lesions were not recommended as target lesion (as per protocol - trea
9、tment 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 lesion 1.1 Stents per patient 1.4 Device Success (%) 99
10、.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,* One patient had two TVRs.,Cumulative,BEACON Registry Clinical Events,BEACON Registry Clinical
11、Events,%,MACE at 12 Months,No stent thrombosis between 30 days and 12 months,Medistra Excel Drug-ElutIng Stent TRiAl,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
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