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1、DES可降解涂层概念及相关临床研究,吉林大学第二医院心血管内科 刘斌,药物支架: 支架, 药物，聚合物对血管造成长期影响的究竟是什么?,0,药物完全洗脱,对血管的影响,时间,1Joner M et al JACC 2006; 48:193-202 2Finn A et al Circulation 2005; 112: 270-278,持久的聚合物 生物可吸收的聚合物,聚合物的发展,假说: 聚合物炎症对于长期安全性和有效性的潜在影响,* 持久涂层: 有潜在的 *可产生持续的炎症反应 * 愈合不良/ 血栓风险,持久的聚合物 生物可吸收的聚合物,聚合物的发展,生物可降解/生物可吸收 指应用药物后,
2、 在数周至数年的时间内通过自然的生物活性降解为无害成分的物质,生物可降解聚合物的优势,100% 的药物释放和聚合物降解 不用担心像传统永久性的聚合物载体可能会引起的 长期结构损坏和慢性炎症影响 支架术后抗血小板药物治疗时间6个月, 减少病人费用 减少了亚急性血栓和血管瘤的发生率, 提高患者的 生存机率 (?),Stent S-stent,Drug Sirolimus (195376g/stent),Polymer Asymmetric Biodegradable PLA,New Generation DES Focus on Reducing Late Adverse Events,Excel
3、TM stent: biodegradable polymer coated SES,fully disolved within 6 months,Two-year Follow-up of EXCEL First-In-Man Clinical Study: The Medistra Excel Drug-elutIng STent TRiAl (MEDISTRA),T. Santoso*, A. Wong+, T.H. Koh+ *Div. of Cardiology, Dept. of Internal Medicine, Univ. of Indonesia Medical Schoo
4、l & the Medistra Hospital, Jakarta, Indonesia +National Heart Centre, Singapore,Follow-up (6 months)(contd) Late loss, mm In-segment0.200.270.020.53 In-stent0.220.320.080.55 Restenosis (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、.5%),CYPHER TAXUS EXCEL BMS,QCA analysis at 6 months*,* Biomatrix = 3 & Endeavour = 1 were not included in the analysis,Multi-Center Registry of Excel BiodegrAdable Polymer-Coated Drug EluTing StEnt,CREATE,Stent Thrombosis Through 2 years,0.73%,LEADERS - TAKING THE LEAD IN DES CLINICAL EXCELLENCE 12
6、 MONTHS RESULTS,Limus Eluted From A Durable vs ERodable Stent Coating,P=0.86,%,P=0.15,P=0.35,P=0.95,P=0.25,P=0.42,SAFETY ENDPOINTS 12 MONTHS,EFFICACY ENDPOINTClinically-Indicated Target Lesion Revascularization,5.9%,5.3%,SUMMARY,DES with biodegradable polymer is safe and effective with: Very low rate of MACE Low rate of restenosis No or very low rate of LST with 6 months dual anti-platelet regiment Better recovery of endothelial function,
