可降解聚乳酸涂层西罗莫司洗脱支架在小型猪冠状动脉模型中的实验研究A novel bioabsorbable polymeric sirolimus-eluting stent:evaluation in a porcine model
郑博,陈明,彭红玉,王新刚,王皓正,霍勇
摘要(Abstract):
目的评价新型L605钴铬合金平台可降解聚乳酸共聚物载体西罗莫司药物洗脱支架(bioabsorbable polymeric sirolimus-eluting stent,BPSES)在小型猪冠状动脉抑制新生内膜增殖的有效性和安全性。方法金属裸支架(bare mental stent,BMS)18枚、单纯可降解聚乳酸共聚物涂层支架(bioabsorbable polymer-only stent,BPOS)18枚以及BPSES 18枚被分别随机置入18头小型猪的前降支(18枚)、回旋支(18枚)以及右冠状动脉(18枚)。置入28天和90天,复查冠状动脉造影评价管腔丢失。置入7天、28天以及90天处死部分动物行塑料包埋硬组织切片染色组织形态学分析。结果置入28天及90天,BPSES与BMS相比,显著降低管腔丢失(28天0.54±0.45 mm比1.11±0.45mm,P=0.048;90天0.42±0.34 mm比0.96±0.41 mm,P=0.024)。在损伤积分相似的情况下,置入28天时BPSES较BMS新生内膜面积明显减少(0.90±0.40 mm2比1.88±0.71 mm2,P=0.015),而在90天时亦可见此趋势。7天、28天和90天BPSES和BPOS炎症反应及内皮化程度与BMS相似。结论BPSES在置入小型猪冠状动脉28天后,可以安全有效地抑制新生内膜增殖,90天时亦可见此趋势。
关键词(KeyWords): 支架;西罗莫司;药物载体;冠状动脉再狭窄;猪,雏型;可降解聚乳酸共聚物
基金项目(Foundation):
作者(Author): 郑博,陈明,彭红玉,王新刚,王皓正,霍勇
参考文献(References):
- [1]Isenberg MJ.A hierarchical Bayesian meta-analysis of random-ised clinical trials of drug-eluting stents.Lancet,2004,364:583-591.
- [2]Sousa JE,Costa MA,Sousa AG,et al.Two-year angiographicand intravascular ultrasound follow-up after implantation of siroli-mus-eluting stents in human coronary arteries.Circulation,2003,107:381-383.
- [3]Morice MC,Serruys PW,Sousa JE,et al.A randomized com-parison of a sirolimus-eluting stent with a standard stent for coro-nary revascularization.N Engl J Med,2002,346:1773-1780.
- [4]Moses J,Leon MB,Popma JJ,et al.Sirolimus-eluting stentsversus standard stents in patients with stenosis in a native coro-nary artery.N Engl J Med,2003,349:1315-1323.
- [5]Stone GW,Ellis SG,CoxDA,et al.Apolymer-based,paclitax-el-eluting stent in patients with coronary artery disease.N Engl JMed,2004,350:221-231.
- [6]Virmani R,Guagliumi G,Farb A,et al.Localized hypersensi-tivity and late coronary thrombosis secondary to a sirolimus-elu-ting stent:Should we be cautious?Circulation,2004,109:701-705.
- [7]Virmani R,Farb A,Guagliumi G,et al.Drug-eluting stents:Caution and concerns for long-term outcome.Coron Artery Dis,2004,15:313-331.
- [8]McFadden EP,Stabile E,Regar E,et al.Late thrombosis indrug-eluting coronary stents after discontinuation of antiplatelettherapy.Lancet,2004,364:1519-1521.
- [9]Fernandez C,Hernandez R.Drug-eluting stent thrombosis:Re-sults from a pooled analysis including 10 randomized studies.JAm Coll Cardiol,2005,45;954-959.
- [10]Wessely R,Hausleiter J,Michaelis C,et al.Inhibition of neoin-tima for mation by a novel drug-eluting stent systemthat allows fordoseadjustable,multiple,and on-site stent coating.ArteriosclerThromb Vasc Biol,2005,25:748-753.
- [11]Schwartz RS,Huber KC,Murphy JG,et al.Restenosis and theproportional neointimal response to coronary artery injury:Resultsin a porcinemodel.J Am Coll Cardiol,1992,19:267-274.
- [12]Cilingiroglu M,Elliott J,Patel D,et al.Long-term effects of no-vel biolimus eluting DEVAX AXXESS plus nitinol self-expandingstent in a porcine coronary model.Catheter Cardiovasc Interv,2006,68:271-279.
- [13]Carter AJ,Aggarwal M,Kopia GA,et al.Long-term effects ofpolymer-based,slow-release,sirolimus-eluting stents in a porcinecoronary model.Cardiovasc Res,2004,63:617-624.
- [14]Van der Giessen WJ,Lincoff AM,Schwartz RS,et al.Marked in-flammation sequelae to implantation of biodegradable and nonbio-degradable plymers in porcine coronary arteries.Circulation,1996,94:1690-1697.
- [15]Kornowski R,Hong MK,Tio FO,et al.In-stent restenosis:con-tributions of inflammatory responses and arterial injury to neointi-mal hyperplasia.J Am Coll Cardiol,1998,31:224-230.
- [16]Carter AJ,Aggarwal M,Kopia GA,et al.Long-term effects ofpolymer-based,slow-release,sirolimus-eluting stents in a porcinecoronary model.Cardiovasc Res,2004,63:617-624.
- [17]Lincoff AM,Furst JG,Ellis SG,et al.Sustained local deliveryof dexamethasone by a novel intravascular eluting stent to preventrestenosis in the porcine coronary injury model.J Am Coll Cardi-ol,1997,29:808-816.