载雷帕霉素可降解聚合物涂层支架治疗冠心病的临床观察  

Safety and efficacy comparison between rapamycin-eluting stent with biodegradable polymer or permanent polymer in patients with coronary artery disease

作　　者：张玉霄[1] 卢才义[1] 薛桥[1] 刘鹏[1] 颜伟[1] 吴兴利[1] 陈瑞[1] 

机构地区：[1]解放军总医院老年心血管病研究所,北京100853

出　　处：《中华心血管病杂志》2006年第11期971-974,共4页Chinese Journal of Cardiology

摘　　要：目的以Cypher支架为标准,评价载雷帕霉素可降解聚合物涂层支架(EXCEL支架)治疗冠心病(CAD)的安全性和临床效果。方法采用前瞻性、非随机对比研究方法,根据入选和剔除标准入选60例CAD患者,根据所置入支架分为EXCEL组(n=32)和Cypher组(n=28);相同方法进行冠状动脉造影(CAG)和支架置入;以6个月主要不良心脏事件(MACE)、再狭窄率、直径狭窄程度和晚期管腔丢失(LLL)为研究终点评价EXCEL支架治疗CAD的安全性和临床效果。结果平均随访(6.04±2.12)个月,两组MACE发生率均为0;EXCEL组27例(84.38%)和Cypher组10例(35.71%)于术后平均(6.04±2.12)个月接受了定量冠状动脉造影随访。各组再狭窄率均为0;直径再狭窄率分别为(5.98±5.52)%和(5.21±6.3)%,LLL分别为-(0.02±0.09)mm和-(0.01±0.07)mm,上述各项指标差异均无统计学意义(P>0.05)。两组均未发现与雷帕霉素及其聚合物相关的不良反应。结论EXCEL支架治疗CAD安全有效。在降低主要心脏不良事件、预防再狭窄和LLL方面可获得与Cypher支架同样满意的临床效果。Objective To evaluate the safety and efficacy of rapamycin-eluting stent with biodegradable polymer （EXCEL） or permanent polymer （Cypher） in patients with coronary artery disease （CAD）. Methods In this prospective, non-random and comparative study, 60 patients with CAD were divided into EXCEL group （ n = 32 ） and Cypher group （ n = 28 ）. The coronary angiography （ CAG ） and stenting procedure were identical. The safety and efficacy of EXCEL stent was evaluated by major adverse cardiac events （ MACE ） , restenosis rate and percent diameter stenosis rate as well as late luminal loss （LLL） at six months post stenting. Results During follow-up （mean： 6. 04 ±2. 12 months）, there was no MACE in the two groups. Quantitative coronary angiography （QCA） data at 6. 0± 2. 1 months post stenting were available in 27 patients （84.38%） in EXCEL group and 10 patients （ 35.71% ） in Cypher group. Restenosis rate was zero in both groups. Percent diameter stenosis rate （5.98% ± 5.52% vs. 5.21% _± 6.3%） and LLL （ -0.02 ± 0.09 mm vs. -0.01 ±0.07 mm） were similar between the 2 groups. Conclusions EXCEL stent was safe for the treatment of CAD and comparable as Cypher stent in preventing MACE and restenosis at 6 months post stenting.

关 键 词：冠状动脉硬化 支架 西罗莫司 聚合物 移植物闭塞 血管 

分 类 号：R541.4[医药卫生—心血管疾病]