国产可降解涂层西罗莫司洗脱支架在冠状动脉长病变中的应用  

Application of Tivoli sirolimus-eluting stents in management of long coronary lesions

作　　者：乔冰[1] 韩雅玲[1] 荆全民[1] 马颖艳[1] 王守力[1] 李毅[1] 徐波[2] 高润霖[2] 

机构地区：[1]沈阳军区总医院全军心血管病研究所心内科,110016 [2]北京阜外心血管病医院

出　　处：《上海医学》2010年第5期408-412,共5页Shanghai Medical Journal

摘　　要：目的初步评价国产可降解涂层西罗莫司洗脱支架(Tivoli支架)治疗冠状动脉长病变的可行性、安全性及有效性。方法 2007年8月-2008年2月共有55例原位冠状动脉长病变的患者分别接受Tivoli支架(Tivoli组,28例)和进口左他莫司洗脱支架(Endeavor组,27例)治疗,观察两组患者的手术即刻成功率、术后8个月冠状动脉造影结果、术后270d时的主要不良心脏事件(MACE)及支架内血栓事件的发生率。结果治疗前,Tivoli组既往有心肌梗死者占50.0%(14/28),显著高于Endeavor组的11.1%(3/27,P=0.002);左心室射血分数为(0.600±0.044),显著低于Endeavor组的(0.659±0.060)(P=0.003);平均病变长度为(29.5±12.5)mm,显著高于Endeavor组的(22.19±9.43)mm(P=0.006)。两组支架植入的成功率均为100%。术后8个月,Tivoli组和Endeavor组的造影随访率分别为92.9%(26/28)和92.6%(25/27),支架内再狭窄的发生率分别为10.5%(4/26)和3.3%(1/25)(P=0.370),支架内晚期管腔丢失分别为(0.37±0.47)和(0.59±0.49)mm(P=0.108);术后270d的随访率为100%,两组均无死亡、心肌梗死和血栓事件发生,MACE的发生率分别为10.7%(3/28)和7.4%(2/27,P=1.000),均为靶病变血运重建。结论 Tivoli支架在冠状动脉长病变中应用的中期疗效及安全性与进口左他莫司洗脱支架相似,初步表明其用于冠状动脉长病变的治疗是可行的。Objective To preliminarily evaluate the feasibility, safety and efficacy of domestic biodegradable polymer-coated sirolimus-eluting stents （Tivoli stents） in treatment of long coronary lesions. Methods A total of 55 patients with de nove long coronary lesions received Tivoli stent （n=28） or zotarolimuseluting stent （Endeavor, n = 27） implantation during August 2007 to February 2008. The procedural success rate was monitored. A repeated angiographic study was scheduled after 8 months and all the patients were followed up clinically up to 270 days to observe the major adverse cardiac events （MACE） and stent thrombosis events. Results Before treatment, patients in Tivoli stent group had a significantly higher incidence of remote myocardial infarction （50,0% [14/28] vs. 11.1% [3/27], P = 0. 002）, a significantly lower left ventricular ejection fraction （[0. 600 ± 0. 044] VS. [0. 659 ± 0. 060], P = 0. 003）, and a significantly longer mean length of lesions （[29.53 ± 12.50] mm vs. [22.19±9.43] mm, P=0. 006] compared to the Endeavor group. Other baseline clinical and angiographic findings were similar in the two groups. The successful rates of stent implantationwere 100% in both groups. The rates of angiographic follow-up were 92.9 % （26/28）and 92.6 % （25/27）, the rates of in-stent stenosis were 10.5 % （4/26） and 3.3 % （1/25） （ P = 0. 370）, and in-stent late losses were （0.37 ±0.47） mm and （0.59 ±0.49） mm （ P = 0. 108） in Tivoli and Endeavor group, respectively. All the patients were followed up for 270 days after operation, and there were no death, myocardial infarction or stent thrombosis. The rate of MACE was 10.7% （3/28） in Tivoli group and 7.4% （2/27, P=1.000） in Endeavor group, with all being the target lesion revascularization. Conclusion The safety and mid-term efficacy of domestic biodegradable polymer-coated sirolimus-eluting stents is similar to that of imported zotarolimus-eluting stents for long coronary lesions, which preliminarily sho

关 键 词：西罗莫司 支架 冠状动脉疾病 长病变 生物可吸收 

分 类 号：R541.4[医药卫生—心血管疾病]