BuMA与Endeavor冠状动脉支架系统的安全性和有效性评估  

A perspective multi center parallel controlled of BuMA^(TM) vs. Endeavor clinical trail program

作　　者：陈欣[1] 田锐[1] 汪国忠[1] 史冬梅[1] 王志坚[1] 迟云鹏[1] 戴文龙[1] 王春梅[1] 卢春山[1] 陈练[2] 刘宏斌[2] 刘长福[2] 李惟铭[3] 倪祝华[3] 李强[3] 张俊杰[4] 林松[4] 袁龙[5] 刘莉[5] 王丽霞[6] 宋坤鹏[6] 齐大屯[6] 张芙荣[7] 邱原刚[7] 尚云鹏[7] 朱岩[8] 卢耀军[9] 吕树铮[1] 周玉杰[1] 陈韵岱[2] 颜红兵[10,1] 王乐丰[3] 陈绍良[4] 李占全[5] 高传玉[6] 朱建华[7] 赵全明[1] 朱小玲[1] 郭成军[1] 李丽[8] 赵瑞平[9] 

机构地区：[1]首都医科大学附属北京安贞医院,100029 [2]中国人民解放军总医院 [3]首都医科大学附属北京红十字朝阳医院 [4]南京医科大学附属南京第一医院 [5]辽宁省人民医院 [6]河南省人民医院 [7]浙江大学医学院附属第一医院 [8]甘肃省人民医院 [9]包头市中心医院 [10]中国医学科学院北京协和医学院阜外心血管病医院

出　　处：《中国介入心脏病学杂志》2013年第3期137-141,共5页Chinese Journal of Interventional Cardiology

摘　　要：目的比较BuMA生物降解药物涂层冠状动脉支架系统与Endeavor冠状动脉支架系统的有效性和安全性。方法采用前瞻性、平行对照、多中心、非劣效性检验研究,国内9个中心参与研究,2008年2月至2008年8月同期入选224例无症状心肌缺血、稳定型或不稳定型心绞痛及心肌梗死超过1周,需要行冠状动脉支架置入术的患者,其中BuMA支架组(试验组)113例,Endeavor支架组(对照组)111例。研究的主要终点为支架置入后(270±30)d使用定量冠状动脉造影(QCA)测定的晚期管腔丢失。次要终点为支架置入后30 d、90 d、180 d、270 d、360 d和540 d的主要不良心血管事件(MACE)、支架血栓事件,并继续随访到术后720 d。结果支架置入后(270±30)d的晚期管腔丢失,BuMA组和Endeavor组分别为0.24 mm和0.50 mm,差异有统计学意义。支架置入后540 d的MACE发生率,BuMA组为6.19%,Endeavor组为8.11%(χ2=0.3097,P=0.5788)。继续随访到术后720 d,MACE发生率,BuMA组仍为6.19%,Endeavor组为9.91%(χ2=1.0533,P=0.3048)。结论 BuMA生物降解药物涂层冠状动脉支架与Endeavor冠状动脉支架相比,能够显著减少晚期管腔丢失,提示BuMA支架在降低支架再狭窄方面可能优于Endeavor支架且具有良好的安全性和有效性。Objective To evaluate the efficacy and safety of BuMA Biodegradable drug eluting coronary stent system compare with the Endeavor Coronary stent system. Methods This is a prospective, parallel-group controlled, multi-center, non-inferiority test study performed in nine centers in China. From Feb. 2008 to Aug. 2008, 224 patients with silent myocardial ischemia, stable or unstable angina and myocardial infarction more than a week, who undertook coronary stentt angiography, were enrolled in the study. Eligible patients were divided into BuMA stent group （test group, 113 patients） and Endeavor stent group （ control group, 111 patients）. The primary endpoint of the study was a 270 （ ± 30） day late lumen loss measured by quantitative coronary angiography （QCA）. The sencondary endpoint was the incidence of major adverse cardiac events （MACE）, stent thrombosis events after the stent implantation 30 days, 90 days, 180 days, 270 days, 360 days and 540 days, following up till 720 days. Results The late lumen loss in 270 （ ± 30） days in BuMA stent group and Endeavor stent group was 0. 24 mm and 0. 50 mm. The 540-day major adverse cardiac event rate in BuMA group and Endeavor group was 6. 19% and 8. 11%, respectively （X2 = 0. 3097, P = 0. 5778）. The 720-day major adverse cardiac event rate in BuMA group and Endeavor group was 6. 19% and 9.91%, respectively （X2 = 1. 0533, P =0. 3.048）. Conclusions Compared with the Endeavor, BuMA Biodegradable drug eluting coronary stent reduced the late lumen loss, which indicates that BuMA may be superior to the Endeavor stent on reducing stent restenosis. The result also proved the safety and efficacy of BuMA.

关 键 词：药物涂层支架 冠心病 设备安全性 可重复性 结果 

分 类 号：R654.2[医药卫生—外科学]