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 BuMATM vs. Endeavor clinical trail program
陈欣,田锐,汪国忠,史冬梅,王志坚,迟云鹏,戴文龙,王春梅,卢春山,陈练,刘宏斌,刘长福,李惟铭,倪祝华,李强,张俊杰,林松,袁龙,刘莉,王丽霞,宋坤鹏,齐大屯,张芙荣,邱原刚,尚云鹏,朱岩,卢耀军,吕树铮,周玉杰,陈韵岱,颜红兵,王乐丰,陈绍良,李占全,高传玉,朱建华,赵全明,朱小玲,郭成军,李丽,赵瑞平
摘要(Abstract)：
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。
关键词(KeyWords)： 药物涂层支架;冠心病;设备安全性;可重复性,结果
基金项目(Foundation):
作者(Author): 陈欣,田锐,汪国忠,史冬梅,王志坚,迟云鹏,戴文龙,王春梅,卢春山,陈练,刘宏斌,刘长福,李惟铭,倪祝华,李强,张俊杰,林松,袁龙,刘莉,王丽霞,宋坤鹏,齐大屯,张芙荣,邱原刚,尚云鹏,朱岩,卢耀军,吕树铮,周玉杰,陈韵岱,颜红兵,王乐丰,陈绍良,李占全,高传玉,朱建华,赵全明,朱小玲,郭成军,李丽,赵瑞平
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