雷帕霉素药物洗脱支架治疗老年退行性冠状动脉粥样硬化性心脏病无保护左主干病变：前瞻性、非随机、对照临床试验方案及预试验结果  

Rapamycin-eluting stents for unprotected left main coronary artery stenosis in coronary atherosclerosis in the older adults:study protocol for a prospective,non-randomized,controlled trial and preliminary results

作　　者：陈伟 方志成 郑翔 刘伯毅 赵继先 廖应英 Chen Wei;Fang Zhi-cheng;Zheng Xiang;Liu Bo-yi;Zhao Ji-xian;Liao Ying-ying(Department of Critical Care Medicine;Department of Cardiovascular Medicine;Department of Digestion,Taihe Hospital（Affiliated Hospital of Hubei University of Medicine）,Shiyan 442000,Hubei Province,China)

机构地区：[1]十堰市太和医院(湖北医药学院附属医院)重症医学科,湖北省十堰市442000 [2]十堰市人民医院(湖北医药学院附属医院)心血管内科,湖北省十堰市442000 [3]十堰市人民医院(湖北医药学院附属医院)消化内科,湖北省十堰市442000

出　　处：《中国组织工程研究》2018年第18期2890-2895,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:冠脉旁路移植术常被认为是治疗冠状动脉粥样硬化性心脏病无保护左主干(unprotected left main coronary artery,ULMCA)病变的金标准疗法。近年来研究表明,药物洗脱支架在治疗ULMCA病变后的心血管不良事件发生率更低,甚至有研究者认为药物洗脱支架将取代冠脉旁路移植术成新的为治疗金标准,但国内外学者对此尚有一定争议。目的:试验拟观察采用雷帕霉素药物洗脱支架植入治疗老年ULMCA病变的安全性和有效性,并与冠脉旁路移植术治疗进行比较。方法:纳入十堰市太和医院(湖北医药学院附属医院)心内科和十堰市人民医院(湖北医药学院附属医院)心内科收治的老年退行性ULMCA病变患者224例,按治疗方式的不同分为2组,支架组采用雷帕霉素药物洗脱支架植入治疗,冠脉旁路移植术采用冠脉旁路移植治疗,每组112例,术后随访9,12,24,36个月。研究中有效性的主要结局指标为术后36个月病变血管再次血运重建率。研究的次要结局指标为术后9,12,24个月病变血管再次血运重建率;术后9,12,24,36个月的血栓事件发生率、病变血管再狭窄率、病死率、死亡原因及生存时间。术前,术后9,12,24,36个月的病变血管的动脉造影形态。研究的安全性指标为术后9,12,24,36个月主要不良心脑血管事件发生率。课题组从2016年1月到2017年12月收集86例患者,分成支架组48例,冠脉旁路移植38例。预试验结果显示,与冠脉旁路移植组比较,支架组术前等待时间,术后住院时间及完全血运重建率均降低(P<0.05)。术后6个月,两组病死率、心肌梗死发生率、再次血运重建率及心脑血管不良事件发生率差异无显著性意义(P>0.05)。试验经十堰市太和医院和十堰市人民医院医学伦理委员会批准(审批单位:十堰市太和医院,审批时间2017年7月;审批号:TH005X;十堰市人民医院,审批时间2017年7月,审批号:RM011X)。研究符合世界BACKGROUND： Coronary artery bypass grafting （CABG） is the gold standard therapy for unprotected left main coronary artery （ULMCA） stenosis in coronary atherosclerosis. However, the treatment of ULMCA stenosis using drug-eluting stents has recently been reported to lead to a relatively low incidence of cardiovascular events.Thus,drug-eluting stents are a potential surrogate for CABG,and could become the new gold standard treatment for ULMCA stenosis; however, this issue remains controversial. OBJECTIVE： To explore the safety and efficacy of CABG versus rapamycin-eluting stents for ULMCA stenosis in older adult patients with degenerative coronary atherosclerosis. METHODS： The proposed prospective, non-randomized, controlled trial will include 224 older adult patients with degenerative coronary atherosclerosis with ULMCA stenosis being treated at the Department of Cardiology at Taihe Hospital and Renmin Hospital of Shiyan, China. Patients will be divided into two groups in accordance with each patient’s treatment choice and indications （n=112/group）： the stent group will receive rapamycin-eluting stents, while the CABG group will undergo CABG.All patients will be followed up at 9, 12, 24, and 36 months postoperatively. The primary outcome measure will be the rate of repeat revascularizations in the target lesion at 36 months postoperatively.The secondary outcome measures will be the rates of repeat revascularizations in the target lesion at 9, 12, and 24 months postoperatively, the rate of restenosis, mortality, causes of death, and survival at 9, 12, 24, and 36 months postoperatively, and the angiographic appearance of the diseased vessels preoperatively and at 9, 12, 24, and 36 months postoperatively. The safety indicator will be the incidence of major adverse cardiac and cerebrovascular events at 9, 12, 24, and 36 months postoperatively. Eighty-six older adult patients with degenerative coronary atherosclerosis who underwent treatment of ULMCA stenosis between January 2016 and December 2017

关 键 词：冠状动脉粥样硬化性心脏病 雷帕霉素药物洗脱支架 冠脉旁路移植术 无保护左主干病变 主要不良心脑血管事件 靶病变血运重建率 晚期管腔丢失 组织工程 

分 类 号：R318[医药卫生—生物医学工程]