比较两种药物洗脱支架在冠心病合并糖尿病患者中的有效性与安全性

发布时间：2018-12-16 17:51

【摘要】：目的:本研究旨在评估国产无聚合物涂层Nano支架与持久聚合物涂层Firebird2TM支架在冠心病合并糖尿病患者中长期应用的有效性和安全性。方法:选取自2015年1月至2015年12月在青岛大学附属医院心内科住院,诊断为冠心病合并糖尿病的患者,在PCI术前将患者随机分为Nano组和Firebird2TM组。无聚合物涂层Nano支架和持久聚合物涂层Firebird2TM支架均为国产第二代药物洗脱支架。所有患者均建议术后12个月行冠脉造影随访。术后患者通过电话、门诊或再住院等方式进行临床随访。主要研究终点为主要不良心脏事件(MACE):包括全因死亡、心肌梗死(MI)、靶血管血运重建(TVR)。次要研究终点为:确定/可能的支架血栓、术后12个月支架内晚期管径丢失大小(LLL)。结果:本研究共纳入314例糖尿病患者(662处病变),其中Nano组168例(351处病变),置入了302枚支架;Firebird2TM组纳入146例(311处病变),置入273枚支架。Nano组与Firebird2TM组间基线资料分布:如年龄、性别、吸烟史、高血压、低密度脂蛋白水平(LDL-C)、左室射血分数(LVEF)等均无显著性差异。两组患者的冠脉造影资料:病变部位主要集中在前降支(36.47%vs.44.37%,P=0.31)和右冠状动脉(36.18%vs.32.48%,P=0.32),但在两组之间没有显著性差异。病变类型、平均支架个数、平均支架长度、平均支架直径及球囊后扩张的比例等均无显著性差异。临床随访15个月后,Nano组与Firebird2TM组相比,主要终点MACE事件发生率有降低趋势(6.55%vs.8.22%,相对危险度RR 0.80,95%置信区间[CI]:0.36-1.75),但没有明显统计学意义(P=0.57),其中Nano组与Firebird2TM组相比,全因死亡(1.79%vs.1.37%,RR 1.30,95%CI:0.22-7.70,P=0.92)、心肌梗死(1.19%vs.2.05%,RR 0.58,95%CI 0.10-3.42,P=0.87)、靶血管血运重建(3.57%vs.4.79%,RR 0.75,95%CI:0.26-2.17,P=0.59)在两组间也无显著差异。术后12个月行造影随访,Nano组31例,Firebird2TM组24例,通过定量冠脉造影分析(QCA)测量支架内晚期管径丢失大小,Nano组支架内晚期管径丢失(0.32±0.23mm)较Firebird2TM组低(0.47±0.25mm),差异有明显统计学意义(P=0.03)。确定/可能的支架血栓在Nano组与Firebird2TM组间的发生率均较低(0.6%vs.0.68%,RR 0.87,95%CI:0.06-13.77,P=1.00)。结论:1、在15个月的临床随访中,国产无聚合物涂层Nano支架与持久聚合物涂层Firebird2TM支架在冠心病合并糖尿病患者中临床应用具有相似的有效性和安全性。2、术后12个月造影随访,QCA测量支架内晚期管径丢失大小,Nano支架内管径丢失大小较Firebird2TM支架小,表明Nano支架在抑制支架内再狭窄的作用较Firebird2TM支架明显。3、Nano支架作为国产新型无聚合物涂层药物洗脱支架的代表,没有晚期聚合物相关的不良反应,但与持久聚合物涂层Firebird2TM支架相比,其晚期支架内血栓风险及需要再次血运重建的比例在两组之间并没有发现明显差异。
[Abstract]:Objective: to evaluate the efficacy and safety of domestic uncoated Nano stents and long-lasting polymer coated Firebird2TM stents in patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods: patients who were hospitalized in Department of Cardiology, affiliated Hospital of Qingdao University from January 2015 to December 2015, were randomly divided into Nano group and Firebird2TM group before PCI. The non-polymer-coated Nano stent and the durable polymer-coated Firebird2TM stent are the second-generation drug-eluting stents made in China. All patients were advised to follow up 12 months after coronary angiography. Postoperative patients were followed up by telephone, outpatient or re-hospitalization. The main endpoint of the study was major adverse cardiac events (MACE):), including all-cause death, myocardial infarction, (MI), target vessel revascularization, (TVR). The secondary end point of the study was to determine / likely stent thrombosis, and the size of late stent diameter loss (LLL).) was 12 months after operation. Results: a total of 314 diabetic patients (662 lesions) were included in this study, including 168 cases (351 lesions) in Nano group and 302 stents were implanted. Firebird2TM group included 146 patients (311 lesions) and placed 273 stents. The distribution of baseline data between Nano group and Firebird2TM group was as follows: age, sex, smoking history, hypertension, low density lipoprotein level (LDL-C). There was no significant difference in left ventricular ejection fraction (LVEF). Coronary angiography data of the two groups: the lesions were mainly located in the anterior descending branch (36.47 vs.44.37) and the right coronary artery (36.18 vs.32.48), but there was no significant difference between the two groups. There was no significant difference in the types of lesions, the number of stents, the length of stents, the mean diameter of stents and the ratio of posterior balloon dilatation. After 15 months of clinical follow-up, the incidence of major end-point MACE events in the Nano group was lower than that in the Firebird2TM group (6.55 vs 8.222.The relative risk RR 0.80% 95% confidence interval [CI]: 0.36-1.75). But there was no significant statistical significance (P < 0. 57), in which the Nano group was all due to death compared with the Firebird2TM group (1. 79 vs.1.37 and RR 1. 30 and 95 CI: 0. 22-7. 70 P0. 92). Myocardial infarction (1.19 vs 2.05), RR 0.58 + 95% CI 0.10-3.42 P0.87, target vessel revascularization (3.57 vs 4.79), RR 0.75% 95CI: 0.26-2.17, There was no significant difference between the two groups. 12 months after operation, 31 cases in Nano group and 24 cases in Firebird2TM group were followed up. The size of late diameter loss in stent was measured by quantitative coronary angiography (QCA). The loss of stent diameter in Nano group (0.32 卤0.23mm) was significantly lower than that in Firebird2TM group (0.47 卤0.25mm) (P < 0.03). The incidence of determined / probable stent thrombus was lower in Nano group and Firebird2TM group (0.6vs.0.68% RR 0.87C95 CI: 0.06-13.77PU 1.00). Conclusion: 1. During the 15-month follow-up, the clinical efficacy and safety of domestic uncoated Nano stents and long-lasting polymer coated Firebird2TM stents in patients with coronary heart disease and diabetes mellitus were similar. After 12 months follow up, QCA was used to measure the size of late diameter loss in stent, and the diameter loss of Nano stent was smaller than that of Firebird2TM stent, which indicated that Nano stent could inhibit restenosis obviously than Firebird2TM stent. As the representative of new drug-eluting stents without polymer coating, Nano stents have no late polymer-related adverse reactions, but compared with long-lasting polymer-coated Firebird2TM stents. There was no significant difference in the risk of late stent thrombosis and the need for revascularization between the two groups.
【学位授予单位】：青岛大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4;R587.1

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