Endeavor resolute支架和国产西罗莫司药物洗脱支架治疗冠心病的长期疗效比较

发布时间：2018-03-17 15:09

本文选题：冠状动脉粥样硬化性心脏病　切入点：Endeavor　出处：《安徽医科大学》2016年硕士论文　论文类型：学位论文

【摘要】：目的:对比观察Endeavor resolute药物洗脱支架和国产西罗莫司药物洗脱支架Firebird2TM、Excel、Partner治疗冠心病患者长期疗效的安全性和有效性。方法:将285例植入药物洗脱支架的冠心病患者纳入此项历史性队列研究,Endeavor resolute支架组(155例)和国产西罗莫司药物洗脱支架组(130例)。观察终点包括主要不良心血管事件(非致死性心肌梗死、致死性心肌梗死、靶血管血运重建)和次要终点事件(心脏原因再次入院、心功能衰竭),分别于2014年12月15号至2014年12月25号对患者进行电话随访和门诊随访,平均随访时间35.95±15.99月,最终随访到252例Endeavor resolute支架组(139例)和国产西罗莫司药物洗脱支架组(113例)。统计分析,计量资料采用均数±标准差表示,两组比较采用t检验或Wilcoxon秩和检验。计数资料采用例数、率或构成比表示,两组之间的比较采用卡方检验或Fisher确切概率法。以P0.05为差异有统计学意义。最后对两组主要疗效指标进行非劣效性检验,未发生MACE事件表示疗效良好,设定非劣效性界值为0.05。结果:1.两组冠心病患者的基线情况:Endeavor resolute支架组和国产西罗莫司支架组患者的平均年龄、性别、高血压、糖尿病患者人数、血脂异常、吸烟、饮酒、脑血管疾病、外周血管疾病、既往PCI、冠心病家族史等均无统计学意义(P0.05)。2.Endeavor resolute支架组和国产西罗莫司药物洗脱支架组入院时诊断:STEMI、NSTEMI、陈旧性心肌梗死、稳定型心绞痛、不稳定型心绞痛,两组之间均无统计学意义(P值0.05)。3.两组患者植入支架情况的t检验均无统计学意义(P0.05)。4.两组之间的实验室检查项目t检验均无统计学意义(P0.05)。5.两组之间的冠状动脉病变均情况均无统计学意义(P0.05)。6.随访结果,Endeavor resolute支架组和国产西罗莫司药物洗脱支架组失访人数分别为16例、17例,两组发生MACE分别为9例、12例,两组致死性心肌梗死分别为1例、6例,两组再次血运重建分别为8例、6例,其中再次PCI的患者分别为6例、3例,经冠状动脉旁路移植术血运重建的患者分别为2例、3例,两组患者的全因死亡分别为3例、8例,对于存活的患者NYHA心功能Ⅰ级分别有132例、96例,NYHA心功能Ⅱ级分别有3例、8例,NYHA心功能Ⅲ级分别有1例、1例,因心脏原因再次入院的患者分别为34例、31例。两组患者的MACE、靶血管再次血运重建、全因死亡、NYHA心功能Ⅱ级、心脏原因再次入院均无统计学意义(P0.05)。其中两组致死性心肌梗死Fisher确切概率法P值为0.0476,有统计学意义,NYHA心功能Ⅰ级卡方检验P值为0.0071,有统计学意义。7.两组患者MACE发生率时间曲线:两组患者植入支架后前20个月的MACE事件发生无明显差异,20个月之后Endeavor resolute支架组MACE事件几乎不再增加,国产西罗莫司药物洗脱支架组MACE事件仍然不断增加。8.两组非劣效性检验,设定非劣效性界值为0.05,统计结果为:Z=2.5604,P=0.0052,两组率的差值为0.0414,其95%可信区间为[-0.0286,0.1114]。结论:Endeavor resolute支架对冠心病患者的长期疗效非劣于国产西罗莫司药物洗脱支架。
[Abstract]:Objective: To observe the stent and homemade sirolimus drug-eluting stent Firebird2TM, Endeavor resolute Excel drug eluting, safety and efficacy of Partner treatment of long-term curative effect in patients with coronary heart disease. Methods: 285 cases of implantation of drug-eluting stents in patients with coronary heart disease included in this historical cohort study, Endeavor resolute stent group (155 cases) and domestic sirolimus eluting stent group (130 cases). The observation end point including major adverse cardiovascular events (nonfatal myocardial infarction, nonfatal myocardial infarction, target vessel revascularization) and secondary end point events (heart function causes of readmission, failure), respectively in December 15, 2014 to December 25, 2014 with telephone follow-up and outpatient follow-up, the average follow-up 35.95 + 15.99 months, eventually up to 252 cases of Endeavor resolute stent group (139 cases) and domestic drug eluting stent West Romo company Group (113 cases). Statistical analysis, measurement data expressed by the mean and standard deviation, two groups were compared with t test or Wilcoxon test. Enumeration data by the number of cases, the rate or constituent ratio, chi square test or Fisher exact test was used to compare between the two groups. The difference is with P0.05 at the end of the two groups was statistically significant. The main index of the curative effect of non inferiority, MACE said the incident did not occur with good effect, setting a noninferiority margin of 0.05. results: at baseline 1. two groups of patients with coronary heart disease: Endeavor resolute stent group and sirolimus support groups of patients with mean age, gender, hypertension. The number of patients with diabetes, dyslipidemia, smoking, drinking, cerebrovascular disease, peripheral vascular disease, previous PCI, family history of coronary heart disease were not statistically significant (P0.05).2.Endeavor resolute stent group and domestic drug eluting stent group West Romo company into The hospital diagnosis: STEMI, NSTEMI, old myocardial infarction, stable angina, unstable angina, between the two groups were not statistically significant (P = 0.05) t test.3. two groups of patients with stent implantation conditions were not statistically significant (P0.05) laboratory examination between the two groups.4. t test project there were no significant coronary artery disease (P0.05) between the two groups of.5. were not statistically significant (P0.05).6. Endeavor resolute follow-up stent group and sirolimus eluting stent group lost there were 16 cases, 17 cases, two groups of MACE were 9 cases, 12 cases, two groups fatal myocardial infarction were 1 cases, 6 cases, two groups of revascularization were 8 cases, 6 cases, which again PCI patients were 6 cases, 3 cases with coronary artery bypass graft revascularization patients were 2 cases, 3 cases, two groups were all because the death of 3 cases were 8. For example, patients with NYHA heart function grade of survival were 132 cases, 96 cases, NYHA cardiac function grade II were 3 cases, 8 cases, NYHA grade of heart function were 1 cases, 1 cases, re hospitalization for cardiac causes were 34 cases, 31 cases of the two groups of patients. MACE, target vessel revascularization, all-cause death, heart function NYHA grade II, cardiac causes of readmission were not statistically significant (P0.05). Two of them died of myocardial infarction group Fisher exact test P value was 0.0476, with statistical significance, NYHA heart function grade of chi square test P value was 0.0071. There was statistical significance in two groups of patients with.7. incidence of MACE time curve: two groups of patients after stent implantation for 20 months before the MACE incident had no significant difference after 20 months Endeavor resolute stent group MACE event almost no increase, domestic sirolimus eluting stent group MACE events are increasing in.8. two group non inferior Effect of test set, a noninferiority margin of 0.05, the statistical results were: Z=2.5604, P=0.0052, the rate of differences between the two groups was 0.0414, 95% confidence interval was [-0.0286,0.1114]. conclusion: the long-term efficacy of resolute stent in patients with coronary heart disease Endeavor is not inferior to the domestic sirolimus eluting stent.

【学位授予单位】：安徽医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R541.4

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