Firebird2^(TM)和Excel药物洗脱支架治疗冠心病的近期疗效比较

Short-term outcomes of Firebird 2^(TM)stents and Excel stents in treatment of coronary heart disease

目的:比较Excel药物洗脱支架和Firebird 2TM药物洗脱支架在冠心病患者中应用的近期疗效。方法:将2009年12月至2010年9月,在安贞医院连续住院的264例原位冠状动脉病变的患者,纳入本项前瞻性随机对照研究。其中137例仅置入Firebird 2TM药物洗脱支架,127例仅置入Excel药物洗脱支架。规律随访患者,比较2组患者支架术后的心脏不良事件发生率。随访的具体内容包括主要终点事件(全因死亡、靶血管血运重建、非致死性心肌梗死、血栓事件)和次要终点事件(不稳定心绞痛、缺血性脑卒中及心功能衰竭)。分析支架多聚物涂层对心脏不良事件的影响。结果:2组患者年龄、性别、吸烟史、高血压、脂质异常、糖尿病、既往介入治疗、既往心肌梗死、既往冠状动脉旁路手术及本次入院诊断急性心肌梗死所占比例方面差异均无统计学意义。Firebird 2TM药物洗脱支架组患者平均支架个数较Excel药物洗脱支架组个数分别为(1.93±1.13)个和(1.57±0.94)个。临床随访1.84～10.78个月,平均(5.36±1.91)个月,2组患者均未发生心源性死亡、靶病变血管导致的心肌梗死、靶病变缺血导致的血运重建及支架血栓事件。Firebird 2TM药物洗脱支架组患者不稳定心绞痛1例,心力衰竭(心衰)1例,Excel药物洗脱支架组,不稳定心绞痛3例,心衰1例,Kaplan-Meier生存曲线显示2组患者全部终点事件没有差别。结论:Firebird 2TM药物洗脱支架和Excel药物洗脱支架,在冠心病患者中应用的近期安全性方面疗效相似。

Objective：To compare the clinical outcomes of Firebird 2TM Stent versus Excel Stent in treatment of coronary heart disease.Methods： 264 consecutively patients with de novo coronary lesions were enrolled in this prospective,randomize controlled try.137 patients in Firebird 2TM Stent group and 127 patients in Excel Stent group.The adverse cardiac events,which included primary endpoints（all cause death,non death myocardial infarction,stent thrombosis,targeted vascular revascularization） and secondary endpoints（unstable angina,ischemic stroke and heart failure）,covering a period of average half a years were compared between these two groups.And analysis was conducted to identify the relationships between the polymer and adverse cardiac events.Results： There were no statistical differences in age,gender,smoking,hypertension,dyslipidemia,diabetes,past PCI,past MI,past CABG and acute myocardial infarction between the two groups.The average stents in Firebird 2TM Stent group was higher than in Excel Stent group.During the period of follow-up,A total of 6 major cardiac adverse events occurred,one case of unstable angina,one case of heart failure in Firebird 2TM Stent group,three cases of unstable angina,one case of heart failure in Firebird 2TMstent group.There were no incidence of cardiac death,target vessel myocardial infarction,non-fatal myocardial infarction and stent thrombosis in both groups.Kaplan-Meier survival analysis suggested patients between two group had no different events free survival ratio.Conclusion： Implanting Firebird 2TM Stent in the treatment of coronary heart disease was as safe as Excel Stent in short-term period.