摘要
目的评价国产第二代生物可降解聚合物雷帕霉素药物洗脱支架(EXCELⅡ)治疗原发原位冠状动脉病变患者的长期疗效与安全性。方法本研究为EXCELⅡ支架上市前首次人体临床研究,前瞻性入选45例原发原位冠状动脉病变的冠心病患者,均植入EXCELⅡ支架1枚,术后使用双联抗血小板药物(阿司匹林和氯吡格雷)12个月,此后长期单用阿司匹林。本研究主要终点为3年的靶病变失败(TLF),为心源性死亡、靶血管心肌梗死(TVMI)和临床症状驱动的靶病变血运重建(CI-TLR)组成的复合终点;次要终点为患者水平的不良临床事件(PoCE,包括全因死亡、所有心肌梗死及任何血运重建)和支架内血栓。结果本研究45例患者,3年随访无TLF事件的发生;Po CE事件发生率为6.7%(3/45),其中,1例为非心源性死亡,2例为非靶病变血运重建;3年随访无支架内血栓事件发生。结论 3年临床随访资料证明,EXCELⅡ支架在治疗原发原位冠状动脉病变中是安全、有效的。
Objective To evaluate the long-term efficacy and safety of a second generation biodegradable polymer sirolimus-eluting stent（ EXCEL Ⅱ） in the treatment of patients with De Novo coronary lesions. Methods CREDIT-Ⅰtrial was first-in-ma,pre-market study of EXCEL Ⅱ stent. A total of 45 patients with De Novo Coronary Lesions exclusively treated with EXCEL Ⅱ stents were prospectively enrolled. After surgery,all patients received dual antiplatelet therapy（ aspirin plus clopidogrel） at least 12 months,then take long-term aspirin alone. The primary endpoint was target lesion failure（ TLF） in 3 years,defined as the composite of cardiac death,target vessel myocardial infarction（ TVMI） and ischemia-driven target lesion revascularization（ CI-TLR）. The secondary endpoint was patient-oriented composite endpoint（ PoCE） of all-cause death,all myocardial infarction（ MI） and any revascularization. Results All the45 cases had no event of TLF and stent thrombosis during 3 years follow-up. The rate of Po CE was 6. 7%（ 3/45）,1 case of all-cause death and 2 cases of non target vessel revascularization. Conclusion Three years follow-up clinical data demonstrates that EXCEL Ⅱstents in the treatment of De Novo coronary lesions is safe and effective.
出处
《临床军医杂志》
CAS
2017年第10期991-994,共4页
Clinical Journal of Medical Officers
基金
国家十三五重点研发计划项目(2016YFC1301300)
国家十三五重点研发计划课题(2016YFC1301303)
