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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 domestic second-generation biodegradable polymer rapamycin eluting stent (EXCELⅡ) in the treatment of patients with primary coronary artery lesions. Methods This study was the first human clinical study of EXCEL Ⅱ stent before the market. 45 patients with coronary artery disease of primary primary coronary artery disease were prospectively enrolled, one of which was implanted with EXCELⅡ stent. Postoperative double antiplatelet drugs (aspirin and chlorine Piogliturine) for 12 months, followed by long-term aspirin alone. The primary endpoint of this study was 3-year target lesion failure (TLF), which is the composite endpoint of cardiac death, target-vessel-myocardial infarction (TVMI), and clinical-pathologic target lesion revascularization (CI-TLR) Endpoints were patient-level adverse clinical events (PoCE, including all-cause death, all myocardial infarctions, and any revascularization) and stent thrombosis. Results The 45 patients in our study had no TLF events at 3-year follow-up. The incidence of Po CE events was 6.7% (3/45), of which 1 was noncardiac death and 2 was non-target lesion revascularization ; 3-year follow-up no stent thrombosis occurred. Conclusion The clinical follow-up data of 3 years proved that EXCEL Ⅱ stent is safe and effective in treating primary coronary lesions.