摘要目的:评价第二代生物可降解涂层钴铬合金西罗莫司洗脱支架EXCROSSAL治疗原发原位冠状动脉病变的长期安全性和有效性。方法:本研究纳入CREDIT Ⅱ研究和CREDIT Ⅲ研究中置入EXCROSSAL支架的冠心病患者，CREDIT Ⅱ研究是一项随机对照研究，CREDIT Ⅲ研究是一项单臂研究。本研究从2013年11月至2014年12月于全国33个中心共成功入选置入EXCROSSAL支架的原发原位冠状动脉病变患者833例。主要终点为支架置入后5年靶病变失败（TLF），即心原性死亡、靶血管心肌梗死和临床症状驱动的靶病变血运重建组成的复合终点；次要终点为支架置入后5年患者相关的心血管复合终点（PoCE，包含全因死亡、所有心肌梗死及任何临床症状驱动的血运重建组成的复合终点）和依据美国学术研究联合会定义的支架内血栓。采用Kaplan-Meier法计算术后5年TLF及PoCE发生率。采用单因素Cox回归分析糖尿病、小血管病变（血管直径≤2.74 mm）、病变长度≥16.7 mm和多支病变对术后5年TLF发生情况的影响。结果:共纳入833例置入EXCROSSAL支架的冠心病患者，年龄为（59.3±9.1）岁，其中男性579例（69.5%）。811例（97.4%）患者完成了5年随访。EXCROSSAL支架置入5年TLF发生率为10.6%（86/811），PoCE发生率为15.5%（126/811），支架内血栓发生率为1.0%（8/811）。单因素Cox回归分析结果显示血管直径≤2.74 mm（ HR=3.20，95% CI 1.90~5.39， P<0.001），病变长度≥16.7 mm（ HR=1.88，95% CI 1.18~2.99， P=0.007）和多支病变（ HR=2.44，95% CI 1.60~3.72， P<0.001）是术后5年TLF的相关因素。 结论:EXCROSSAL支架治疗原发原位冠状动脉病变的长期有效性与安全性较好，术后5年TLF及PoCE的发生率均较低。

abstractsObjective:To evaluate the five-year safety and efficacy of the second generation biodegradable polymer sirolimus-eluting stent (EXCROSSAL) in treating patients with de novo coronary artery diseases.Methods:Patients with coronary artery disease (CAD)who were implanted with EXTROSSAL stents in CREDIT Ⅱ and CREDIT Ⅲ study were included. CREDIT Ⅱ was a randomized trial, and CREDIT Ⅲ was a single-arm study. From November 2013 to December 2014, 833 CAD patients with de novo coronary lesions implanted with EXTROSSAL stents were selected from 33 centers in China. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. Secondary endpoints was patient-oriented composite endpoint (PoCE), including all-cause death, all myocardial infarction, or any revascularization within 5 years post stenting and stent thrombosis according to Academic Research Consortium′s (ARC) definition. Kaplan Meier method was used to calculate the incidence of TLF and PoCE within 5 years after operation. Univariate Cox regression analysis was used to analyze the impacts of diabetes, small vessel disease (vessel diameter ≤ 2.74 mm), lesion length ≥ 16.7 mm and multivessel disease on the incidence of TLF within 5 years after operation.Results:A total of 833 patients were included in this study including 579 males (69.5%), the age was (59.3±9.1) years. And 832 (99.9%) patients completed 5-year clinical follow-up. The incidence of TLF and PoCE in the 5-year follow-up were 10.6%(86/811) and 15.5%(126/811), respectively. Stent thrombosis occurred in 1.0%(8/811) of patients. Univariate Cox regression analysis showed that vessel diameter ≤ 2.74 mm ( HR=3.20,95% CI 1.90-5.39, P<0.001), lesion length ≥ 16.7 mm ( HR=1.88,95% CI 1.18-2.99, P=0.007) and multivessel disease ( HR=2.44,95% CI 1.60-3.72, P<0.001) were related factors of TLF within 5 years after operation. Conclusion:EXCROSSAL stent is effective and safe in treating CAD patients with de novo coronary lesions, with low incidence of TLF and PoCE within 5 years after operation.