Objective: To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases. Methods: CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting (n=419) were randomized to receive either the EXCEL2 stent (n=208) or the EXCEL stent (n=211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium's (ARC) definition. Results: Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P=0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P=0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P=0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P=0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P=0.285). Conclusion: 3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.
目的： 评价第二代生物可降解聚合物涂层西罗莫司洗脱支架（EXCEL2）治疗原发原位冠心病患者的长期有效性与安全性。 方法： CREDITⅡ研究是一项前瞻性、多中心、随机对照研究。2013年11月至2014年12月在全国15个中心共成功入选419例原发原位冠心病患者，按1∶1的比例随机分为EXCEL支架组（n=211例），EXCEL2支架组（n=208例），分析CREDITⅡ研究的3年临床随访结果。主要终点为支架置入后3年内的靶病变失败（TLF），即心原性死亡、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驱动的血运重建的复合终点）和依据美国学术研究联合会定义的支架内血栓。 结果： 419例患者中413例（98.6%）完成3年随访。与EXCEL支架组比较，EXCEL2支架组3年TLF发生率[5.4%（11/204）比11.5%（24/209），P=0.025]和PoCE发生率[9.8%（20/204）比20.1%（42/209），P=0.003]均较低。其中EXCEL2支架组CI-TLR发生率[2.0%（4/204）比5.7%（12/209），P=0.042]和临床驱动的血运重建发生率[4.9%（10/204）比14.4%（30/209），P=0.001]均低于EXCEL支架组。两组的全因死亡和所有心肌梗死发生率比较，差异无统计学意义（P>0.05）。EXCEL2支架组和EXCEL支架组3年支架内血栓发生率分别为1.0%（2/204）和2.9%（6/209），差异无统计学意义（P=0.285）。 结论： 3年随访结果显示，EXCEL2支架TLF和PoCE发生率较EXCEL支架更低，且仅有2例可能的支架内血栓发生。初步证实了EXCEL2支架治疗原发原位冠心病患者的长期有效性与安全性。.
Keywords: Biodegradable-polymer; Coronary artery disease; Drug-eluting stent; Prognosis.