第二代生物可降解聚合物涂层西罗莫司洗脱支架治疗原发原位冠心病患者的长期疗效分析

Long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases

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.

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 CREDITⅡtrial 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.