Long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases
10.3760/cma.j.issn.0253-3758.2019.10.004
- VernacularTitle: 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
- Author:
Geng WANG
1
;
Liya BIAN
;
Yi LI
;
Quanmin JING
;
Xiaozeng WANG
;
Haiwei LIU
;
Bin WANG
;
Kai XU
;
Yaling HAN
Author Information
1. Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
- Publication Type:Journal Article
- Keywords:
Coronary artery disease;
Drug-eluting stent;
Biodegradable-polymer;
Prognosis
- From:
Chinese Journal of Cardiology
2019;47(10):784-789
- CountryChina
- Language:Chinese
-
Abstract:
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.
