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题名: Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents: Nine months angiographic and 5-year clinical outcomes
作者: Zhang, Haijun1, 2; Wang, Xiangfei2; Deng, Wei3; Wang, Shenguo1, 4; Ge, Junbo2; Toft, Egon1, 5
关键词: abluminal biodegradable polymer ; late lumen loss ; major adverse cardiovascular events ; sirolimus-eluting stent
刊名: MEDICINE
发表日期: 2016-09-01
卷: 95, 期:38
收录类别: SCI
英文摘要: Background:The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimaxa novel abluminal biodegradable polymer SES and Cypher Selecta durable polymer SES, at 9 months angiographic and 5-year clinical follow-up.Methods:We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up.Results:Cordimax was noninferior to Cypher select for in-stent LLL (0.250.47 vs 0.18 +/- 0.49mm; P = 0.587) and in-stent mean diameter stenosis (22.19 +/- 12.21% vs 19.89 +/- 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039).Conclusion:Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group.
语种: 英语
内容类型: 期刊论文
URI标识: http://ir.iccas.ac.cn/handle/121111/35463
Appears in Collections:高分子物理与化学实验室_期刊论文

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作者单位: 1.Aalborg Univ, Dept Hlth Sci & Technol, Fac Med, Niels, Denmark
2.Zhongshan Hosp, Shanghai Inst Cardiovasc Dis, Shanghai, Peoples R China
3.Fudan Univ, Sch Publ Hlth, Key Lab Publ Hlth Safety, Minist Educ, Shanghai, Peoples R China
4.Chinese Acad Sci, Inst Chem, Beijing, Peoples R China
5.Qatar Univ, Coll Med, Biomed Res Ctr, Postbox 2716, Doha 999043, Qatar
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