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学科主题: 临床医学
题名:
Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial
作者: Yuan Fei1; Chen Xin1; Song Xiantao1; Wang Dongqi2; Zhang Zheng3; Li Weimin4; Li Zhanquan5; Li Hui6; Chen Xinyi7; Huo Yong8; Wang Lefeng9; Lu Caiyi10; Lu Qinghua11; Xu Bo12,13,14; Li Wei15; Lyu Shuzheng1; HOPE Investigator
关键词: biodegradable polymer ; titanium oxides films ; drug-eluting stents
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2014-07-20
DOI: 10.3760/cma.j.issn.0366-6999.20140010
卷: 127, 期:14, 页:2561-2566
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: BARE-METAL STENTS ; NETWORK METAANALYSIS ; RANDOMIZED-TRIALS ; DRUG ; THROMBOSIS ; IMPLANTATION ; HEMOCOMPATIBILITY ; RESTENOSIS ; REDUCTION ; TITANIUM
英文摘要:

Background Drug-eluting stents (DES) with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELIOS completed biodegradable polymer sirolimus-eluting stent (SES) in de novo coronary lesions.

Methods Totally, 287 patients with one or two de novo coronary lesions (lesion length 538 mm and reference vessel diameter 2.5-4.0 mm) were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES (n=142) or PARTNER durable polymer SES (n=145). The primary endpoint was angiographic in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR).

Results The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, (0.16 +/- 0.22) mm vs. (0.19 +/- 0.30) mm (P=0.28). The difference and 95% confidence interval were -0.03 (-0.09, 0.04), and the P value for non-inferiority <0.01. Major adverse cardiovascular event (MACE) occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER group at three-year follow-up (all P>0.05). The three-year cardiac death was lower in the HELIOS group, but with no significant difference, 0 vs. 3.0% (P=0.12).

Conclusions In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clinical endpoints was low for both of the stents in three-year follow-up.

语种: 英语
WOS记录号: WOS:000339860900001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/56921
Appears in Collections:北京大学第一临床医学院_心血管内科_期刊论文

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作者单位: 1.Natl Ctr Cardiovasc Dis China, Beijing 100037, Peoples R China
2.Capital Med Univ, Dept Cardiol, Beijing Anzhen Hosp, Beijing 100029, Peoples R China
3.Xi An Jiao Tong Univ, Dept Cardiol, Affiliated Hosp 1, Xian 710061, Shaanxi, Peoples R China
4.Lanzhou Univ, Dept Cardiol, Affiliated Hosp 1, Lanzhou 730000, Gansu, Peoples R China
5.Harbin Med Univ, Dept Cardiol, Affiliated Hosp 1, Harbin 150001, Heilongjiang, Peoples R China
6.Peoples Hosp Liaoning Prov, Dept Cardiol, Shenyang 110016, Liaoning, Peoples R China
7.Gen Hosp Daqing Oilfield, Dept Cardiol, Daqing 163411, Heilongjiang, Peoples R China
8.Peoples Hosp Shaanxi Prov, Dept Cardiol, Xian 710068, Shaanxi, Peoples R China
9.Peking Univ, Dept Cardiol, Hosp 1, Beijing 100044, Peoples R China
10.Capital Med Univ, Dept Cardiol, Chaoyang Hosp, Being 100020, Peoples R China
11.Chinese Peoples Liberat Army Gen Hosp, Dept Cardiol, Beijing 100853, Peoples R China
12.Shandong Univ, Dept Cardiol, Hosp 2, Jinan 250033, Shandong, Peoples R China
13.Chinese Acad Med Sci, Cardiac Catheterizat Lab, Cardiovasc Inst, Beijing 100037, Peoples R China
14.Chinese Acad Med Sci, Fuwai Hosp, Beijing 100037, Peoples R China
15.Peking Union Med Coll, Beijing 100037, Peoples R China

Recommended Citation:
Yuan Fei,Chen Xin,Song Xiantao,et al. Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial[J]. CHINESE MEDICAL JOURNAL,2014,127(14):2561-2566.
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