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学科主题: 临床医学
题名:
A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based sirolimus-eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of coronary artery disease: 8-month angiographic and 2-year clinical follow-up results
作者: Xu Bo2; Dou Ke-fei1; Han Ya-ling5; Lue Shu-zheng6; Yang Yue-jin1; Huo Yong7; Wang Le-feng8; Chen Yun-dai9; Wang Hai-chang10; Li Wei-min11; Chen Ji-yan12; Wang Lei13; Wang Yong14; Ge Jun-bo15; Li Wei16; Gao Run-lin1
关键词: TIVOLI stent ; biodegradable polymer ; sirolimus-eluting stent ; clinical outcome
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2011-03-20
DOI: 10.3760/cma.j.issn.0366-6999.2011.06.003
卷: 124, 期:6, 页:811-816
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]: 1ST HUMAN-EXPERIENCE ; DRUG ; MASSACHUSETTS ; THROMBOSIS ; OUTCOMES ; REGISTRY ; LESIONS
英文摘要:

Background Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.

Methods A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length 40 mm, reference vessel diameter 2.25-4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.

Results Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25 +/- 0.33) mm vs. (0.57 +/- 0.55) mm, diff (95% Cl) -0.23 (-0.32, -0.14), P<0.0001; in-segment (0.25 0.33) mm vs. (0.42 +/- 0.55) mm, diff (95% Cl) -0.13 (-0.23, -0.02), P=0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P=0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P=0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P=0.1630).

Conclusions TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups. Chin Med J2011;124(6):811-816

语种: 英语
WOS记录号: WOS:000289040900003
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/65796
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.Chinese Acad Med Sci, Dept Cardiol, Cardiovasc Inst, Beijing 100037, Peoples R China
2.Chinese Acad Med Sci, Cardiac Catheterizat Lab, Cardiovasc Inst, Beijing 100037, Peoples R China
3.Chinese Acad Med Sci, Fuwai Hosp, Beijing 100037, Peoples R China
4.Peking Union Med Coll, Beijing 100037, Peoples R China
5.Shenyang No Hosp, Dept Cardiol, Shenyang 110015, Liaoning, Peoples R China
6.Capital Med Univ, Beijing Anzhen Hosp, Dept Cardiol, Beijing 100029, Peoples R China
7.Natl Ctr Cardiovasc Dis China, Beijing 100037, Peoples R China
8.Peking Univ, Hosp 1, Dept Cardiol, Beijing 100044, Peoples R China
9.Capital Med Univ, Beijing Chao Yang Hosp, Dept Cardiol, Beijing 100020, Peoples R China
10.Chinese Peoples Liberat Army Gen Hosp, Dept Cardiol, Beijing 100853, Peoples R China
11.Fourth Mil Med Univ, Xijing Hosp, Dept Cardiol, Xian 710032, Shaanxi, Peoples R China
12.Harbin Med Coll, Affiliated Hosp 1, Dept Cardiol, Harbin 150001, Heilongjiang, Peoples R China
13.Guangdong Prov Cardiovasc Inst, Dept Cardiol, Guangzhou 510080, Guangdong, Peoples R China
14.Capital Med Univ, Beijing Friendship Hosp, Dept Cardiol, Beijing 100050, Peoples R China
15.China Japan Friendship Hosp, Dept Cardiol, Beijing 100029, Peoples R China
16.Fudan Univ, Zhongshan Hosp, Dept Cardiol, Shanghai 200032, Peoples R China

Recommended Citation:
Xu Bo,Dou Ke-fei,Han Ya-ling,et al. A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based sirolimus-eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of coronary artery disease: 8-month angiographic and 2-year clinical follow-up results[J]. CHINESE MEDICAL JOURNAL,2011,124(6):811-816.
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