Details

Autor(en) / Beteiligte

• Xu, Bo
• Dou, Ke-fei
• Han, Ya-ling
• Lü, Shu-zheng
• Yang, Yue-jin
• Huo, Yong
• Wang, Le-feng
• Chen, Yun-dai
• Wang, Hai-chang
• Li, Wei-min
• Chen, Ji-yan
• Wang, Lei
• Wang, Yong
• Ge, Jun-bo
• Li, Wei
• Gao, Run-lin

Titel

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

Ist Teil von

• Chinese medical journal, 2011-03, Vol.124 (6), p.811-816

Ort / Verlag

China: Cardiac Catheterization Laboratory,Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China%Department of Cardiology,Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China%Department of Cardiology, Shenyang Northern Hospital,Shenyang, Liaoning 110015, China%Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China%Department of Cardiology, Peking University First Hospital,Beijing 100044, China%Department of Cardiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China%Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China%Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, China%Department of Cardiology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China%Department of Cardiology, Guangdong Provincial Cardiovascular Institute, Guangzhou, Guangdong 510080, China%Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China%Department of Cardiology, China-Japan Friendship Hospital,Beijing 100029, China%Department of Cardiology, Zhongshan Hospital, Fudan University,Shanghai 200032, China%National Center for Cardiovascular Diseases of China, Beijing 100037, China

Erscheinungsjahr

2011

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• 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% CI）-0.23 （-0.32, -0.14）, P 〈0.0001; in-segment （0.25±-0.33） mm vs. （0.42±-0.55） mm, diff （95% CI） -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.