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 Bo DOU Ke-fei HAN Ya-ling LU 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 

机构地区：[1]Cardiac Catheterization Laboratory,Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China [2]Department of Cardiology,Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China [3]Department of Cardiology, Shenyang Northern Hospital,Shenyang, Liaoning 110015, China [4]Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China [5]Department of Cardiology, Peking University First Hospital,Beijing 100044, China [6]Department of Cardiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China [7]Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China [8]Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, China [9]Department of Cardiology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China [10]Department of Cardiology, Guangdong Provincial Cardiovascular Institute, Guangzhou, Guangdong 510080, China [11]Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China [12]Department of Cardiology, China-Japan Friendship Hospital,Beijing 100029, China [13]Department of Cardiology, Zhongshan Hospital, Fudan University,Shanghai 200032, China [14]National Center for Cardiovascular Diseases of China, Beijing 100037, China

出　　处：《Chinese Medical Journal》2011年第6期811-816,共6页中华医学杂志（英文版）

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% 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 caBackground 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 ca

关 键 词：TIVOLI stent biodegradable polymer sirolimus-eluting stent clinical outcome 

分 类 号：Q51[生物学—生物化学] TQ326.9[化学工程—合成树脂塑料工业]