中华医学杂志（英文版）2011，Vol.124Issue(6)：811-816,6.DOI:10.3760/cma.j.issn.0366-6999.2011.06.003
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
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
XU Bo 1LI Wei-min 2CHEN Ji-yan 3WANG Lei 4WANG Yong 5GE Jun-bo 6LI Wei 7GAO Run-lin 8DOU Ke-fei 8HAN Ya-ling 9L(U) Shu-zheng 10YANG Yue-jin 8HUO Yong 11WANG Le-feng 12CHEN Yun-dai 13WANG Hai-chang14
作者信息
- 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, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China
- 3. Department of Cardiology, Guangdong Provincial Cardiovascular Institute, Guangzhou, Guangdong 510080, China
- 4. Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
- 5. Department of Cardiology, China-Japan Friendship Hospital,Beijing 100029, China
- 6. Department of Cardiology, Zhongshan Hospital, Fudan University,Shanghai 200032, China
- 7. National Center for Cardiovascular Diseases of China, Beijing 100037, China
- 8. Department of Cardiology,Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China
- 9. Department of Cardiology, Shenyang Northern Hospital,Shenyang, Liaoning 110015, China
- 10. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China
- 11. Department of Cardiology, Peking University First Hospital,Beijing 100044, China
- 12. Department of Cardiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
- 13. Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China
- 14. Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, China
- 折叠
摘要
Abstract
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.关键词
TIVOLI stent/biodegradable polymer/sirolimus-eluting stent/clinical outcomeKey words
TIVOLI stent/biodegradable polymer/sirolimus-eluting stent/clinical outcome引用本文复制引用
XU Bo,LI Wei-min,CHEN Ji-yan,WANG Lei,WANG Yong,GE Jun-bo,LI Wei,GAO Run-lin,DOU Ke-fei,HAN Ya-ling,L(U) Shu-zheng,YANG Yue-jin,HUO Yong,WANG Le-feng,CHEN Yun-dai,WANG Hai-chang..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].中华医学杂志（英文版）,2011,124(6):811-816,6.
