Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes
Yaling Han, Quanmin Jing, Bo Xu, Lixia Yang, Huiliang Liu, Xiaoming Shang, Tieming Jiang, Zhanquan Li, Hua Zhang, Hui Li, Jian Qiu, Yingfeng Liu, Yi Li, Xuezhi Chen, Runlin Gao, CREATE (Multi-Center Registry of Excel Biodegradable Polymer Drug-Eluting Stents) Investigators, Yaling Han, Runlin Gao, Bo Xu, Jingxuan Guo, Xuchen Zhou, Yawei Xu, Yaling Han, Lixia Yang, Huiliang Liu, Xiaoming Shang, Tieming Jiang, Zhanquan Li, Hua Zhang, Hui Li, Jian Qiu, Yingfeng Liu, Maoru Ma, Lan Huang, Shumei Li, Kui Pu, Tingshu Yang, Fakuan Tang, Shifang Ding, Chaozhong Liu, Chengming Yang, Xiaoqun Zheng, Zonggui Wu, Guizhou Tao, Shulin Zhang, Qi Sun, Yuqing Hou, Dongju Jiang, Zhenshan He, Peng Qu, Hengjian Hao, Guoxiang He, Xueqi Li, Weize Zhang, Teguh Santoso, Xiaoyan Li, Weimin Li, Ming Yang, Shuguang Yang, Xiaofei Wang, Guoying Zhu, Yongwen Qin, Beijie Luo, Taohong Hu, Caiyi Lu, Chunshan Li, You Wang, Shisen Jiang, Lianru Gao, Yingxian Sun, Yong Wang, Guoxian Qi, Guoliang Jia, Mingde Zhang, Yuntian Li, Qiangsun Zheng, Xingwen Zhou, J K Yeoh, Guoming Huang, Damras Tresukusol, Shengqiang Wang, Yaling Han, Quanmin Jing, Bo Xu, Lixia Yang, Huiliang Liu, Xiaoming Shang, Tieming Jiang, Zhanquan Li, Hua Zhang, Hui Li, Jian Qiu, Yingfeng Liu, Yi Li, Xuezhi Chen, Runlin Gao, CREATE (Multi-Center Registry of Excel Biodegradable Polymer Drug-Eluting Stents) Investigators, Yaling Han, Runlin Gao, Bo Xu, Jingxuan Guo, Xuchen Zhou, Yawei Xu, Yaling Han, Lixia Yang, Huiliang Liu, Xiaoming Shang, Tieming Jiang, Zhanquan Li, Hua Zhang, Hui Li, Jian Qiu, Yingfeng Liu, Maoru Ma, Lan Huang, Shumei Li, Kui Pu, Tingshu Yang, Fakuan Tang, Shifang Ding, Chaozhong Liu, Chengming Yang, Xiaoqun Zheng, Zonggui Wu, Guizhou Tao, Shulin Zhang, Qi Sun, Yuqing Hou, Dongju Jiang, Zhenshan He, Peng Qu, Hengjian Hao, Guoxiang He, Xueqi Li, Weize Zhang, Teguh Santoso, Xiaoyan Li, Weimin Li, Ming Yang, Shuguang Yang, Xiaofei Wang, Guoying Zhu, Yongwen Qin, Beijie Luo, Taohong Hu, Caiyi Lu, Chunshan Li, You Wang, Shisen Jiang, Lianru Gao, Yingxian Sun, Yong Wang, Guoxian Qi, Guoliang Jia, Mingde Zhang, Yuntian Li, Qiangsun Zheng, Xingwen Zhou, J K Yeoh, Guoming Huang, Damras Tresukusol, Shengqiang Wang
Abstract
Objectives: This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice.
Background: It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events.
Methods: Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy.
Results: The average duration of clopidogrel treatment was 199.8 +/- 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 +/- 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.
Conclusions: This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578).
Source: PubMed