A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial
Run-Lin Gao, Bo Xu, Alexandra J Lansky, Yue-Jin Yang, Chang-Sheng Ma, Ya-Ling Han, Shao-Liang Chen, Hui Li, Rui-Yan Zhang, Guo-Sheng Fu, Zu-Yi Yuan, Hong Jiang, Yong Huo, Wei Li, Yao-Jun Zhang, Martin B Leon, TARGET I Investigators, Run-Lin Gao, Martin B Leon, Run-Lin Gao, Martin B Leon, Bo Xu, Alexandra J Lansky, Yong Huo, Weimin Wang, Wei Gao, Lefeng Wang, Wei Li, Yang Wang, Xuan Jia, Qi-Chao Zhai, Ye-Lin Zhao, Jue Chen, Ke-Fei Dou, Li-Jian Gao, Chong-Jian Li, Hai-Bo Liu, Chao-Wei Mu, Jie Qian, Shu-Bin Qiao, Xue-Wen Qin, Hong Qiu, Yong-Jian Wu, Liang Xu, Hong-Bing Yan, Yue-Jin Yang, Shi-Jie You, Li-Ying Chen, Yu-Tong Cheng, De'an Jia, Zhi-Zhong Li, Wen-Xian Liu, Xin-Min Liu, Yu-Yang Liu, Shu-Zheng Lu, Chang-Sheng Ma, Bin Nie, Shang-Qiu Ning, Dong-Mei Shi, Kai Tan, Feng Xu, Dong-Hua Zhang, Yu-Jie Zhou, Ya-Ling Han, Quan-Min Jing, Hai-Wei Liu, Ying-Yan Ma, Bin Wang, Geng Wang, Xiao-Zeng Wang, Kai Xu, Shao-Liang Chen, Zhi-Zhong Liu, Ling Lin, Song Lin, Shou-Jie Shan, Hai-Mei Xu, Fei Ye, Wei You, Jun-Jie Zhang, Zhong-Sheng Zhu, Hui Li, Sheng-Quan Liu, Zhi-Qi Sun, Bai-Ying Wang, Shang-Yu Wen, Qin Chen, Feng-Hua Ding, Run Du, Jian Hu, Wei-Feng Shen, Zhen-Kun Yang, Jian-Sheng Zhang, Qi Zhang, Rui-Yan Zhang, Guo-Sheng Fu, He Huang, Zhan-Lu Li, Shao-Xiang Weng, Xiao-Jun Bai, Ning Guo, Hong-Bing Li, Xin-Jun Lei, Jian-Jun Mou, Dong-Qi Wang, Zu-Yi Yuan, Jing Bai, Xiao-Rong Hu, Hong Jiang, Xue-Jun Jiang, Bo Yang, Cheng-Yang Li, Zhan-Quan Li, Li Liu, Yun-Qi Shi, Yong-Xin Wang, Long Yuan, Guo Dong, Wei-Min Li, Yue Li, Dang-Hui Sun, Jian-Tao Sun, Jing-Yi Liang, Ying Liu, Cheng-Zhi Lu, Da-Sheng Xia, Jian-Qiang Xu, Xiang-Dong Zhao, Ji-Yan Chen, Zhu-Jun Chen, Peng-Cheng He, Wen-Hui Huang, Yuan Liu, Ning Tan, Nian-Jin Xie, Dan-Qing Yu, Jun-Bo Ge, Lei Ge, Dong Huang, Xue-Bo Liu, Ju-Ying Qian, Kang Yao, Feng Zhang, Xin Zhong, Jun Chen, Yun-Dai Chen, Kai Guo, Chang-Fu Liu, Hong-Bin Liu, Zhi-Jun Sun, Run-Lin Gao, Bo Xu, Alexandra J Lansky, Yue-Jin Yang, Chang-Sheng Ma, Ya-Ling Han, Shao-Liang Chen, Hui Li, Rui-Yan Zhang, Guo-Sheng Fu, Zu-Yi Yuan, Hong Jiang, Yong Huo, Wei Li, Yao-Jun Zhang, Martin B Leon, TARGET I Investigators, Run-Lin Gao, Martin B Leon, Run-Lin Gao, Martin B Leon, Bo Xu, Alexandra J Lansky, Yong Huo, Weimin Wang, Wei Gao, Lefeng Wang, Wei Li, Yang Wang, Xuan Jia, Qi-Chao Zhai, Ye-Lin Zhao, Jue Chen, Ke-Fei Dou, Li-Jian Gao, Chong-Jian Li, Hai-Bo Liu, Chao-Wei Mu, Jie Qian, Shu-Bin Qiao, Xue-Wen Qin, Hong Qiu, Yong-Jian Wu, Liang Xu, Hong-Bing Yan, Yue-Jin Yang, Shi-Jie You, Li-Ying Chen, Yu-Tong Cheng, De'an Jia, Zhi-Zhong Li, Wen-Xian Liu, Xin-Min Liu, Yu-Yang Liu, Shu-Zheng Lu, Chang-Sheng Ma, Bin Nie, Shang-Qiu Ning, Dong-Mei Shi, Kai Tan, Feng Xu, Dong-Hua Zhang, Yu-Jie Zhou, Ya-Ling Han, Quan-Min Jing, Hai-Wei Liu, Ying-Yan Ma, Bin Wang, Geng Wang, Xiao-Zeng Wang, Kai Xu, Shao-Liang Chen, Zhi-Zhong Liu, Ling Lin, Song Lin, Shou-Jie Shan, Hai-Mei Xu, Fei Ye, Wei You, Jun-Jie Zhang, Zhong-Sheng Zhu, Hui Li, Sheng-Quan Liu, Zhi-Qi Sun, Bai-Ying Wang, Shang-Yu Wen, Qin Chen, Feng-Hua Ding, Run Du, Jian Hu, Wei-Feng Shen, Zhen-Kun Yang, Jian-Sheng Zhang, Qi Zhang, Rui-Yan Zhang, Guo-Sheng Fu, He Huang, Zhan-Lu Li, Shao-Xiang Weng, Xiao-Jun Bai, Ning Guo, Hong-Bing Li, Xin-Jun Lei, Jian-Jun Mou, Dong-Qi Wang, Zu-Yi Yuan, Jing Bai, Xiao-Rong Hu, Hong Jiang, Xue-Jun Jiang, Bo Yang, Cheng-Yang Li, Zhan-Quan Li, Li Liu, Yun-Qi Shi, Yong-Xin Wang, Long Yuan, Guo Dong, Wei-Min Li, Yue Li, Dang-Hui Sun, Jian-Tao Sun, Jing-Yi Liang, Ying Liu, Cheng-Zhi Lu, Da-Sheng Xia, Jian-Qiang Xu, Xiang-Dong Zhao, Ji-Yan Chen, Zhu-Jun Chen, Peng-Cheng He, Wen-Hui Huang, Yuan Liu, Ning Tan, Nian-Jin Xie, Dan-Qing Yu, Jun-Bo Ge, Lei Ge, Dong Huang, Xue-Bo Liu, Ju-Ying Qian, Kang Yao, Feng Zhang, Xin Zhong, Jun Chen, Yun-Dai Chen, Kai Guo, Chang-Fu Liu, Hong-Bin Liu, Zhi-Jun Sun
Abstract
Aims: The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V.
Methods and results: A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority <0.0001). Cardiac death (0.4% vs. 0.0%), TVMI (1.3% vs. 1.7%), iTLR (0.4% vs. 0.4%) and TLF (2.2% vs. 2.2%) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up (all p>0.05). No definite/probable stent thrombosis was observed in both of these groups.
Conclusions: In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).
Source: PubMed