Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions
10.3760/cma.j.issn.0253-3758.2017.11.009
- VernacularTitle: 新型单面刻槽生物可降解聚合物涂层雷帕霉素洗脱支架治疗冠状动脉原位病变的长期有效性和安全性
- Author:
Chongjian LI
1
;
Bo XU
;
Changdong GUAN
;
Runlin GAO
Author Information
1. Department of Cardiology, Fuwai Hospital, National Cardiovascular Center, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
- Publication Type:Clinical Trail
- Keywords:
Drug-eluting stents;
Coronary artery disease;
Treatment outcome
- From:
Chinese Journal of Cardiology
2017;45(11):940-947
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions.
Methods:This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups.
Results:(1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1-5 years were similar in Firehawk stent group and Xience V stent group (5.7% and 6.6% respectively, HR=0.88, 95%CI 0.42-1.84, P=0.72). Land-Mark analysis showed that TLF rates bewteen 1-5 years were similar in Firehawk stent group and Xience V stent group (3.6% and 4.4% respectively, HR=0.83, 95%CI 0.34-2.00, P=0.67). Kaplan-Meier analysis showed that PoCE rates between 1-5 years were also similar in Firehawk stent group and Xience V stent group (11.4% and 17.3% respectively, HR=0.64, 95%CI 0.39-1.04, P=0.07). Land-Mark analysis showed that PoCE rates after 5 years were similar in Firehawk stent group and Xience V stent group (8.4% and 10.0% respectively, HR=0.66, 95%CI 0.40-1.10, P=0.11). (5) No stent thrombosis was documented in Firehawk stent group during the 5 years follow-up period, and there was 1 case of stent thrombosis in Xience V stent group after 3 years of stent implantation.
Conclusion:TARGETⅠ trial results of 5 years follow up indicate the novel Firehawk stent have a durable safety and efficacy profile which is comparable to the Xience V stent in treating patients with single de novo coronary lesion. Clinical Trial Registration North American Clinical Trial Registration Center, NCT01196819.
