Efficacy and safety of FIREHAWK abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions： nine-month angiographic and one-year clinical results from TARGET I trial lona cohort  

作　　者：XU Bo GAO Run-lin ZHANG Rui-yan WANG Hai-chang LI Zhan-quan YANG Yue-jin MA Chang-sheng HAN Ya-ling Alexandra J. Lansky HUO Yong LI Wei Martin B. Leon 

机构地区：[1]Division of Biometrics , Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peiking Union Medical College, Beijing 100037, China [2]Department of Cardiology, Affiliated Xijing Hospital of the Fourth Military Medical University, Xi'an, Shaanxi 710032, China [3]Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, Liaoning 110016, China [4]Department of Cardiology, Affiliated An Zhen Hospital of CapitalMedical University, Beijing 100029, China [5]Department of Cardiology, Shenyang Northern Hospital,Shenyang, Liaoning 110015, China [6]Yale New Haven Hospital, New Haven, USA [7]Department of Cardiology, Peking University First Hospital, Beijing 100034, China [8]Coiumbia University Medical Center and Cardiovascular Research Foundation, New York, USA

出　　处：《Chinese Medical Journal》2013年第6期1026-1032,共7页中华医学杂志（英文版）

摘　　要：Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent （DES） failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK stent in long coronary artery disease. Methods The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention （PCI） for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion（s） with diameter stenosis 〉70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month. Results Fifty patients （mean age （57.6±10.2） years） with 59 de novo long lesions （reference vessel diameter （2.85±0.44） mm, lesion length （35.2±9.4） mm, and stent length （41.8±11.3） mm） were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was （0.16±0.16） mm. Proximal edge, distal edge and in-segment late loss （mm） were 0.21±0.35, 0.03±0.33, and 0.07±0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction （MI）, or stent thrombosis occurred. Non-Q-wave MI occurred in two patients （4%） due to procedural complications. Conclusions Treatment of long coronary lesions with the FIREHAWK stent is able to produce similar results as observed in the FIREHAWK~ FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK for long coronary lesions.Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent （DES） failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK stent in long coronary artery disease. Methods The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention （PCI） for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion（s） with diameter stenosis 〉70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month. Results Fifty patients （mean age （57.6±10.2） years） with 59 de novo long lesions （reference vessel diameter （2.85±0.44） mm, lesion length （35.2±9.4） mm, and stent length （41.8±11.3） mm） were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was （0.16±0.16） mm. Proximal edge, distal edge and in-segment late loss （mm） were 0.21±0.35, 0.03±0.33, and 0.07±0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction （MI）, or stent thrombosis occurred. Non-Q-wave MI occurred in two patients （4%） due to procedural complications. Conclusions Treatment of long coronary lesions with the FIREHAWK stent is able to produce similar results as observed in the FIREHAWK~ FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK for long coronary lesions.

关 键 词：SIROLIMUS drug-eluting stents biodegradable coronary artery disease 

分 类 号：S858.31[农业科学—临床兽医学] Q51[农业科学—兽医学]