First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease： results of the first in man FIREHAWK trial

作     者：QIAN Jie XU Bo Alexandra J. Lansky YANG Yue-jin QIAO Shu-bin WU Yong-jian CHEN Jue HU Feng-huan YANG Wei-xian Gary S. Mintz Martin B. Leon GAO Run-lin 

作者机构：Department of Cardiology Cardiovascular Institute and Fu Wai Hospital Chinese Academy Of Medical Sciences and Peking Union Medical College Beijing 100037 China Catheterization Laboratory Cardiovascular Institute and Fu Wai Hospital Chinese Academy Of Medical Sciences and Peking Union Medical College Beijing 100037 China Yale University School of Medicine New Haven CT USA Cardiovascular Research Foundation New York NY USA Columbia University Medical Center New York NY USA 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2012年第125卷第6期

页      面：970-976页

核心收录：

学科分类：0710[理学-生物学] 071010[理学-生物化学与分子生物学] 1002[医学-临床医学] 081704[工学-应用化学] 07[理学] 08[工学] 0817[工学-化学工程与技术] 0805[工学-材料科学与工程（可授工学、理学学位）] 080502[工学-材料学] 

主　　题：rapamycin-eluting stent first-in-man study optical coherence tomography coronary artery disease 

摘      要：Background Durable polymers used for first-generation drug-eluting stents （DES） potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove. Methods A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses 〈30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events （MACE） at 30 days defined as the composite of cardiac death, myocardial infarction （Q and non-Q）, or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography （QCA）, proportion of uncovered or malapposed stent struts by optical coherence tomograpphy （OCT） at 4 months, and MACE at 4, 12, 24 and 36-month follow-up. Results Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was （0.13±0.18） mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel （non-target lesion） revascularization. Conclusions The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.