First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting st

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

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

【期刊名称】《中华医学杂志（英文版）》 【年(卷),期】2012(125)006

【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