title: 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.
abstract: 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.
authors.affiliation: Department of Cardiology, Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Qian
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Yue-jin
authors.initials: YJ
authors.lastname: Yang
authors.forename: Shu-bin
authors.initials: SB
authors.lastname: Qiao
authors.forename: Yong-jian
authors.initials: YJ
authors.lastname: Wu
authors.forename: Jue
authors.initials: J
authors.lastname: Chen
authors.forename: Feng-huan
authors.initials: FH
authors.lastname: Hu
authors.forename: Wei-xian
authors.initials: WX
authors.lastname: Yang
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Run-lin
authors.initials: RL
authors.lastname: Gao
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000008:administration & dosage; D020123:Sirolimus / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence
chemical_list: D011108:Polymers; D020123:Sirolimus