title: Biodegradable polymer-based, argatroban-eluting, cobalt-chromium stent (JF-04) for treatment of native coronary lesions: final results of the first-in-man study and lessons learned.
abstract: OBJECTIVE
  The aim of the study was to investigate the six-month angiographic and nine-month clinical follow-up outcomes in a first-in-man study using the biodegradable polymer-based cobalt-chromium argatroban-eluting stent (JF-04) for treatment of native coronary atherosclerotic lesions.
  
  
  RESULTS
  A total of 31 patients with either stable or unstable angina, or silent myocardial ischaemia, exhibiting de novo coronary lesions were enrolled at seven Japanese sites. The lesions were treated with the JF-04 stent after predilatation. The primary endpoint was angiographic in-stent late loss six months after implantation. The secondary endpoints included angiographic restenosis and in-stent volume obstruction by intravascular ultrasound at six months and target vessel failure (TVF) at nine months. Procedural success was achieved in 100% of cases. At six months, angiographic in-stent late loss was 1.01±0.48 mm and binary restenosis was observed in nine cases (29.0%). Among these restenotic cases, most (n=8) demonstrated advanced angiographic restenosis patterns, including diffuse/proliferative restenosis and total occlusion. At nine months, TVF was observed in four cases (12.9%), exclusively attributed to target vessel revascularisation.
  
  
  CONCLUSIONS
  This argatroban-eluting stent failed to inhibit neointimal hyperplasia sufficiently, despite the theoretical benefits and promising clinical experience with local drug delivery.
authors.affiliation: Division of Cardiology, Iwate Medical University, Morioka, Iwate, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Tobaru
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yasuda
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Kataoka
authors.forename: Kengo
authors.initials: K
authors.lastname: Tanabe
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hirohata
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001120:Arginine / Q000031:analogs & derivatives; D002857:Chromium / Q000627:therapeutic use*; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000628:therapy*; D023921:Coronary Stenosis / Q000628:therapy; D003331:Coronary Vessels / Q000473:pathology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010875:Pipecolic Acids / Q000627:therapeutic use*; D013449:Sulfonamides; D016896:Treatment Outcome
chemical_list: D010875:Pipecolic Acids; D013449:Sulfonamides; D002857:Chromium; D001120:Arginine; C031942:argatroban