title: Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.
abstract: BACKGROUND
  Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent.
  
  
  RESULTS
  Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months.
  
  
  CONCLUSIONS
  Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.
authors.affiliation: Department of Cardiology, Shiga Medical Center for Adults, Shiga, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Tamai
authors.forename: K
authors.initials: K
authors.lastname: Igaki
authors.forename: E
authors.initials: E
authors.lastname: Kyo
authors.forename: K
authors.initials: K
authors.lastname: Kosuga
authors.forename: A
authors.initials: A
authors.lastname: Kawashima
authors.forename: S
authors.initials: S
authors.lastname: Matsui
authors.forename: H
authors.initials: H
authors.lastname: Komori
authors.forename: T
authors.initials: T
authors.lastname: Tsuji
authors.forename: S
authors.initials: S
authors.lastname: Motohara
authors.forename: H
authors.initials: H
authors.lastname: Uehata
mesh_terms: D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D001672:Biocompatible Materials; D005260:Female; D006801:Humans; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers; D015607:Stents
chemical_list: D001672:Biocompatible Materials; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)