title: Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents.
abstract: BACKGROUND
  The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid.
  
  
  RESULTS
  Between September 1998 and April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121 ± 17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change.
  
  
  CONCLUSIONS
  Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.
authors.affiliation: Department of Cardiology, Shiga Medical Center for Adults, 5-4-30, Moriyama, Moriyama City, Shiga, 524-8524 Japan.
authors.forename: Soji
authors.initials: S
authors.lastname: Nishio
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Kosuga
authors.forename: Keiji
authors.initials: K
authors.lastname: Igaki
authors.forename: Masaharu
authors.initials: M
authors.lastname: Okada
authors.forename: Eisho
authors.initials: E
authors.lastname: Kyo
authors.forename: Takafumi
authors.initials: T
authors.lastname: Tsuji
authors.forename: Eiji
authors.initials: E
authors.lastname: Takeuchi
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Inuzuka
authors.forename: Shinsaku
authors.initials: S
authors.lastname: Takeda
authors.forename: Tatsuhiko
authors.initials: T
authors.lastname: Hata
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Kawada
authors.forename: Takeshi
authors.initials: T
authors.lastname: Harita
authors.forename: Junya
authors.initials: J
authors.lastname: Seki
authors.forename: Shunji
authors.initials: S
authors.lastname: Akamatsu
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hasegawa
authors.forename: Nico
authors.initials: N
authors.lastname: Bruining
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.forename: Sebastiaan
authors.initials: S
authors.lastname: de Winter
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Shigeru
authors.initials: S
authors.lastname: Ikeguchi
mesh_terms: D020341:Absorbable Implants / Q000706:statistics & numerical data*; D000368:Aged; D001706:Biopsy; D015331:Cohort Studies; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D003328:Coronary Thrombosis / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D009204:Myocardial Revascularization / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D010045:Outpatients / Q000706:statistics & numerical data; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011091:Polyesters; D011108:Polymers; D011446:Prospective Studies; D015607:Stents / Q000706:statistics & numerical data*; D016019:Survival Analysis; D013997:Time Factors; D018084:Ultrasonography, Interventional
chemical_list: D010975:Platelet Aggregation Inhibitors; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)