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Long-Term (>10 Years) Clinical Outcomes of First-In-Man Biodegradable Poly-l-lactic Acid Coronary Stents: Igaki-Tamai Stents.
MedLine Citation:
PMID:  22508795     Owner:  NLM     Status:  Publisher    
BACKGROUND: The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-man fully biodegradable coronary stent made of poly-l-lactic acid. METHODS AND 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 (MACE) and rates of scaffold thrombosis were analyzed together with the results of angiography and intravascular ultrasound (IVUS). MACE included all-cause death, nonfatal myocardial infarction (MI) and target lesion revascularization / target vessel revascularization (TLR/TVR). During the overall clinical follow-up period (121±17 months), 2 patients were lost to follow-up. There was 1 cardiac death, 6 non-cardiac deaths and 4 MIs. Survival rates free of all-cause death, cardiac death and MACE at 10 years were 87%, 98% and 50%, respectively. The cumulative rates of TLR (TVR) 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 IVUS data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and the stent area did not change. CONCLUSIONS: Acceptable MACE and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.
Soji Nishio; Kunihiko Kosuga; Keiji Igaki; Masaharu Okada; Eisho Kyo; Takafumi Tsuji; Eiji Takeuchi; Yasutaka Inuzuka; Shinsaku Takeda; Tatsuhiko Hata; Yuzo Takeuchi; Yoshitaka Kawada; Takeshi Harita; Junya Seki; Shunji Akamatsu; Shinichi Hasegawa; Nico Bruining; Salvatore Brugaletta; Sebastiaan de Winter; Takashi Muramatsu; Yoshinobu Onuma; Patrick W Serruys; Shigeru Ikeguchi
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-4-16
Journal Detail:
Title:  Circulation     Volume:  -     ISSN:  1524-4539     ISO Abbreviation:  -     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-4-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
1 Shiga Medical Center for Adults, Shiga, Japan;
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