Long-term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents

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 MuramatsuYoshinobu Onuma, Patrick W. Serruys, Shigeru Ikeguchi

Research output: Contribution to journalArticlepeer-review

177 Citations (Scopus)

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. 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 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. Conclusion-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.

Original languageEnglish
Pages (from-to)2343-2352
Number of pages10
JournalCirculation
Volume125
Issue number19
DOIs
Publication statusPublished - 15-05-2012
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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