Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly-l-Lactic Acid Coronary Stents: Igaki-Tamai Stents
In: Circulation (New York, N.Y.), Jg. 125 (2012), Heft 19, S. 2343-2352
Online
academicJournal
- print, 28 ref
Zugriff:
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.
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Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly-l-Lactic Acid Coronary Stents: Igaki-Tamai Stents
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Autor/in / Beteiligte Person: | NISHIO, Soji ; KOSUGA, Kunihiko ; TAKEUCHI, Yuzo ; KAWADA, Yoshitaka ; HARITA, Takeshi ; SEKI, Junya ; AKAMATSU, Shunji ; HASEGAWA, Shinichi ; BRUINING, Nico ; BRUGALETTA, Salvatore ; DE WINTER, Sebastiaan ; MURAMATSU, Takashi ; IGAKI, Keiji ; ONUMA, Yoshinobu ; SERRUYS, Patrick W ; IKEGUCHI, Shigeru ; OKADA, Masaharu ; KYO, Eisho ; TSUJI, Takafumi ; TAKEUCHI, Eiji ; INUZUKA, Yasutaka ; TAKEDA, Shinsaku ; HATA, Tatsuhiko |
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Zeitschrift: | Circulation (New York, N.Y.), Jg. 125 (2012), Heft 19, S. 2343-2352 |
Veröffentlichung: | Hagerstown, MD: Lippincott Williams & Wilkins, 2012 |
Medientyp: | academicJournal |
Umfang: | print, 28 ref |
ISSN: | 0009-7322 (print) |
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