Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly- l -Lactic Acid Coronary Stents
In: Circulation, Jg. 125 (2012-05-15), S. 2343-2353
Online
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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
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Autor/in / Beteiligte Person: | Sebastiaan de Winter ; Kosuga, Kunihiko ; Kawada, Yoshitaka ; Serruys, Patrick W. ; Hata, Tatsuhiko ; Bruining, Nico ; Tsuji, Takafumi ; Takeuchi, Yuzo ; Inuzuka, Yasutaka ; Hasegawa, Shinichi ; Nishio, Soji ; Seki, Junya ; Akamatsu, Shunji ; Igaki, Keiji ; Harita, Takeshi ; Brugaletta, Salvatore ; Takeuchi, Eiji ; Muramatsu, Takashi ; Onuma, Yoshinobu ; Kyo, Eisho ; Ikeguchi, Shigeru ; Okada, Masaharu ; Takeda, Shinsaku ; Cardiology |
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Zeitschrift: | Circulation, Jg. 125 (2012-05-15), S. 2343-2353 |
Veröffentlichung: | Ovid Technologies (Wolters Kluwer Health), 2012 |
Medientyp: | unknown |
ISSN: | 1524-4539 (print) ; 0009-7322 (print) |
DOI: | 10.1161/circulationaha.110.000901 |
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