TY - JOUR
T1 - Long-term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents
T2 - Igaki-Tamai stents
AU - Nishio, Soji
AU - Kosuga, Kunihiko
AU - Igaki, Keiji
AU - Okada, Masaharu
AU - Kyo, Eisho
AU - Tsuji, Takafumi
AU - Takeuchi, Eiji
AU - Inuzuka, Yasutaka
AU - Takeda, Shinsaku
AU - Hata, Tatsuhiko
AU - Takeuchi, Yuzo
AU - Kawada, Yoshitaka
AU - Harita, Takeshi
AU - Seki, Junya
AU - Akamatsu, Shunji
AU - Hasegawa, Shinichi
AU - Bruining, Nico
AU - Brugaletta, Salvatore
AU - De Winter, Sebastiaan
AU - Muramatsu, Takashi
AU - Onuma, Yoshinobu
AU - Serruys, Patrick W.
AU - Ikeguchi, Shigeru
PY - 2012/5/15
Y1 - 2012/5/15
N2 - 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.
AB - 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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U2 - 10.1161/CIRCULATIONAHA.110.000901
DO - 10.1161/CIRCULATIONAHA.110.000901
M3 - Article
C2 - 22508795
AN - SCOPUS:84861231496
VL - 125
SP - 2343
EP - 2352
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 19
ER -