Long-Term Safety Shown for Biodegradable Stent
(HealthDay News) – Long-term follow-up indicates that the fully biodegradable Igaki-Tamai stent is safe for coronary artery use in humans.
Soji Nishioa, MD, of the Shiga Medical Center for Adults in Japan, and colleagues followed 50 patients with 63 lesions that were treated with 84 Igaki-Tamai stents, for more than 10 years. Major adverse cardiac events (MACE; including all-cause death, nonfatal myocardial infarction [MI] and target lesion revascularization/target vessel revascularization [TLR/TVR]) and rates of scaffold thrombosis were analyzed. Patients were assessed with angiography and intravascular ultrasound (IVUS).
During the clinical follow-up, the researchers found that two patients were lost to follow-up and there was one cardiac death, six non-cardiac deaths, and four MIs. At 10 years, survival rates free of all-cause death, cardiac death, and MACE were 87, 98, and 50%, respectively. The cumulative rates of TLR and TVR were both 16% at one year; 18 and 22%, respectively, at five years; and 28 and 38%, respectively, at 10 years. There were two definite scaffold thromboses recorded: one subacute and one very late, which was related to a sirolimus-eluting stent implanted for a lesion proximal to an Igaki-Tamai stent. Evidence from IVUS analysis showed that, within three years, the stent struts mostly disappeared.
"Acceptable MACE and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent," the authors write.
One author invented and developed the Igaki-Tamai stent and is employed by the Kyoto Medical Planning Co. Ltd., which commercialized the technology.