Favorable pharmacokinetics of biolimus A9 after deployment of Nobori stent for coronary artery disease: insights from No
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ORIGINAL ARTICLE
Favorable pharmacokinetics of biolimus A9 after deployment of Nobori stent for coronary artery disease: insights from Nobori PK study in Japanese subjects Masato Nakamura • Yoritaka Otsuka Yasunori Ueda • Kazuaki Mitsudo
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Received: 7 September 2011 / Accepted: 8 November 2011 / Published online: 7 December 2011 Ó Japanese Association of Cardiovascular Intervention and Therapeutics 2011
Abstract The Nobori stent is a new drug-eluting stent (DES) with biodegradable polymer coating limited to the abluminal side of stents. Biolimus A9 is a novel sirolimus derivative specifically developed for DES, and polymer load 15.6 lg of biolimus A9 per 1 mm of stent. A nonrandomized multicenter trial was conducted in Japan. Twenty-two de novo lesions were treated by Nobori stents and biolimus A9 concentration in whole blood was serially measured at 14 predetermined time points using a validated chromatography-tandem mass spectrometry (LC–MS/MS) assay. The Cmax was 85.3 ± 37.9 pg/mL (min–max 46.7– 169 pg/mL) in the 18 mm cohort and 198 ± 81 pg/mL (min–max 82.5–365 pg/mL) in the C28 mm cohort and no early or late bursts of biolimus A9 release were documented. After 4 weeks, no measurable concentration of biolimus A9 was observed in any patient. Estimated AUC0–t was 1.12 ± 1.16 ng/mL h in the 18 mm group, and
M. Nakamura Division of Cardiovascular Medicine, Ohashi Medical Center, Toho University, Tokyo, Japan M. Nakamura (&) Department of Cardiovascular Medicine, Ohashi Medical Center, Toho University School of Medicine, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan e-mail: [email protected] Y. Otsuka Department of Cardiology, National Cardiovascular Center, Osaka, Japan Y. Ueda Cardiovascular Division, Osaka Police Hospital, Osaka, Japan K. Mitsudo Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
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5.93 ± 4.41 ng/mL h for the C28 mm group. A significant association between loaded biolimus A9 dose adjusted by patient weight and pharmacokinetic parameters was observed. The systemic exposure of biolimus A9 eluting from the Nobori stent was low and proportional to the loaded amount of biolimus A9, and clearance from the blood was rapid. These findings suggest that the Nobori stent is feasible and safe. Systemic lower exposure of biolimus A9 after Nobori stent implantation may have beneficial effects on stent endothelialization. Keywords Pharmacokinetics Biolimus A9 Drug-eluting stents Biodegradable polymer
Introduction Since a groundbreaking trial on drug-eluting stents (DESs) demonstrated that DES led to a dramatic reduction in intimal hyperplasia following stent deployment and reduced rates of restenosis [1], the indications of percutaneous coronary intervention (PCI) have expanded to include not only complex lesion morphology [2] but also difficult clinical conditions such as diabetes and myocardial infarction [3, 4]. Accordingly, DES has now become standard in the practice of PCI. However, it has been revealed that adverse events such as delayed healing, chronic inflammat
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