The pharmacokinetics of Biolimus A9 after elution from the Nobori stent in patients with coronary artery disease: The NOBORI PK study

Abstract

Objectives-The aim of this study was to assess the pharmacokinetics and tolerability of Biolimus A9 eluted from Nobori coronary stents.Background-The release kinetics and pharmacokinetics of drugs delivered via coronary stents have been shown to play an essential role in the efficacy and safety of drug eluting stents.

Nobori Biolimus-Eluting Stent vs. Permanent Polymer Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention

“…10 Biolimus A9 is eluted in a 2-phase process: the first phase is a burst release (≈40%) immediately after stent deployment, followed by sustained drug release and polymer degradation over a period of 6-9 months. 28 The potential advantages of the Nobori BES are mainly related to the biodegradable polymer, which should decrease the risk of late and very late events (especially ST) and, in turn, the need for prolonged dual antiplatelet therapy and the risk of long-term bleeding events after PCI. 29 However, despite any potential advantage of biodegradable polymer DES not emerging until the late follow-up period after polymer dissolution, it should be mandatory to demonstrate at least an equivalent efficacy and safety profile of the Nobori BES to currently approved DES at 1-year follow-up.…”

Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention

“…Third-generation biolimuseluting stent was designed with a biodegradable polymer. 16 In large randomized trials, the biolimus-eluting stent has shown noninferiority after 1 year to the first-generation sirolimuseluting cypher stent 15 and the second-generation everolimuseluting Xience stent, 14 whereas long-term outcome favored the biolimus-eluting stent. 15 However, in the Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) V trial, 17 comparing the biolimus-eluting Nobori stent and the sirolimus-eluting Cypher stent, the biolimuseluting stent failed to show noninferiority within 12 months.…”

“…The biodegradable polylactic acid polymer (PLLA and poly d,l-lactide-co-glycolide) is applied to the abluminal surface and metabolized within 6 to 9 months. 16 The stent elutes biolimus (15.6 μg/mm 2 ), for ≤30 days. Stents were implanted according to standard techniques.…”

Polymer-Free Biolimus A9-Coated Stent Demonstrates More Sustained Intimal Inhibition, Improved Healing, and Reduced Inflammation Compared With a Polymer-Coated Sirolimus-Eluting Cypher Stent in a Porcine Model

“…Thus, BA9 easily crosses the cell membrane to achieve therapeutic effects in its target tissue and, compared with sirolimus-eluting Cypher stent (SES), leads to relatively low systemic exposure. 10 Third, the drug coating is asymmetrical on the abluminal surface of the stent, allowing the drug release to be directed almost entirely into the vessel wall for treatment of injured smooth muscle cells. Therefore, the textured surface is made only on the outside of stent.…”