Drug-eluting coronary stent “Ultimaster<sup>®</sup>”

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Other Title
  • 薬剤溶出型冠動脈ステント「アルチマスター（Ultimaster<sup>®</sup>）」
  • DDS製品開発の最前線(33)薬剤溶出型冠動脈ステント「アルチマスター(Ultimaster)」
  • DDS セイヒン カイハツ ノ サイゼンセン(33)ヤクザイ ヨウシュツガタ カンドウミャク ステント 「 アルチマスター(Ultimaster)」
  • Drug-eluting coronary stent &ldquo;Ultimaster<sup>&reg;</sup>&rdquo;

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Abstract

We have developed the 3rd generation drug-eluting stent (DES), the Ultimaster sirolimus eluting coronary stent, in order to reduce the risk of late stent thrombosis and subsequently to shorten the dual anti-platelet therapy (DAPT) duration, because the DAPT is a critical issue on high bleeding risk patients or non-cardiac surgery. The mechanisms behind late stent thrombosis are multi-factorial, varying from factors such as stent malapposition to delayed endothelialization or endothelial dysfunction due to inflammation induced by polymer excipients. The Ultimaster DES is distinguished by the very flexible stent platform having thin-strut, in order to avoid stent malapposition, and also distinguished by the unique abluminal gradient coating which leaves the abluminal surface of the curves and link parts of the stent free from the drug and biodegradable polymer coating by gradually decreasing the coating layer thickness toward the hinge area, in order to accelerate endothelialization on the luminal surface and to avoid coating delamination. The biodegradable polymer, poly (D,L-lactide-co-caprolactone) was newly designed and developed as the excipients and adhesives, considering the drug release profile and the coating integrity. The drug, sirolimus, is released from the Ultimaster DES after implantation till 3 months, and the polymer is degraded and metabolized within 3-4 months, consequently only a bare metal stent leaves in the artery and the risk of late stent thrombosis can be minimized. The clinical trial data demonstrate the efficacy and safety of Ultimaster DES with non-inferiority to the 2nd generation DES and also corroborates the possibility of shortening the DAPT duration, with high endothelialization rate at 3 months after. The issue of the stent thrombosis will be solved in the near future by being introduced such 3rd generation DES and new anti-platelet agents into daily clinical practices. A new challenge to the remaining issue in DES, i.e. improvement of the long-term clinical outcomes, has already started with the development of bio-resorbable scaffolds.

Journal

  • Drug Delivery System

    Drug Delivery System 31 (3), 235-240, 2016

    THE JAPAN SOCIETY OF DRUG DELIVERY SYSTEM

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