Drug-delivery endovascular stent and method for treating restenosis

A method for inhibiting restenosis at an in vascular injury site, comprising

• delivering to the vascular injury site, an endovascular stent comprising
• (a) a body formed of one or more filaments,
• (b) carried on the one or more filament(s), a bioerodable drug-release coating having a thickness of between 3-20 microns, and composed of (i) 20 to 60 weight percent poly-dl-lactide polymer substrate and (ii) 40-80 weight percent of macrocyclic triene immunosuppressive compound, and
• (c) a polymer undercoat having a thickness of between 1-5 microns, disposed between the stent-body filaments and said coating, and
• expanding the stent at the vascular injury site, to bring the stent coating in contact with the vessel at the injury site,
• wherein said coating is effective to release a restenosis-inhibiting amount of the compound over a period of at least 4 weeks, thus to inhibit restenosis at the site.

An endovascular stent for placement at a vascular injury site, for inhibiting restenosis at the site, comprising

• a body having an open-lattice structure formed of linked filaments, and
• carried on the one or more filaments, a drug-release coating having a thickness of between 3-30 microns, and composed of (i) 20 to 70 weight percent polymer substrate and (ii) 30-80 weight percent macrocyclic triene immunosuppressive compound having the form:
• where R is CH2−—X—OH, and X is a linear alkyl group containing 1 to 7 carbon atoms,
• said stent being expandable from a contracted condition in which the stent can be delivered to a vascular injury site via catheter, and an expanded condition in which the stent coating can be placed in contact with the vessel at the injury site,
• said coating being effective to release said a restenosis-inhibiting amount of the compound over a period of at least 4 weeks after the stent is placed at the vascular injury site.