Drug/Drug Delivery Systems For The Prevention And Treatment Of Vascular Disease

Abstract

A drug and drug delivery system may be utilized in the treatment of vascular disease. A local delivery system is coated with rapamycin or other suitable drug, agent or compound and delivered intraluminally for the treatment and prevention of neointimal hyperplasia following percutaneous transluminal coronary angiography. The local delivery of the drugs or agents provides for increased effectiveness and lower systemic toxicity.

1 - 4 . (canceled) 
     
     
         5 . A method for treating or preventing intimal hyperplasia following percutaneous transluminal angioplasty of a human coronary artery, said method comprising intraluminally implanting a drug delivery device in said human coronary artery, said device comprising: a stent; a biocompatible, nonerodible polymeric coating affixed to the stent; and from about 35 μg to about 430 μg of an inhibitor of the mammalian Target of Rapamycin incorporated into the polymeric coating, wherein said method provides an in-stent late loss in diameter of said coronary artery at 12 months following implantation of less than about 0.5 mm, as measured by quantitative coronary angiography. 
     
     
         6 . The method according to  claim 5  wherein said inhibitor of the mammalian Target of Rapamycin is rapamycin. 
     
     
         7 . The method according to  claim 5  or  6  wherein said stent comprises from about 64 μg to about 197 μg of said inhibitor of the mammalian Target of Rapamycin. 
     
     
         8 . The method according to  claim 5  or  6  wherein said method provides an in-stent late loss in diameter at 12 months following implantation of less than about 0.3 mm, as measured by quantitative coronary angiography. 
     
     
         9 . The method according to  claim 8  wherein said method provides an in-stent diameter stenosis at 12 months following implantation of less than about 22%, as measured by quantitative coronary angiography.) 
     
     
         10 . The method according to  claim 8  wherein said method provides an in-stent diameter stenosis at 12 months following implantation of less than about 15%, as measured by quantitative coronary angiography.