Polymeric Surface Modifications of Tantalum Stents

Abstract

To compare two kinds of polymer-coated tantalum stents with bare tantalum stents (control) to determine if the coatings can improve thromboresistance. Twenty-seven Fontaine-Dake stents were balloon expanded in three 8-mm x 80-cm polytetrafluoroethylene (PTFE) grafts; 9 stents were bare tantalum (T); 9 were coated with polyetherurethane (PL); and 9 were coated with parylene (PA). There were 9 stents placed in each graft as follows: 3 tantalum, 3 polyetherurethane, and 3 parylene. In swine whose platelets had been radiolabeled with indium 111, the ends of each stented graft were connected to 14F femoral and venous sheaths to create an ex vivo fistula. Each graft was exposed to blood for 30, 60, and 120 minutes. At the end of each test period, the stented grafts were disconnected from the sheaths, flushed with saline until clear, and then flushed with formalin. The stents were removed from the grafts, and a radionuclide well counter recorded radionuclide counts from each stent type at each period of blood contact. These values were converted to platelet density per 1000 microns 2. Stents were then photographed and scanned with electron microscopy (EM) for qualitative analysis. Possible significant differences in platelet adhesion with the three types of stents (both between stent groups and within stent groups) were examined using a two-tailed Student's t-test. There were significantly fewer platelets adsorbed on PA versus T at all time periods (p < 0.005); on PL versus T at 60 and 120 minutes (p < 0.005); and on PA versus PL at 30 and 120 minutes (p < 0.0005). There was no significant difference in platelet density within each stent group (p = 0.1). Mean platelet density (number of platelets per 1000 microns 2 +/- SD) was as follows: at 30 minutes: T = 1891 +/- 965; PL = 373 +/- 193; and PA = 27 +/- 3; at 60 minutes: T = 6226 +/- 1621; PL = 1573 +/- 793; and PA = 1185 +/- 710; at 120 minutes: T = 5307 +/- 591; PL = 3164 +/- 318; and PA = 180 +/- 100. Gross inspection of the 120-minute groups demonstrated focal areas of thrombus on T, less on PL, and none on PA. Scanning EM demonstrated extensive platelet accumulation covering T at all time periods, less on PL, and even less on PA.