Biocompatibility of biodegradable and nonbiodegradable polymer-coated stents implanted in porcine peripheral arteries.

PURPOSE: To investigate the neointimal response to poly(organo)phosphazene- and amphiphilic polyurethane-coated, oversized, stainless steel stents implanted in porcine peripheral arteries. METHODS: Nonarticulated, stainless steel, slotted-tube stents were coated with 1) a biodegradable poly-(organo)phosphazene with aminoacid ester side groups and 2) a biostable polyurethane prepared from an amphiphilic polyether, diphenyl methane-4,4'-diisocyanate and butane diol as chain extender. The stents were deployed in porcine peripheral arteries using an oversized balloon. RESULTS: The neonintimal response to amphiphilic polyurethane-coated stents was similar to the uncoated metallic stents. Poly(organo)phosphazene-coated stents, however, induced a severe histiolymphocytic and fibromuscular reaction resembling a foreign body reaction. CONCLUSIONS: Amphiphilic polyurethane is very promising as a biocompatible stent coating. Poly-(organo)phosphazene, however, appears unsuitable for this purpose.

Biocompatibility of polymer-coated oversized metallic stents implanted in normal porcine coronary arteries.

Polymer coatings have been suggested to decrease the thrombogenicity of metallic intravascular stents. The purpose of the present study was to investigate the intimal response to two different polymers when used as coatings for stents implanted in normal porcine coronary arteries. Non-articulated stainless steel-slotted tube stents were coated with either a biodegradable poly(organo)phosphazene with amino-acid ester side groups or a biostable polyurethane prepared from an amphiphilic polyether, dephenylmethane-4,4'-diisocyanate and butane diol as chain extender. In order to induce vascular wall injury, the stents were deployed using an oversized balloon. At 6 weeks follow-up, the angiographic luminal diameter measured in four polyurethane-coated stents and in six bare metallic stents was similar and 20% less than immediately post-stenting. However, in four polyphosphazene-coated stents the difference was 65% (P = 0.01 when compared to bare metal). At post-mortem morphometry the degree of luminal area stenosis was also similar in polyurethane-coated and in bare metallic stents (32 +/- 7.6% vs. 39 +/- 14%, NS) but reached 81 +/- 19% in polyphosphazene-coated stents (P < 0.03 when compared to bare metal). Thus, poly(organo)phosphazene induced a more pronounced histiolymphocytic and fibromuscular reaction than amphiphilic polyurethane, which appeared to be promising as biocompatible stent coating and, consequently, as a potential carrier for vasoactive drugs.