Experimental Evaluation of a New Tubular Coronary Stent (V-Flexª).
The safety, efficacy, angiographic and histological effects of a new 316 L, SS seamless stainless steel tubular stent (V-Flexª, Global Therapeutics, Broomfield, Colorado) was evaluated in a porcine coronary and peripheral artery model. Implantation in the right coronary artery was successful in all 16 pigs. Eight pigs were angiographically controlled after 6 weeks and then sacrificed for morphometric analysis. All stented coronary vessels were widely patent at this moment and morphometric analysis showed only a mild fibromuscular neointimal hyperplasia resulting in a neointimal hyperplasia of 1.15 +/- 0.38 mm2. The remaining 8 pigs were controlled and sacrificed at 12 weeks. At that time, all stented vessels were patent and neointimal hyperplasia was 1.22 +/- 0.34 mm2. Comparison with the Palmaz-Schatzª coronary stent (Cordis, Miami, Florida) in a porcine peripheral artery model demonstrated significantly less neointimal hyperplasia at 6 weeks (1.11 +/- 0.73 vs. 2.40 +/- 0.36, p = 0.001) and at 12 weeks (1.53 +/- 0.42 vs. 2.47 +/- 0.63, p = 0.003) for the V-Flex stent. In conclusion, V-Flex coronary stent implantation in a porcine coronary and peripheral arteries results in a high procedural success rate without subacute thrombotic occlusions, despite no further anticoagulation nor antiplatelet therapy. Six and 12 week histopathological and morphometric evaluation demonstrated only a mild fibromuscular neointimal hyperplasia. Comparison with the Palmaz-Schatz coronary stent in a peripheral artery model showed significantly less neointimal hyperplasia in the V-Flex stent.
Shun
LX
UH Gasthuisberg, Dept. Cardiology, 49, Herestraat, 3000 Leuven, Belgium.
Wang
K
Zhou
XR
Verbeken
E
Ping
QB
Szilard
M
Yanming
H
Jianhua
H
De Scheerder IK