Evaluation of three polytetrafluoroethylene stent-grafts in a model of neointimal hyperplasia.

PURPOSE: The authors tested three different porosities of expanded polytetrafluoroethylene (ePTFE)-covered stents and bare stents by using an animal model of restenosis.

MATERIALS AND

METHODS

Both iliac arteries in 18 female pigs were injured by overdilating 20-mm-long angioplasty balloons. A 40-mm-long bare stent or one of three 44-mm-long ePTFE-covered stents was deployed at the injury site. To determine restenosis, neointimal area measurements were made with intravascular ultrasonography. Histologic analyses were performed at an independent laboratory to determine neointimal attachment.

RESULTS

Neointimal area was greatest at the middle of the bare stent, where balloon injury was centered. When the middle location of the covered stents was evaluated, the neointimal area of both the medium- and high-porosity covered stents was smaller than that of the matched control stents (P = .0018 and P = .0118, respectively). The neointimal area of the low-porosity covered stents was similar to that of the bare stents. Histologic study showed dehiscence of the neointima of the low-porosity covered stents.

CONCLUSIONS

The microstructure of the low-porosity covered stents did not provide a suitable surface for neointimal attachment and did not reduce neointimal growth compared to that with the control stents. The microstructure of the medium- and high-porosity covered stents yielded less neointimal growth than both the control stents and the low-porosity covered stents without evidence of neointimal dehiscence. The authors believe that covered stents made with ePTFE with either medium or high porosity could limit restenosis in humans compared to that with bare stents.