Circulation, Vol 86, 1596-1604, Copyright © 1992 by American Heart Association
JG Murphy, RS Schwartz, WD Edwards, AR Camrud, RE Vlietstra and DR Holmes Jr
BACKGROUND. To test the feasibility of percutaneous deployment of
intracoronary polymeric stents, a prototype polyethylene terephthalate
(PET) stent and a catheter-based delivery system were developed. METHODS
AND RESULTS. Polymeric stents were deployed in the coronary arteries of 11
Yucatan swine: six stents were placed in the left anterior descending
coronary artery, four stents were placed in the circumflex artery, and one
stent was placed in the right coronary artery. Stent deployment was
achieved by withdrawal of an outer delivery sheath, thus allowing the PET
stent to self-expand to a preformed configuration. Two animals died during
surgery, one during stent placement and the other several hours after
implantation due to intracoronary thrombus formation. Two animals were
electively sacrificed within 24 hours of stent implant to examine the
adequacy of stent deployment within the coronary vessel. The remaining
seven animals survived until the termination of the study 4-6 weeks later.
Light microscopic examination of the stented vessels showed an extensive
neointimal proliferative response with vessel occlusion in all animals who
survived initial stent placement. There were two distinct types of
histological responses to the PET stent--a chronic foreign body
inflammatory response around the stent tines and a neointimal proliferative
response in the center of the occluded vessel lumen. The histological
response seen in the central area of the vessel was morphologically similar
to that seen in patients with restenosis after successful percutaneous
transluminal coronary angioplasty, whereas the morphological response seen
at the periphery of the stent tine was similar to that exhibited by a
chronic foreign body reaction and was not typical of that seen in a
restenosis lesion. A ventricular aneurysm also developed in the area of
myocardium that was previously supplied by the occluded vessel.
CONCLUSIONS. This study demonstrates that percutaneous deployment of
polymeric stents in the coronary arteries is technically feasible. The use
of PET polymer was associated with an intense proliferative neointimal
response that resulted in complete vessel occlusion. Histological
examination of the stented segments of the vessel revealed no evidence that
dissection of the vessel wall had occurred at the time of initial stent
deployment. Although the PET polymer was of similar quality to that used in
the manufacture of balloon angioplasty catheters, a toxic chemical or
contaminant effect cannot be completely excluded as the stimulus to intimal
proliferation. This finding may have relevance to the selection of
materials for use as intravascular devices.
ARTICLES
Percutaneous polymeric stents in porcine coronary arteries. Initial experience with polyethylene terephthalate stents
Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, Minn. 55905.
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