Circulation. 2001;104:473-479
doi: 10.1161/hc3001.092037
doi: 10.1161/hc3001.092037
(Circulation. 2001;104:473.)
© 2001 American Heart Association, Inc.
Basic Science Reports |
Pathological Analysis of Local Delivery of Paclitaxel Via a Polymer-Coated Stent
From the Department of Cardiovascular Pathology (A.F., S.S., F.D.K., A.J.C., D.S.S., R.V.), Armed Forces Institute of Pathology, Washington, DC, and the Laboratory of Cardiovascular Science (P.F.H., L.C., J.F.), Gerontology Research Center, National Institute on Aging, Baltimore, Md.
Correspondence to Renu Virmani, MD, Department of Cardiovascular Pathology, Armed Forces Institute of Pathology, Washington, DC 20306-6000. E-mail virmani{at}afip.osd.mil
Background—— Paclitaxel can inhibit vascular smooth muscle proliferation in vitro, and early studies suggest that paclitaxel may be useful in preventing restenosis. Early and late intimal growth and local vascular pathological changes associated with paclitaxel delivered via stents have not been fully explored.
Methods and Results—— Localized drug delivery was accomplished with balloon-expandable stainless steel stents coated with a cross-linked biodegradable polymer, chondroitin sulfate and gelatin (CSG), containing various doses of paclitaxel. CSG-coated stents with paclitaxel (42.0, 20.2, 8.6, or 1.5 µg of paclitaxel per stent), CSG-coated stents without paclitaxel, and uncoated stents (without paclitaxel or CSG) were deployed in the iliac arteries of New Zealand White rabbits, which were killed 28 days after implant. Mean neointimal thickness at stent strut sites was reduced 49% (P<0.0003) and 36% (P<0.007) with stents containing 42.0 and 20.2 µg of paclitaxel per stent, respectively, versus CSG-coated stents without paclitaxel. However, histological findings suggested incomplete healing in the higher-dose (42.0 and 20.2 µg) paclitaxel-containing stents consisting of persistent intimal fibrin deposition, intraintimal hemorrhage, and increased intimal and adventitial inflammation. Stents coated with CSG alone (without paclitaxel) had similar neointimal growth as uncoated stents. In a separate group of rabbits killed at 90 days, neointimal growth was no longer suppressed by CSG-coated stents containing 42.0 or 21.0 µg of paclitaxel
Conclusions—— CSG coating appears to be a promising medium for localized drug delivery. Paclitaxel polymer–coated stents reduce neointima formation but are associated with evidence of incomplete healing at 28 days. However, neointimal suppression was not maintained at 90 days.
Key Words: stents • restenosis • pathology
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C.-W. Hwang and E. R. Edelman Arterial Ultrastructure Influences Transport of Locally Delivered Drugs Circ. Res., April 19, 2002; 90(7): 826 - 832. [Abstract] [Full Text] [PDF]
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C.-W. Hwang and E. R. Edelman Arterial Ultrastructure Influences Transport of Locally Delivered Drugs Circ. Res., April 19, 2002; 90(7): 826 - 832. [Abstract] [Full Text] [PDF]
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F. Liistro, G. Stankovic, C. Di Mario, T. Takagi, A. Chieffo, S. Moshiri, M. Montorfano, M. Carlino, C. Briguori, P. Pagnotta, et al. First Clinical Experience With a Paclitaxel Derivate-Eluting Polymer Stent System Implantation for In-Stent Restenosis: Immediate and Long-Term Clinical and Angiographic Outcome Circulation, April 23, 2002; 105(16): 1883 - 1886. [Abstract] [Full Text] [PDF]
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