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European Heart Journal Advance Access published online on January 31, 2006
European Heart Journal, doi:10.1093/eurheartj/ehi752
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received January 14, 2005
Revised December 15, 2005
Accepted January 12, 2006

Preclinical research

Zotarolimus-eluting stents reduce experimental coronary artery neointimal hyperplasia after 4 weeks

Arturo Garcia-Touchard 1, Sandra E. Burke 2, John L. Toner 2, Keith Cromack 2, and Robert S. Schwartz 1 *

1 Minneapolis Heart Institute and Foundation, Minneapolis Heart Institute, 920 E. 28th St., Suite 620, Minneapolis, MN 55407, USA
2 Abbott Laboratories, Abbott Park, IL 60064, USA

* To whom correspondence should be addressed.
Robert S. Schwartz, E-mail: rss{at}rsschwartz.com


  Abstract

Aims The addition of drug elution to coronary stents plays an integral role in coronary restenosis prevention. The present study was undertaken to determine the mechanism of action and the in vitro and in vivo efficacy of zotarolimus, a new chemical entity designed specifically for elution from phosphorylcholine (PC)-coated stents, for the reduction of neointimal hyperplasia in porcine coronary arteries.

Methods and results In vitro studies of Zotarolimus bound to FKBP-12 potently inhibited smooth muscle cells (SMCs) and endothelial cell (EC) proliferation. Twenty PC-only and 20 stents eluting zotarolimus 10 µg/mm were implanted in the coronary arteries of 20 domestic juvenile swine. After 28 days, zotarolimus stents exhibited less area stenosis (22.4 ± 8.6 vs. 35.7 ± 13%, P = 0.01), less neointimal area (1.69 ± 0.55 vs. 2.78 ± 1.07 mm2, P = 0.01), less neointimal thickness (0.25 ± 0.07 vs. 0.38 ± 0.13 mm, P = 0.01), and greater lumen area (6.07 ± 1.39 vs. 5.02 ± 1.3 mm2, P = 0.01). All arteries in both the polymer-only and polymer/drug stent showed near-complete healing and minimal toxicity. Zotarolimus did not affect the extrastent segments nor alter the overall artery size (external elastic lamina cross-sectional area 9.18 ± 1.19 vs. 9.06 ± 1.28 mm2, P = 0.7).

Conclusion Zotarolimus binds to FKBP-12 and in vitro inhibits SMC and EC proliferation. Zotarolimus applied to PC-coated stents reduces neointima in the swine coronary model after 28 days. These results suggest potentially promising human clinical application for coronary stenting with this polymer/drug combination.

Keywords: Stents; Restenosis; Zotarolimus; Phosphorphylcholine.
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