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Short- and long-term effects of a novel paclitaxel coated stent in the porcine coronary model

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Abstract

Background

Drug eluting stents (DES) are unique in allowing sustained release for weeks after a single short intervention. The challenge with DES still remaining is the combination of a biocompatible drug-eluting matrix including an antiproliferative drug showing efficacy and safety in restenosis prevention. The aim of the present animal studies was to evaluate the novel paclitaxel coated Coroflex® Please stent in the porcine coronary model.

Methods and results

Stents were implanted into LAD and CX arteries of 49 domestic pigs. After 5 days, 4 weeks, 3 months, or 6 months, the animals underwent control angiography including dissection of the stented coronary arteries for histology. After 5 days, 3 and 6 months the Coroflex® Please stent was compared with its uncoated counterpart and a paclitaxel free but polymer coated version. After 28 days, an additional group received the Taxus® Express2 stent. After 5 days, healing with the paclitaxel coated stent was comparable to the uncoated bare metal stent as reflected in a similar neointimal proliferation. Compared to the Taxus® stent, the new Coroflex® Please stent showed a similar neointimal proliferation after 4 weeks. Inflammatory reaction was comparable among the bare stent and polymer coated stent groups. Paclitaxel coating was associated with a slightly increased inflammatory reaction with both DES. After 3 and 6 months, all groups showed a similar neointimal proliferation and inflammatory reaction.

Conclusion

The present porcine studies demonstrate excellent safety of the new paclitaxel coated Coroflex® stent in the porcine coronary stent model.

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References

  1. Axel DI, Kunert W, Goggelmann C, et al. (1997) Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation 96:636–645

    PubMed  CAS  Google Scholar 

  2. Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R (2004) Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res 63:617–624

    Article  PubMed  CAS  Google Scholar 

  3. Creel CJ, Lovich MA, Edelman ER (2000) Arterial paclitaxel distribution and deposition. Circ Res 86:879–884

    PubMed  CAS  Google Scholar 

  4. Farb A, Heller PF, Shroff S, et al. (2001) Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 104:473–479

    Article  PubMed  CAS  Google Scholar 

  5. Heldman AW, Cheng L, Jenkins GM, et al. (2001) Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation 103:2289–2295

    PubMed  CAS  Google Scholar 

  6. Herdeg C, Oberhoff M, Baumbach A, et al. (2000) Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol 35:1969–1976

    Article  PubMed  CAS  Google Scholar 

  7. Kornowski R, Hong MK, Tio FO, et al. (1998) In-stent restenosis contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol 31:224–230

    Article  PubMed  CAS  Google Scholar 

  8. Oberhoff M, Kunert W, Herdeg C, et al. (2001) Inhibition of smooth muscle cell proliferation after local drug delivery of the antimitotic drug paclitaxel using a porous balloon catheter. Basic Res Cardiol 96:275–282

    Article  PubMed  CAS  Google Scholar 

  9. Rowinsky EK, Donehower RC (1995) Paclitaxel (taxol). N Engl J Med 332:1004–1014

    Article  PubMed  CAS  Google Scholar 

  10. Scheller B, Grandt A, Wnendt S, Kuttler B, Bolz U, Lorenz G, Böhm M, Nickenig G (2005) Comparative study of tacrolimus and paclitaxel stent coating to prevent restenosis after coronary intervention. Z Kardiol 94:445–452

    Article  PubMed  CAS  Google Scholar 

  11. Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G (2004) Paclitaxel balloon coating—a novel method for prevention and therapy of restenosis. Circulation 110:810–814

    Article  PubMed  CAS  Google Scholar 

  12. Scheller B, Speck U, Romeike B, et al. (2003) Contrast media as a carrier for local drug delivery: successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J 24:1462–1467

    Article  PubMed  CAS  Google Scholar 

  13. Scheller B, Speck U, Schmitt A, Böhm M, Nickenig G (2003) Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol 42:1415–1420

    Article  PubMed  CAS  Google Scholar 

  14. Schwartz RS, Chronos NA, Virmani R (2004) Preclinical restenosis models and drug-eluting stents: still important, still much to learn. J Am Coll Cardiol 44:1373–1385

    PubMed  CAS  Google Scholar 

  15. Schwartz RS, Huber KC, Murphy JG, et al. (1992) Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. J Am Coll Cardiol 19:267–274

    Article  PubMed  CAS  Google Scholar 

  16. Suzuki T, Kopia G, Hayashi S, et al. (2001) Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation 104:1188–1193

    Article  PubMed  CAS  Google Scholar 

  17. Unverdorben M, Degenhardt R, Vallbracht C, Wiemer M, Horstkotte D, Schneider H, Nienaber C, Bocksch W, Gross M, Boxberger M (2006) The paclitaxel-eluting Coroflextrade mark please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic follow-up. Catheter Cardiovasc Interv 67:703–710

    Article  PubMed  Google Scholar 

  18. Unverdorben M, Degenhardt R, Wiemer M, Horstkotte D, Schneider H, Nienaber C, Bocksch W, Gross M, Boxberger M, Vallbracht C, for the PECOPS I Investigators (2007) The Paclitaxel-Eluting Coroflextrade mark Please Stent Pilot Study (PECOPS I): The 1-year clinical follow-up. Clin Res Cardiol 96(11):803–811

    Article  PubMed  CAS  Google Scholar 

  19. van der Giessen WJ, Lincoff AM, Schwartz RS, et al. (1996) Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94:1690–1697

    PubMed  CAS  Google Scholar 

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Correspondence to Bruno Scheller MD.

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Scheller, B., Kühler, M., Cremers, B. et al. Short- and long-term effects of a novel paclitaxel coated stent in the porcine coronary model. Clin Res Cardiol 97, 118–123 (2008). https://doi.org/10.1007/s00392-007-0597-6

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  • DOI: https://doi.org/10.1007/s00392-007-0597-6

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