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CardioVascular and Interventional Radiology

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01-09-2008 | Laboratory Investigation

Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model

Authors: Boris Radeleff, Heidi Thierjung, Ulrike Stampfl, Sibylle Stampfl, Ruben Lopez-Benitez, Christof Sommer, Irina Berger, Goetz M. Richter

Published in: CardioVascular and Interventional Radiology | Issue 5/2008

Abstract

Purpose

To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model.

Methods

The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks.

Results

Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 ± 62.52 μm) versus the TAXUS (74.864 ± 66.03 μm) and versus the CCPS (63.542 ± 39.57 μm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks.

Conclusions

The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.

Moliterno DJ (2005) Healing Achilles: Sirolimus versus paclitaxel. N Engl J Med 353:724–727PubMedCrossRef

Farb A, Boam AB (2007) Stent thrombosis redux: The FDA perspective. N Engl J Med 356:984–987PubMedCrossRef

Camenzind E, Steg PG, Wijns W (2007) Stent thrombosis late after implantation of first-generation drug-eluting stents: A cause for concern. Circulation 115:1440–1455PubMedCrossRef

Maisel WH (2007) Unanswered questions: Drug-eluting stents and the risk of late thrombosis. N Engl J Med 356:981–984PubMedCrossRef

Virmani R, Liistro F, Stankovic G, et al. (2002) Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation 106:2649–2651PubMedCrossRef

Tur DR, Korshak VV, Vinogradova SV, et al. (1986) Effects of biological medium on the properties of poly[bis(trifluoroethoxy)phosphazene]. Acta Polym 37:203–208CrossRef

Vinogradova SV, Tur DR, Vasnev VA (1998) Open-chain poly(organophosphazenes). Synthesis and properties. Russian Chem Rev 67:515–534CrossRef

Welle A, Grunze M, Tur D (1998) Plasma protein adsorption and platelet adhesion on poly[bis(trifluoroethoxy)phosphazene] and reference material surfaces. J Colloid Interface Sci 197:263–274PubMedCrossRef

Richter GM, Stampfl U, Stampfl S, et al. (2005) A new polymer concept for coating of vascular stents using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to reduce thrombogenicity and late in-stent stenosis. Invest Radiol 40:210–218PubMedCrossRef

10.

Satzl S, Henn C, Christoph P, et al. (2007) The efficacy of nanoscale poly[bis(trifluoroethoxy) phosphazene] (PTFEP) coatings in reducing thrombogenicity and late in-stent stenosis in a porcine coronary artery model. Invest Radiol 42:303–311PubMedCrossRef

11.

Bayne K (1998) Developing guidelines on the care and use of animals. Ann N Y Acad Sci 862:105–110PubMedCrossRef

12.

Schwartz RS, Edelman ER, Carter A, et al. (2002) Drug-eluting stents in preclinical studies: Recommended evaluation from a consensus group. Circulation 106:1867–1873PubMedCrossRef

13.

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 19:267–274PubMedCrossRef

14.

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 31:224–230PubMedCrossRef

15.

Finis K, Sultmann H, Ruschhaupt M, et al. (2006) Analysis of pigmented villonodular synovitis with genome-wide complementary DNA microarray and tissue array technology reveals insight into potential novel therapeutic approaches. Arthritis Rheum 54:1009–1019PubMedCrossRef

16.

Hong MK, Kornowski R, Bramwell O, et al. (2001) Paclitaxel-coated Gianturco-Roubin II (GR II) stents reduce neointimal hyperplasia in a porcine coronary in-stent restenosis model. Coron Artery Dis 12:513–515PubMedCrossRef

17.

Drachman DE, Edelman ER, Seifert P, et al. (2000) Neointimal thickening after stent delivery of paclitaxel: Change in composition and arrest of growth over six months. J Am Coll Cardiol 36:2325–2332PubMedCrossRef

18.

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

19.

Carter AJ, Aggarwal M, Kopia GA, et al. (2004) Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res 63:617–624PubMedCrossRef

20.

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

21.

Finn AV, Kolodgie FD, Harnek J, et al. (2005) Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation 112:270–278PubMedCrossRef

22.

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 103:2289–2295PubMed

23.

Gaspardone A, Versaci F, Tomai F, et al. (2006) C-Reactive protein, clinical outcome, and restenosis rates after implantation of different drug-eluting stents. Am J Cardiol 97:1311–1316PubMedCrossRef

24.

Chamberlain J, Gunn J, Francis SE, et al. (2001) TGFbeta is active, and correlates with activators of TGFbeta, following porcine coronary angioplasty. Cardiovasc Res 50:125–136PubMedCrossRef

25.

Lagerqvist B, James SK, Stenestrand U, et al. (2007) Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356:1009–1019PubMedCrossRef

26.

Luscher TF, Steffel J, Eberli FR, et al. (2007) Drug-eluting stent and coronary thrombosis: Biological mechanisms and clinical implications. Circulation 115:1051–1058PubMedCrossRef

27.

Virmani R, Guagliumi G, Farb A, et al. (2004) Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: Should we be cautious? Circulation 109:701–705PubMedCrossRef

28.

Richter GM, Palmaz JC, Noeldge G, et al. (1999) Relationship between blood flow, thrombus, and neointima in stents. J Vasc Interv Radiol 10:598–604PubMedCrossRef

29.

Virmani R, Kolodgie FD, Farb A, et al. (2003) Drug eluting stents: are human and animal studies comparable? Heart 89:133–138PubMedCrossRef

Title: Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model
Authors: Boris Radeleff
Heidi Thierjung
Ulrike Stampfl
Sibylle Stampfl
Ruben Lopez-Benitez
Christof Sommer
Irina Berger
Goetz M. Richter
Publication date: 01-09-2008
Publisher: Springer-Verlag
Published in: CardioVascular and Interventional Radiology / Issue 5/2008
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-007-9243-y

At a glance: The STEP trials

Springer Medicine

Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model

Abstract

Purpose

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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