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Abstract:

Eighteen experimental animals (9 rabbits and 9 mongrel dogs) were used in a feasibility study of heparin and a polymer belonging to polyoxyalkanoates class - homopolymer of в-oxybutyric acid - polyoxybutyrate (POB) to be applied onto the surface of the nitinole self-expanding stent "Alex" ("Komed", Russia) in order to decrease responsiveness of the vascular wall. During a three-month chronic experiment at various terms following implantation, we examined the degree of biocompatibility of the coat-free stents, heparin-treated stents, and those coated with the above polymer. The studies were carried out by means of arteriography, binocular light microscopy, histological examination, electron microscopy; and the study of the ultrastructure of thestented segmentsof the vessels. The experiments carried out on animals showed that: 1. The coating of the stents may positively influence structural alterations in the vascular wall, which improve the conditions of the blood flow along the vessel; 2. Using POB-coated stents is accompanied by lesser intimal hyperplasia, relatively decreased leukocytic infiltration, and development of vasa vasorum; 3. POB may safely be considered the most favourable coating for stents because of minimal structural alterations in the vascular wall. The obtained findings would make it possible to plan future research on polyoxyalkanoatesas modifiers of the histological responseof the vascular wall tissues while implanting stents.

 

       References

1.     Holmes D.RJr., Leon M.B., Moses J.W., Popma J.J., Cutlip D., Fitzgerald P.J., Brown C., Fischell T., Wong SC., Midei M., Snead D., Kuntz R.E.. Analysis of 1-Year Clinical Outcomes in the SIRIUS Trial. A Randomized Trial of a Sirolimus-Eluting Stent Versus a Standard Stent in Patients at High Risk for Coronary Restenosis. Circulation. 2004; 109: 634-640.

2.     Machan L. Drug eluting stents in the infrainguinal circulation. Tech. Vasc. Interv. Radiol. 2004; 7: 28-32.

3.     Tanabe K., Serruys P., Grube E., Smits P.C., Selbach G., van der Gissen W.J., Staberock M., de Feyter P., Muller R., Reger E., Degertekin M., Ligthart J.M.R., Disco C., Backx B., Russell M.ETAXUS III Trial. In-Stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formation. Circulation. 2003; 107: 559-564.

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5.     Kerner A., Gruberg L., Kapeliovich L., Grenadier E. Late stent thrombosis after implantation of a sirolimus-eluting stent. Catheter Cardiovasc. Interv. 2003; 60: 505-508.

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9.     Peck P. Concerns About Subacute Thrombosis and the Sirolimus-Eluting Stents: Hype or Reality? Posted 12.10.2003. Available at:http//www.medscape.com/viewarticle/465210 - 50k.

10.   FDA Public Health Web Notification: Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary Stent. Issuing Date: October 28, 2003. Available at:http: //www.fda.gov/cdrh/safety/cypher.html.

11.   FDA Public Health Web Notification: Updated information for physicians on sub-acute thromboses (SAT) and hypersensitivity reactions with use of the Cordis CYPHER™ sirolimus-eluting coronary stent. Issuing Date: November 25, 2003. Available at: http://www.fda.gov/cdrh/safety/cypher2.pdf.

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17.   Unverdorben M., Spielberger A., Schywaisky M., Labahn D., Hartwig S., Schneider M., Lootz D., Behrend D., Schmitz K., Degenhardt R., Schaldach M., Vallbracht C. A polyhydroxybutyrate biodegradable stent: preliminary experience in the rabbit. CVIR.2002; 25: 127-132.

18.   Tamai H., Igaki K., Kyo E., Kosuga K., Kawashima A., Matsui S., Komori H.,TsujiT., Motohara S., Uehata H.. Initial and 6-month results of biodegradable poly-L- lactic acid coronary stents in human. Circulation. 2000; 102: 399-404.

 

Abstract:

A multicentered study based on retrospective data covered 2012 patients and aimed at ascertaining the eficiency of various methods of treating patients with coronary restenosis after stenting. The average percent of complications after restenosis was about 20% during the period of study (1 1+4 months). The metaregression data analysis showed the positive correlation between the stage of residual stenosis of the stentet segment and the probability of complications. As the residual stenosis decreased at 1%, the frequency of complications diminished at 0,9%. Another factors under analysis did not show any evident influence, although we have registered a tendency towards better outcomes of the recurring operations as the diameter of the vessel increased. The recurring balloon angioplasty in cases of short restenosis and intracoronar radiation in cases of diffused restenotic lesions have proved to be the most effective operations. The indications for implanting the additional stents must be given very carefully, especially in cases of diabetes.

 

References

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2.     Serruys P.W, de Jaeger P., Kimeneij E, et al. A comparison of balloon-expandable stent implantation with balloon angioplasty in patients with coronary heart disease. N. Engl]. Med. 1994; 331: 489 - 495.

3.     Di Mario C, Marsico E, Adamian M. et al. New recipes for in-stent restenosis: cut, grate, roast, or sandwich the neointima? Heart. 2000; 84: 471 - 475.

4.     Hoffmann R., Mintz G. S. Coronary in-stent restenosis-predictors, treatment and prevention. Eur. Heart J. 2000; 21: 1739- 1749.

5.     Leon M.B., Tierstein P.S., Moses J.W et al. Localized intracoronary gamma-radiation therapy to inhibit the occurrence of restenosis after stenting. N. Egl. J. Med. 2001; 344: 250-256.

6.     Waksman R., White R.L., Chan R.C., et al. Intracoronary gamma-radiation therapy after angioplasty inhibits reccurence in patients with in-stent restenosis. Circulation. 2000; 101: 2165 - 2171.

7.     Sousa J. E., Costa M.A., Abizaid A., et al. Lack of neoitimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001; 10: 192 - 195.

8.     Kuntz R.E., Gibson СМ., Nobuyoshi M., et al. Generalized model of restenosis after conventional balloon angioplasty, stenting and directional atherectomy. J. Am. Coll. Cardiology. 1993; 21: 15 - 25.

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