Современное поколение стентов с лекарственным покрытием: фокус на сиролимус-покрытый стент «Калипсо»

Автор: Кудряшов А.Н., Требушат Д.В., Верин В.В., Воробьев Вячеслав Леонидович

Журнал: Патология кровообращения и кардиохирургия @journal-meshalkin

Рубрика: Эндоваскулярная хирургия

Статья в выпуске: 1 т.21, 2017 года.

Бесплатный доступ

Статья посвящена обзору эволюции интервенционных процедур при коронарных вмешательствах, развитию и современному состоянию рынка коронарных стентов. В основу работы положен анализ технических характеристик наиболее популярных коронарных стентов в сравнении с российским стентом с биорезорбируемым лекарственным покрытием «Калипсо». Также данный обзор представляет собой краткий и критический анализ коронарного стента «Калипсо».

Коронарная ангиопластика, коронарный стент, сиролимус, "калипсо", технические параметры

Короткий адрес: https://sciup.org/142140781

IDR: 142140781   |   DOI: 10.21688-1681-3472-2017-1-37-43

Список литературы Современное поколение стентов с лекарственным покрытием: фокус на сиролимус-покрытый стент «Калипсо»

  • Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978;1(8058):263.
  • Grüntzig A.R., Senning A., Siegenthaler W.E. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979;301(2):61-8. http://dx.doi. org/10.1056/NEJM197907123010201
  • Biondi-Zoccai G.G., Abbate A., Agostoni P., Testa L., Burzotta F., Lotrionte M., Trani C., Biasucci L.M. Long-term benefits of an early invasive management in acute coronary syndromes depend on intracoronary stenting and aggressive antiplatelet treatment: a metaregression. Am Heart J. 2005;149(3):504-11.
  • Burzotta F., Trani C., Romagnoli E., Mazzari M.A., Rebuzzi A.G., De Vita M., Garramone B., Giannico F., Niccoli G., Biondi-Zoccai G.G., Schiavoni G., Mongiardo R., Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial.J Am Coll Cardiol. 2005;46(2):371-6. http://dx.doi.org/10.1016/j. jacc.2005.04.057
  • Hochman J.S., Sleeper L.A., White H.D., Dzavik V., Wong S.C., Menon V., Webb J.G., Steingart R., Picard M.H., Menegus M.A., Boland J., Sanborn T., Buller C.E., Modur S., Forman R., Desvigne-Nickens P., Jacobs A.K., Slater J.N., LeJemtel T.H., SHOCK Investigators. Should we emergently revascularize occluded coronaries for cardiogenic shock. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001;285(2):190-2.
  • Fischman D.L., Leon M.B., Baim D.S., Schatz R.A., Savage M.P., Penn I., Detre K., Veltri L., Ricci D., Nobuyoshi M. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med. 1994;331(8):496-501. http://dx.doi.org/10.1056/NEJM199408253310802
  • Serruys P.W., de Jaegere P., Kiemeneij F., Macaya C., Rutsch W., Heyndrickx G., Emanuelsson H., Marco J., Legrand V., Materne P. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994;331(8):489-95. http://dx.doi. org/10.1056/NEJM199408253310801
  • Kasaoka S., Tobis J.M., Akiyama T., Reimers B., Di Mario C., Wong N.D., Colombo A. Angiographic and intravascular ultrasound predictors of in-stent restenosis. J Am Coll Cardiol. 1998;32(6):1630 5. http://dx.doi.o DOI: rg/10.1016/S0735-1097(98)00404-5
  • Albiero R., Adamian M., Kobayashi N., Amato A., Vaghetti M., Di Mario C., Colombo A. Short-and intermediate-term results of (32)P radioactive beta-emitting stent implantation in patients with coronary artery disease: the Milan dose-response study. Circulation. 2000;101(1):18-26. https://doi.org/10.1161/01.CIR.101.1.18
  • Leon M.B., Teirstein P.S., Moses J.W., Tripuraneni P., Lansky A.J., Jani S., Wong S.C., Fish D., Ellis S., Holmes D.R., Kerieakes D., Kuntz R.E. Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. N Engl J Med. 2001;344(4):250-6. https://doi.org/10.1056/NEJM200101253440402
  • Waksman R., Ajani A.E., White R.L., Chan R.C., Satler L.F., Kent K.M., Pichard A.D., Pinnow E.E., Bui A.B., Ramee S., Teirstein P., Lindsay J. Intravascular gamma radiation for in-stent restenosis in saphenous-vein bypass grafts. N Engl J Med. 2002;346(16):1194-9. https://doi.org/10.1056/NEJMoa012579
  • Albiero R., Nishida T., Adamian M., Amato A., Vaghetti M., Corvaja N., Di Mario C., Colombo A. Edge restenosis after implantation of high activity (32)P radioactive beta-emitting stents. Circulation. 2000;101(21):2454-7.
  • Grube E., Lansky A., Hauptmann K.E., Di Mario C., Di Sciascio G., Colombo A., Silber S., Stumpf J., Reifart N., Fajadet J., Marzocchi A., Schofer J., Dumas P., Hoffmann R., Guagliumi G., Pitney M., Russell M.E., SCORE randomized trial. High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial. J Am Coll Cardiol. 2004;44(7):1368-72. https://doi.org/10.1016/j.jacc.2004.06.054
  • Morice M.C., Serruys P.W., Sousa J.E., Fajadet J., Ban Hayashi E., Perin M., Colombo A., Schuler G., Barragan P., Guagliumi G., Molnar F., Falotico R., RAVEL Study Group. Randomized study with the sirolimus-coated bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346(23):1773-80. https://doi.org/10.1056/NEJMoa012843
  • Moses J.W., Leon M.B., Popma J.J., Fitzgerald P.J., Holmes D.R., O'Shaughnessy C., Caputo R.P., Kereiakes D.J., Williams D.O., Teirstein P.S., Jaeger J.L., Kuntz R.E., SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349(14):1315-23. https://doi.org/10.1056/NEJMoa035071
  • Grube E., Silber S., Hauptmann K.E., Mueller R., Buellesfeld L., Gerckens U., Russell M.E. TAXUS I: six-and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003;107(1):38-42.
  • Colombo A., Drzewiecki J., Banning A., Grube E., Hauptmann K., Silber S., Dudek D., Fort S., Schiele F., Zmudka K., Guagliumi G., Russell M.E., TAXUS II Study Group. Randomized study to assess the effectiveness of slow-and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003;108(7):788-94. https://doi.org/10.1161/01. CIR.0000086926.62288.A6
  • Stone G.W., Ellis S.G., Cox D.A., Hermiller J., O'Shaughnessy C., Mann J.T., Turco M., Caputo R., Bergin P., Greenberg J., Popma J.J., Russell M.E., TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350(3):221-31. https://doi.org/10.1056/NEJMoa032441
  • McFadden E.P., Stabile E., Regar E., Cheneau E., Ong A.T., Kinnaird T., Suddath W.O., Weissman N.J., Torguson R., Kent K.M., Pichard A.D., Satler L.F., Waksman R., Serruys P.W. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004;364(9444):1519-21. http://dx.doi. org/10.1016/S0140-6736(04)17275-9
  • Cosgrave J., Corbett S.J., Melzi G., Babic R., Biondi-Zoccai G.G., Airoldi F., Chieffo A., Sangiorgi G.M., Montorfano M., Michev I., Carlino M., Colombo A. Late restenosis following sirolimus-eluting stent implantation. Am J Cardiol. 2007;100(1):41-4. http://dx.doi. org/10.1016/j.amjcard.2007.01.070
  • Hiatt B.L., Ikeno F., Yeung A.C., Carter A.J. Drug-eluting stents for the prevention of restenosis: in quest for the Holy Grail. Catheter Cardiovasc Interv. 2002;55(3):409-17.
  • Biondi-Zoccai G.G., Agostoni P., Abbate A., Testa L., Burzotta F., Lotrionte M., Crea F., Biasucci L.M., Vetrovec G.W., Colombo A. Adjusted indirect comparison of intracoronary drug-eluting stents: evidence from a metaanalysis of randomized bare-metal-stent-controlled trials. Int J Cardiol. 2005;100(1):119-23. http://dx.doi. org/10.1016/j.ijcard.2004.11.001
  • Biondi-Zoccai G.G., Lotrionte M., Abbate A., Valgimigli M., Testa L., Burzotta F., Crea F., Agostoni P. Int J Cardiol. Direct and indirect comparison meta-analysis demonstrates the superiority of sirolimus-versus paclitaxel-eluting stents across 5854 patients. 2007;114(1):104-5. http://dx.doi.o DOI: rg/10.1016/j.ijcard.2005.11.019
  • Meredith I.T., Ormiston J., Whitbourn R., Kay I.P., Muller D., Bonan R., Popma J.J., Cutlip D.E., Fitzgerald P., Prpic R., Kuntz R.E. First-inhuman study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I Trial. Eurointervention. 2005;1(2):157-64.
  • Fajadet J., Wijns W., Laarman G.J., Kuck K.H., Ormiston J., Münzel T., Popma J.J., Fitzgerald P.J., Bonan R., Kuntz R.E., ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006;114(8):798-806. http://dx.doi.org/10.1161/ href='contents.asp?titleid=14507' title='Circulation'>CirculationAHA.105.591206
  • Fajadet J., Wijns W., Laarman G.J., Kuck K.H., Ormiston J., Münzel T., Popma J.J., Fitzgerald P.J., Bonan R., Kuntz R.E., ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions. Clinical and angiographic results of the ENDEAVOR II Trial. Minerva Cardioangiol. 2007;55(1):1-18. (In English, Italian)
  • Palmerini T., Biondi-Zoccai G., Della Riva D., Mariani A., Sabate M., Smits PC., Kaiser C., D'Ascenzo F., Frati G., Mancone M., Genereux P., Stone G.W. Clinical outcomes with bioabsorbable polymer versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014;63(4):299-307. http://dx.doi.org/10.1016/j. jacc.2013.09.061
  • Ormiston J.A., Serruys P.W., Regar E., Dudek D., Thuesen L., Webster M.W., Onuma Y., Garcia-Garcia H.M., McGreevy R., Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective openlabel trial. Lancet. 2008;371:899-907. http://dx.doi.o DOI: rg/10.1016/S0140-6736(08)60415-8
  • Capodanno D., Gori T., Nef H., Latib A., Mehilli J., Lesiak M., Caramanno G., Naber C., Di Mario C., Colombo A., Capranzano P., Wiebe J., Araszkiewicz A., Geraci S., Pyxaras S., Mattesini coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015;10(10):1144-53. http://dx.doi.org/10.4244/EIJY14M07_11
  • Serruys P.W., Chevalier B., Sotomi Y., Cequier A., Carrie D., Piek J.J., Van Boven A.J., Dominici M., Dudek D., McClean D., Helqvist S., Haude M., Reith S., de Sousa Almeida M., Campo G., Iniguez A., Sabate M., Windecker S., Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388(10059):2479-91. http://dx.doi.o DOI: rg/10.1016/S0140-6736(16)32050-5
  • Iqbal J., Gunn J., Serruys P.W. Coronary stents: historical development, current status and future directions. Br Med Bull. 2013;106(1):193-211. http://dx.doi.o DOI: rg/10.1093/bmb/ldt009
  • Shah S.N. Coronary Bare-Metal Stent. Available at: http://emedicine. medscape.com/article/2009987-overview (accessed 24.12.16).
  • Nikam N., Steinberg T.B., Steinberg D.H. Advances in stent technologies and their effect on clinical efficacy and safety. Med Devices (Auckl). 2014;7:165-78. http://dx.doi.o DOI: rg/10.2147/MDER.S31869
  • Кудряшов А.Н., Лопотовский П.Ю. Сравнительная оценка механических свойств коронарного стента «Синус». Диагнос тическая и интервенционная радиология. 2014;8(1-1):70-7.
  • Martin D., Boyle F. Drug-eluting stents for coronary artery disease: a review. Med Eng Phys. 2011;33(2):148-63. http://dx.doi. org/10.1016/j.medengphy.2010.10.009
  • Прохорихин А.А., Верин В.В., Осиев А.Г., Ганюков В.И., Протопопов А.В., Демин В.В., Абугов С.А., Байструков В.И., Гражданкин И.О., Пономарев Д.Н., Кретов Е.И. Простое слепое проспективное рАндомизированное мультиценровое исследование эффективности и безопасности сиролимусдоставляющего коРонарного стента «КалИпсО» по сравнению с эверолимус-доставляющим сТентом Xience Prime. Патология кровообращения и кардиохирургия. 2016;20(4):96-101. http://dx.doi.o DOI: rg/10.21688/1681-3472-2016-4-96-101
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