ЭВОЛЮЦИЯ КОРОНАРНЫХ СТЕНТОВ: ОТ ПЕРВЫХ ЭКСПЕРИМЕНТОВ К СОВРЕМЕННЫМ ТЕХНОЛОГИЯМ

Основные положения

Данный обзор представляет собой систематизацию научных достижений в области разработки и использования коронарных стентов. Он включает анализ главных исследований, посвящённых различным аспектам их функционирования. В статье рассматриваются существующие поколения коронарных стентов, применяемые материалы для их изготовления, особенности конструктивного исполнения, а также описаны новейшие разработки в этой области.

Резюме

Внедрение технологии имплантации коронарных стентов. позволило снизить частоту тромбоза и необходимости повторной реваскуляризации по сравнению с баллонной ангиопластикой, однако высокий риск рестеноза ограничивал их применение. Появление стентов с лекарственным покрытием в 2000-х гг. привело к резкому снижению неоинтимальной гиперплазии и повторных вмешательств, но сопровождалось риском позднего тромбоза, современные поколения обладают лучшей эффективностью и безопасностью применения. Биорезорбируемые стенты являлись инновационной разработкой, однако не продемонстрировали превосходства в крупных рандомизированных исследованиях. В настоящее время разрабатываются стенты с добавлением инновационных противовоспалительных агентов (например, колхицина). Эволюция коронарных стентов отражает стремление к созданию оптимального биосовместимого устройства, которое будет вызывать минимальный воспалительный ответ, способствовать заживлению сосудистой стенки в короткие сроки и не требовать длительного применения двойной антитромбоцитарной терапии.

Поиск научных публикаций проводился в электронной базе данных PubMed за период с 1994 по 2025 год. В качестве ключевых слов использовались следующие термины: «coronary stent», «bare metal stent», «drug-eluting stent», «polymer-free», «bioresorbable scaffold». В обзор были включены клинические исследования, систематические обзоры, мета-анализы, рандомизированные контролируемые исследования и сравнительные исследования, соответствующие тематике анализа.

1. Lee D, de la Torre Hernandez J. The Newest Generation of Drug-eluting Stents and Beyond. Eur Cardiol. 2018; 13:54-59. doi: 10.15420/ecr.2018:8:2.

2. Stefanini G, Byrne R, Windecker S, Kastrati A. State of the art: coronary artery stents - past, present and future. EuroIntervention. 2017;13:706-716. doi: 10.4244/EIJ-D-17-00557.

3. Fischman D, Leon M, Baim D, Schatz R, Savage M, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein P, Fish D, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994;25;331:496-501. doi: 10.1056/NEJM199408253310802.

4. Serruys P, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi J, Sigwart U, Colombo A, Goy J, van den Heuvel P, Delcan J, Morel M. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994;25;331:489-95. doi: 10.1056/NEJM199408253310801.

5. Serruys P, Kutryk M, Ong A. Coronary-artery stents. N Engl J Med. 2006 2;354:483-95. doi: 10.1056/NEJMra051091.

6. Schömig А, Neumann F, Kastrati A, Schühlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth E, Richardt G, Alt E, Schmitt C, Ulm K. A Randomized Comparison of Antiplatelet and Anticoagulant Therapy after the Placement of Coronary-Artery Stents. N Engl J Med. 1996;334:1084-1089. DOI: 10.1056/NEJM199604253341702.

7. Serruys P, Degertekin M, Tanabe K, Abizaid A, Sousa J, Colombo A, Guagliumi G, Wijns W, Lindeboom W, Ligthart J, de Feyter P, Morice M; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 13;106:798-803. doi: 10.1161/01.cir.0000025585.63486.59.

8. Schofer J, Schlüter M, Gershlick A, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 4;362:1093-9. doi: 10.1016/S0140-6736(03)14462-5.

9. Grube E, Silber S, Hauptmann K, Mueller R, Buellesfeld L, Gerckens U, Russell M. 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 7;107:38-42. doi: 10.1161/01.cir.0000047700.58683.a1.

10. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell M; 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 19;108:788-94. doi: 10.1161/01.CIR.0000086926.62288.A6.

11. Tanabe K, Serruys P, Grube E, Smits PC, Selbach G, van der Giessen W, Staberock M, de Feyter P, Müller R, Regar E, Degertekin M, Ligthart J, Disco C, Backx B, Russell M. TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003 4;107:559-64. doi: 10.1161/01.cir.0000048184.96491.8a.

12. Stone G, Ellis S, Cox D, Hermiller J, O'Shaughnessy C, Mann J, Turco M, Caputo R, Bergin P, Greenberg J, Popma J, Russell M; TAXUS-IV Investigators. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation. 2004 27;109:1942-7. doi: 10.1161/01.CIR.0000127110.49192.72.

13. Windecker S, Remondino A, Eberli F, Jüni P., Räber L, Wenaweser P, Togni M, Billinger M, Tüller В, Seiler С, Roffi M, Corti R, Sütsch G, Maier W, Lüscher T, Hess O, Egger M, Meier B, M.D. Sirolimus-Eluting and Paclitaxel-Eluting Stents for Coronary Revascularization. N Engl J Med 2005;353:653-662. DOI: 10.1056/NEJMoa051175

14. Schömig A, Dibra A, Windecker S, Mehilli J, Suárez de Lezo J, Kaiser C, Park S, Goy J, Lee J, Di Lorenzo E, Wu J, Jüni P, Pfisterer M, Meier B, Kastrati A. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol. 2007 2;50:1373-80. doi: 10.1016/j.jacc.2007.06.047.

15. Camenzind E, Steg P, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007 20;115:1440-55. doi: 10.1161/CIRCULATIONAHA.106.666800.

16. Bavry A, Kumbhani D, Helton T, Borek P, Mood G, Bhatt D. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006;119:1056-61. doi: 10.1016/j.amjmed.2006.01.023.

17. Serruys P, Silber S, Garg S, van Geuns R, Richardt G, Buszman P, Kelbaek H, van Boven A, Hofma S, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 8;363:136-46. doi: 10.1056/NEJMoa1004130.

18. Onuma Y, Miquel-Hebert K, Serruys P. SPIRIT II Investigators. Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial. EuroIntervention. 2013 22;8:1047-51. doi: 10.4244/EIJV8I9A161.

19. Smits P, Vlachojannis G, McFadden E, Royaards K, Wassing J, Joesoef K, van Mieghem C, van de Ent M. Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice). JACC Cardiovasc Interv. 2015 17;8:1157-1165. doi: 10.1016/j.jcin.2015.03.028.

20. Fajadet J, Wijns W, Laarman G, Kuck K, Ormiston J, Münzel T, Popma J, Fitzgerald P, Bonan R, Kuntz RE; 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 22;114:798-806. doi: 10.1161/CIRCULATIONAHA.105.591206.

21. Ferreira-González, I, Marsal J, Ribera A, Permanyer-Miralda G, García-Del Blanco B, Martí G, Cascant P, Masotti-Centol M, Carrillo X, Mauri J, Batalla N, Larrousse E, Martín E, Serra A, Rumoroso J, Ruiz-Salmerón R, de la Torre J, Cequier A, Gómez-Hospital A, Alfonso F, Martín-Yuste V, Sabatè M, García-Dorado D .Double Antiplatelet Therapy After Drug-Eluting Stent Implantation: Risk Associated With Discontinuation Within the First Year. JACC. 2012,60;1333–1339. doi.org/10.1016/j.jacc.2012.04.057

22. Joner M, Finn A, Farb A, Mont E, Kolodgie F, Ladich E, Kutys R, Skorija K, Gold H, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 4;48:193-202. doi: 10.1016/j.jacc.2006.03.042.

23. Khan W, Farah S, Domb A. Drug eluting stents: developments and current status. J Control Release. 2012 20;161:703-12. doi: 10.1016/j.jconrel.2012.02.010.

24. Windecker S, Serruys P, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice M, Mario C, Davies S, Geuns R, Eerdmans P, Es G, Meier B, Jüni P. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (LEADERS): a randomised non-inferiority trial. Lancet. 2008;372:1563–1570. doi:10.1016/S0140-6736(08)61343-3.

25. Serruys P, Farooq V, Kalesan B, Ton de Vries, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Claude M, Mario C, Corti R, Antoni D, Sohn H, Eerdmans P, Rademaker-Havinga T, Gerrit-Anne van Es, Meier B, Jüni P, Windecker S. Improved Safety and Reduction in Stent Thrombosis Associated With Biodegradable Polymer-Based Biolimus-Eluting Stents Versus Durable Polymer-Based Sirolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report of the LEADERS. JACC: Cardiovascular Interventions. 2013; 6 :777-789 doi.org/10.1016/j.jcin.2013.04.011.

26. Worthley S, Abizaid A, Kirtane A, Simon D, Windecker S, Brar S, Meredith I, Shetty S, Sinhal A, Almonacid A, Chamié D, Maehara A, Stone G, Worthley S, Shetty S, Sinhal A, Meredith I, Abizaid A, Jepson N, Bhindi R, TeikLim S, Stewart P,Barlis P, Walters D, Muller D, Cox S, Bhagwandeen R. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. J Am Coll Cardiol Intv. 2017, 10: 147–156. doi.org/10.1016/j.jcin.2016.10.020

27. Gracida M, Romaguera R, Jacobi F, Gómez-Hospital J, Cequier A. The MGuard coronary stent: safety, efficacy, and clinical utility. Vasc Health Risk Manag. 2015 18;11:533-9. doi: 10.2147/VHRM.S68007.

28. Kandzari D, Mauri L, Koolen J, Massaro J, Doros G, Garcia-Garcia H, Bennett J, Roguin A, Gharib E, Cutlip D, Waksman R; BIOFLOW V Investigators. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017 21;390:1843-1852. doi: 10.1016/S0140-6736(17)32249-3.

29. Kandzari D, Koolen J, Doros G, Garcia-Garcia H, Bennett J, Roguin A, Gharib E, Cutlip D , Waksman R. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial. J Am Coll Cardiol Intv. 2020,13;1343–1353. doi.org/10.1016/j.jcin.2020.02.019

30. Jensen L, Jakobsen L, Eftekhari A, Ellert-Gregersen J, Støttrup N, Engstrøm T, Kahlert J, Freeman P, Veien K, Jensen R, Lassen J, Junker A, Christiansen E. Five-year outcomes of a drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent. EuroIntervention. 2025 2;21:617-628. doi: 10.4244/EIJ-D-24-00586.

31. Ellis S, Kereiakes D, Metzger C, Caputo R, Rizik D,Teirstein S, Litt M, Kini A, Kabour A, Marx O, Popma J, McGreevy R, Zhang Z, Simonton C, Stone G. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease N Engl J Med; 2015;373:1905-1915. DOI: 10.1056/NEJMoa1509038.

32. Farhan M, Hasan G, Sobhi A, Yasser K, Humam M, Ali M, Younes S, Nazir M, Mateen M, Misra G, Patel T. Bioresorbable scaffolds advances, challenges, and future directions. Ann Med Surg (Lond). 2025 22;87:4173-4183. doi: 10.1097/MS9.0000000000003424.

33. Stone G, Kimura T, Gao R, Kereiakes D, Ellis S, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali Z, Serruys P. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 20191;4:1261-1269. doi: 10.1001/jamacardio.2019.4101.

34. Kandzari D, Mauri L, Koolen J, Massaro J, Doros G, Garcia-Garcia H, Bennett J, Roguin A, Gharib E, Cutlip D, Waksman R; BIOFLOW V Investigators. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017 21;390:1843-1852. doi: 10.1016/S0140-6736(17)32249-3.

35. Haude M, Ince H, Kische S, Toelg R, Van Mieghem N, Verheye S, von Birgelen C, Christiansen E, Barbato E, Garcia-Garcia H, Waksman R. Sustained Safety and Performance of the Second-Generation Sirolimus-Eluting Absorbable Metal Scaffold: Pooled Outcomes of the BIOSOLVE-II and -III Trials at 3 Years. Cardiovasc Revasc Med. 2020;21:1150-1154. doi: 10.1016/j.carrev.2020.04.006.

36. Verheye S, Wlodarczak A, Montorsi P, Torzewski J, Bennett J, Haude M, Starmer G, Buck T, Wiemer M, Nuruddin A, Yan B, Lee M. BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients. Catheter Cardiovasc Interv. 2021 1;98:E1-E8. doi: 10.1002/ccd.29260.

37. Song L, Xu B, Chen Y, Zhou Y, Jia S, Zhong Z, Su X, Ma Y, Zhang Q, Liu J, Wang Y, Guan C, Zheng M, Qiao S, Gao R; FUTURE-II Trial Investigators. Thinner Strut Sirolimus-Eluting BRS Versus EES in Patients With Coronary Artery Disease: FUTURE-II Trial. JACC Cardiovasc Interv. 2021 12;14:1450-1462. doi: 10.1016/j.jcin.2021.04.048.

38. Jiang J, Li C, Chen D, Song L, Cui Z, Li P, Gan L, Chen Y, Li H, Jia S, He S, Lu W, Gao R, Wang J. FUTURE III Investigators. Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes. BMC Med. 2025 9;23:419. doi: 10.1186/s12916-025-04254-0.

39. Haude M, Wlodarczak A, van der Schaaf R, Torzewski J, Ferdinande B, Escaned J, Iglesias J, Bennett J, Toth G, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Waksman R. Clinical outcomes of the third-generation resorbable magnesium scaffold for coronary artery lesions: three-year results of the BIOMAG-I study. EuroIntervention. 2025 18;21:971-973. doi: 10.4244/EIJ-D-25-00396.

40. Hua W, Shi W, Mitchell K, Raymond L, Coulter R, Zhao D, Jin Y. 3D Printing of Biodegradable Polymer Vascular Stents: A Review. Chinese Journal of Mechanical Engineering: Additive Manufacturing Frontiers,2022, https://doi.org/10.1016/j.cjmeam.2022.100020.

41. Jakobsen L, Christiansen E, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen A, Kristensen S, Christensen M, Terkelsen C, Aaroe J, Thim T, Lassen J, Hougaard M, Eftekhari A, Jensen R, Støttrup N, Rasmussen J, Junker A, Jensen S, Hansen H, Jensen L. Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. EuroIntervention. 2023 23;19:676-683. doi: 10.4244/EIJ-D-23-00330.

42. Dubashynskaya N, Bokatyi A, Galagudza M, Skorik Y. Revitalizing Colchicine: Novel Delivery Platforms and Derivatives to Expand Its Therapeutic Potential. Int J Mol Sci. 2025 6;26:7591. doi: 10.3390/ijms26157591