Tactics of Endovascular Treatment of Patients with Coronary Heart Disease with Recurrent Coronary In-Stent Restenosis Using Second- and Third-Generation Stent Systems and Paclitaxel-Coated Balloon Catheters

Abstract

INTRODUCTION: The binary in-stent restenosis (ISR) still remains the main factor limiting the effectiveness of percutaneous coronary intervention in the long-term period. Histologically, ISR is defined as neointimal hyperplasia leading to hemodynamically significant narrowing of the arterial lumen. Patients with coronary artery (CA) restenosis represent a particularly challenging group for endovascular treatment.

AIM: To compare effectiveness and safety of the endovascular correction of coronary in-stent restenosis using second- and third-generation stent systems and balloon angioplasty with a drug-coated balloon catheter.

MATERIALS AND METHODS: The study retrospectively included 62 patients with recurrent ISR after the previous endovascular correction. The patients underwent treatment with re-stenting in Saint George Clinic of Thoracic and Cardiovascular Surgery of the National Pirogov Medical Surgical Center in 2016–2023 with use of second- and third-generation drug-eluting stents — cobalt (cobalt alloy) systems with zotarolimus, cobalt-chromium stent systems with sirolimus and zotarolimus, platinum-chromium stent systems with everolimus with biodegradable drug coating. Balloon angioplasty was performed using paclitaxel-coated balloon catheters. The primary endpoint of the study was the target lesion failure (TLF) of CA. The secondary endpoint was major adverse cardiovascular events (MACE).

RESULTS: The TLF rate was 15.6% vs. 13.3% and 28.1% vs. 46.7% in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.30). MACE was recorded in 18.8% vs. 16.7% and 37.5% vs. 56.7% of cases in the groups with use of a drug-eluting stent and balloon angioplasty at 1- and 2-year follow-up, respectively (p = 0.25). The dispersion analysis of predictors of TFL risks identified three factors showing a reliable correlation with the probability for TFL by the second follow-up year in both groups: (1) recurrence of binary ISR (hazard ratio (HR) 2.21; 95% confidence interval (CI) 0.95–4.01; p = 0.03)) in 365 days after the third stage of the percutaneous coronary intervention; (2) length of coronary restenotic lesion (per every 10 mm) (HR 1.25; 95% CI 0.99–1.40; p = 0.002); (3) occlusive restenosis (HR 4.16; 95% CI 0.43–26.96; p = 0.04).

CONCLUSIONS: The implantation of a second- and third-generation drug-eluting stent and balloon angioplasty with use of a drug-coated catheter are comparable in the effectiveness and safety in correcting the recurrent ISR, however, restenting is associated with a lower probability for developing TFL and adverse events.

Keywords

percutaneous coronary intervention / coronary heart disease / recurrence of in-stent restenosis / drug-eluting stent systems / drug-coated balloon catheters / drug-coated balloon angioplasty

References

[1] Bogatyreva KB, Azova MM, Aghajanyan AV, et al. Association of the ITGB3 gene T1565C polymorphism with the development of atherosclerosis and in-stent restenosis in patients with stable coronary artery disease. Research Results in Biomedicine. 2018;4(4):3–9. (In Russ).doi: 10.18413/2313-8955-2018-4-4-0-1

[2] Богатырева К.Б., Азова М.М., Агаджанян А.В., и др. Ассоциация полиморфизма T1565C гена ITGB3 с развитием атеросклероза и ин-стент рестеноза коронарных артерий у пациентов со стабильной ишемической болезнью сердца // Научные результаты биомедицинских исследований. 2018. Т. 4, № 4. С. 3–9. doi:10.18413/2313-8955-2018-4-4-0-1

[3] Sostoyaniyeserdechno-sosudistoykhirurgii v RossiyskoyFederatsii — 2021 [Internet]. (In Russ). Available at: https://bakulev.ru/news/glavnoe/sostoyanie-serdechno-sosudistoy-khirurgii-v-rossiyskoy-federatsii-2021/. Accessed: 2024 January 30.

[4] Состояние сердечно-сосудистой хирургии в Российской Федерации — 2021 [Интернет]. Доступно по: https://bakulev.ru/news/glavnoe/sostoyanie-serdechno-sosudistoy-khirurgii-v-rossiyskoy-federatsii-2021/. Ссылка активна на 30.01.2024.

[5] Shevchenko YuL, Stojko YuM, Gudymovich VG, et al. Endothelial glycocalyx in ensuring the functioning of the cardiovascular system. Bulletin of Pirogov National Medical & Surgical Center. 2020;15(1):107–12. (In Russ). doi: 10.25881/BPNMSC.2020.60.73.019

[6] Шевченко Ю.Л., Стойко Ю.М., Гудымович В.Г., и др. Эндотелиальный гликокаликс в обеспечении функции сердечно-сосудистой системы // Вестник Национального медико-хирургического Центра им. Н.И. Пирогова. 2020. Т. 15, № 1. С. 107–112. doi: 10.25881/BPNMSC.2020.60.73.019

[7] Shevchenko YuL, ErmakovDYu, Marchak DI. Dysfunction of coronary bypass grafts and stents after surgical myocardial revascularization in patients with coronary artery disease: pathogenesis, risk factors and clinical assessment. Bulletin of Pirogov National Medical & Surgical Center. 2022;17(3):94–100. (In Russ). doi: 10.25881/20728255_2022_17_3_94

[8] Шевченко Ю.Л., Ермаков Д.Ю., Марчак Д.И. Дисфункция коронарных шунтов и стентов после хирургической реваскуляризации миокарда больных ИБС: патогенез, факторы риска и клиническая оценка // Вестник Национального медико-хирургического центра им. Н.И. Пирогова. 2022. Т. 17, № 3. С. 94–100. doi: 10.25881/20728255_2022_17_3_94

[9] Abduzhamalova NM, Kabardieva MR, Merkulov EV, et al. Mechanisms of development of in stent restenosis in coronary patients. Kardiologicheskij Vestnik. 2016;(2):100–3. (In Russ).

[10] Абдужамалова Н.М., Кабардиева М.Р., Меркулов Е.В., и др. Механизмы развития рестеноза в стенте коронарных артерий у больных ишемической болезнью сердца // Кардиологический вестник. 2016. № 2. С. 100–103.

[11] Digay AM. On the question of the antiproliferative coating of coronary stents. Patologiya Krovoobrashcheniya i Kardiokhirurgiya. 2018;22(2):22–9. (In Russ). doi: 10.21688/1681-3472-2018-2-22-29

[12] Дыгай А.М. К вопросу об антипролиферативном покрытии коронарных стентов // Патология кровообращения и кардиохирургия. 2018. Т. 22, № 2. С. 22–29. doi: 10.21688/1681-3472-2018-2-22-29

[13] Viller AG, Kharpunov VF, Bolomatov NV, et al. Long-term outcome after endovascular treatment of coronary in-stent restenosis by paclitaxel-eluting balloons. Bulletin of Pirogov National Medical & Surgical Center. 2013;8(2):15–23. (In Russ).

[14] Виллер А.Г., Харпунов В.Ф., Боломатов Н.В., и др. Отдаленные результаты эндоваскулярной хирургии внутристентового рестеноза венечных артерий // Вестник Национального медико-хирургического Центра им. Н.И. Пирогова. 2013. Т. 8, № 2. С.15–23.

[15] Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography. Heart. 2014;100(2):153–9. doi: 10.1136/heartjnl-2013-304933

[16] Cassese S., Byrne R.A., Tada T., et al. Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography // Heart. 2014. Vol. 100, No. 2. P. 153–159. doi: 10.1136/heartjnl-2013-304933

[17] Giacoppo D, Alfonso F, Xu B, et al. Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study). Eur Heart J. 2020;41(38):3715–28. doi: 10.1093/eurheartj/ehz594

[18] Giacoppo D., Alfonso F., Xu B., et al. Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study) // Eur. Heart J. 2020. Vol. 41, No. 38. P. 3715–3728. doi: 10.1093/eurheartj/ehz594

[19] Abdelmegid MAKF, Ahmed TAN, Kato M, et al. Drug-eluting stents or balloon angioplasty for drug-eluting stent-associated restenosis: An observational follow-up study of first-time versus repeated restenosis. J Saudi Heart Assoc. 2017;29(2):76–83. doi: 10.1016/j.jsha.2016.10.001

[20] Abdelmegid M.A.–K.F., Ahmed T.A.N., Kato M., et al. Drug-eluting stents or balloon angioplasty for drug-eluting stent-associated restenosis: An observational follow-up study of first-time versus repeated restenosis // J. Saudi Heart Assoc.2017. Vol. 29, No. 2. P. 76–83. doi: 10.1016/j.jsha.2016.10.001

[21] Kawamoto H, Ruparelia N, Latib A, et al. Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents forthe Management of Recurrent Multimetal-Layered In-Stent Restenosis. JACC Cardiovasc Interv. 2015;8(12):1586–94. doi: 10.1016/j.jcin.2015.04.032

[22] Kawamoto H., Ruparelia N., Latib A., et al. Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis // JACC Cardiovasc.Interv. 2015. Vol. 8, No. 12. P. 1586–1594. doi: 10.1016/j.jcin.2015.04.032

[23] УДК 618-085:618.39-021.3

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