Vol. 21 No. 4 (2017)
ANGIOLOGY & VASCULAR SURGERY

Optical coherence tomography for evaluating Synergy everolimus-eluting stents with biodegradable polymer and Xience durable polymer everolimus-eluting stents following percutaneous coronary intervention in patients with left main coronary artery stenosis

PDF (Русский)
  • R. Ibragimov,
  • A. Badoyan,
  • O. Krestyaninov,
  • E. Pokushalov,
  • I. Naryshkin,
  • E. Kretov,
  • A. Prokhorikhin,
  • D. Khelimskiy
R. Ibragimov
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
Bio
A. Badoyan
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
O. Krestyaninov
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
E. Pokushalov
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
I. Naryshkin
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
E. Kretov
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
A. Prokhorikhin
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
D. Khelimskiy
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
DOI: https://doi.org/10.21688/1681-3472-2017-4-59-68

Published 2017-12-28

Keywords

  • Synergy,
  • Xience,
  • optical coherence tomography,
  • biodegradable polymer

How to Cite

Ibragimov, R., Badoyan, A., Krestyaninov, O., Pokushalov, E., Naryshkin, I., Kretov, E., Prokhorikhin, A., & Khelimskiy, D. (2017). Optical coherence tomography for evaluating Synergy everolimus-eluting stents with biodegradable polymer and Xience durable polymer everolimus-eluting stents following percutaneous coronary intervention in patients with left main coronary artery stenosis. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 21(4), 59–68. https://doi.org/10.21688/1681-3472-2017-4-59-68

Copyright (c) 2017 Ibragimov R.U., Badoyan A.G., Krestyaninov O.V., Pokushalov E.A., Naryshkin I.A., Kretov E.I., Prokhorikhin A.A., Khelimskiy D.A.

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Aim. The development of on a new generation of stents with abluminal biodegradable polymer is aimed at accelerating the neointimal growth and reducing the inflammatory response of the vascular wall. This article presents an analysis of healing characteristics, as assessed by optical coherence tomography (OCT), of ultrathin Synergy everolimus-eluting stent with biodegradable polymer and Xience everolimus-eluting stent with durable polymer three months after implantation.
Methods. In this prospective, single-center study fifty patients with significant stenosis of the left main coronary artery were randomized in 2 groups for implantation of everolimus-eluting stents with durable polymer (Xience) or abluminal biodegradable polymer (Synergy). After three months all patients underwent control coronarography supported by optical coherence tomography. A Neointimal Healing Score (NIH Score) obtained at three months after stent implantation by means of optical coherence tomography was the primary endpoint. Such OCT data as percentage of uncovered or malapposed struts only and presence of both malapposed and uncovered struts were planned as the secondary endpoints. To study the freedom from adverse events, one composite endpoint including myocardial infarction, repeat left coronary artery revascularization and death within 12 months after the procedure was determined.
Results. There were no significant differences in the NIH score (primary endpoint) in two groups (25.6±12.3 in Xience vs 32.5±20.3 in Synergy, respectively; p = 0.12). The struts of both types of stents showed statistically similar coverage and apposition at 3-month OCT follow-up: percentage of uncovered struts only was 6.3±3.9 and 9.9±7.8 in Xience and Synergy groups, respectively (p = 0.098) and malapposed struts only 0.25±0.5 vs 0.37±0.5; p = 0.628. The presence of both malapposed and uncovered struts was 4.9±3.8 and 5.1±4.5 in two groups and didn’t differ statistically (p = 0.92). During 12-month follow-up, two cases of stent thrombosis were recorded (one in each group), which required repeat revascularization. In addition, one case of myocardial infarction related to the right coronary artery occurred in the Synergy group.
Conclusion. The Synergy everolimus-eluting stent with abluminal biodegradable polymer has a healing profile comparable to that of Xience everolimus-eluting stent with durable polymer with a low rate of uncovered and malapposed struts at 3-month follow-up. A low incidence of adverse events in both groups during 12-month follow-up indicates the safety of the stents under study.

Received 18 September 2017. Revised 13 December 2017. Accepted 15 December 2017.

Funding: The study did not have sponsorship.

Conflict of interest: Authors declare no conflict of interest.

Author contributions
All authors contributed equally to the work.

PDF (Русский)

References

  1. Министерство здравоохранения Российской Федерации [Интернет]. Доклад о состоянии здоровья населения и организации здравоохранения по итогам деятельности органов исполнительной власти субъектов Российской Федерации за 2014 год (дата обращения 10.12.17). Режим доступа: https://static-0.rosminzdrav.ru/system/attachments/attaches/000/026/627/original/Doklad_o_sostojanii_zdorovja_naselenija_2014.pdf?1434640648 [Ministry of Health of Russian Federation [Internet]. The report on population health and healthcare management by results of bodies' of Executive power of subjects of the Russian Federation activity in 2014. (In Russ.); (cited 2017 December 10). Available from: https://static-0.rosminzdrav.ru/system/attachments/attaches/000/026/627/original/Doklad_o_sostojanii_zdorovja_naselenija_2014.pdf?1434640648]
  2. Акбашева М.Т., Закарян Н.В., Алекян Б.Г. Атеросклероз и его осложнения. Актуальные вопросы диагностики и лечения ишемической болезни сердца. Креативная кардиология. 2009;3(2):68-79. Режим доступа: https://cardiology-journal.com/catalog/detail.php?SECTION_ID=3281&ID=32846 [Akbasheva M.T., Zakaryan N.V., Alekyan B.G. Атеросклероз и его осложнения. Актуальные вопросы диагностики и лечения ишемической болезни сердца. Kreativnaya kardiologiya = Creative Cardiology. 2009;3(2):68-79. (In Russ.) Available from: https://cardiology-journal.com/catalog/detail.php?SECTION_ID=3281&ID=32846]
  3. Dacosta A., Tardy В., Favre J., Guy J.M., Rachet F., Lamaud M., Barral X., Verneyre H. Left main coronary artery disease. Arch Mal Coeur Vaiss. 1994;87(9):1225-32. (In French) PMID: 7646237.
  4. Кузнецов В.А., Бессонов И.С., Зырянов И.П., Самойлова Е.П., Горбатенко Е.А., Игнатов Д.И. Клинико-функциональная характеристика и лечение пациентов с поражением ствола левой коронарной артерии в реальной клинической практике. Кардиология. 2014;(1):55-60. https://dx.doi.org/10.18565/cardio.2014.1.55-60 [Kuznetsov V.A., Bessonov I.S., Zyrianov I.P., Samoilova E.P., Gorbatenko E.A., Ignatov D.I. Clinical profile and treatment of left main coronary artery disease in a real-world practice. 2014;(1):55-60. Kardiologiia. https://dx.doi.org/10.18565/cardio.2014.1.55-60]
  5. Sianos G., More M., Kappetein A.P., Morice M., Colombo A., Dawkin K., van den Brand M., Van Dyck N., Russell M.E., Mohr F.W., Serruys P.W. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroInterv. 2005;1(2):219-27.
  6. Virani S.S., Mendoza C.E., Ferreira A.C., de Marchena E. Left main coronary artery stenosis: factors predicting cardiac events in patients awaiting coronary surgery. Tex Heart Inst J. 2006;33(1):23-6. PMID: 16572864, PMCID: PMC1413613.
  7. Caracciolo E.A., Davis K.B., Sopko G., Kaiser G.C., Corley S.D., Schaff H., Taylor H.A., Chaitman B.R. Comparison of surgical and medical group survival in patients with left main equivalent coronary artery disease long-term CASS experience. Circulation. 1995;91:2335-44. PMID: 7729019.
  8. Caracciolo E.A., Davis K.B., Sopko G., Kaiser G.C., Corley S.D., Schaff H., Taylor H.A., Chaitman B.R. Comparison of surgical and medical group survival in patients with left main coronary artery disease long-term CASS experience. Circulation. 1995;91(9):2325-34. PMID: 7729018.
  9. Long-term results of prospective randomised study of coronary artery bypass surgery in stable angina pectoris. European Coronary Surgery Study Group. Lancet. 1982;2(8309): 73-80. PMID: 6128492.
  10. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)1; European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W., Kolh P., Danchin N., Di Mario C., Falk V., Folliguet T., Garg S., Huber K., James S., Knuuti J., Lopez-Sendon J., Marco J., Menicanti L., Ostojic M., Piepoli M.F., Pirlet C., Pomar J.L., Reifart N., Ribichini F.L., Schalij M.J., Sergeant P., Serruys P.W., Silber S., Sousa Uva M., Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010;31(20):2501-55. PMID: 20802248. https://dx.doi.org/10.1093/eurheartj/ehq277
  11. Montalescot G., Sechtem U., Achenbach S., Andreotti F., Arden C., Budaj A., Bugiardini R., Crea F., Cuisset T., Di Mario C., Ferreira J.R., Gersh B.J., Gitt A.K., Hulot J.-S., Marx N., Opie L.H., Pfisterer M., Prescott E., Ruschitzka F., Sabaté M., Senior R., Taggart D.P., van der Wall E.E., Vrints C.J.M. Corrigendum to: ‘2013 ESC guidelines on the management of stable coronary artery disease’. Eur Heart J. 2014;35(33):2260-1. https://doi.org/10.1093/eurheartj/ehu038
  12. Windecker S., Kolh P., Alfonso F., Collet J.-P., Cremer J., Falk V., Filippatos G., Hamm C., Head S.J., Jüni P., Kappetein A.P., Kastrati A., Knuuti J., Landmesser U., Laufer G., Neumann F.J., Richter D.J., Schauerte P., Sousa Uva M., Stefanini G.G., Taggart D.P., Torracca L., Valgimigli M., Wijns W., Witkowski A.; European Society of Cardiology Committee for Practice Guidelines, Zamorano J.L., Achenbach S., Baumgartner H., Bax J.J., Bueno H., Dean V., Deaton C., Erol Ç., Fagard R., Ferrari R., Hasdai D., Hoes A.W., Kirchhof P., Knuuti J., Kolh P., Lancellotti P., Linhart A., Nihoyannopoulos P., Piepoli M.F., Ponikowski P., Sirnes P.A., Tamargo J.L., Tendera M., Torbicki A., Wijns W., Windecker S.; EACTS Clinical Guidelines Committee, Sousa Uva M., Achenbach S., Pepper J., Anyanwu A., Badimon L., Bauersachs J., Baumbach A., Beygui F., Bonaros N., De Carlo M., Deaton C., Dobrev D., Dunning J., Eeckhout E., Gielen S., Hasdai D., Kirchhof P., Luckraz H., Mahrholdt H., Montalescot G., Paparella D., Rastan A.J., Sanmartin M., Sergeant P., Silber S., Tamargo J., ten Berg J., Thiele H., van Geuns R.J., Wagner H.O., Wassmann S., Wendler O., Zamorano J.L.; Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery; European Association of Percutaneous Cardiovascular Interventions. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2014;35(37):2541-2619. https://doi.org/10.1093/eurheartj/ehu278
  13. Nomura A., Yamaji K., Shirai S., Omata F., Soga Y., Nagashima M., Arita T., Ando K., Sakai K., Goya M., Yokoi H., Iwabuchi M., Nobuyoshi M. Very long-term outcomes after percutaneous coronary intervention with bare metal stents for unprotected left main coronary artery disease. EuroIntervention. 2012;8(8):962-9. PMID: 23014985. https://doi.org/10.4244/EIJV8I8A146
  14. Silvestri M., Barragan P., Sainsous J., Bayet G., Simeoni J.B., Roquebert P.O., Macaluso G., Bouvier J.L., Comet B. Unprotected left main coronary artery stenting: immediate and medium-term outcomes of 140 elective procedures. J Am Coll Cardiol. 2000;35(6):1543-50. PMID: 10807458.
  15. Wang X.Z., Xu K., Li Y., Jing Q.-M., Liu H.-W., Zhao X., Wang G., Wang B., Ma Y.-Y., Chen S.-L., Han Y.-L. Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease. Chin Med J. 2015;128(6):721-726. PMCID: PMC4833972. https://doi.org/10.4103/0366-6999.152460.
  16. Stone G.W., Sabik J.F., Serruys P.W., Simonton C.A., Généreux P., Puskas J., Kandzari D.E., Morice M.C., Lembo N., Brown W.M. 3rd, Taggart D.P., Banning A., Merkely B., Horkay F., Boonstra P.W., van Boven A.J., Ungi I., Bogáts G., Mansour S., Noiseux N., Sabaté M., Pomar J., Hickey M., Gershlick A., Buszman P., Bochenek A., Schampaert E., Pagé P., Dressler O., Kosmidou I., Mehran R., Pocock S.J., Kappetein A.P.; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease (EXCEL Trial). N Engl J Med. 2016;375(23):2223-2235. PMID: 27797291. https://doi.org/10.1056/NEJMoa1610227
  17. Parodi G., Maehara A., Giuliani G., Kubo T., Mintz G.S., Migliorini A., Valenti R., Carrabba N., Antoniucci D. Optical coherence tomography in unprotected left main coronary artery stenting. EuroIntervention. 2010;6(1):94-9. PMID: 20542803. Available from: https://www.pcronline.com/eurointervention/27th_issue/14
  18. Taniwaki M., Radu M.D., Zaugg S., Amabile N., Garcia-Garcia H.M., Yamaji K., Jørgensen E., Kelbæk H., Pilgrim T., Caussin C., Zanchin T., Veugeois A., Abildgaard U., Jüni P., Cook S., Koskinas K.C., Windecker S., Räber L. Mechanisms of very late drug-eluting stent thrombosis assessed by optical coherence tomography. Circulation. 2016;133(7):650-60. PMID: 26762519. https://doi.org/10.1161/CIRCULATIONAHA.115.019071
  19. Silber S., Kirtane A.J., Belardi J.A., Liu M., Brar S., Rothman M., Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014;35(29):1949-56. PMID: 24510638. https://doi.org/10.1093/eurheartj/ehu026
  20. Fujino Y., Bezerra H.G., Attizzani G.F., Wang W., Yamamoto H., Chamié D., Kanaya T., Mehanna E., Tahara S., Nakamura S., Costa M.A. Frequency domain optical coherence tomography assessment of unprotected left main coronary artery disease – a comparison with intravascular ultrasound. Catheter Cardiovasc Interv. 2013;82(3):E173-83. PMID: 23359350. https://doi.org/10.1002/ccd.24843
  21. Burzotta F., Dato I., Trani C., Pirozzolo G., De Maria G.L., Porto I., Niccoli G., Leone A.M., Schiavoni G., Crea F. Frequency domain optical coherence tomography to assess non-ostial left main coronary artery. EuroIntervention. 2015;10(9):e1-8. PMID: 25599698. https://doi.org/10.4244/EIJV10I9A179
  22. Кретов Е.И., Нарышкин И.А., Гражданкин И.О., Байструков В.И., Найденов Р.А., Крестьянинов О.В., Обединский А.А., Ибрагимов Р.У., Прохорихин А.А. Проспективное исследование Orsiro OCT Healing Russia: анализ эндотелиального покрытия сиролимус-выделяющего стента с биодеградируемым покрытием с помощью оптической когерентной томографии через три месяца после чрескожного коронарного вмешательства. Эндоваскулярная хирургия. 2017;4(2):134-145. https://doi.org/10.24183/2409-4080-2017-4-2-134-145 [Kretov E.I., Naryshkin I.A., Grazhdankin I.O., Baystrukov V.I., Naydenov R.A., Krest'yaninov O.V., Obedinskiy A.A., Ibragimov R.U., Prokhorikhin A.A. Orsiro OCT Healing Russia: optical coherence tomography analysis of biodegradable polymer sirolimus-eluting stent three months after percutaneous coronary intervention. Endovaskulyarnaya Khirurgiya = Russian Journal of Endovascular Surgery. 2017;4(2):134-45. (In Russ.) https://doi.org/10.24183/2409-4080-2017-4-2-134-145]
  23. Murata A., Wallace-Bradley D., Tellez A. Alviar C., Aboodi M., Sheehy A., Coleman L., Perkins L., Nakazawa G., Mintz G., Kaluza G.L., Virmani R., Granada J.F. Accuracy of optical coherence tomography in the evaluation of neointimal coverage after stent implantation. JACC Cardiovasc Imaging. 2010;3(1):76-84. PMID: 20129535. https://doi.org/10.1016/j.jcmg.2009.09.018
  24. Tanigawa J., Barlis P., Di Mario C. Intravascular optical coherence tomography: optimisation of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention. 2007;3(1):128-36. PMID: 19737696.
  25. Cook S., Wenaweser P., Togni M. Billinger M., Morger C., Seiler C., Vogel R., Hess O., Meier B., Windecker S. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation. 2007;115(18):2426-34. PMID: 17485593. https://doi.org/10.1161/CIRCULATIONAHA.106.658237
  26. Finn A.V., Joner M., Nakazawa G., Kolodgie F., Newell J., John M.C., Gold H.K., Virmani R. Pathological correlates of late drug-eluting stent thrombosis strut coverage as a marker of endothelialization. Circulation. 2007;115(18):2435-41. PMID: 17438147. https://doi.org/10.1161/CIRCULATIONAHA.107.693739
  27. Palmerini T., Biondi-Zoccai G., Della Riva D., Mariani A., Sabaté M., Valgimigli M., Frati G., Kedhi E., Smits P.C., Kaiser C., Genereux P., Galatius S., Kirtane A.J., Stone G.W. Clinical outcomes with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2013;62(6):496-504. PMID: 23747778. https://doi.org/10.1016/j.jacc.2013.05.022
  28. Min G.S., Lee J.H., Park J.H., Choi U.L., Lee Y.D., Seong S.W., Jin S.A., Park S.J., Kim J.H., Park J.H., Choi S.W., Jeong J.O., Seong I.W. Long-term safety and efficacy of sirolimus-and Paclitaxel-eluting stents in patients with acute myocardial infarction: four-year observational study. Korean Circ J. 2012;42(4):266-73. PMID: 22563340 PMCID: PMC3341424. https://doi.org/10.4070/kcj.2012.42.4.266
  29. Gutierrez-Chico J.L., van Geuns R.J., Regar E., van der Giessen W.J., Kelbæk H., Saunamäki K., Escaned J., Gonzalo N., di Mario C., Borgia F., Nüesch E., García-García H.M., Silber S., Windecker S., Serruys P.W. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011;32(19):2454-63.
  30. Virmani R., Farb A., Guagliumi G., Kolodgie F.D. Drug-eluting stents: caution and concerns for long-term outcome. Coron Artery Dis. 2004;15(6):313-8. PMID: 15346088.
  31. Claessen B.E., Beijk M.A., Legrand V., Ruzyllo W., Manari A., Varenne O., Suttorp M.J., Tijssen J.G., Miquel-Hebert K., Veldhof S., Henriques J.P., Serruys P.W., Piek J.J. Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial. Circ Cardiovasc Interv. 2009;2(4):339-47. PMID: 20031737. https://doi.org/10.1161/CIRCINTERVENTIONS.108.831800.108.831800
  32. Balleby I.R., Ørhøj T.K., Terkelsen C.J., Jensen L.O., Maeng M., Krusell L.R., Dijkstra J., Antonsen L., Kaltoft A., Kristensen S.D., Hougaard M., Bøtker H.E., Lassen J.F., Christiansen E.H., Holm N.R. Early healing after treatment of coronary lesions by everolimus, or biolimus eluting bioresorbable polymer stents. One-month results of the SORT-OUT VIII OCT study. c2017 [cited 2017 December 7]. Available from: http://www.clinicaltrialresults.org/Slides/Synergy/SORT%20OUT_VIII_Synergy-PCR.pdf