Vol. 23 No. 3 (2019)
Endovascular Surgery

Long-term outcomes after bioresorbable scaffold implantation in patients with coronary artery stenosis

A. Prokhorikhin
Meshalkin National Medical Research Center, Novosibirsk
Bio
E. Fartakov
Meshalkin National Medical Research Center, Novosibirsk
D. Malaev
Meshalkin National Medical Research Center, Novosibirsk
A. Boykov
Meshalkin National Medical Research Center, Novosibirsk
V. Baystrukov
Meshalkin National Medical Research Center, Novosibirsk
I. Grazhdankin
Meshalkin National Medical Research Center, Novosibirsk
D. Zubarev
Almazov National Medical Research Center, Novosibirsk
E. Kretov
Meshalkin National Medical Research Center, Novosibirsk

Published 2019-11-27

Keywords

  • bioresorbable vascular scaffold,
  • coronary artery disease,
  • coronary stenting,
  • ischemic heart disease,
  • revascularization

How to Cite

Prokhorikhin, A., Fartakov, E., Malaev, D., Boykov, A., Baystrukov, V., Grazhdankin, I., Zubarev, D., & Kretov, E. (2019). Long-term outcomes after bioresorbable scaffold implantation in patients with coronary artery stenosis. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 23(3), 9–21. https://doi.org/10.21688/1681-3472-2019-3-9-21

Abstract

Aim. The present study aimed to demonstrate the long-term outcomes after Absorb (Abbott Vascular, USA) everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in real-world patients with coronary artery disease.
Methods. This trial involved the largest registry of Absorb BVS implantation in patients with coronary artery disease from Russia, and it was conducted between 2014 and 2018 (n = 500). Safety and efficacy parameters (target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation; major adverse cardiac and cardiovascular events, defined as a composite of cardiac death, myocardial infarction, target vessel revascularisation and stroke, stent thrombosis according to the Academic Research Consortium definition) were assessed over a period of 2 years after the index procedure.
Results. Lesion treatment success was achieved in 98.51% (n = 594) of patients. In the 2 years after Absorb BVS implantation, long-term outcomes were assessed via phone calls. Only 9.8% (n = 49) of patients were lost to follow-up. The rates of target vessel failure and major adverse cardiac and cerebrovascular events were 11.6% (n = 58) and 12.6% (n = 63), respectively. Definite/probable stent thrombosis was observed in 3.2% (n = 16) of patients.
Conclusion. Using an optimal implantation technique during Absorb BVS implantation in routine clinical practice leads to a high level of lesion treatment success. However, despite this, Absorb BVS use is associated with an increased risk of device-related adverse events, particularly stent thrombosis. Absorb BVS use in long and bifurcated lesions and BVS implantation in the distal segment of the coronary artery are independent predictors of stent thrombosis. In addition, Absorb BVS use in patients with a high functional class of angina and heart failure, multivessel coronary artery disease as well as BVS implantation in the distal segment of the coronary artery are independent predictors of device-related adverse events.

Received 22 July 2019. Revised 1 October 2019. Accepted 14 October 2019.

Funding: The study did not have sponsorship.

Conflict of interest: Authors declare no conflict of interest.

References

  1. Roth G.A., Johnson C., Abajobir A., Abd-Allah F., Abera S.F., Abyu G., Ahmed M., Aksut B., Alam T., Alam K., Alla F., Alvis-Guzman N., Amrock S., Ansari H., Ärnlöv J., Asayesh H., Atey T.M., Avila-Burgos L., Awasthi A., Banerjee A., Barac A., Bärnighausen T., Barregard L., Bedi N., Belay Ketema E., Bennett D., Berhe G., Bhutta Z., Bitew S., Carapetis J., Carrero J.J., Malta D.C., Castañeda-Orjuela C.A., Castillo-Rivas J., Catalá-López F., Choi J.Y., Christensen H., Cirillo M., Cooper L. Jr., Criqui M., Cundiff D., Damasceno A., Dandona L., Dandona R., Davletov K., Dharmaratne S., Dorairaj P., Dubey M., Ehrenkranz R., El Sayed Zaki M., Faraon E.J.A., Esteghamati A., Farid T., Farvid M., Feigin V., Ding E.L., Fowkes G., Gebrehiwot T., Gillum R., Gold A., Gona P., Gupta R., Habtewold T.D., Hafezi-Nejad N., Hailu T., Hailu G.B., Hankey G., Hassen H.Y., Abate K.H., Havmoeller R., Hay S.I., Horino M., Hotez P.J., Jacobsen K., James S., Javanbakht M., Jeemon P., John D., Jonas J., Kalkonde Y., Karimkhani C., Kasaeian A., Khader Y., Khan A., Khang Y.H., Khera S., Khoja A.T., Khubchandani J., Kim D., Kolte D., Kosen S., Krohn K.J., Kumar G.A., Kwan G.F., Lal D.K., Larsson A., Linn S., Lopez A., Lotufo P.A., El Razek H.M.A., Malekzadeh R., Mazidi M., Meier T., Meles K.G., Mensah G., Meretoja A., Mezgebe H., Miller T., Mirrakhimov E., Mohammed S., Moran A.E., Musa K.I., Narula J., Neal B., Ngalesoni F., Nguyen G., Obermeyer C.M., Owolabi M., Patton G., Pedro J., Qato D., Qorbani M., Rahimi K., Rai R.K., Rawaf S., Ribeiro A., Safiri S., Salomon J.A., Santos I., Santric Milicevic M., Sartorius B., Schutte A., Sepanlou S., Shaikh M.A., Shin M.J., Shishehbor M., Shore H., Silva D.A.S., Sobngwi E., Stranges S., Swaminathan S., Tabarés-Seisdedos R., Tadele Atnafu N., Tesfay F., Thakur J.S., Thrift A., Topor-Madry R., Truelsen T., Tyrovolas S., Ukwaja K.N., Uthman O., Vasankari T., Vlassov V., Vollset S.E., Wakayo T., Watkins D., Weintraub R., Werdecker A., Westerman R., Wiysonge C.S., Wolfe C., Workicho A., Xu G., Yano Y., Yip P., Yonemoto N., Younis M., Yu C., Vos T., Naghavi M., Murray C. Global, regional, and national burden of cardiovascular diseases for 10 causes, 1990 to 2015. J Am Coll Cardiol. 2017;70(1):1-25. PMID: 28527533, PMCID: PMC5491406. https://doi.org/10.1016/j.jacc.2017.04.052
  2. Rafieian-Kopaei M., Setorki M., Doudi M., Baradaran A., Nasri H. Atherosclerosis: process, indicators, risk factors and new hopes. Int J Prev Med. 2014;5(8):927-46. PMID: 25489440, PMCID: PMC4258672.
  3. Task Force Members, 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.; ESC Committee for Practice Guidelines, Zamorano J.L., Achenbach S., Baumgartner H., Bax J.J., Bueno H., Dean V., Deaton C., Erol C., 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.; Document Reviewers, Knuuti J., Valgimigli M., Bueno H., Claeys M.J., Donner-Banzhoff N., Erol C., Frank H., Funck-Brentano C., Gaemperli O., Gonzalez-Juanatey J.R., Hamilos M., Hasdai D., Husted S., James S.K., Kervinen K., Kolh P., Kristensen S.D., Lancellotti P., Maggioni A.P., Piepoli M.F., Pries A.R., Romeo F., Rydén L., Simoons M.L., Sirnes P.A., Steg P.G., Timmis A., Wijns W., Windecker S., Yildirir A., Zamorano J.L. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013;34(38):2949-3003. PMID: 23996286. https://doi.org/10.1093/eurheartj/eht296
  4. Head S.J., Milojevic M., Taggart D.P., Puskas J.D. Current practice of state-of-the-art surgical coronary revascularization. Circulation. 2017;136(14):1331-45. PMID: 28972063. https://doi.org/10.1161/CIRCULATIONAHA.116.022572
  5. Waksman R. Biodegradable stents: they do their job and disappear. J Invasive Cardiol. 2006;18(2):70-4. PMID: 16446520.
  6. Nieman K., Dudek D., Ormiston J., Thuesen L., Serruys P.W. ABSORB cohort a trial: five year clinical and MSCT results of the ABSORB bioresorbable everolimus eluting vascular scaffold. Circulation. 2011;124(Suppl 21):A10570.
  7. Serruys P.W., Ormiston J., van Geuns R.J., de Bruyne B., Dudek D., Christiansen E., Chevalier B., Smits P., McClean D., Koolen J., Windecker S., Whitbourn R., Meredith I., Wasungu L., Ediebah D., Veldhof S., Onuma Y. A polylactide bioresorbable scaffold eluting everolimus for treatment of coronary stenosis: 5-year follow-up. J Am Coll Cardiol. 2016;67(7):766-76. PMID: 26892411. https://doi.org/10.1016/j.jacc.2015.11.060
  8. Serruys P.W., Chevalier B., Dudek D., Cequier A., Carrié D., Iniguez A., Dominici M., van der Schaaf R.J., Haude M., Wasungu L., Veldhof S., Peng L., Staehr P., Grundeken M.J., Ishibashi Y., Garcia-Garcia H.M., Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385(99620):43-54. PMID: 25230593. https://doi.org/10.1016/S0140-6736(14)61455-0
  9. Ellis S.G., Kereiakes D.J., Metzger D.C., Caputo R.P., Rizik D.G., Teirstein P.S., Litt M.R., Kini A., Kabour A., Marx S.O., Popma J.J., McGreevy R., Zhang Z., Simonton C., Stone GW; ABSORB III Investigators. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. New Engl J Med. 2015;373(20):1905-15. PMID: 26457558. https://doi.org/10.1056/NEJMoa1509038
  10. Capodanno D. et al. Percutaneous 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. PMID: 25042421 DOI: 10.4244/EIJY14M07_11
  11. Прохорихин А.А., Фартаков Е.И., Малаев Д.У., Бойков А.А., Ойдуп-Оол С.В., Байструков В.И., Гражданкин И.О., Зубарев Д.Д., Покушалов Е.А., Кретов Е.И. Оценка эффективности и безопасности биодеградируемого каркаса Absorb: 6-месячные результаты регистра Gabi R: Russia. Патология кровообращения и кардиохирургия. 2019;23(1 Suppl. 1):S26-S33. http://dx.doi.org/10.21688/1681-3472-2019-1S-S26-S33 [Prokhorikhin A.A., Fartakov E.I., Malaev D.U., Boykov A. A., Oidup-Ool S.V., Baystrukov V.I., Grazhdankin I.O., Zubarev D.D., Pokushalov E.A., Kretov E.I. Efficacy and safety of bioresorbable vascular scaffold Absorb: 6-month outcomes of GABI-R: Russia registry. Patologiya krovoobrashcheniya I kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2019;23(1 Suppl. 1):S18-S25. http://dx.doi.org/10.21688/1681-3472-2019-1S-S26-S33 (In Russ.)]
  12. Grouve E., Kristensen S. Stent thrombosis: definitions, mechanisms and prevention. E-journal of Cardiology Practice. 2007;32(5). Available from: https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-5/Stent-thrombosis-definitions-mechanisms-and-prevention-Title-Stent-thrombos
  13. TCT-192: Two-Year Patient Outcomes with the Resolute Zotarolimus-Eluting Stent: Results of the RESOLUTE International Registry. J Am Coll Cardiol. 2011;58(20 Suppl.):B51. https://doi.org/10.1016/j.jacc.2011.10.196
  14. Serruys P.W., Chevalier B., Sotomi Y., Cequier A., Carrié 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., Iñiguez A., Sabaté 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. PMID: 27806897. https://doi.org/10.1016/S0140-6736(16)32050-5
  15. Ellis S.G., Kereiakes D.J., Metzger D.C., Caputo R.P., Rizik D.G., Teirstein P.S., Litt M.R., Kini A., Kabour A., Marx S.O., Popma J.J., McGreevy R., Zhang Z., Simonton C., Stone G.W.; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015;373(20):1905-15. PMID: 26457558 https://doi.org/10.1056/NEJMoa1509038
  16. Sorrentino S., Giustino G., Mehran R., Kini A.S., Sharma S.K., Faggioni M., Farhan S., Vogel B., Indolfi C., Dangas G.D. Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents. J Am Coll Cardiol. 2017;69(25):3055-66. PMID: 28412389. https://doi.org/10.1016/j.jacc.2017.04.011
  17. Neumann F.J., Sousa-Uva M., Ahlsson A., Alfonso F., Banning A.P., Benedetto U., Byrne R.A., Collet J.P., Falk V., Head S.J., Jüni P., Kastrati A., Koller A., Kristensen S.D., Niebauer J., Richter D.J., Seferovic P.M., Sibbing D., Stefanini G.G., Windecker S., Yadav R., Zembala M.O.; ESC Scientific Document Group. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165. PMID: 30165437. https://doi.org/10.1093/eurheartj/ehy394
  18. Grimfjärd P., James S., Persson J., Angerås O., Koul S., Omerovic E., Varenhorst C., Lagerqvist B., Erlinge D. Outcome of percutaneous coronary intervention with the Absorb bioresorbable scaffold: data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). EuroIntervention. 2017;13(11):1303-10. PMID: 28781242. https://doi.org/10.4244/EIJ-D-17-00458
  19. Ali Z.A., Serruys P.W., Kimura T., Gao R., Ellis S.G., Kereiakes D.J., Onuma Y., Simonton C., Zhang Z., Stone G.W. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet. 2017;390(10096):760-72. PMID: 28732815. https://doi.org/10.1016/S0140-6736(17)31470-8
  20. Bozsak F., Gonzalez-Rodriguez D., Sternberger Z., Belitz P., Bewley T., Chomaz J.M., Barakat A.I. Optimization of drug delivery by drug-eluting stents. PloS One. 2015;10(6):e0130182. PMID: 26083626, PMCID: PMC4470631. https://doi.org/10.1371/journal.pone.0130182
  21. Moreno R., Jimenez-Valero S., Sanchez-Recalde A., Galeote G., Calvo L., Martin-Reyes R., Sabate M., Plaza I., Macaya C., Lopez-Sendon J.L. Periprocedural (30-day) risk of myocardial infarction after drug-eluting coronary stent implantation: a meta-analysis comparing cobalt-chromium and stainless steel drug-eluting coronary stents. EuroIntervention. 2011;6(8):1003-10. PMID: 21330250. https://doi.org/10.4244/EIJV6I8A173
  22. Philip F., Agarwal S., Bunte M.C., Goel S.S., Tuzcu E.M., Ellis S., Kapadia S.R. Stent thrombosis with second-generation drug-eluting stents compared with bare-metal stents: network meta-analysis of primary percutaneous coronary intervention trials in ST-segment–elevation myocardial infarction. Circ Cardiovasc Interv. 2014;7(1):49-61. PMID: 24280964. https://doi.org/10.1161/CIRCINTERVENTIONS.113.000412
  23. Kolandaivelu K., Swaminathan R., Gibson W.J., Kolachalama V.B., Nguyen-Ehrenreich K.L., Giddings V.L., Coleman L., Wong G.K., Edelman E.R. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011;123(13):1400-9. PMID: 21422389, PMCID: PMC3131199. https://doi.org/10.1161/CIRCULATIONAHA.110.003210