COMPARISON OF A NOVEL BIODEGRADABLE STENT MAGMARIS WITH DRUG ELUTING RESOLUTE ONYX STENT: SAFETY AND 12 MONTH OUTCOMES

Received: 06/04/2023/ Accepted: 27/09/023 / Published online: October 30, 2023
УДК 616.12-005.4-089:615.472.5
DOI 10.53511/PHARMKAZ.2023.99.27.004
ALIMBAEV KAISAR SERIKOVICH1, ARIPOV MARAT ASANOVICH1, GONCHAROV ALEXEY YURYEVICH1, KALIYEV BAUYRZHAN BAKHYTOVICH2, AINABEKOVA BAYAN ALKENOVNA3
1 NpJSC «National research cardiac surgery center», Astana, Kazakhstan
2 «University Medical Center» Corporate Fund, National Research Center for Maternal and Child Health, Astana, Kazakhstan
3 NpJSC «Astana medical university», Astana, Kazakhstan

COMPARISON OF A NOVEL BIODEGRADABLE STENT MAGMARIS WITH DRUG
ELUTING RESOLUTE ONYX STENT: SAFETY AND 12 MONTH OUTCOMES

Resume: stent implantation is effective method of overcome critical vessel narrowing and restore normal
flowing of blood in affected ones in patients with сoronary artery disease. Using biodegradable stent platform
was the next step of treatment evolution and innovative idea for reducing complication.
Purpose of the study: : to determine and compare the efficacy, safety and outcomes of implantation of a
biodegradable Magmaris and drug eluting Resolute Onyx stent in patients with сoronary artery disease in
12-month follow-up.
Material and methods: The single-center prospective study included 50 patients with coronary heart disease
who underwent stent implantation (Magmaris, main group – 25 patient, Resolute Onyx, control group – 25
patient). Inclusion criteria: verified coronary artery lesion by angiographic method, signed voluntary informed
consent of the patient to participate in the study. The exclusion criteria: the presence of chronic occlusion
of the coronary vessel, calcification, acute myocardial infarction, restenosis of a previously implanted stent.
Results: after stent implantation there were statistically approved positive dynamic both in severity of angina
pectoris signs and in severity of heart failure (p=0.002 and p=0.012 respectively). Evidence of the first
endpoints was only in Resolute Onyx group where in 1 case occurred stroke after 12 month of implantation
(n=1, p=0.625). Death and myocardial infarction were not recorded. Two patient developed restenosis (8%)
after stenting in main group (p=0.422), thrombosis was documented in both groups: one case after Magmaris
and two cases after Resolute Onyx implantations (p=0.512).
Conclusion: using of biodegradable Magmaris and drug eluting Resolute Onyx stents demonstrated good
clinical effects and comparable efficacy and safety in patients with сoronary artery disease in 12-month follow-up.
Keywords: coronary heart disease, bioresorbable stents, drug eluting stents, endovascular methods of treatment

REFERENCES
1 J.Knuuti, W. Wijns, A. Saraste et all. ESC Scientific Document Group, 2019 ESC Guidelines for the diagnosis and management of chronic coronary
syndromes: The Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC). European Heart
Journal 2020; 41(3): 407–477 https://doi.org/10.1093/eurheartj/ehz425
2 Zong J, He Q, Liu Y, Qiu M, Wu J, Hu B. Advances in the development of biodegradable coronary stents: A translational perspective. Mater Today Bio. 2022
Jul 19;16:100368. doi: 10.1016/j.mtbio.2022.100368. PMID: 35937578; PMCID: PMC9352968.
3 Johan Bennett, Quentin De Hemptinne & Keir McCutcheon (2019) Magmaris resorbable magnesium scaffold for the treatment of coronary heart disease:
overview of its safety and efficacy, Expert Review of Medical Devices 2019;16:9:757-769, https://doi.org/10.1080/17434440.2019.1649133
4 Qiao S, Chen L, Chen SL, Wang W, Ferri B, Liu M, Zhu G. Long-term safety and efficacy of the Resolute stent: 5-year results from the RESOLUTE China
Registry: RESOLUTE China Registry 5-year outcomes. AsiaIntervention. 2021 Jul;7(1):45-51. doi: 10.4244/AIJ-D-20-00003. PMID: 34913001; PMCID:
PMC8657040.
5 Barkholt TØ, Webber B, Holm NR, Ormiston JA. Mechanical properties of the drug-eluting bioresorbable magnesium scaffold compared with polymeric
scaffolds and a permanent metallic drug-eluting stent. Catheter Cardiovasc Interv. 2020 Dec;96(7):E674-E682. doi: 10.1002/ccd.28545. Epub 2019 Nov 11.
PMID: 31710149; PMCID: PMC7754471.
6 Kumar B, Rakesh Ram R, Dahiya N, Gawalkar AA. Real-World Clinical Outcomes of Indigenous Biodegradable Polymer Drug-Eluting Stents. Cureus. 2021
Sep 11;13(9):e17886. doi: 10.7759/cureus.17886. PMID: 34660085; PMCID: PMC8503863.
7 Lou Y, Yu Y, Xi Z, Gao Y, Liu W, Nie X. Five-Year Outcomes of Biodegradable Polymer Drug-Eluting Stents Versus Second-Generation Durable Polymer
Drug-Eluting Stents: a Meta-Analysis of Randomized Controlled Trials. Cardiovasc Drugs Ther. 2019 Oct;33(5):557-566. doi: 10.1007/s10557-019-06912-x.
PMID: 31773343.
8 Torii, S., Jinnouchi, H., Sakamoto, A. et al. Drug-eluting coronary stents: insights from preclinical and pathology studies. Nat Rev Cardiol 2020;17:37–51.
https://doi.org/10.1038/s41569-019-0234-x
9 Rapetto C, Leoncini M. Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives. J Thorac
Dis. 2017 Aug;9(Suppl 9):S903-S913. doi: 10.21037/jtd.2017.06.34. PMID: 28894596; PMCID: PMC5583079.
10 Boeder NF, Dörr O, Koepp T, Blachutzik F, Achenbach S, Elsässer A, Hamm CW, Nef HM. Acute Mechanical Performance of Magmaris vs. DESolve
Bioresorbable Scaffolds in a Real-World Scenario. Front Cardiovasc Med. 2021 Jun 14;8:696287. doi: 10.3389/fcvm.2021.696287. PMID: 34195239; PMCID:
PMC8236697.
11 Rola P, Włodarczak A, Włodarczak S, Barycki M, Szudrowicz M, Łanocha M, Furtan Ł, Woźnica K, Kulczycki JJ, Jaroszewska-Pozorska J, Kędzierska M,
Doroszko A, Lesiak M. Magnesium Bioresorbable Scaffold (BRS) Magmaris vs Biodegradable Polymer DES Ultimaster in NSTE-ACS Population-12-Month
Clinical Outcome. J Interv Cardiol. 2022 Dec 20;2022:5223317. doi: 10.1155/2022/5223317. PMID: 36605917; PMCID: PMC9794423.

12 Toušek P, Lazarák T, Varvařovský I, Nováčková M, Neuberg M, Kočka V. Comparison of a Bioresorbable, Magnesium-Based Sirolimus-Eluting Stent with
a Permanent, Everolimus-Eluting Metallic Stent for Treating Patients with Acute Coronary Syndrome: the PRAGUE-22 Study. Cardiovasc Drugs Ther. 2022
Dec;36(6):1129-1136. doi: 10.1007/s10557-021-07258-z. Epub 2021 Sep 10. PMID: 34505954; PMCID: PMC9652234.
13 Bossard M, Madanchi M, Avdijaj D, Attinger-Toller A, Cioffi GM, Seiler T, Tersalvi G, Kobza R, Schüpfer G, Cuculi F. Long-Term Outcomes After
Implantation of Magnesium-Based Bioresorbable Scaffolds-Insights From an All-Comer Registry. Front Cardiovasc Med. 2022 Apr 14;9:856930. doi: 10.3389/
fcvm.2022.856930. PMID: 35498044; PMCID: PMC9046914.

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