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open access

Vol 30, No 6 (2023)
Original Article
Submitted: 2021-10-20
Accepted: 2022-05-10
Published online: 2022-05-24
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Outcomes of the two generations of bioresorbable scaffolds (Magmaris vs. Absorb) in acute coronary syndrome in routine clinical practice

Piotr Rola12, Adrian Włodarczak1, Magdalena Łanocha3, Mateusz Barycki2, Marek Szudrowicz1, Jan J. Kulczycki1, Joanna Jaroszewska-Pozorska1, Alicja Gosiewska4, Katarzyna Woźnica4, Maciej Lesiak5, Adrian Doroszko6
DOI: 10.5603/CJ.a2022.0047
·
Pubmed: 35621089
·
Cardiol J 2023;30(6):870-880.
Affiliations
  1. Department of Cardiology, The Copper Health Center (MCZ), Lubin, Poland
  2. Department of Cardiology, Provincial Specialized Hospital, Legnica, Poland
  3. Adalbert’s Hospital, Poznan, Poland
  4. Faculty of Mathematics and Information Science, Warsaw University of Technology, Warsaw, Poland
  5. 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
  6. Department of Internal Medicine, Hypertension and Clinical Oncology, Wroclaw Medical University, Wroclaw, Poland

open access

Vol 30, No 6 (2023)
Original articles — Interventional cardiology
Submitted: 2021-10-20
Accepted: 2022-05-10
Published online: 2022-05-24

Abstract

Background: Acute coronary syndrome (ACS) as a clinical manifestation of coronary artery disease
(CAD) remains a significant cause of mortality and morbidity, as reported worldwide annually. The
second generation of drug-eluting stents (DES) is a gold standard in percutaneous interventions in ACS
patients however, permanent caging of the vessel with metallic DES has some drawbacks. Bioresorbable
vascular scaffolds (BRS) were designed as a temporal vessel-supporting technology allowing for anatomical
and functional restoration. Nevertheless, following the initial encouraging reports, numerous
concerns about the safety of BRS occurred.
Methods: In this study, a 1-year performance of 193 patients with magnesium BRS — Magmaris
(Biotronik, Berlin, Germany) was evaluated in comparison to 160 patients with polymer BRS —
Absorb (Abbott-Vascular, Chicago, USA) in the non-ST-segment elevation-ACS setting.
Results: The Magmaris, when compared to Absorb showed a significantly lower rate of primary
endpoint (death from cardiac causes, myocardial infarction, stent thrombosis) as well as target lesion
failure in 30-day and 1 year follow-up. In the Absorb group, a significantly higher rate of stent thrombosis
was observed.
Conclusions: Data from the present study suggests encouraging safety a profile and more favorable
clinical outcomes of magnesium BRS in comparison to the polymer Absorb — BRS.

Abstract

Background: Acute coronary syndrome (ACS) as a clinical manifestation of coronary artery disease
(CAD) remains a significant cause of mortality and morbidity, as reported worldwide annually. The
second generation of drug-eluting stents (DES) is a gold standard in percutaneous interventions in ACS
patients however, permanent caging of the vessel with metallic DES has some drawbacks. Bioresorbable
vascular scaffolds (BRS) were designed as a temporal vessel-supporting technology allowing for anatomical
and functional restoration. Nevertheless, following the initial encouraging reports, numerous
concerns about the safety of BRS occurred.
Methods: In this study, a 1-year performance of 193 patients with magnesium BRS — Magmaris
(Biotronik, Berlin, Germany) was evaluated in comparison to 160 patients with polymer BRS —
Absorb (Abbott-Vascular, Chicago, USA) in the non-ST-segment elevation-ACS setting.
Results: The Magmaris, when compared to Absorb showed a significantly lower rate of primary
endpoint (death from cardiac causes, myocardial infarction, stent thrombosis) as well as target lesion
failure in 30-day and 1 year follow-up. In the Absorb group, a significantly higher rate of stent thrombosis
was observed.
Conclusions: Data from the present study suggests encouraging safety a profile and more favorable
clinical outcomes of magnesium BRS in comparison to the polymer Absorb — BRS.

Full Text:

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Keywords

bioresorbable scaffolds, acute coronary syndrome, magnesium scaffolds, Magmaris, Absorb, percutaneous coronary intervention

About this article
Title

Outcomes of the two generations of bioresorbable scaffolds (Magmaris vs. Absorb) in acute coronary syndrome in routine clinical practice

Journal

Cardiology Journal

Issue

Vol 30, No 6 (2023)

Article type

Original Article

Pages

870-880

Published online

2022-05-24

Page views

1799

Article views/downloads

467

DOI

10.5603/CJ.a2022.0047

Pubmed

35621089

Bibliographic record

Cardiol J 2023;30(6):870-880.

Keywords

bioresorbable scaffolds
acute coronary syndrome
magnesium scaffolds
Magmaris
Absorb
percutaneous coronary intervention

Authors

Piotr Rola
Adrian Włodarczak
Magdalena Łanocha
Mateusz Barycki
Marek Szudrowicz
Jan J. Kulczycki
Joanna Jaroszewska-Pozorska
Alicja Gosiewska
Katarzyna Woźnica
Maciej Lesiak
Adrian Doroszko

References (45)
  1. Vedanthan R, Seligman B, Fuster V. Global perspective on acute coronary syndrome: a burden on the young and poor. Circ Res. 2014; 114(12): 1959–1975.
    CrossRefPubMed
  2. Dudek D, Siudak Z, Grygier M, et al. Interventional cardiology in Poland in 2019. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK) and Jagiellonian University Medical College. Advances Interventional Cardiology. 2020; 16(2): 123–126.
    CrossRefPubMed
  3. Torii S, Jinnouchi H, Sakamoto A, et al. Drug-eluting coronary stents: insights from preclinical and pathology studies. Nat Rev Cardiol. 2020; 17(1): 37–51.
    CrossRefPubMed
  4. Ochijewicz D, Tomaniak M, Opolski G, et al. Inflammation as a determinant of healing response after coronary stent implantation. Int J Cardiovasc Imaging. 2021; 37(3): 791–801.
    CrossRefPubMed
  5. Serruys PW, Onuma Y, Dudek D, et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011; 58(15): 1578–1588.
    CrossRefPubMed
  6. Serruys P, Chevalier B, Sotomi Y, et al. 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): 2479–2491.
    CrossRef
  7. Kereiakes DJ, Ellis SG, Metzger DC, et al. 3-Year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: the ABSORB III trial. J Am Coll Cardiol. 2017; 70(23): 2852–2862.
    CrossRefPubMed
  8. Rizik DG, Hermiller JB, Simonton CA, et al. Bioresorbable vascular scaffolds for the treatment of coronary artery disease: what have we learned from randomized-controlled clinical trials? Coron Artery Dis. 2017; 28(1): 77–89.
    CrossRefPubMed
  9. Tamburino C, Latib A, van Geuns RJ, et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. EuroIntervention. 2015; 11(1): 45–52.
    CrossRefPubMed
  10. Verheye S, Wlodarczak A, Montorsi P, et al. 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; 98(1): E1–E8.
    CrossRefPubMed
  11. Wlodarczak A, Lanocha M, Jastrzebski A, et al. Early outcome of magnesium bioresorbable scaffold implantation in acute coronary syndrome-the initial report from the Magmaris-ACS registry. Catheter Cardiovasc Interv. 2019; 93(5): E287–E292.
    CrossRefPubMed
  12. Wiebe J, Nef HM, Hamm CW. Current status of bioresorbable scaffolds in the treatment of coronary artery disease. J Am Coll Cardiol. 2014; 64(23): 2541–2551.
    CrossRefPubMed
  13. Schmidt W, Behrens P, Brandt-Wunderlich C, et al. In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond. Cardiovasc Revasc Med. 2016; 17(6): 375–383.
    CrossRefPubMed
  14. Roffi M, Patrono C, Collet JP, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016; 37(3): 267–315.
    CrossRefPubMed
  15. Valgimigli M, Bueno H, Byrne R, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2017; 39(3): 213–260.
    CrossRefPubMed
  16. Fajadet J, Haude M, Joner M, et al. Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016. EuroIntervention. 2016; 12(7): 828–833.
    CrossRefPubMed
  17. Thygesen K, Alpert JS, Jaffe AS, et al. Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018; 72(18): 2231–2264.
    CrossRefPubMed
  18. R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2020. https://www.R-project.org/.
  19. Tamburino C, Capranzano P, Gori T, et al. 1-Year outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: a propensity-matched comparison of the GHOST-EU and XIENCE v USA registries. JACC Cardiovasc Interv. 2016; 9(5): 440–449.
    CrossRefPubMed
  20. Capodanno D, Gori T, Nef H, 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): 1144–1153.
    CrossRefPubMed
  21. Ali Z, Serruys P, Kimura T, et al. 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): 760–772.
    CrossRef
  22. Sotomi Y, Suwannasom P, Serruys PW, et al. Possible mechanical causes of scaffold thrombosis: insights from case reports with intracoronary imaging. EuroIntervention. 2017; 12(14): 1747–1756.
    CrossRefPubMed
  23. Regazzoli D, Leone PP, Colombo A, et al. New generation bioresorbable scaffold technologies: an update on novel devices and clinical results. J Thorac Dis. 2017; 9(Suppl 9): S979–S985.
    CrossRefPubMed
  24. Sabaté M, Windecker S, Iñiguez A, et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction: TROFI II trial. Eur Heart J. 2016; 37(3): 229–240.
    CrossRefPubMed
  25. Bangalore S, Bezerra HG, Rizik DG, et al. The state of the Absorb bioresorbable scaffold: consensus from an expert panel. JACC Cardiovasc Interv. 2017; 10(23): 2349–2359.
    CrossRefPubMed
  26. Stone G, Ellis S, Gori T, et al. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet. 2018; 392(10157): 1530–1540.
    CrossRef
  27. Karanasos A, Van Mieghem N, van Ditzhuijzen N, et al. Angiographic and optical coherence tomography insights into bioresorbable scaffold thrombosis: single-center experience. Circ Cardiovasc Interv. 2015; 8(5).
    CrossRefPubMed
  28. Boeder NF, Weissner M, Blachutzik F, et al. Incidental finding of strut malapposition is a predictor of late and very late thrombosis in coronary bioresorbable scaffolds. J Clin Med. 2019; 8(5).
    CrossRefPubMed
  29. Collet JP, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: the Task Force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2021; 42: 1289–1367.
    CrossRefPubMed
  30. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. European heart journal. 2019; 40: 87–165.
    CrossRefPubMed
  31. Capodanno D, Angiolillo DJ. Antiplatelet therapy after implantation of Bioresorbable vascular scaffolds: a review of the published data, practical recommendations, and Future directions. JACC Cardiovasc Interv. 2017; 10(5): 425–437.
    CrossRefPubMed
  32. Ellis SG, Steffenino G, Kereiakes DJ, et al. Clinical, angiographic, and procedural correlates of acute, subacute, and late Absorb scaffold thrombosis. JACC Cardiovasc Interv. 2017; 10(18): 1809–1815.
    CrossRefPubMed
  33. Azzalini L, Ellis SG, Kereiakes DJ, et al. Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials. EuroIntervention. 2021; 17(12): e981–e988.
    CrossRefPubMed
  34. Hideo-Kajita A, Garcia-Garcia HM, Kolm P, et al. Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials. Int J Cardiol. 2020; 300: 60–65.
    CrossRefPubMed
  35. Bayón J, Gordo V, Santás-Álvarez M, et al. Long-term (> 12 months) single-center registry of Magmaris implantation in the acute coronary syndrome setting. REC: Interventional Cardiology (English Edition). 2021.
    CrossRef
  36. Włodarczak A, Łanocha M, Lesiak M, et al. Long-term clinical follow-up of the resorbable magnesium scaffolds in acute coronary syndrome patients. Kardiol Pol. 2021; 79(7-8): 827–832.
    CrossRefPubMed
  37. Haude M, Ince H, Kische S, et al. Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III. Catheter Cardiovasc Interv. 2018; 92(7): E502–E511.
    CrossRefPubMed
  38. Waksman R, Lipinski MJ, Acampado E, et al. Comparison of acute thrombogenicity for metallic and polymeric bioabsorbable scaffolds: Magmaris versus Absorb in a porcine arteriovenous shunt model. Circ Cardiovasc Interv. 2017; 10(8).
    CrossRefPubMed
  39. Tarrahi I, Colombo M, Hartman EMJ, et al. Impact of bioresorbable scaffold design characteristics on local haemodynamic forces: an ex vivo assessment with computational fluid dynamics simulations. EuroIntervention. 2020; 16(11): e930–e937.
    CrossRefPubMed
  40. Wlodarczak A, Garcia LA, Karjalainen PP, et al. Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold. Cardiovasc Revasc Med. 2019; 20(12): 1140–1145.
    CrossRefPubMed
  41. Jang JS, Song YJ, Kang W, et al. Intravascular ultrasound-guided implantation of drug-eluting stents to improve outcome: a meta-analysis. JACC Cardiovasc Interv. 2014; 7(3): 233–243.
    CrossRefPubMed
  42. Prati F, Di Vito L, Biondi-Zoccai G, et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention. 2012; 8(7): 823–829.
    CrossRefPubMed
  43. Regazzoli D, Leone PP, Colombo A, et al. New generation bioresorbable scaffold technologies: an update on novel devices and clinical results. J Thorac Dis. 2017; 9(Suppl 9): S979–S985.
    CrossRefPubMed
  44. Haude M, Ince H, Kische S, et al. Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III. EuroIntervention. 2017; 13(4): 432–439.
    CrossRefPubMed
  45. Bayón J, Santás-Álvarez M, Ocaranza-Sánchez R, et al. Magmaris very late in-scaffold restenosis: Has the "black boxes" nightmare come back? Catheter Cardiovasc Interv. 2020; 96(2): E174–E176.
    CrossRefPubMed

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