Preclinical evaluation of the degradation kinetics of third-generation resorbable magnesium scaffolds

DOI: 10.4244/EIJ-D-22-00718

Masaru Seguchi
Masaru Seguchi1, MD; Philine Baumann-Zumstein2, MSc; Armin Fubel2, MSc; Ron Waksman3, MD; Michael Haude4, MD; Stefano Galli5, MD; Michael Joner1,6, MD
1. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany; 2. BIOTRONIK AG, Bülach, Switzerland; 3. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA; 4. Department of Cardiology, Rheinlandklinikum Neuss, Neuss, Germany; 5. Centro Cardiologico Monzino, IRCCS, Milan, Italy; 6. Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

Background: The novel sirolimus-eluting resorbable scaffold DREAMS 3G was designed as a third-generation development of its predecessor, the Magmaris scaffold.

Aims: This preclinical study aimed to examine the qualitative and temporal course of the degradation of the DREAMS 3G relative to the Magmaris scaffold.

Methods: Forty-nine DREAMS 3G and 24 Magmaris scaffolds were implanted into 48 mini swine for degradation kinetics analysis. Another DREAMS 3G was implanted into one mini swine for crystallinity analysis of the degradation end product after 730 days. Degradation kinetics were determined at 28, 90, 120, 180, and 365 days.

Results: Discontinuity density in DREAMS 3G was significantly lower than that in Magmaris scaffolds for the follow-up timepoints of 90 and 120 days. Planimetric analysis indicated 99.6% backbone degradation for DREAMS 3G at 12 months. Compared to the Magmaris scaffold, individual strut degradation in DREAMS 3G showed less variability and the remaining backbone core was more homogeneous. The degradation end product of DREAMS 3G manifested as calcium phosphate with a minor share of aluminium phosphate.

Conclusions: DREAMS 3G showed almost complete degradation after one year, with amorphous calcium and aluminium phosphate as the end products of degradation. Despite its thinner struts, scaffold discontinuity was significantly lower in the DREAMS 3G than in the Magmaris scaffold, likely providing a longer scaffolding time.

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bioresorbable scaffoldscoronary artery diseasepercutaneous coronary intervention
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