Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives

Abstract

Drug-eluting stents (DES) have reached a high safety and efficacy profile, becoming the best option for percutaneous coronary interventions (PCI) based revascularization. However, despite their optimal performance, a few concerns remain regarding their use, mainly due to permanent caging of the vessels and its consequences, first of all late stent thrombosis (ST). Bioresorbable scaffolds (BRS) aim to overcome these issues. The results achieved in randomized controlled trials (RCT) by the first generation of poly-L-lactic acid (PLLA) based scaffolds were promising at 1 year, but the first long term reports (albeit flawed by nonoptimal implantation technique) have been disappointing, showing, for instance, an increased risk of ST and target vessel myocardial infarction (TV-MI). In such a scenario the advent of a newer generation magnesium (Mg) based BRS is welcome, mainly because of its innovative mechanical and chemical features coupled with well proven biocompatibility. Despite being in its infancy, this technology seems to promise a great potential.In our article, we review the Magmaris (Biotronik AG, Bülach, Switzerland) Mg BRS development from animal models to human use, underscore its best qualities and weaknesses, and provide hints of its possible future perspectives.

Early outcome of magnesium bioresorbable scaffold implantation in acute coronary syndrome—the initial report from the Magmaris‐ACS registry

“…The process of Mg alloy resorption starts at the backbone surface and continues inward until only an amorphous footprint of hydroxyapatite is left instead of the struts. About 95% of the Mg is resorbed within 12 months . The currently available scaffold lengths are 15, 20, and 25 mm, with scaffold diameters of 3.0 and 3.5 mm.…”

“…About 95% of the Mg is resorbed within 12 months. 3 The currently available scaffold lengths are 15, 20, and 25 mm, with scaffold diameters of 3.0 and 3.5 mm.…”

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

“…Due to the intrinsic radiolucency of magnesium and lack of markers mounted, the first generation stents are not visible in conventional imaging, but at the same time they are compatible with magnetic resonance imaging (MRI). These stents have bioresorbable coating of poly-lactic-co-glycolic acid (PLGA) eluting paclitaxel, and decompose in approximately 3-4 months [20,22,[61][62][63]. The absorption of the magnesium alloy is a two-stage process, starting on the luminal surface of the scaffold, progressing towards the layers, until only the trace of hydroxyapatite remains at the site of implantation.…”

“…A poor safety profile, especially in terms of target vessel myocardial infarction (TVMI) and an ST of 3 year follow up in ABSORB, as well as the negative results of the Amsterdam Investigator-Initiated ABSORB Strategy All-Comers Trial (AIDA) induced the manufacturer, Abbott Vascular, to halt the commercialization of ABSORB BVS [17][18][19]. Similarly, despite good outcomes of the BIOSOLVE I trial, the DREAMS BVS is still not ready for clinical use as the sparse data available stem from a small number of nonrandomized studies, conducted on a small number of patients [20][21][22][23]. Nevertheless, thanks to the encouraging results from the BIOSOLVE II and III studies which report very good outcomes in the 184 patients enrolled, with a more complex anatomical setting, we are facing a steady rise in the clinical use of the Magmaris stent within the ongoing prospective registry BIOSOLVE IV [24,25].…”

Current perspectives on the role of bioresorbable scaffolds in the management of coronary artery disease

“…It gained CE mark approval in June 2016. It is the successor to the paclitaxel-eluting DREAMS platform [56]. Thanks to its metallic alloy, Magmaris BRS is believed to have better lesion crossing, trackability, and pushability than polymeric BRSs.…”