Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds - magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort

Diab Vasc Dis Res. 2023 Jul-Aug;20(4):14791641231188705. doi: 10.1177/14791641231188705.

Abstract

Background: Diabetes type 2 is one of the strongest risk factors affecting coronary artery disease (CAD) and is also a marker of poor short and long-term prognosis in subjects with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) with subsequent drug-eluting stent (DES) implantation. Chronic local vascular inflammation along with endothelial dysfunction is postulated to be the pathophysiological background of unfavorable results. The second generation of metallic magnesium BRS -Magmaris (Biotronik, Berlin, Germany) had been introduced to clinical practice to overcome these limitations.

Methods: We evaluated 2-years clinical outcomes after Magmaris BRS implantation in NSTE-ACS diabetic (n-72) and non-diabetic (n-121) cohorts.

Results: No significant differences between diabetic and non-diabetes cohorts were noticed in terms of Primary Outcome (cardiac death, myocardial infarction, stent thrombosis) (8.1% vs 3.3% p = 0.182) and Principal secondary outcome - TLF- target lesion failure (9.5% vs 3.3% p = 0.106) at 2-years follow-up.

Conclusions: 2-years outcome suggests good safety and efficacy of the magnesium BRS (Magmaris) in NSTE- ACS and concomitant DM. Nevertheless, there is a strong need for large multicenter, randomized, prospective studies for a full assessment of this novel device in diabetic patients with ACS.

Keywords: Diabetes mellitus (DM); acute coronary syndrome (ACS); bioresorbable materials; coronary artery disease (CAD); magmaris; magnesium bioresorbable scaffold (BRS); mid-term outcome; percutaneous coronary intervention (PCI).

Publication types

  • Multicenter Study

MeSH terms

  • Absorbable Implants
  • Acute Coronary Syndrome* / diagnosis
  • Acute Coronary Syndrome* / therapy
  • Diabetes Mellitus*
  • Drug-Eluting Stents*
  • Humans
  • Inflammation
  • Magnesium / adverse effects
  • Percutaneous Coronary Intervention* / adverse effects
  • Prospective Studies

Substances

  • Magnesium