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Recent studies have demonstrated favorable clinical outcomes for the sirolimus-eluting magnesium-based bioresorbable vascular scaffold (BVS) MAGMARIS® (Biotronik, Berlin, Germany) in patients with stable coronary artery disease. There are currently no data on its use in patients with ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess safety and efficacy of magnesium-based BVS implantation in the setting of primary percutaneous coronary intervention (PCI) in patients presenting with STEMI to our institution.
We are conducting a single-center feasibility study of Magmaris® implantation in STEMI patients. Primary endpoints are procedural success and device-oriented composite endpoint including cardiac death, target vessel myocardial infarction and target lesion revascularization as defined by the Academic Research Consortium criteria. This study is intended to obtain data from 25 consecutive STEMI patients undergoing primary PCI with magnesium-based BVS implantation, according to pre-specified inclusion/exclusion criteria.
Median age of the first 10 patients included is 42 years [38-49]. Mean number of implanted device is 1.2 ± 0.4, with a mean length of 25 ± 8 mm and mean diameter of 3.35 ± 0.2. So far procedural success is 100% with one case of distal edge dissection requiring a second scaffold implantation, and in-hospital DOCE rate is 0%.
This is the first reported initial clinical experience of magnesium-based BVS (Magmaris®) implantation in STEMI patients. Preliminary results of this single-center feasibility study seem reassuring with excellent procedural success rates, low complication rates and excellent short-term clinical outcomes. We will report further results of additional included patients, mid-term clinical outcomes, and intra-coronary imaging results.
CORONARY: Acute Coronary Syndromes