Why the study?
Promising data for Magmaris bioresorbable vascular scaffolds in stable angina encouraged validation of this second-generation device in acute coronary syndrome.
Does magnesium bioresorbable scaffold implantation provide procedural safety and favorable early clinical outcomes in patients with non-ST elevation acute coronary syndrome?
Does magnesium bioresorbable scaffold implantation provide procedural safety and favorable early clinical outcomes in patients with non-ST elevation acute coronary syndrome?
The use of a magnesium bioresorbable scaffold in non-ST elevation ACS appears safe and feasible, demonstrating excellent early angiographic and clinical outcomes at 6 months.
Supports the early feasibility of magnesium bioresorbable scaffolds in non-ST-elevation ACS;.
OBJECTIVES: The Magmaris-ACS Registry is the first assessment of the Magmaris implantation in the acute coronary syndrome (ACS) population. BACKGROUND: Bioresorbable vascular scaffolds (BRS), the newest coronary stent technology, was developed to overcome the limitations of the metallic drug-eluting stents (DES). Current promising data of the Magmaris in patients with stable angina have encouraged to validate the second generation BRS in ACS indications. METHODS: The study population consisted of the consecutive patients who underwent PCI with the Magmaris BRS in the settings of ACS. Patients with ST-segment elevation myocardial infarction were excluded from enrolment. Baseline demographic and angiographic characteristics, as well as 30-day and 6-month clinical, follow up were prospectively analyzed. RESULTS: Fifty patients were enrolled at mean age 62.9 ± 8.4 years (unstable angina-52% and non-ST-segment myocardial infarction [NSTEMI]-48%). Treated fifty-one de novo lesions were located in LAD (37%), LCx (14%), and RCA (49%), respectively. Angiographic success in the target lesion was 100%. One case of recurrent ischemia was observed a day after the index procedure, due to the significant distal edge dissection a regular metallic DES overlapping Magmaris was implanted. No other in-hospital events occurred (procedural success 98%). Six-Month follow up showed none device-oriented endpoints such as cardiac mortality, target vessel myocardial infarction or target vessel revascularization. None early scaffold thrombosis was reported. CONCLUSION: The use of the Magmaris BRS in non-ST elevation ACS patient is associated with a procedural safety and promising early angiographic and clinical outcomes. Long-term follow-up and further evaluation in large prospective randomized controlled trials are needed.
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Włodarczak et al. (2018) studied this question.
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