Why the study?
Evaluating coronary devices in ACS provides important safety and efficacy information, and mid-term data comparing the Magmaris BRS with the new-generation ultrathin DES Ultimaster in this setting were needed.
Does a magnesium bioresorbable scaffold (Magmaris) improve clinical outcomes compared to a polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in patients with non-ST-elevation acute coronary syndrome?
Does a magnesium bioresorbable scaffold (Magmaris) improve clinical outcomes compared to a polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in patients with non-ST-elevation acute coronary syndrome?
In patients with NSTE-ACS, treatment with a magnesium bioresorbable scaffold showed similar rates of target lesion failure and primary composite outcomes at 2 years compared to an ultrathin drug-eluting stent.
Provides hypothesis-generating data on bioresorbable scaffolds in acute coronary syndrome; leaves open whether safety.
Introduction: Acute coronary syndrome (ACS) is a well-known risk factor for adverse clinical outcomes in percutaneous coronary intervention (PCI).Therefore, evaluation of coronary stents in this challenging clinical scenario can provide unique information on device safety and efficacy.Bioresorbable scaffolds (BRS) were designed to overcome long-term complications related to permanent vessel caging with a permanent metallic drug-eluting stent (DES).Aim: We designed this study to evaluate the mid-term safety and efficiency of the Magmaris BRS in comparison to the leading new-generation ultrathin DES Ultimaster in the ACS population. Material and methods:We present a retrospective analysis of 2-year follow-up data.The primary outcomes consisted of death from cardiac causes, myocardial infarction, and in-stent thrombosis.The second main study endpoint was defined as target-lesion failure (TLF).Results: The study population consisted of two cohorts, the first of 193 patients treated with Magmaris implantation and the second of 169 patients treated with Ultimaster implantation.At the 2-year follow-up, there were no significant differences in both study cohorts in terms of primary outcome (5.1% vs. 11%; p = 0.051), and TLF (5.6% vs. 8%, p = 0.41).Conclusions: Treatment with a second-generation BRS (Magmaris) versus a novel second-generation DES (Ultimaster) in non-ST-elevation acute coronary syndrome (NSTE-ACS) was associated with similar rates of target lesion failure at 2-year follow-up.
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Włodarczak et al. (2024) studied this question.
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