Key result
Magmaris magnesium bioresorbable scaffolds reduced the 1-year composite of cardiac death, myocardial infarction, and stent thrombosis compared to Absorb polymer scaffolds (1.5% vs 8.1%, p=0.003).
Why the study?
Permanent caging with metallic DES has drawbacks, but following initial encouraging reports, safety concerns arose regarding bioresorbable vascular scaffolds.
Does a magnesium bioresorbable scaffold (Magmaris) improve safety and clinical outcomes compared to a polymer bioresorbable scaffold (Absorb) in patients with acute coronary syndrome undergoing PCI?
Observational (n=353)
No
Does a magnesium bioresorbable scaffold (Magmaris) improve safety and clinical outcomes compared to a polymer bioresorbable scaffold (Absorb) in patients with acute coronary syndrome undergoing PCI?
Absolute Event Rate: 1.5% vs 8.1%
p-value: p=0.003
In patients with acute coronary syndrome, the use of a magnesium bioresorbable scaffold (Magmaris) was associated with significantly lower rates of target lesion failure and scaffold thrombosis at 1 year compared to a polymer bioresorbable scaffold (Absorb).
Magmaris was associated with lower primary endpoint rates than Absorb in ACS; leaves open comparative efficacy of second-generation BRS versus modern DES.
BACKGROUND: Acute coronary syndrome (ACS) as a clinical manifestation of coronary artery disease (CAD) remains a significant cause of mortality and morbidity, as reported worldwide annually. The second generation of drug-eluting stents (DES) is a gold standard in percutaneous interventions in ACS patients however, permanent caging of the vessel with metallic DES has some drawbacks. Bioresorbable vascular scaffolds (BRS) were designed as a temporal vessel-supporting technology allowing for anatomical and functional restoration. Nevertheless, following the initial encouraging reports, numerous concerns about the safety of BRS occurred. METHODS: In this study, a 1-year performance of 193 patients with magnesium BRS - Magmaris (Biotronik, Berlin, Germany) was evaluated in comparison to 160 patients with polymer BRS - Absorb (Abbott-Vascular, Chicago, USA) in the non-ST-segment elevation-ACS setting. RESULTS: The Magmaris, when compared to Absorb showed a significantly lower rate of primary endpoint (death from cardiac causes, myocardial infarction, stent thrombosis) as well as target lesion failure in 30-day and 1 year follow-up. In the Absorb group, a significantly higher rate of stent thrombosis was observed. CONCLUSIONS: Data from the present study suggests encouraging safety a profile and more favorable clinical outcomes of Magnesium BRS in comparison to the polymer Absorb - BRS.
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Rola et al. (2022) conducted an observational in Acute coronary syndrome (NSTEMI or unstable angina) (n=353). Magmaris (magnesium bioresorbable scaffold) vs. Absorb (polymer bioresorbable scaffold) was evaluated on Composite of death from cardiac causes, myocardial infarction, or definite or probable stent thrombosis at 1-year follow-up (p=0.003). Magmaris magnesium bioresorbable scaffolds reduced the 1-year composite of cardiac death, myocardial infarction, and stent thrombosis compared to Absorb polymer scaffolds (1.5% vs 8.1%, p=0.003).
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