Key result
The Magmaris sirolimus-eluting bioresorbable scaffold suffered from premature dismantling, resulting in a 43.4% reduction in minimal lumen area and a 33.3% binary restenosis rate at 8 months.
Why the study?
Coronary magnesium bioresorbable scaffolds emerged as alternatives to polymeric scaffolds with faster resorption, prompting evaluation of the commercially available Magmaris sirolimus-eluting scaffold using invasive imaging.
Does the Magmaris sirolimus-eluting bioresorbable scaffold maintain structural integrity and lumen area in patients with stable de novo coronary artery lesions?
Does the Magmaris sirolimus-eluting bioresorbable scaffold maintain structural integrity and lumen area in patients with stable de novo coronary artery lesions?
The Magmaris magnesium bioresorbable scaffold exhibits premature dismantling and rapid degradation, leading to a higher than expected decrease in minimal lumen area.
Signals need for clinical caution with Magmaris; leaves open durability questions for bioresorbable scaffolds.
OBJECTIVES: To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points. BACKGROUND: Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points. METHODS: A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points. RESULTS: At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months. CONCLUSIONS: Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA.
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Forero et al. (2019) studied stable de novo coronary artery lesions (n=6). Magmaris sirolimus-eluting bioresorbable scaffold was evaluated on target lesion failure. The Magmaris sirolimus-eluting bioresorbable scaffold suffered from premature dismantling, resulting in a 43.4% reduction in minimal lumen area and a 33.3% binary restenosis rate at 8 months.
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