One-Year Results of the Magmaris BRS in Coronary Artery Disease Patients: The IT-MASTERS Registry

Recent studies have highlighted the potential of the Magmaris Resorbable Magnesium Scaffold (RMS; Biotronik AG, Bülach, Switzerland) in routine clinical practice. However, limited data are available on its clinical and procedural performance in challenging coronary lesions. The IT-MASTERS registry is a prospective, investigator-initiated study conducted at 21 Italian centers, aiming to evaluate the safety and efficacy of Magmaris in a real-world cohort. The primary endpoint was the cumulative incidence of target lesion failure (TLF) at 1 year, with scaffold thrombosis (ST) as a secondary endpoint. Clinical follow-up was scheduled at 30 days, 6, 12, and 24 months. A total of 367 patients with 417 lesions were included (median age 59 years; 83% male; 17.2% had diabetes; 48% ACS). The median lesion length was 20 mm, with a median reference vessel diameter of 3.2 mm; 49% of lesions were type B2/C, 16% involved bifurcations, and 37% were located in the proximal LAD. Adherence to the “4P” rule—proper patient selection, scaffold sizing, pre-dilation (93%), and post-dilation (97%)—resulted in procedural and device success rates of 100% and 99%, respectively, with no adverse events reported at 30 days. The 12-month TLF was 5.0% [95% confidence interval, CI 2.7% to 7.3%]: 1.7% myocardial infarction; 4.7% clinically driven target lesion revascularization. ST was 0.6% up to 12 months. In conclusion, the IT-MASTERS registry confirms that the Magmaris RMS is safe and effective in a highly selected population with low rates of TLF and ST at 12 months.