Name of the Study: Results of the Magnesium BRS in complex lesions: data from the IT-MASTERS Registry

Published in Congress: Euro PCR 2024

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 Dr. Ömer Kümet

 Background:
Magmaris (Biotronic) resorbable magnesium scaffold (RMS) with high radial force, low thrombogenicity, and complete resorption at 12 months has been investigated in multiple studies, showing a good long-term safety and efficacy profile. There are not enough studies on the effectiveness of RMS in complex lesions.

Objective:
The IT-Masters registry aimed to evaluate the procedural and clinical performance of the RMS Magmaris in more complex lesions.

Methods:
The IT-Masters Registry is a multicenter, prospective, observational registry including patients with the following angiographic indications: 1) multivessel up to 3 lesions to be treated with Magmaris; or 2) single long lesion >20 mm (<25 mm to cover with one long 25 mm device). Follow-up is scheduled at 30 days and 6,12 and 24 months. The primary endpoint is the target lesion failure (TLF) as composite of cardiac death, non-fatal MI, urgent CABG, clinically-driven target lesion revascularization (TLR) at 12 months.

Results:
359 patients enrolled in 21 clinical sites in Italy. 409 lesions were treated with Magmaris resorbable magnesium metallic scaffold. Clinical follow-up at 30 days was 100% (n=359) and 84% at 12 months (n=303). Median age was 60±10 years, most patients were male (82%, n=296), and 18% (n=63) had diabetes. 4.2% (n=15) of patiens had renal failure and 133 of patients (37%) had >3 cardiovascular risk factors. Clinical presentations were acute coronary syndrome in 48% (70% NSTEMI), stable angina in 29%, and silent ischemia in 23% of patients. 44 of patients had 2 or more lesions (12%). Treated lesions had a median length of 19.5±5.2 mm with a reference vessel diameter of 3.23±0.33 mm. Lesions were complex (type B2/C) in 49% of cases. None of cases had severe calcifications and 17% were bifurcation lesions that treated with one scaffold. Target lesion locations were 57%, 24% and 19% for LAD, RCA and LCx respectively. Compliance with the 4P’s strategy was high with patients and lesions selected according to scaffold indications (100%), and pre-dilation and post-dilatation was performed in 93% and 97% of lesions, respectively. Before the procedure, coronary imaging was performed with IVUS in 21% of the patients and with OCT in 28%. After post-dilatation, IVUS was performed in 20% of the patients and OCT was performed in 27% of the patients. Procedural success was 100%, and device success was 99%. No adverse events were observed to 30 days. The TLF at 12 months was 4.3% (95% CI: 2%-6.6%); 1.3% target-vessel myocardial infarction and 4.0% clinically driven target lesion revascularization (TLR). None of the patients died of cardiac cause. Scaffold thrombosis occurred in only 2 patient (0.7%) in up to 12 months.

Conclusion:
Preliminary data of the IT-Masters registry showed good procedural and clinical performance of the Magmaris scaffold in complex lesions, with a low 12-month TLF rate.

Interpretations:
IT-MASTERS results confirm 12 months efficacy and safety of Resorbable Mg scaffold observed in BIOSOLVE-IV study, but in more complex lesion settings. Particularly, TLF 4.3% and Scaffold Thrombosis 0.7% at 12 months, are comparable with second generation DES, despite of selected lesion/population. New resorbable Mg Scaffold Freesolve (with new alloy Mg+Al; longer scaffolding time; more visible markers and thinner struts with larger portfolio) that showed increased performance in terms of LLL than Magmaris, will replace for the future. Freesolve will be compared with DES in the upcoming BIOMAG-II RCT study.