One-year outcomes of bioresorbable magnesium scaffold implantation in complex coronary lesions

Magmaris is a bioresorbable magnesium scaffold that has shown favorable safety and efficacy in the treatment of de-novo coronary lesions.

To report 1-year outcomes after Magmaris implantation in patients with predominantly complex coronary lesions in the Resorbable Magnesium Scaffold registry (RMS) and to compare them with outcomes from patients with mainly non-complex lesions in the BIOSOLVE-IV registry.

The RMS registry is an ongoing, prospective, national, multicenter registry conducted in Germany. Enrollment took place from November 2020 until May 2023 at Cardiovascular Center Oberallgaeu-Kempten, Bavaria, Germany. Follow-up was performed by phone 12 months after index procedure. We report 1-year outcomes of the first 100 consecutively enrolled patients and provide an unadjusted statistical comparison with 1-year outcomes from the BIOSOLVE-IV registry.

RMS patients were older (64.9 ± 8.5 vs. 61.9 ± 10.5 years; p = 0.006) and had a significantly more complex lesion profile (p < 0.001), with higher rates of type B2/C lesions (74.0% vs. 15.1%) and moderate-to-severe calcification (24.0% vs. 7.5%), whereas lesion length was similar between the registries (p = 0.118). At 12 months, target-lesion failure did not differ significantly between RMS and BIOSOLVE-IV (p = 0.885), while scaffold thrombosis was numerically more frequent in RMS (2.0% vs. 0.8%; p = 0.384).

Despite a more complex lesion profile in RMS, no statistically significant differences in 1-year clinical outcomes were observed between the two registries. This analysis is hypothesis-generating though not conclusive. Conclusive analysis can only be provided by a randomized controlled trial.

RMS registry, NCT04679740.