Outcomes of Patients With High-Risk Plaques Treated With a Bioresorbable Magnesium Scaffold: Insights From the BIOMAG-I Study.

BACKGROUND

Early identification and targeted treatment of coronary lesions at higher risk of future events remains a major unmet need in coronary artery disease research. Invasive treatment of such plaques is controversial. The third-generation bioresorbable magnesium scaffold (DREAMS 3G) may provide a valuable alternative, but it has not been evaluated in this setting. The BIOMAG-I study, with comprehensive OCT and IVUS imaging, offers a unique opportunity to investigate high-risk plaque morphology and its vascular response.

AIMS: We aimed to assess the association between lesions with high-risk plaque features treated with the DREAMS 3G scaffold and late lumen loss (LLL) at follow-up.

METHODS

This post-hoc analysis included patients with stable coronary artery disease and high-quality intravascular imaging. High-risk plaque was defined as μFR > 0.80 with PB ≥ 70%. Subgroups were further stratified by the presence of MLA < 4 mm², TCFA < 80 μm, lipid arc >90°, or all combined PB was assessed by IVUS or estimated by OCT when IVUS was unavailable. LLL was measured at 6 and 12 months.

RESULTS

Of 83 patients, 42 (50.6%) met the definition of μFR > 0.80 with PB ≥ 70%. Within this cohort, 41 also had MLA < 4 mm², 23 had TCFA < 80 μm, 16 had lipid arc ≥ 180°, and 16 presented all four features. LLL remained low in the overall PB ≥ 70% group (0.21 ± 0.29 mm at 6 months; 0.27 ± 0.44 mm at 12 months) and was similarly low or even lower across the additional subgroups, including those with all features combined (0.19 ± 0.21 mm and 0.16 ± 0.19 mm).

CONCLUSIONS

In this sub-analysis of the BIOMAG-I trial, the DREAMS 3G bioresorbable magnesium scaffold demonstrated favorable performance, with low LLL and a low rate of clinical outcomes during the resorption period. These findings support DREAMS 3G as a promising "leave-nothing-behind" strategy for selected high-risk plaques, warranting confirmation in larger prospective studies.