The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months.

Abstract

Background: Third-generation resorbable magnesium scaffold (RMS) was developed with stronger mechanical properties and thinner struts compared to its predecessor. This study aimed to assess the influence of the OCT-derived underlying plaque characteristics on in-scaffold late lumen loss (LLL) in patients treated with RMS up to 12-months.

Methods: Patients enrolled in the BIOMAG-I trial and who underwent OCT imaging before and after the index procedure were included in the current analysis. The acquired intravascular imaging data were evaluated to assess the presence of fibrous, calcific, or lipidic lesions. We calculated the proportions of each plaque feature per pullback and assessed their correlation with LLL obtained at 6- and 12-months follow-up. In addition, we investigated the potential impact of scaffold edge dissection and strut malapposition on in-scaffold LLL.

Results: Eighty-four patients and 84 lesions were evaluated in the current analysis. There was no significant correlation between the underlying plaque characteristic and in-scaffold LLL at 6-months (p = 0.79 for fibrous, p = 0.88 for calcific, p = 0.67 for lipid lesions). This trend was similar at 12 months follow-up (p = 0.56 for fibrous, p = 0.75 for calcific, p = 0.69 for lipid lesions). The presence or absence of edge dissection did not influence the degree of in-scaffold - (p = 0.51 at 6-months, p = 0.68 at 12-months follow-up) or in-segment LLL (p = 0.88 at 6-months, p = 0.70 at 12-months follow-up).

Conclusion: The underlying plaque characteristics, edge dissection or strut malapposition had no significant impact on in-scaffold LLL following DREAMS 3 G implantation up to 12 months. This suggests better device performance irrespective of the underlying plaque characteristics.

Trial registration: ClinicalTrials.gov ID: NCT04157153.