Masaru Seguchi; Alp Aytekin; Erion Xhepa; Michael Haude; Adrian Wlodarczak; René van der Schaaf; Jan Torzewski; Bert Ferdinande; Javier Escaned; Juan Iglesias; Johan Bennett; Gabor Toth; Ralph Toelg; Marcus Wiemer; Göran Olivecrona; Paul Vermeersch; Ron Waksman; Hector Garcia-Garcia; Michael Joner

doi:10.4244/EIJ-D-24-00055

Vascular response following implantation of the third-generation drug-eluting resorbable coronary magnesium scaffold: an intravascular imaging analysis of the BIOMAG-I first-in-human study

Masaru Seguchi¹, MD, PhD; Alp Aytekin¹, MD, PhD; Erion Xhepa¹, MD, PhD; Michael Haude², MD, PhD; Adrian Wlodarczak³, MD; René J. van der Schaaf⁴, MD, PhD; Jan Torzewski⁵, MD, MPhil; Bert Ferdinande⁶, MD; Javier Escaned⁷, MD, PhD; Juan F. Iglesias⁸, MD; Johan Bennett⁹, MD, PhD; Gabor G. Toth¹⁰, MD, PhD; Ralph Toelg¹¹^,¹²^,¹³, MD; Marcus Wiemer¹⁴, MD; Göran Olivecrona¹⁵, MD, PhD; Paul Vermeersch¹⁶, MD, PhD; Ron Waksman¹⁷, MD; Hector M. Garcia-Garcia¹⁷, MD, MSc, PhD; Michael Joner¹, MD

Abstract

BACKGROUND: The 12-month outcomes of BIOMAG-I − the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) − showed promising results regarding clinical outcomes and late lumen loss.

AIMS: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns.

METHODS: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing.

RESULTS: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm² to 4.75 mm²; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) − a unique neointimal presentation observed following resorbable magnesium scaffold implantation − was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months.

CONCLUSIONS: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.

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