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
Authors' conclusion
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.
Study context
- Population
- Patients treated with DREAMS 3G in BIOMAG-I with available serial optical coherence tomography (OCT) and intravascular ultrasound (IVUS) dataof 116 enrolled
- Participants
- 56 patients
- Primary endpoint
- Vascular healing by OCT and IVUS: strut visibility, vessel and scaffold areas, neointimal growth patterns
- Follow-up
- Up to 12 months
Methodological detailsserial OCT and IVUS, frame-based analysis
- Serial OCT and IVUS
- Frame-based analysis
Primary result
As reported in the abstract
Struts invisible by OCT
99.0%
Minimum lumen area, post-PCI to 6 months
6.88 mm² to 4.75 mm²
p<0.0001
Protruding neointimal tissue (PNT) observed at 12 months
89.3%
PNT area decrease from 6 to 12 months
47.4%
Original publication
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. EuroIntervention. Published 16 September 2024. doi:10.
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