A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study
Authors' conclusion
Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES.
Study context
- Population
- Patients with de novo coronary lesions
- Participants
- 116 patients117 lesions
- Outcome
- In-scaffold late lumen loss
- Follow-up
- 12 months
Methodological detailsmulticentre, single-group, Clinical and imaging follow-up at 6 and 12 months; clinical follow-up continues for 5 years
- Multicentre
- Single-group
- Clinical and imaging follow-up at 6 and 12 months; clinical follow-up continues for 5 years
Main finding
As reported in the abstract
In-scaffold late lumen loss, mean±SD
0.24±0.36 mm
In-scaffold late lumen loss, median (IQR)
0.19
0.06–0.36
Observational data: associations, not effects.
Further findings
Minimum lumen area · 12 months
- Minimum lumen area by intravascular ultrasound
- 4.95±2.24 mm²
- Minimum lumen area by optical coherence tomography
- 4.68±2.32 mm²
Cardiac death, target vessel MI, definite or probable scaffold thrombosis · 12 months
- Cardiac death, target vessel MI and definite or probable scaffold thrombosis absent
Safety
Target lesion failure · 12 months
- Target lesion failures
- 3
- Target lesion failure rate
- 2.6% (95% CI 0.9-7.9)
- All clinically driven target lesion revascularisations
Original publication
A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention. Published 7 August 2023. doi:10.
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