A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.
Journal
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
ISSN: 1969-6213
Titre abrégé: EuroIntervention
Pays: France
ID NLM: 101251040
Informations de publication
Date de publication:
07 Aug 2023
07 Aug 2023
Historique:
pmc-release:
07
08
2024
medline:
8
8
2023
pubmed:
19
6
2023
entrez:
19
6
2023
Statut:
epublish
Résumé
The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES). The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold. This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years. A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent. 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. gov: NCT04157153.
Sections du résumé
BACKGROUND
BACKGROUND
The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES).
AIMS
OBJECTIVE
The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold.
METHODS
METHODS
This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years.
RESULTS
RESULTS
A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent.
CONCLUSIONS
CONCLUSIONS
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.
CLINICALTRIALS
RESULTS
gov: NCT04157153.
Identifiants
pubmed: 37334655
pii: EIJ-D-23-00326
doi: 10.4244/EIJ-D-23-00326
pmc: PMC10397670
pii:
doi:
Substances chimiques
Magnesium
I38ZP9992A
Banques de données
ClinicalTrials.gov
['NCT04157153']
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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