AI Article Synopsis

  • The DREAMS 3G is a new coronary magnesium scaffold designed to match the performance of traditional drug-eluting stents (DES).
  • The BIOMAG-I study is a first-in-human trial that evaluates the safety and effectiveness of this scaffold with a follow-up period of up to 5 years.
  • Results showed that after 12 months, the scaffold demonstrated low rates of complications, confirming its safety and efficacy as a potential alternative to DES.

Article Abstract

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: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold.

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: 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: 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: gov: NCT04157153.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10397670PMC
http://dx.doi.org/10.4244/EIJ-D-23-00326DOI Listing

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