New resorbable magnesium scaffold promising for coronary lesions: BIOMAG-1 first-in-human study

The study was designed as a multicentre, prospective, first-in-human study with clinical and imaging follow-ups scheduled at 6 and 12 months. The clinical follow-up will continue for five years. The researchers enrolled 116 patients (mean age 61 years; 77.8% male) with 117 lesions, with documented silent ischemia, stable or unstable angina, or hemodynamically stable NSTEMI. Most lesions were classified as type B2/C, and just 2.6% were considered moderately or severely calcified.

The study led to the following findings:

• At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm.
• 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 (2.6%) were reported, 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 revealed that the third-generation bioresorbable magnesium scaffold is clinically effective and effective, making it a possible alternative to DES," the researchers concluded.

Reference:

The study, "A new resorbable magnesium scaffold for de novo coronary lesions, the DREAMS 3G: one-year results of the BIOMAG-1 first-in-human study," was published in EuroIntervention.

DOI: 10.4244/EIJ-D-23-00326