EuroPCR 2023: One-year BIOMAG-I results demonstrate safety and efficacy of resorbable scaffold platform

Magnesium resorbable scaffold

Results of the first-in-human study BIOMAG-I study, assessing Biotronik’s latest-generation Dreams 3G resorbable magnesium scaffold (RMS) showed significantly lower in-scaffold late lumen loss (LLL) than its predecessor at 12 months as well as excellent safety and efficacy.

Michael Haude (Rheinland Klinikum, Neuss, Germany), BIOMAG-I coordinating clinical investigator, presented the latest results in the late breaking trial session at EuroPCR 2023 (16 – 19 May, Paris, France).

At one-year follow-up, BIOMAG-I data confirmed the excellent safety profile of Dreams 3G RMS with a low target lesion failure rate of 2.6%. Neither cardiac death, myocardial infarction, nor scaffold thrombosis was reported. After completion of the resorption, the in-scaffold LLL was 0.24±0.36mm, comparable to contemporary drug-eluting stents (DESs).

“At the end of the scaffold resorption, at 12 months the data showed, that the Dreams 3G scaffold has an excellent safety and efficacy profile,” said Haude. “The late lumen loss is not just 38% better than the predecessor but also on a level of a contemporary DES making it a valuable alternative to DES.”

The prospective BIOMAG-I clinical trial assesses the angiographic, clinical and safety performance of Dreams 3G RMS of 116 patients with single de novo lesions in up to two coronary arteries. A total of 14 clinics in eight European countries are taking part. Twenty percent of the patients presented with non-ST-elevation myocardial infarction (NSTEMI) and more than 75% with B2/C lesions. The ‘4P’-protocol for RMS implantation—patient selection, adequate pre-dilatation, proper sizing and adequate post-dilatation—was adhered to.

Bioresorbable scaffolds have been developed to provide initial ‘stent-like’ mechanical support to the vessel but thereafter disappear and thus prevent long-term stent-related adverse events.

The BIOMAG-I 12-month-results were simultaneously published in EuroIntervention.


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