Resorbable scaffolds were developed to provide temporary vessel support, maintaining patency during the healing phase and subsequently dissolving to eliminate long-term complications associated with permanent metallic drug-eluting stents (DES). However, early-generation polymeric scaffolds failed to meet clinical expectations, exhibiting higher event rates than DES. In contrast, magnesium-based scaffolds have emerged as a promising alternative, given that magnesium offers mechanical properties more akin to metallic DES. While earlier iterations demonstrated an excellent safety profile, they fell short in achieving competitive angiographic performance metrics such as low late lumen loss (LLL). The third-generation sirolimus-eluting resorbable magnesium scaffold (DREAMS 3G, commercial name Freesolve [Biotronik]) was developed to address these limitations. Leveraging an enhanced magnesium alloy, DREAMS 3G features thinner struts, increased radial strength, more uniform degradation, and a prolonged scaffolding duration compared to its predecessor. One-year results from the BIOMAG-I study confirmed that the design objectives were met, with a median LLL of 0.19 mm (interquartile range [IQR]: 0.06-0.36)123. Herein, we present the 3-year clinical outcomes, two years after complete scaffold resorption.
BIOMAG-I is a prospective, multicentre, single-arm, first-in-human trial conducted...
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