Long-term safety and effectiveness of the Fantom bioresorbable coronary artery scaffold: final results of the FANTOM II trial

To overcome the long-term limitations of metallic drug-eluting stents (DES), fully bioresorbable scaffolds (BRS) were developed to restore late vasomotion and adaptive remodelling capability, and reduce the risk of late inflammation, late strut fracture and neoatherosclerosis formation, all of which contribute to restenosis and revascularisation failure. The first-generation bioresorbable scaffolds were launched in Europe in 2012; these were characterised by thick struts (>150 μm) and were derived from a poly-L-lactic acid (PLLA) material. Clinical data from the first-generation PLLA BRS demonstrated their potential for favourable long-term outcomes after their complete bioresorption (~3 years). Before 3 years, however, first-generation BRS were shown to be less safe and effective than DES1.

The Fantom BRS (REVA Medical) was developed to address the limitations of the first-generation BRS. The Fantom BRS is manufactured from Tyrocore (REVA Medical), a unique desaminotyrosine-based polymer, which improves both material strength and elasticity while allowing for a reduced strut thickness of the scaffold. The first-generation Fantom BRS used in this study had a uniform strut thickness of 125 μm. The Fantom scaffold has an estimated surface-to-artery ratio of...