Aims: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom siroli-mus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings. Methods and results: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months). Conclusions: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

Additional Metadata
Keywords Bioresorbable scaffolds, Intravascular ultrasound, Stable angina
Persistent URL dx.doi.org/10.4244/EIJ-D-18-00491, hdl.handle.net/1765/113374
Journal EuroIntervention
Citation
Van Zandvoort, L, Dudek, D, Weber-Albers, J. (Joachim), Abizaid, A.C, Christiansen, E.H, Muller, D.W.M. (David W.M.), … Daemen, J. (2018). Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: The FANTOM II study. EuroIntervention, 14(11), E1215–E1223. doi:10.4244/EIJ-D-18-00491