@article {Simonsene000941, author = {Jo Krogsgaard Simonsen and Emil Nielsen Holck and Didier Carri{\'e} and Norbert Frey and Matthias Lutz and Joachim Weber-Albers and Dariusz Dudek and Bernard Chevalier and Joost Daemen and Jouke Dijkstra and Camilla Fox Maule and Omeed Neghabat and Jens Flensted Lassen and Jeffrey Anderson and Evald H{\o}j Christiansen and Alexandre Abizaid and Niels Ramsing Holm}, title = {Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study}, volume = {6}, number = {1}, elocation-id = {e000941}, year = {2019}, doi = {10.1136/openhrt-2018-000941}, publisher = {Archives of Disease in childhood}, abstract = {Objectives We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).Background The Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 {\textmu}m, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.Methods and results FANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8{\textpm}1.7 mm2 and 5.7{\textpm}1.4 mm2 at baseline and follow-up (p\<0.0001) and was 7.2{\textpm}1.6 mm2 and 5.6{\textpm}1.4 mm2 in cohort B (p\<0.0001). Mean scaffold area remained stable from 7.1{\textpm}1.5 mm2 at baseline to 7.2{\textpm}1.4 mm2 at 6 months (p=0.12), and from 7.4{\textpm}1.5 mm2 to 7.3{\textpm}1.4 mm2 at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)\% and 1.8 (IQR 0.3;6.0)\% at baseline and was 0.0 (IQR 0.0;0.0)\% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)\% at 6 months and 98.9 (IQR 98.3;100.0)\% at 9 months.Conclusions The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.}, URL = {https://openheart.bmj.com/content/6/1/e000941}, eprint = {https://openheart.bmj.com/content/6/1/e000941.full.pdf}, journal = {Open Heart} }