Journal Article

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

Carrié, Didier, Dijkstra, Jouke, Holck, Emil Nielsen, Simonsen, Jo Krogsgaard, Abizaid, Alexandre, Frey, Norbert, Christiansen, Evald Høj, Dudek, Dariusz, Fox Maule, Camilla, Weber-Albers, Joachim, Neghabat, Omeed, Lutz, Matthias, Anderson, Jeffrey, Chevalier, Bernard, Daemen, Joost, Lassen, Jens Flensted, Holm, Niels Ramsing

2019

Overview

ObjectivesWe aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).BackgroundThe Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.Methods and resultsFANTOM 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±1.7 mm2 and 5.7±1.4 mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm2 and 5.6±1.4 mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm2 at baseline to 7.2±1.4 mm2 at 6 months (p=0.12), and from 7.4±1.5 mm2 to 7.3±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.ConclusionsThe 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.

• Publisher: British Cardiovascular Society,BMJ,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Angina pectoris / bioresorbable scaffold / coronary artery / Coronary vessels / Diseases of the circulatory (Cardiovascular) system / EMC COEUR-09 / Heart attacks / Interventional Cardiology / Iodine / Ischemia / Medical imaging / optical coherence tomography / Polymers / Population / RC666-701 / Stents / Thrombosis / Veins & arteries