FANTOM II long lesion study: initial safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold in long lesionsdfirst report: 2-year outcomes
J. Am. Coll. Cardiol; 77 (14 suppl. s), 2021
Ano de publicação: 2021
BACKGROUND The primary objective of the FANTOM II Long Lesion study was to evaluate the safety and performance of native coronary artery stenting of lesions 20 mm in length using 1 or more Fantom sirolimus-eluting bioresorbable coronary scaffolds. Fantom is a fully resorbable scaffold, manufactured from TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque, enabling multiple scaffolds to be placed in a precise edge-to-edge configuration, allowing complete coverage of longer target lesions. METHODS The FANTOM II Long Lesion study is a prospective, multicenter trial that enrolled 33 patients with de novo coronary stenosis with reference vessel diameters between 2.5 and 3.5 mm and lesion lengths 20 mm. In this study, all lesions were predilated using a 1:1 noncompliant balloon and then subsequently assessed to determine vessel diameter and lesion length. Once sizing was com plete, between 1 and 3 scaffolds were selected to enable complete target lesion coverage. RESULTS In this study, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 100% (33 of 33) in all cases. Angiographic imaging re sults from for all patients through 6 months of follow-up as well as major adverse cardiac events, target lesion failure, and scaffold thrombosis through 24 months of follow-up will be available in August and reported for the first time at the TCT conference. CONCLUSION As in the Fantom II trial, which was used as a basis for obtaining Conformité Européenne Mark approval, the Fantom siroli mus-eluting bioresorbable coronary scaffold demonstrated favorable initial acute safety in this first cohort of patients with more complex lesions. Longer term follow-up through 5 years is ongoing to examine late outcomes with this novel device.