FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffolddfirst report: 4-year clinical outcomes
J. Am. Coll. Cardiol; 76 (17 suppl. b), 2020
Ano de publicação: 2020
BACKGROUND The primary objective of the FANTOM II (Safety and Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold) was to evaluate the safety and performance of native coronary artery stenting using the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold by assessing the incidence of major adverse cardiac events and late lumen loss. The Fantom scaffold is a fully resorbable scaffold (Tyrocore, REVA Medical) that is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque and is composed of thin struts (125 mm) that facilitate device delivery and precise target lesion treatment. METHODS The FANTOM II study is a prospective, multicenter trial that enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm and lesion length 20 mm. Major adverse cardiac events through 48-month follow-up were assessed. Angiographic follow-up was performed in consecutive pa tient cohorts at 6 months (n ¼ 117) and 9 months (n ¼ 123). Additional angiographic and optical coherence tomography serial imaging has been performed in a subset of patients at 24 months. RESULTS Acute delivery success, acute technical success, acute pro cedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235 of 240), 95.8% (230 of 240), 99.1% (228 of 230), and 99.6% (227 of 228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25 0.40 mm and 0.33 0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Patient follow-up is now complete through 48 months. Adjudication of all events is in process, and final clinical outcomes through 48 months will be re ported for the first time at the Transcatheter Cardiovascular Thera peutics 2020 annual meeting. CONCLUSION The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness perfor mance at 4 years of follow-up. Longer-term follow-up through 5 years is ongoing to examine the late outcomes with this novel device.