FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold: first report: final 5-year clinical outcomes
Lutz, Matthias; Anderson, Jeffrey; Chevalier, Bernard; Carrie, Didier; Muller, David; Abizaid, Alexandre.
J. Am. Coll. Cardiol
; 77(14 suppl. s): B5-B5, Apr., 2021.
Artigo
Inglês
| CONASS, SES-SP, SES SP - Instituto Dante Pazzanese de Cardiologia, SES-SP | ID: biblio-1343555
BACKGROUND The primary objective of the FANTOM II study was to evaluate the safety and performance of native coronary artery stent ing using the Fantom sirolimus-eluting bioresorbable coronary scaf fold (Tyrocore, Reva Medical LLC) by assessing the incidence of major adverse cardiac events (MACE) and late lumen loss. The Fantom scaffold is a fully resorbable scaffold, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine ana logs. Fantom is completely radiopaque and is composed of thin struts (125 microns) 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 diameter and lesion length 20 mm. MACE through 48 months of follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n » 117) and 9 months (n » 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 procedural 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 respec tively. Patient follow-up is now complete through the planned 60- month endpoint. Adjudication of all events is in process and final clinical outcomes through 60 months will be reported for the first time at the Transcatheter Cardiovascular Therapeutics (TCT) conference. CONCLUSION The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness perfor mance at 5 years of follow-up. Longer-term follow-up in real-world clinical post-market evaluations is ongoing to examine the late out comes with this novel device.
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BR79.1
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