FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold: first report on initial 48-month outcomes

ABSTRACT

BACKGROUND: Bioresorbable vascular scaffolds (BRS) provide temporary mechanical support and may help restore normal vessel reactivity, positive remodeling, and reduce chronic inflammation. The Fantom scaffold (REVA Medical) is a sirolimus-eluting BRS, with a TyroCoreTM radiopaque tyrosine analog polymer. METHODS: FANTOM II is a prospective, multi-center, safety and performance study of patients with myocardial ischemia or a positive functional study. The study included patients with single de novo lesions in native coronary vessels ranging in diameter from 2.5 to 3.5 mm and lesion lengths up to 20 mm. The primary objective of the study is to demonstrate safety and performance of the Fantom sirolimus-eluting bioresorbable scaffold by assessing the incidence of Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months. RESULTS: FANTOM II enrolled 240 patients across 28 clinical centers in 8 countries. Two separate sequential cohorts followed patients with a 6-month (Cohort A, N=117) versus 9-month (Cohort B, N=123) angiographic assessment. A sub-set of Cohort A patients, returned for serial angiographic follow-up at 24-month. We report 24-month adjudicated clinical endpoints. Acute technical success, acute procedural success, and clinical procedural success were 95.8%, 99.1% and 99.6%, respectively. The primary safety endpoint of MACE at 24 months was 5.0%. Late Lumen Loss at 6 months in the Cohort A was 0.25 ± 0.35mm In-Scaffold and 0.17 ± 0.29mm In-Segment. At 24-months the subset of Cohort A patients (n=36) demonstrated stable late lumen loss values of 0.23 ± 0.49mm In-Scaffold and 0.21 ± 0.49mm In-Segment. CONCLUSION: FANTOM II demonstrates safe and stable performance of the REVA BRS at 24-months. (AU)