The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study
EuroIntervention 2018;14:e1215-e1223 published online September 2018 published online e-edition December 2018. DOI: 10.4244/EIJ-D-18-00491
Laurens J.C. van Zandvoort1, BSc; Dariusz Dudek2, MD, PhD; Joachim Weber-Albers3, MD; Alexandre Abizaid4, MD, PhD; Evald H. Christiansen5, MD, PhD; David W.M. Muller6, MD, FRACP, FACC; Janusz Kochman7, MD; Łukasz Kołtowski7, BA, MD, PhD; Jens Flensted Lassen8, MD, PhD, FESC; Roman Wojdyla9, MD; Joanna J. Wykrzykowska10, MD, PhD; Yoshinobu Onuma1,11, MD, PhD; Joost Daemen1*, MD, PhD
1. Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands; 2. Department of Cardiology, University Hospital, Kraków, Poland; 3. Cardiac Research GmbH, St.-Johannes-Hospital, Dortmund, Germany; 4. Dante Pazzanese Cardiology Institute, São Paulo, Brazil; 5. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; 6. Department of Cardiology, St Vincent’s Hospital, Sydney, Australia; 7. 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 8. Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen, Denmark; 9. Department of Cardiology, St. Raphael Hospital, Kraków, Poland; 10. Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands; 11. Clinical Core Laboratory, Cardialysis, Rotterdam, the Netherlands
Aims: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings.
Methods and results: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months).
Conclusions: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.