Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

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  • Jo Krogsgaard Simonsen
  • ,
  • Emil Nielsen Holck
  • Didier Carrié, Department of Cardiology, Rangueil University Hospital, Toulouse, France (N.B.).
  • ,
  • Norbert Frey, Department of Cardiology and Angiology, University Medical Center Schleswig-Holstein, Kiel, Germany.
  • ,
  • Matthias Lutz, Department of Cardiology and Angiology, University Medical Center Schleswig-Holstein, Kiel, Germany.
  • ,
  • Joachim Weber-Albers, St. Johannes-Hospital, Dortmund, Germany.
  • ,
  • Dariusz Dudek, Institute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland.
  • ,
  • Bernard Chevalier, Department of Interventional Cardiology, Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Massy, France (T.L.).
  • ,
  • Joost Daemen, Department of Cardiology, Erasmus Universiteit Rotterdam, Rotterdam, Netherlands.
  • ,
  • Jouke Dijkstra, Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.
  • ,
  • Camilla Fox Maule
  • Omeed Neghabat
  • Jens Flensted Lassen
  • Jeffrey Anderson, REVA Medical Inc, San Diego, USA.
  • ,
  • Evald Høj Christiansen
  • ,
  • Alexandre Abizaid, Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
  • ,
  • Niels Ramsing Holm

Objectives: We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).

Background: The Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.

Methods and results: FANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm2 and 5.7±1.4 mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm2 and 5.6±1.4 mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm2 at baseline to 7.2±1.4 mm2 at 6 months (p=0.12), and from 7.4±1.5 mm2 to 7.3±1.4 mm2 at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months.

Conclusions: The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.

Original languageEnglish
JournalOpen heart
Volume6
Issue1
Pages (from-to)e000941
ISSN2053-3624
DOIs
Publication statusPublished - 2019

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