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Original research article
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
  1. Jo Krogsgaard Simonsen1,
  2. Emil Nielsen Holck1,
  3. Didier Carrié2,
  4. Norbert Frey3,
  5. Matthias Lutz3,
  6. Joachim Weber-Albers4,
  7. Dariusz Dudek5,
  8. Bernard Chevalier6,
  9. Joost Daemen7,
  10. Jouke Dijkstra8,
  11. Camilla Fox Maule1,
  12. Omeed Neghabat1,
  13. Jens Flensted Lassen9,
  14. Jeffrey Anderson10,
  15. Evald Høj Christiansen1,
  16. Alexandre Abizaid11 and
  17. Niels Ramsing Holm1
  1. 1 Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
  2. 2 Department of Cardiology, University Hospital Rangueil, Toulouse, France
  3. 3 Department of Cardiology and Angiology, University Medical Center Schleswig-Holstein, Kiel, Germany
  4. 4 St. Johannes-Hospital, Dortmund, Germany
  5. 5 Institute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland
  6. 6 Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France
  7. 7 Department of Cardiology, Erasmus Universiteit Rotterdam, Rotterdam, Netherlands
  8. 8 Division of Image Processing, Leiden University Medical Center, Leiden, Netherlands
  9. 9 The Heart Center, Rigshospitalet, Copenhagen, Denmark
  10. 10 REVA Medical Inc, San Diego, USA
  11. 11 Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil
  1. Correspondence to Dr Niels Ramsing Holm ; niels.holm{at}clin.au.dk

Abstract

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.

  • bioresorbable scaffold
  • coronary artery
  • optical coherence tomography

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JS: study design, OCT analysis, data analysis, drafting manuscript, interpretation; direct access to all data. EH: study design, study management, OCT analysis, interpretation; critical revision; direct access to all data. DC, NF, JW-A, DD, BC, JDa: patient enrolment, interpretation, critical revisions. ML: design, patient enrolment, interpretation, critical revisions. JDi: analysis design, OCT analysis, interpretation, critical revision. CFM: OCT analysis, interpretation, critical revision. ON: analysis design, OCT analysis, interpretation, critical revision. JL: analysis design, national coordinator, OCT analysis, interpretation, critical revision. JA: study design, study setup, study management, critical revision. EHC: study design, patient enrolment, interpretation, critical revision. AA: study design, patient enrolment, interpretation, critical revision. NRH: study design, OCT analysis, data analysis, interpretation, drafting of manuscript; direct access to all data; final responsibility.

  • Funding This article was funded by REVA Medical Inc., San Diego, USA.

  • Competing interests JKS received travel grants from St. Jude Medical, and institutional research grant from Reva Medical. AA received consulting fees and research grants from Reva Medical. NRH has received institutional research grants from Abbott, Boston Scientific, Reva Medical and Elixir, and speaker fees from Abbott, Reva Medical and Biotronik. EHC has received institutional research grant from Abbott, Biotronik, OrbusNiech, Reva Medical and Elixir, and speaker fees from Abbott and Terumo. Allother authors report no disclosures.

  • Patient consent for publication Obtained.

  • Ethics approval The study was approved by national health authorities and local or national medical ethics committees as appropriate

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Undecided.

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