Author + information
- Received March 16, 2017
- Revision received July 13, 2017
- Accepted July 14, 2017
- Published online September 18, 2017.
- Alexandre Abizaid, MD, PhDa,∗ (, )
- Didier Carrié, MD, PhDb,
- Norbert Frey, MDc,
- Matthias Lutz, MDc,
- Joachim Weber-Albers, MDd,
- Darius Dudek, MDe,
- Bernard Chevalier, MDf,
- Shu-Chuan Weng, MVM, PhDg,
- Ricardo A. Costa, MD, PhDa,
- Jeffrey Anderson, BSg,
- Gregg W. Stone, MDh,
- on behalf of the FANTOM II Clinical Investigators
- aInstituto Dante Pazzanese de Cardiologia and Hospital Albert Einstein, São Paulo, Brazil
- bCHU Toulouse Rangueil, Toulouse, France
- cUniversitätsklinikum Schleswig-Holstein, Kiel, Germany
- dSt.-Johannes-Hospital, Dortmund, Germany
- eSzpital Uniwersytecki w Krakowie, Krakow, Poland
- fInstitut Hospitalier J. Cartier, Massy, France
- gREVA Medical, San Diego, California
- hColumbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Alexandre Abizaid, Department of Cardiology, Institute Dante Pazzanese of Cardiology, Av. Dr. Dante Pazzanese 500, Ibirapuera, 0401210 Sao Paulo, Brazil.
Objectives The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months.
Background The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment.
Methods The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Results Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%).
Conclusions The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.
This study was funded by REVA Medical Inc. Drs. Abizaid and Stone are consultants to REVA Medical. Dr. Frey has received an honorarium for a presentation for REVA Medical. Dr. Chevalier is a consultant for Abbott Vascular. Dr. Weng and Mr. Anderson are employees of REVA Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 16, 2017.
- Revision received July 13, 2017.
- Accepted July 14, 2017.