Author + information
- Alexandre Abizaid1,
- Carrie Didier2,
- Norbert Frey3,
- Matthias Lutz4,
- Joachim Weber-Albers5,
- Darius Dudek6,
- Bernard Chevalier7,
- Alexandra Lansky8 and
- Jeffrey Anderson9
- 1Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil
- 2CHU Rangueil, Toulouse, France
- 3Department of Internal Medicine III, Cardiology and Angiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
- 4Department of Cardiology and Angiology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany
- 5St.- Johannes-Hospital, Dortmund, Germany
- 6Szpital Uniwersytecki w Krakowie, Krakow, Poland
- 7Institut Hospitalier J. Cartier, Massy, France
- 8Yale School of Medicine, New Haven, Connecticut, United States
- 9REVA Medical, San Diego, California, United States
Bioresorbable vascular scaffolds ( BRS ) have been developed to provide temporary mechanical support for the healing artery subsequent to PCI . The Fantom® scaffold (REVA Medical) is a sirolimus-eluting BRS, which is made from a unique radiopaque polymer. It includes incorporation of covalently bound iodine into the polymer backbone, which allows the device to be directly visualized using conventional angiography as with metal stents.
The FANTOM II Study is a prospective, multi-center, safety and performance evaluation. 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 was to demonstrate the safety and performance of native coronary artery stenting by assessing the incidence of Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months. In addition to the primary objective, the FANTOM II Trial included two groups of long term imaging sub-study patients. In the Cohort A study group up to 25 patients who received imaging at baseline and 6 months’ post implant were scheduled to return for an additional imaging assessment at 24 months and in the Cohort B study group up to 25 patients were scheduled to return for an additional imaging assessment at 48 months.
The FANTOM II Study enrolled a total of 240 patients across 28 clinical centers. The Cohort A group included a total of 117 patients and the Cohort B group included 123 patients. All patients enrolled in the study have completed the required follow-up through the 12-month clinical endpoint and many of the patients are now beyond the 24-month clinical follow-up endpoint. The primary safety endpoint of MACE at 6 months was 2.1%. The secondary safety endpoint of MACE at 12 months was 4.2%. The preliminary results from both the clinical follow-up at 24 months and the imaging sub-study of up to 25 patients which included both angiographic and OCT assessments will be presented at the conference.
The results continue to be encouraging and confirm the initial safety and performance outcomes of the Fantom scaffold. Patient follow-up is ongoing through 5 years.
CORONARY: Bioresorbable Vascular Scaffolds