Author + information
- Georgios Bouras1,
- Alexandre Abizaid2,
- Didier Carrie3,
- Norbert Frey4,
- Matthias Lutz5,
- Joachim Weber-Albers6,
- Darius Dudek7,
- Bernard Chevalier8,
- Ecaterina Cristea1 and
- Alexandra Lansky1
- 1Yale School of Medicine, New Haven, Connecticut, United States
- 2Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil
- 3Chu Rangueil, Toulouse, France
- 4Department of Internal Medicine III, Cardiology and Angiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
- 5Department of Cardiology and Angiology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany
- 6St.- Johannes-Hospital, Dortmund, Germany
- 7Szpital Uniwersytecki w Krakowie, Krakow, Poland
- 8Institut Hospitalier J. Cartier, Massy, France
Fully bioresorbable coronary scaffolds are designed to overcome the limitations of metallic stents. Potential benefits include restoration of endothelial function and vasomotion, complete resorption over time and no side branch jailing. The sirolimus-eluting bioresorbable FANTOM scaffold is visible under x-ray, and designed to maintain structural integrity for 3 months before degrading over time. This study is designed to demonstrate the safety and efficacy of the FANTOM scaffold in the treatment of native coronary arteries.
This prospective, multi-center study enrolled patients with clinical evidence of myocardial ischemia and de novo lesions in 2.5 to 3.5 mm vessels. Angiographic and IVUS or OCT was planned at 6 months in Cohort A and 9 months in cohort B. Independent core laboratories reviewed all imaging.
A total of 240 patients (117 Cohort A and 123 Cohort B) were enrolled in 28 centers. Patients were 70.4% male with mean age of 62.7±10.1 years and 23.8% with diabetes. Mean vessel diameter was 2.71 ± 0.37 mm, lesion length 11.56 ± 3.89 mm, acute gain 1.68 ± 0.41 mm and late lumen loss (LLL) 0.25 ± 0.40 mm for Cohort A and 0.33 ± 0.36 mm for Cohort B, respectively. IVUS and OCT will be presented. Acute technical success (successful implantation of the scaffold without device related complications) was 95.8% and acute procedural success (acute technical success with no in-hospital major adverse cardiac events (MACE) and residual DS% <50%) was 99.1%. At 30-days clinical success, defined as acute procedural success with no MACE at 30 days was 99.6%. At 12 months MACE was 4.2% and included a single stent thrombosis (ARC defined). Clinically driven target lesion revascularization (TLR) was 2.5%
Based on the results of this registry, the FANTOM scaffold appears safe, is associated with a low LLL and very low target lesion revascularization at 12 months. A randomized clinical trial is planned to confirm these results.
CORONARY: Bioresorbable Vascular Scaffolds