6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold: The FANTOM II Study

• Published in: JACC. Cardiovascular interventions 2017-09, Vol.10 (18), p.1832-1838
• Main Authors: Abizaid, Alexandre, Carrié, Didier, Frey, Norbert, Lutz, Matthias, Weber-Albers, Joachim, Dudek, Darius, Chevalier, Bernard, Weng, Shu-Chuan, Costa, Ricardo A, Anderson, Jeffrey, Stone, Gregg W
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Angioplasty, Balloon, Coronary - mortality; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Coronary Stenosis - diagnostic imaging; Coronary Stenosis - mortality; Coronary Stenosis - therapy; Female; Humans; Male; Middle Aged; Myocardial Infarction - diagnostic imaging; Myocardial Infarction - etiology; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus - administration & dosage; Sirolimus - adverse effects; Time Factors; Treatment Outcome
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2017.07.033

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months. 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. 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). 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%). 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.