Clinical safety and performance of the third-generation Fantom Encore sirolimus-eluting bioresorbable scaffold: Insights from a single-center study.

Abstract

Background: The third-generation Fantom Encore bioresorbable scaffold (BRS), made with Tyrocore polymer, features full radiopacity, 95-115 μm strut thickness, and high expansion capacity. Currently, there is a lack of real-world data on this device.

Methods and results: We conducted a retrospective, single-center study involving 28 elective patients undergoing percutaneous coronary intervention (PCI) for 43 de novo coronary lesions with implantation of the Fantom Encore BRS. Mean age was 66.6 ± 8.5 years (male 82.1 %). Number of target lesions/patient was 1.54 ± 0.99, and 89.3 % of patients had single-vessel disease; most lesions were type C (58.1 %). Number of BRS/lesion was 1.02 ± 0.15, with a mean maximum scaffold diameter/lesion of 3.39 ± 0.41 mm and a mean scaffold length/lesion of 24.8 ± 8.17 mm. Plaque debulking was necessary in 32.6 % of lesions and IVUS was employed in 74.4 % of lesions. Acute technical success was achieved in 97.7 % of cases. Clinical follow-up was available in 96.4 % of cases. At a median of 18 months (range: 9-31 months) no patient experienced major adverse cardiovascular events (MACE); notably, no scaffold thrombosis was reported. Angiographic follow-up was performed in 50 % of patients at a median of 17 months (range: 6-35), with no documented cases of target lesion failure.

Conclusion: Fantom Encore BRS shows good potential in delivering safe and effective PCI outcomes in patients with stable coronary artery disease, including those with complex coronary lesions.