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.