A randomized trial of iron bioresorbable scaffold compared with XIENCE in coronary artery disease

Published in Congress: Euro PCR 2024

Link: https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2024/EuroPCR/Hotline-new-coronary-devices-DES-BRS-DCB

Dr. Cemalettin Yılmaz

Introduction:
Previous thick-strut (approximately 157 µm) poly-L-lactic acid-based bioresorbable stents were associated with an increased risk of stent thrombosis and myocardial infarction during the resorption period. IBS has sirolimus-eluting, iron-based, bioresorbable, thin-strut scaffold. Preclinical studies have shown that this new device is safe.

Objective:
To evaluate the safety and efficacy of IBS in the treatment of patients with coronary artery disease (CAD).

Methods:
This study is a prospective, multicenter, single-blind, randomized trial. The study compares two different types of stents: the iron-based, sirolimus-eluting bioresorbable scaffold stent (IBS, Biotyx Medical) and the metallic, everolimus-eluting stent (EES) (XIENCE Xpedition, Abbott). A total of 518 patients were randomized into two groups, with 259 patients in each group. The primary endpoint of the study was in-segment late lumen loss (LLL) at 2 years. Clinical follow-up was conducted at 1 month, 6 months, 1 year, and annually up to 5 years, with an additional angiographic follow-up at 2 years.

Results:
At 12-month clinical follow-up, in-segment LLL was found to be 0.21 mm in the EES group and 0.29 mm in the IBS group. Target lesion failure (TLF) was 2.3% for IBS and 2.7% for EES (p=0.78); patient-oriented composite endpoint was 5.0% for IBS and 4.6% for EES (p=0.84); cardiac death was 0% for IBS and 1.2% for EES (p=0.20); target vessel myocardial infarction was 0.4% for IBS and 1.2% for EES (p=0.37); ischemia-driven target lesion revascularization was 1.9% for IBS and 0.4% for EES (p=0.22).

Conclusions:
The 12-month clinical results demonstrate the safety and efficacy of the thin-strut IBS device. The primary endpoint of intraluminal loss at 2 years will be reported next year.

Comment:
This study is the first randomized trial comparing the safety and efficacy of an iron-based bioresorbable scaffold stent with a metallic ESS in patients with CAD. Despite the adverse outcomes associated with the earlier generation of bioresorbable stents, the 1-year results of this study with the new generation bioresorbable stents appear promising. However, we will need to wait for the results to be reported next year for definitive conclusions.