A Randomized Comparison of Bioheart Sirolimus-Eluting Bioresorbable Scaffold and Everolimus-Eluting Stents: The BIOHEART-II Trial.

Background: First-generation bioresorbable scaffolds (BRS) increased risks of stent thrombosis and adverse events. The Bioheart scaffold is a new poly-L-lactic acid-based BRS.
Objectives: This study sought to evaluate the efficacy and safety of the BRS in patients with coronary artery disease.
Methods: This was a prospective, multicenter, randomized, noninferiority trial comparing the Bioheart BRS with a cobalt-chromium everolimus-eluting stent (CoCr-EES) in patients with coronary artery disease. Angiography was planned at 12 months in all patients. The primary endpoint was 12-month in-segment late loss. The key secondary endpoint was the 12-month proportion of covered struts assessed on optical coherence tomography. Three-year clinical follow-up was completed.
Results: A total of 434 patients from 22 Chinese sites were included (Bioheart BRS, n =218; CoCr-EES, n = 216). One-year in-segment late loss was 0.17 ± 0.38 mm with the Bioheart BRS vs 0.14 ± 0.24 mm with CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.10 mm (P for noninferiority < 0.0001). The proportion of covered struts was 97.9% in the Bioheart BRS and 98.5% in the CoCr-EES (difference 0.02%; 95% CI: -0.3% to 0.26%; P for noninferiority < 0.0001; P for superiority = 0.91). Clinical outcomes at 3 years were similar in the 2 groups, as were the rates of target lesion failure (5.6% vs 5.2%; P = 0.84).
Conclusions: In this multicenter randomized trial, the Bioheart BRS was noninferior to the CoCr-EES for 1-year in-segment late loss, and resulted in a comparable 3-year clinical outcome. (Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study; NCT03284255).
Competing Interests: Funding Support and Author Disclosures The study was sponsored by Bioheart Biological Technology (Shanghai, China). The sponsor had no role in data collection, data analysis, data interpretation, writing of the manuscript, or the decision to submit the manuscript for publication. There was no funding of grants, contracts, and other forms of financial support. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)