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

Abstract

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).

Keywords: bioresorbable scaffold(s); coronary artery disease; noninferiority trial.