Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating.

ABSTRACT

OBJECTIVES: The STEALTH (STent Eluting A9 BioLimus Trial in Humans) trial was the first-in-man study to assess the safety and efficacy of the bioabsorbable-polymer-coated Biolimus A9-eluting BioMATRIX-Stent, as compared to a bare metal stent control (S-Stent). METHODS: One hundred twenty patients were enrolled in a prospective, 21 randomised, double-blind, multi-center clinical study. Patients with single de novo coronary lesions received either a Biolimus-eluting stent (n=80 patients with 82 lesions) or bare metal control stent (n=40 patients with 40 lesions). The primary study endpoint was in-lesion late lumen loss at 6 month follow-up. RESULTS: The six month in-lesion late loss was significantly reduced in the Biolimus-eluting stent group (0.14 +/- 0.45mm) as compared to the control (0.40 +/- 0.41mm) (p=0.004). The in-stent late loss was 0.26 +/- 0.43mm in the Biolimus-eluting stent group vs. 0.74 +/- 0.45mm in the control (p<0.001). The secondary study endpoint of event-free survival at 6-months was similar in both groups (96.3% Biolimus group vs. 97.5% control; p=0.72). There was no significant difference in target lesion revascularizations due to the low binary restenosis rates in both groups (3.9% in Biolimus group vs. 7.7% in control; p=ns). CONCLUSIONS: In this first-in-man feasibility trial, the bioabsorbable-polymer-coated Biolimus A9-eluting stent demonstrated superior efficacy in reducing 6-month in-stent and in-lesion late loss and percent diameter stenosis, with clinical safety similar to bare metal control stents.