Abstract 2640: Long-Term Clinical Follow-up of Patients with De Novo Coronary Bifurcation Lesions Treated with the Nitinol Self-Expanding Biolimus A9-Eluting “AXXESS” Stent - Results from the Prospective, Multicenter Axxess Plus Trial
Background: The AXXESSTM Plus Biolimus-A9-coated stent (DEVAX, Inc.) is a novel technology developed for coronary bifurcation lesions, based on a nickel-titanium self-expanding conical stent platform that permits deployment across the carina of a bifurcation while providing easy access to the distal the main vessel (MV) concurrent with the ostium of the side branch (SB).
Methods: 136 pts were enrolled at 13 clinical sites. Inclusion criteria were lesions >50% DS within 5mm of a bifurcation in vessels 2.5– 4.0mm in diameter in the MV and ≥2.25mm in the SB.
Results: Procedural success, defined as <50% residual DS of the target lesion without in-hospital MACE (death, MI, or TLR) using any combination of percutaneous devices, was achieved in 94.9% (3 pts had in-hospital MI and 4 pts had final residual DS >50% in the SB). Treatment modality was performed as follow: 19.1% had AXXESS stent only; 27.9% had AXXESS stent + stent in the distal MV; 12.5% had AXXESS stent + stent in the SB only; and the majority (40%) had AXXESS stent + stents in the distal MV and SB. Angiographic FU at 6 months (92.6% of pts) showed 0.09mm in-stent late lumen loss in the AXXESS stent, and in-stent restenosis of 7.1% in the MV and 9.2% in the SB. Short- and mid-term clinical outcomes are shown in the Table⇓.
Conclusions: The AXXESS stent showed safety, feasibility and high procedural success rate in the treatment of bifurcation lesions. At 6 months angiographic follow-up, late lumen loss and restenosis were exceptionally low considering this high risk subset. Complete 1-year clinical follow-up will be presented at the meeting.