AXXESS PLUS Trial Shows Long-Term Safety, Efficacy of Biosensors DES


November 8, 2011

November 8, 2011 — Biosensors International Group Ltd. announced final results of the AXXESS PLUS trial, which demonstrated the long-term efficacy and safety of the Axxess stent for patients with coronary bifurcation lesions. The device is a self-expanding bifurcation stent that releases Biolimus A9 from an abluminal biodegradable polymer coating.

Prof. Eberhard Grube, University Hospital Bonn, Germany, will present the results at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

AXXESS PLUS is a prospective, single-arm multi-center study involving 139 patients at 13 clinical sites in Europe, South America and New Zealand. 117 patients were followed through five years. In addition to Axxess implantation in the proximal parent vessel, conventional stents could be implanted in the distal parent vessel and/or the side branch at the discretion of the operator. In more than 76 percent of cases, the additional stent implanted was sirolimus-eluting; 23 percent were non-sirolimus drug-eluting stents (DES), and less than 1 percent were bare-metal stents (BMS).

Axxess implantations in the parent vessel achieved high levels of procedural and angiographic success (94.9 percent and 100 percent respectively). At five years post-procedure, the cumulative rate of major adverse cardiac events (MACE) was 19.7 percent. MACE is a composite of cardiac death, myocardial infarction (MI), emergent cardiac artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).

The occurrences of the individual components were 3.4 percent for cardiac death, 9.4 percent for MI, and 12.8 percent for clinically driven TLR; there were no incidences of emergent CABG. There were no cases of definite and/or probable very late stent thrombosis (VLST) observed, as defined by ARC.   

"These results confirm that this new dedicated bifurcation DES is both safe and effective in the long term for the treatment of bifurcation lesions," commented Grube. "This is particularly impressive considering that these types of lesion are associated with higher complication and restenosis rates than conventional lesions."

The Axxess bifurcation DES consists of a self-expanding, nitinol (nickel/titanium) stent platform specifically designed to conform to the shape of the bifurcation anatomy. It has been tailored to reconstruct the bifurcation without creating a false carina, lowering the risk of uncovered struts at the flow divider. The device is abluminally coated with a biodegradable polylactic acid (PLA) polymer that releases Biolimus A9, an anti-restenotic drug developed and patented by Biosensors specifically for use with DES.

BA9 is a vital component of the BioMatrix Flex DES system, which has been proven safe and efficacious in the landmark “all-comers” LEADERS study.

Biosensors received CE Mark approval for Axxess in April 2011, supported by the positive nine-month results from the DIVERGE trial. Those results were published in the Journal of the American College of Cardiology (JACC) in March 2009. They demonstrated low overall rates of MACE (7.7 percent), restenosis (0.7 percent) and late stent thrombosis (0.3 percent) in patients treated with Axxess.

Three-year data from the DIVERGE trial, presented at EuroPCR in May 2011, confirmed that low overall rates of MACE (16 percent) and VLST (1 percent) were maintained over the long term.

The device is now available in certain markets in Europe and Asia.  

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