Five-Year Data Presented for Biosensors' Axxess Bifurcation DES at TCT

November 8, 2011—Biosensors International Group, Ltd. (Singapore) announced that Professor Eberhard Grube, MD, presented final results of the AXXESS PLUS trial at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California. The data demonstrated the long-term efficacy and safety of the company's Axxess self-expanding bifurcation drug-eluting stent (DES) in the treatment of patients with coronary bifurcation lesions.

"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 Professor Grube. "This is particularly impressive considering that these types of lesion are associated with higher complication and restenosis rates than conventional lesions."

According to the company, AXXESS PLUS is a prospective, single-arm multicenter study involving 139 patients at 13 clinical sites in Europe, South America, and New Zealand. There were 117 patients followed-up through 5 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% of cases, the additional stent implanted was sirolimus-eluting; 23% were non-sirolimus drug-eluting stents, and less than 1% were bare-metal stents.

Biosensors stated that Axxess implantations in the parent vessel achieved high levels of procedural and angiographic success (94.9% and 100%, respectively). At 5 years post-procedure, the cumulative rate of major adverse cardiac events—a composite of cardiac death, myocardial infarction, emergent cardiac artery bypass graft, and clinically-driven target lesion revascularization)—was 19.7%. The occurrences of the individual components were 3.4% for cardiac death, 9.4% for myocardial infarction, and 12.8% for clinically driven target lesion revascularization, and no incidences of emergent cardiac artery bypass graft. There were no cases of Academic Research Consortium–defined definite and/or probable very late stent thrombosis observed.

The Axxess bifurcation DES consists of a self-expanding, nitinol stent platform 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 Axxess stent is abluminally coated with a biodegradable polylactic acid polymer that releases the company's Biolimus A9 antirestenotic drug.

Biosensors received CE Mark approval for Axxess in April 2011, supported by the positive 9-month results from the DIVERGE trial, which were published in the Journal of the American College of Cardiology in March 2009 (2009;53:1031–1039). These demonstrated low overall rates of MACE (7.7%), restenosis (0.7%), and late stent thrombosis (0.3%) in patients treated with Axxess.

As reported in Cardiac Interventions Today, 3-year data from the DIVERGE trial, presented at EuroPCR in May 2011, confirmed that low overall rates of major adverse cardiac events (16%) and very late stent thrombosis (1%) were maintained over the long term. The Axxess device is available in certain markets in Europe and Asia, the company advised.