News | June 03, 2011

Axxess Self-Expanding Bifurcation Drug-Eluting Stent Safe, Effective at Three Years

June 3, 2011 – New long-term data from the DIVERGE study, presented at EuroPCR 2011, showed that the use of the Axxess drug-eluting stent (DES) for the treatment of complex coronary bifurcation lesions resulted in low levels of both major adverse coronary events (MACE) over a three-year period. Axxess is a self-expanding bifurcation stent that releases Biolimus A9 from an abluminal biodegradable polymer coating.

DIVERGE, a prospective, single-arm, multi-center study of 302 patients with de novo bifurcation lesions across 16 sites in Europe, Australia and New Zealand, is the largest study conducted to date with a DES specifically designed for treating coronary bifurcation lesions. Following implantation of Axxess, the sidebranch treatments were left at the operators’ discretion. Additional conventional sirolimus-eluting stents (SES) were placed in 21.7 percent of the distal parent and/or side branch vessels. In 64.7 percent of the cases, both branches were treated with an additional SES.

At three years post-procedure, the cumulative rate of MACE (a composite of cardiac death, MI and ischemia-driven target lesion revascularization [TLR]) was 16.3 percent. The occurrences of the individual components were 2 percent for cardiac death, 7.5 percent for myocardial infarction and 10.2 percent for ischemia-driven TLR.

There were only three cases (1 percent) of definite very late stent thrombosis (VLST), all of which involved at least one SES: however, just one of these cases also involved Axxess.

"These long-term results from DIVERGE are important because of the frequent presentation of bifurcation lesions in our daily clinical practice," said principal investigator Stefan Verheye, M.D., Middelheim Hospital, Antwerp, Belgium. "These types of lesions are associated with higher complication and restenosis rates compared to conventional lesions. The three-year results confirm the earlier results already presented, and strengthen the evidence that the Axxess stent is a safe and effective alternative for patients with certain bifurcation lesions."

The Axxess bifurcation DES consists of a self-expanding, conically-shaped nitinol (nickel/titanium) stent platform, specifically designed to conform to the shape of the bifurcation anatomy. It supports the carina while preserving the side branch. The Axxess stent is abluminally coated with a biodegradable poly-lactic acid (PLA) polymer that releases Biolimus A9 (BA9), an anti-restenotic drug developed and patented by Biosensors specifically for use with drug-eluting stents.

Biosensors received CE mark approval for the Axxess bifurcation DES in April 2011, supported by the positive nine-month results from the DIVERGE trial, which were published in the Journal of the American College of Cardiology (JACC) in March 2009. These demonstrated low overall rates of MACE (7.6 percent), restenosis (0.7 percent) and late-stent thrombosis (0.3 percent) in patients treated with Axxess.

Biosensors expects to make the Axxess bifurcation DES available later this year. The device will be manufactured in diameters of 3 and 3.5 mm, and lengths of 11 and 14 mm.

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