News | June 11, 2013

Axxess Self-Expanding Bifurcation DES Safe, Effective up to Five Years

June 11, 2013 — New long-term data from the DIVERGE clinical study, presented at EuroPCR 2013 by Principal Investigator Dr. Stefan Verheye, Antwerp Cardiovascular Centre, ZNA Middelheim Hospital, Belgium, has shown that the use of the Axxess drug-eluting stent (DES) for the treatment of complex coronary bifurcation lesions resulted in low levels of both MACE and VLST over a five-year period. Axxess is now the only dedicated bifurcation stent with a substantial body of supporting data out to five years.

DIVERGE is a prospective, single-arm, multi-center study of 302 patients with de novo bifurcation lesions across 14 sites in Europe, Australia and New Zealand. It is the largest study conducted to date with a DES specifically designed for treating coronary bifurcation lesions. Following implantation of Axxess in the main branch, the side branch 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 five years post-procedure, 96.3 percent of patients originally enrolled in the study (291) were available for follow-up. The cumulative rate of MACE (a composite of death, MI and ischemia-driven TLR) was 21.3 percent. The occurrences of the individual components were 6.5 percent for death, 8.6 percent for myocardial infarction and 12.4 percent for ischemia-driven TLR.

Only five cases (1.7 percent) of very late definite stent thrombosis (VLST) were reported, all of which involved at least one SES. None of these very rare VLST events resulted in the death of a patient.

"These long-term results from DIVERGE are important because of the frequent presentation of bifurcation lesions in our daily clinical practice," commented Verheye. "These types of lesions are associated with higher complication and restenosis rates compared to conventional lesions. Axxess is now the only dedicated bifurcation stent with this level of supporting data out to five years."

Axxess is a self-expanding dedicated bifurcation stent, which releases Biolimus A9 [BA9], an anti-restenotic drug designed by Biosensors specifically for use with stents, from an abluminal biodegradable polymer coating. Axxess incorporates a conical-shaped self-expanding nitinol (nickel/titanium) stent platform, specifically designed to conform to the shape of the bifurcation anatomy. This has been tailored to reconstruct the bifurcation without creating a false carina (the ridge where the two vessels join), lowering the risk of uncovered struts at the flow divider.

Biosensors received CE mark approval for Axxess 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 a very low in-stent restenosis rate of 6.4 percent in the overall bifurcation, and MACE rate of 7.6 percent, in patients treated with Axxess.

Axxess is currently available in many major markets worldwide (excluding the USA).

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