Axxess self-expanding stent is safe and effective at five years


According to a study presented at EuroPCR EuroPCR (21–24 May, Paris, France), the use of the Axxess drug-eluting stent for the treatment of complex coronary bifurcation lesions resulted in low levels of both major adverse cardiovascular events (MACE) and very late definite stent thrombosis over a five-year period.

According to a company press release, Axxess is now the only dedicated bifurcation stent with a substantial body of supporting data out to five years.

The press release reported that DIVERGE is a prospective, single-arm, multi-centre 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 drug-eluting stent 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 were placed in 21.7% of the distal parent and/or side branch vessels. In 64.7% of the cases both branches were treated with an additional sirolimus-eluting stents.

At five years post-procedure, 96.3% of patients originally enrolled in the study (291) were available for follow-up. The cumulative rate of MACE (a composite of death, myocardial infarction and ischaemia-driven target lesion revascularisation) was 21.3%. The occurrences of the individual components were 6.5% for death, 8.6% for myocardial infarction and 12.4% for ischemia-driven target lesion revascularisation.

Only five cases (1.7%) of very late definite stent thrombosis were reported, all of which involved at least one sirolimus-eluting stent. None of these very rare very late definite stent thrombosis 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 principal investigator Stefan Verheye, Antwerp Cardiovascular Centre, ZNA Middelheim Hospital, Belgium.

Axxess is a self-expanding dedicated bifurcation stent which releases Biolimus A9, an anti-restenotic drug designed by Biosensors specifically for use with stents, from an abluminal biodegradable polymer coating. The stent 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.