Aims: To report the three-year clinical outcome of the Axxess™ stent, a nitinol self-expanding Biolimus A9™ eluting stent for treatment of de novo coronary bifurcation lesions. The Axxess stent is a new-generation drug-eluting stent that might offer advantages in terms of improved clinical outcomes and safety profile in bifurcation lesion stenting.
Methods and results: The DIVERGE study was a multicentre, prospective, single-arm trial. The primary endpoint was the cumulative rate of major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and ischaemia-driven target lesion revascularisation (TLR) at one, two and three years. Secondary safety endpoints were cumulative stent thrombosis (ST). A total of 302 patients were included across 14 sites: 77.4% had a true bifurcation lesion, with the left anterior descending/diagonal as target vessel in 80.8%. The Axxess stent was placed in 299 patients (99.0%) and scored as optimal in 93.0%. Two hundred and ninety-eight patients (98.7%) returned for the three-year follow-up. The MACE rate was 9.3% at one year, 14.0% at two years and 16.1% at three years. Individual components at three years were 10.1% for ischaemia-driven TLR, 3.0% for death (2.0% cardiac death), and 7.4% for MI. In the secondary safety endpoint at three years, a total of seven patients (2.3%) had ST with six (2.0%) definite and two (0.7%) probable ST events.
Conclusions: The present large study of the Axxess stent reports a good cumulative MACE rate during three years of long-term follow-up. The Axxess stent offers a promising treatment strategy for bifurcation lesions.