Three-year clinical results of the Axxess Biolimus A9 eluting bifurcation stent system: the DIVERGE study.
OBJECTIVE
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.


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.
ZNA Middelheim, Antwerp, Belgium.
Ian
I
Buysschaert
Christophe L
CL
Dubois
Joseph
J
Dens
John
J
Ormiston
Stephen
S
Worthley
Dougal
D
McClean
Jan Paul
JP
Ottervanger
Ian
I
Meredith
Neal
N
Uren
William
W
Wijns
Rob
R
Whitbourn
Roxana
R
Mehran
Alexandra J
AJ
Lansky
Marzena
M
Bichalska
Susanne
S
Meis
Stefan
S
Verheye
D000368:Aged; D003324:Coronary Artery Disease / Q000628:therapy*; D003328:Coronary Thrombosis / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
C518022:umirolimus; D020123:Sirolimus