Analysis of bifurcation lesions treated with novel drug-eluting dedicated bifurcation stent system: intravascular ultrasound results of the AXXESS PLUS trial.
OBJECTIVE
The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions.


BACKGROUND
The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9.


METHODS
Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated.


RESULTS
Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29).


CONCLUSIONS
This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.
Miyazawa
Akiyoshi
A
Stanford University Medical Center, Stanford, CA 94305-5637, USA.
Ako
Junya
J
Hassan
Ali
A
Hasegawa
Takao
T
Abizaid
Alexandre
A
Verheye
Stefan
S
McClean
Dougal
D
Neumann
Franz J
FJ
Grube
Eberhard
E
Honda
Yasuhiro
Y
Fitzgerald
Peter J
PJ
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; C518022:umirolimus; D020123:Sirolimus