Analysis of left main coronary artery bifurcation lesions treated with biolimus-eluting DEVAX AXXESS plus nitinol self-expanding stent: intravascular ultrasound results of the AXXENT trial.
OBJECTIVE
To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS.


BACKGROUND
The treatment of LMCA bifurcation lesions remains challenging even with the use of drug-eluting stents. The AXXESS system is a biolimus A9-eluting self-expanding stent, dedicated to the treatment of bifurcation lesions.


METHODS
Data were obtained from the AXXENT trial, a prospective, single-arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6-months follow-up. Volumetric and cross-sectional analyses within the AXXESS stent, and cross-sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed.


RESULTS
Within the AXXESS stent, percent neointimal volume obstruction was (3.0 +/- 4.1)% with a minimal lumen area of 10.3 +/- 2.6 mm(2). AXXESS stent volume showed an 12.4% increase at follow-up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow-up (3.6 +/- 1.3 mm(2) vs. 5.5 +/- 2.0 mm(2), P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 +/- 1.20 mm(2) vs. 0.30 +/- 0.36 mm(2), P = 0.0003).


CONCLUSIONS
The AXXESS stent in the LMCA showed enlargement through 6-months follow-up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium.
Hasegawa
Takao
T
Stanford University Medical Center, Stanford, CA 94305-5637, USA.
Ako
Junya
J
Koo
Bon-Kwon
BK
Miyazawa
Akiyoshi
A
Sakurai
Ryota
R
Chang
Hyeonsoo
H
Dens
Joseph
J
Verheye
Stefan
S
Grube
Eberhard
E
Honda
Yasuhiro
Y
Fitzgerald
Peter J
PJ
D000368:Aged; D000497:Alloys; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D049109:Cell Proliferation; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D017539:Tunica Intima / Q000473:pathology; D018084:Ultrasonography, Interventional; D014481:United States
D000497:Alloys; D002317:Cardiovascular Agents; C013616:nitinol; C518022:umirolimus; D020123:Sirolimus