Baseline and 9 months IVUS analysis of the bifurcation-dedicated biolimus A9-eluting Axxess stent system: the DIVERGE IVUS substudy.
BACKGROUND
Percutaneous treatment of complex coronary bifurcation lesions remains challenging, even in the drug-eluting stent era. We sought to evaluate the baseline and 9 months intravascular ultrasound (IVUS) analysis of the Axxess™ stent, a self-expanding, Biolimus A9™-eluting, and dedicated bifurcation stent.


RESULTS
We enrolled the first 76 patients from selected sites of the 302 patients large DIVERGE trial (a prospective, single-arm, multicenter trial evaluating the safety and efficacy of the Axxess stent). Both baseline and 9 months IVUS images were collected for serial two-dimensional (2D) and 3D analysis. A minimal amount and a low percentage of neointimal volume index were seen in the Axxess stent at 9 months (0.4 ± 0.6 mm(3) /mm and 4.3 ± 5.2%, respectively). Vessel, lumen, and stent volume indices increased significantly (respectively, 17.0 ± 3.6 to 18.9 ± 3.7 mm(3) /mm, P < 0.0001; 7.3 ± 2.0 to 9.2 ± 2.5 mm(3) /mm, P < 0.0001; and 7.4 ± 2.0 to 9.6 ± 2.6 mm(3) /mm, P < 0.0001). This resulted in minimum lumen area (MLA) enlargement (6.1 ± 1.9 to 7.2 ± 2.3 mm(2) , P < 0.0001), whereas peristent plaque area decreased (8.7 ± 2.5 to 8.5 ± 2.1 mm(3) /mm, P = 0.016). At 9 months, 16 (26%) incomplete stent apposition (ISA) persisted from baseline, while six resolved (9.7%). Only one (2%) ISA was late acquired. In the additional distal sirolimus-eluting stents, MLA decreased from 4.3 ± 1.1 to 4.1 ± 1.2 mm(2) (P = 0.04) at 9 months for the main branch, and from 3.4 ± 1.2 to 3.2 ± 1.2 mm(2) (P = 0.09) for the side branch.


CONCLUSIONS
The dedicated bifurcation Axxess stent system demonstrates significant stent volume increase with minimal neointimal formation and a low incidence of late-acquired ISA at 9 months.
Antwerp Cardiovascular Center Middelheim, Ziekenhuis Netwerk Antwerpen, Lindendreef 1, B-2020, Antwerp, Belgium.
Ian
I
Buysschaert
Elias
E
Sanidas
Takao
T
Hasegawa
Bon-Kwon
BK
Koo
Yasuhiro
Y
Honda
Peter J
PJ
Fitzgerald
Stefan
S
Verheye
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000601:surgery; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D015203:Reproducibility of Results; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*; D055815:Young Adult
D007166:Immunosuppressive Agents; C518022:umirolimus; D020123:Sirolimus
angioplasty; atherosclerosis; imaging; stents