Premium
Baseline and 9 months IVUS analysis of the bifurcation‐dedicated biolimus A9‐eluting Axxess stent system: The DIVERGE IVUS substudy
Author(s) -
Buysschaert Ian,
Sanidas Elias,
Hasegawa Takao,
Koo BonKwon,
Honda Yasuhiro,
Fitzgerald Peter J.,
Verheye Stefan
Publication year - 2014
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25414
Subject(s) - medicine , intravascular ultrasound , stent , lumen (anatomy) , percutaneous coronary intervention , cardiology , drug eluting stent , nuclear medicine , radiology , restenosis , myocardial infarction
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. Methods and 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. © 2014 Wiley Periodicals, Inc.