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 mm². 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 mm² vs. 5.5 ± 2.0 mm², P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 ± 1.20 mm² vs. 0.30 ± 0.36 mm², 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. © 2008 Wiley‐Liss, Inc.