Abstract
Backgrounds Bifurcation location remains one of the most challenging lesion subsets even in the era of drug-eluting stents. AXXESS stent is a self-expanding drug-eluting stent designed to be placed in the proximal part of the main vessel, at the level of the carina. This stent has flared configuration so as to properly expand into the bifurcation anatomy. This study was performed to assess the efficacy of the AXXESS stent on the treatment of left main and non-left main bifurcation lesions using intravascular ultrasound (IVUS). Methods Volumetric IVUS data from 3 multi-center trials using AXXESS stent in bifurcation lesions (AXXESS trial: non-left main bifurcation, N=37, AXXENT trial: left main bifurcation, N=21 and DIVERGE trial: non-left main bifurcation, N=56) were analyzed. All IVUS analyses were performed at an independent core laboratory. To adjust the difference in length of measured segments, the parameter of volume index was derived from each volume parameter using the formula of volume/measured length (mm 3 /mm). Percent neointimal volume was defined as neointimal volume divided by stent volume. Results During follow-up, AXXESS stent volume index was increased by 27.6±20.2% (from 8.5±2.8 to 10.6±3.3mm 3 /mm). Percent neointimal volume obstruction was 3.4±4.2%. Lumen volume index was increased by 22.4±19.9% (from 8.5±2.8 to 10.3±3.2mm 3 /mm). Patients with 9 month follow-up IVUS had more NIV obstruction than with 6 month follow up (4.3±5.0 vs. 2.5±3.0%, p=0.03). There was a trend toward more stent expansion in non-left main bifurcation lesions than in left main bifurcation lesions (30±16% vs. 19±29%, P=0.1). However, percent neointimal volume obstruction was not different according to the location of lesions (P=0.5). Late acquired incomplete stent apposition was occurred in only 1 case. Conclusion This combined IVUS analysis suggests that AXXESS stent seems to be an effective treatment option for wide range of bifurcation lesion morphologies.
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