Abstract 11963: Randomized Ivus Comparison Between a Durable and a Biodegradable-Polymer Second Generation Drug-Eluting Stents: The Bioactive Trial
Background: New generation drug-eluting stents (DES), biolimus-eluting stents (BES) and everolimus-eluting stents (EES) were conceived to minimize local coronary inflammation allowing better endothelial healing. The aim of this study is to compare the IVUS patterns observed with both stents at midterm follow-up.
Methods: The Bioactive trial is a multicentre, randomized trial (1:1) comparing BES and EES based on surrogate safety and efficacy endpoints. Inclusion criteria was single, de novo lesions in native coronary arteries of 3.0 to 3.5mm and maximum lesion length of 20 mm. Patients with in-stent restenosis, lesion in grafts and treated in the setting of STEMI were excluded. The present analysis aims to compare the main IVUS findings for both DES at 9-month invasive follow-up. IVUS analyses were performed in an independent corelab blinded to the type of DES used.
Results: A total of 40 patients were enrolled in the trial and 35 had IVUS performed. Procedure success was achieved in all cases. Baseline clinical characteristics as well as reference vessel diameter and lesion length did not significantly differ between the 2 cohorts. At 9 month, QCA measured in stent late loss was also comparable (0.15±0.18mm for BES vs. 0.20±0.47mm for EES, p=0.7). By IVUS, vessel volume (349±158mm3 for BES vs. 326±127mm3 for EES, p=0.6) and stent volume (178±78 for BESmm3 vs. 154±54mm3 for EES, p=0.4) did not significantly differ between the groups as well as neointimal tissue volume (3.6±2.8mm3 for BES vs 4.3±6.1mm3 for EES, p=0.4) and the % of stent obstruction (2.3±2.1% for BES vs. 2.5±2.8% for EES. OF note, the pattern of neointimal distribution was very similar between the two DES (figure).
Conclusions: In this head-to-head to comparison, both second-generation DES were shown to be effective and safety in the treatment of coronary artery disease with no significant differences in terms of IVUS findings.
Author Disclosures: J. Costa: None. B. Almeida: None. R. Costa: None. D. Chamie: None. M. Perin: None. A. Abizaid: None. A. Sousa: None. A. Abizaid: None.
- © 2014 by American Heart Association, Inc.