Comparison of Drug-Eluting Stents with Durable or Bioabsorbable Polymer: Intracoronary Ultrasound Results of the BIOACTIVE Trial

Background:  The everolimus-eluting stent with durable polymer or biolimus A9-eluting stent with bioabsorbable polymer were designed to minimize local inflammatory response providing better endothelial coverage of the struts. The aim of this study was to report the intravascular ultrasound results at 6 months comparing these devices, a secondary endpoint of the BIOACTIVE study.

Methods:  The BIOACTIVE trial is a multicenter, randomized trial (1:1), whose primary endpoint was to compare coronary endothelial function and the percentage of strut coverage of the BioMatrix^TM and Xience V^TM stents using optical coherence tomography. Patients with single de novo lesions in native coronary arteries, between 3.0 and 3.5 mm, and maximum length of 20 mm were included. Diabetic patients or patients with ST segment elevation myocardial infarction, ostial lesions, bifurcation lesions or lesions with thrombus were excluded.

Results:  Intracoronary ultrasound was performed in 35 (87.5%) of 40 patients included in the study (BioMatrix^TM = 21, and Xience V^TM = 14). Vessel volume (339.8 ± 149.4 mm3 vs. 343.0 ± 118.6 mm3; p = 0.95), stent volume (174.9 ± 73.6 mm3 vs. 166.2 ± 53.6 mm3; p = 0.70), intimal hyperplasia volume (3.7 ± 2.6 mm3 vs. 4.5 ± 5.9 mm3; p = 0.57) and percent intimal hyperplasia volume (2.3 ± 2.0% vs. 2.4 ± 2.8%; p = 0.90) did not show statistically significant differences.

Conclusions:  In this randomized comparison, both stents proved to be effective in suppressing neointimal response in medium-term follow-up and did not show indirect signs of local toxicity.

Drug-eluting stents; Polymers; Treatment outcome