Vascular response after implantation of biolimus A9-eluting stent with bioabsorbable polymer and everolimus-eluting stents with durable polymer. Results of the optical coherence tomography analysis of the BIOACTIVE randomized trial

Abstract

Background

In BIOACTIVE study, we evaluated vascular responses after the implant of biolimus A9-eluting stent (BES; BioMatrix^TM) and the everolimus-eluting stent (EES; XIENCE V^TM). In this study, we present the optical coherence tomography analysis (OCT) 6 months post-intervention.

Methods

Patients were randomized to treatment with BES (n = 22) or EES (n = 18). The primary outcome was the frequency of non-covered, poorly positioned struts by OCT.

Results

OCT was performed in 26 patients (BES: n = 15; EES: n = 11) and 749 tomographic images and 7,725 stent struts were analyzed. BES and EES showed similar luminal and stent areas. Neointimal hyperplasia area, neointimal thickness and the percentage of in-stent obstruction (8.44 ± 5.10% vs. 9.21 ± 6.36%; p = 0.74) were similar. The rates of not covered struts (BES: 2.10 ± 3.60% vs. ESS: 2.46 ± 2.15%, p = 0.77) and poorly positioned struts (BES: 0.48 ± 1.48% vs. EES 0.44 ± 1.05%, p = 0.94) were similarly low. The frequency of frames with signs consistent with peri-strut inflammatory infiltrate was low and similar between BES (15.53 ± 20.77%) and EES (11.70 ± 27.51%; p = 0.68).

Conclusions

The second-generation drug-eluting stents BES and EES were equally effective at suppressing the neointimal formation after 6 months, with favorable vascular responses. The frequency of frames with peri-strut infiltrate signals per patient was low, and lower than that observed historically with first-generation drug-eluting stents.