Randomised comparison of strut coverage between Nobori biolimus-eluting and sirolimus-eluting stents: an optical coherence tomography analysis

Abstract

Aims: The aims of this study were to compare strut tissue coverage at six-month follow-up after Nobori biolimus-eluting stent (N-BES) versus sirolimus-eluting stent (SES) implantation.

Methods and results: A total of 120 patients with a single stenotic lesion requiring revascularisation were randomly assigned to either N-BES (n=60) or SES (n=60). Baseline optical coherence tomography (OCT) was performed post stent implantation, and follow-up OCT was scheduled at six months. Post-intervention and follow-up OCT analyses were available in 51 (85.0%) and 52 (86.7%) patients, respectively. The primary endpoint was the percentage of uncovered struts at follow-up OCT in all cross-sections with analysis of 0.2 mm longitudinal intervals. In addition, an OCT contour plot analysis was constructed to investigate the distribution patterns of uncovered struts. The percentage of uncovered struts of N-BES was significantly lower versus SES (15.9±12.2% versus 25.1±18.3%, respectively, p=0.003). N-BES showed a greater NIH thickness than SES (median [interquartile range] 52.4 μm [41.9-74.9] versus 42.1 μm [30.6-56.0], p=0.005). Contour plot analyses showed a lower incidence of a diffuse distribution pattern of uncovered struts (46.8% versus 75.0%, respectively, p=0.022).

Conclusions: This randomised OCT study showed that N-BES had a significantly lower percentage of uncovered struts, and less common diffuse distribution pattern of uncovered struts versus SES.

Trial registration: ClinicalTrials.gov NCT01502904.