Establishment of healing profile and neointimal transformation in the new polymer-free biolimus A9-coated coronary stent by longitudinal sequential optical coherence tomography assessments: the EGO-BIOFREEDOM study.

AIMS

This study aimed to establish the early healing and neointimal transformation profile of the new polymer-free BioFreedom stent through sequential optical coherence tomography (OCT) within the first nine months following stent implantation.

METHODS AND RESULTS

We randomly assigned 104 BFS recipients to one of five groups with angiography and OCT follow-up at 1, 2, 3, 4, or 5 months, together with another follow-up for all at nine months. The primary endpoint was the degree of OCT-detected strut coverage at nine months. From 1, 2, 3, 4, and 5 months, median neointimal strut coverage increased from 85.8, 87.0, 88.6, 96.8 to 97.1%, respectively, to 99.6% (IQR 98.2-99.9) at nine months. At nine months, median percent neointimal volume was 13.0% and angiographic late lumen loss was 0.21±0.30 mm. Major adverse cardiac events (MACE) were limited to one non-cardiac death, one non-ST-elevation myocardial infarction not related to BFS, and two target lesion revascularisations without stent thrombosis (MACE rate 4.0%).

CONCLUSIONS

Neointimal strut coverage of the BFS was rapid and the BFS was shown to be clinically safe and effective.