Undiscovered pathology of transient scaffolding t1remains a driver of failures in clinical trials

Figure 2 Plaque burden in patients of ABSORB cohort A and B trials at 60 mo. The top panel outlines the acute/subacute and chronic inflammatory/immune response to the implantation of the BVS, which is ongoing during the first 24-36 mo. The middle panel renders a pooled analysis of the plaque burden (PB) and mean plaque area (MPA) in the selected ABSORB phase I/II trials and different multimodality imaging analyses through the five years of the study. The bottom panel shows an example of the grey scale- and virtual histology-IVUS analyses in the five-year time-frame of the ABSORB trial highlighting a clear reduction of the plaque area and artery remodeling with the lumen enlargement and positive expansive remodeling of the vessel at least until 24 mo with the further constrictive-like remodeling. The figure was adapted from reference [34].