Optical coherence tomography endpoints in stent clinical investigations: strut coverage.

Late stent thrombosis (LST) and very LST (VLST) are infrequent complications after drug-eluting stent (DES) implantation, but they carry a significant risk for patients. Delayed healing, which may be represented by incomplete stent coverage, has been observed in necropsy vessel specimens treated with DES. As a result, in vivo assessment of stent coverage, as well as stent apposition using optical coherence tomography (OCT), have been recently used as surrogate safety endpoints in clinical trials testing DES platforms. By adopting strut coverage assessed by OCT, one can assess the safety profile of the new generation of DES in preregistration studies. This article focuses on stent strut coverage as a central predictor of late DES thrombosis from the histopathological point of view, discusses the limitations of the current imaging modalities and presents the technical characteristics of OCT for the detection of neointimal coverage after stent implantation. We also review the preclinical and clinical investigations using this novel imaging modality.