Optical coherence tomography endpoints in stent clinical investigations: strut coverage

Area of Science:

• Cardiovascular research
• Medical device technology
• Histopathology

Background:

• Late stent thrombosis (LST) and very late stent thrombosis (VLST) are serious complications following drug-eluting stent (DES) implantation.
• Delayed healing, indicated by incomplete stent coverage, is a known factor in LST/VLST.
• In vivo assessment of stent coverage and apposition is crucial for evaluating DES safety.

Purpose of the Study:

• To highlight stent strut coverage as a key predictor of late DES thrombosis from a histopathological perspective.
• To discuss the limitations of current imaging techniques for assessing stent healing.
• To present the technical aspects of optical coherence tomography (OCT) for detecting neointimal coverage.

Main Methods:

• Review of preclinical and clinical investigations utilizing OCT for stent coverage assessment.
• Focus on OCT's technical characteristics for visualizing neointimal coverage post-stent implantation.
• Analysis of stent strut coverage as a surrogate safety endpoint in DES clinical trials.

Main Results:

• Incomplete stent coverage is a significant histopathological predictor of late DES thrombosis.
• OCT provides in vivo assessment of neointimal coverage and stent apposition.
• OCT enables evaluation of the safety profile of new-generation DES in preregistration studies.

Conclusions:

• Stent strut coverage assessed by OCT is a vital surrogate endpoint for predicting late DES thrombosis.
• OCT is a valuable tool for assessing the healing response after DES implantation.
• Further investigation into OCT's role in evaluating DES safety is warranted.