Vascular response to a third generation everolimus-eluting stent.

Area of Science:

• Cardiovascular research
• Biomaterials science
• Medical device engineering

Background:

• Coronary artery disease necessitates advanced stenting solutions.
• Evaluating the vascular compatibility of novel drug-eluting stents is crucial for clinical adoption.
• The PROMUS Element is a new platinum chromium everolimus-eluting stent.

Purpose of the Study:

• To assess the vascular compatibility of the PROMUS Element stent.
• To compare the PROMUS Element against PROMUS (XIENCE V), bare metal Element, and polymer-only Element stents.
• To evaluate endothelial cell coverage, inflammatory response, and neointima formation.

Main Methods:

• A non-injured porcine coronary artery model was used.
• 228 stent pairs were implanted in 79 pigs.
• Pathological analysis was performed at 7, 30, 90, 180, and 270 days.

Main Results:

• No stent-related mortality, morbidity, occlusions, or strut fractures were observed.
• PROMUS Element demonstrated higher radiopacity than PROMUS.
• Vascular compatibility, including endothelialization and inflammation, was similar across all stent types by 90 days, despite transient fibrin presence in drug-eluting stents at 30 days.

Conclusions:

• The PROMUS Element stent exhibits equivalent vascular compatibility to PROMUS, bare metal Element, and polymer-only Element stents.
• The novel platinum chromium everolimus-eluting stent is well-tolerated in the porcine coronary artery model.
• Findings support the potential clinical utility of the PROMUS Element stent.