Study Suggests Stents Coated With Endothelial Progenitor Cell Capture Antibody Improves Neointimal Appearance At 9 Months

In short

EuroPCR is being accompanied this week by a flurry of press releases, not least from Hong Kong based global cardiovascular company OrbusNeich which has today announced presentation of clinical data supporting its Combo Dual Therapy Stent.

Two subgroup analyses from the REMEDEE trial assessing vascular healing of the company’s Combo Dual Therapy Stent versus the TAXUS paclitaxel-eluting stent demonstrate an early advantage with the Combo Stent.

Background

The Combo Stent, touted by OrbusNeich as the world’s first “dual therapy” stent (DTS), combines an abluminal biodegradable sirolimus elution for the regulation of hyperplasia with Genous™, OrbusNeich’s proven endothelial progenitor cell (EPC) capture technology, to accelerate re-endothelialisation.

The patented Genous EPC capture technology promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. It consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

The study

An independent OCT core laboratory performed a blinded quantitative analysis of the percent strut coverage and “in stent” neointimal characteristics along with a qualitative assessment of neointimal tissue appearance and make-up of 23 Combo Stents and 10 TAXUS stents at nine-month follow-up.

The data show that neointimal volumes and thicknesses were comparable, while the qualitative analysis inside the stent showed a more homogenous neointimal tissue appearance in the Combo Stent compared to the TAXUS stent.

The Combo Stent placements had statistically significant more homogeneous tissue appearance compared to the TAXUS stent placements (79.2% versus 40%). Heterogeneous and layered tissue appearance was observed in 60% of the TAXUS stent placements and in 20.8% of the Combo Stent placements. Additionally, there were fewer microvessels (8.3% vs 30%) and macrophage-like appearances (4.2% vs 10%) inside the Combo Stent compared to the TAXUS stent, supporting the theory that by capturing endothelial progenitor cells the Genous technology had contributed to an improved neointimal appearance.

Investigator comments

“These intriguing data possibly demonstrate a more homogenous tissue appearance with the Combo Stent versus a more heterogeneous appearance with the TAXUS stent in a blinded analysis,” said Akiko Maehara, M.D.,director of Intravascular Imaging Core Laboratory at the Cardiovascular Research Foundation and assistant professor of medicine at Columbia University College of Physicians and Surgeons in New York. “There is a trend of differences in morphology that may support the Combo Stent’s approach of improved vascular healing while maintaining effective control of neointimal proliferation.”

Company comments

“The Combo Stent is the only technology that combines the value of endothelial progenitor cell capture to promote vessel healing with an abluminal sirolimus drug elution to limit neointimal proliferation,” said Stephen M. Rowland, Ph.D., vice president of research and development at OrbusNeich. “We are committed to bringing innovation to interventional cardiologists to help them address unmet needs with contemporary percutaneous coronary intervention.”

Source: OrbusNeich, PR Newswire