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Minerva Cardioangiologica 2015 February;63(1):31-43

Copyright © 2015 EDIZIONI MINERVA MEDICA

language: English

A novel “pro-healing” approach: the COMBO™ dual therapy stent from a pathological view

Zarpak R. 1, Sanchez O. D. 1, Joner M. 1, Guy L. G. 2, Leclerc G. 2, Virmani R. 1

1 CVPath Institute, Inc., Gaithersburg, MD, USA; 2 AccelLAB, Boisbriand, QC, Canada


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Current generations of monotherapy drug-eluting stents only inhibit neointimal hyperplasia. However, these stent designs have other drawbacks such as delayed arterial healing, hypersensitivity, late stent thrombosis, and neoatherosclerosis, creating a need for a new generation of safer devices. The novel ‘pro-healing’ COMBOTM dual therapy stent aims to address these issues by reducing neointimal hyperplasia via an abluminal bioabsorbable polymer eluting sirolimus, and by simultaneously capturing circulating endothelial progenitor cells via luminally immobilized anti-CD34+ antibodies. Short-term preclinical data shows promising results as compared to 1st generation and 2nd generation drug-eluting stents; however long-term literature remains unavailable until now. This review aims to evaluate, histopathologically, drawbacks of the current era of stents at autopsy, review short-term preclinical and clinical data from the REMEDEE trial, and present original long-term preclinical data. To date, preclinical data shows good performance of the COMBOTM stent comparable with the safety profile of bare metal stents with minimal inflammation, increased endothelialization, and acceptable neointimal hyperplasia with no statistical evidence of late catch-up. Clinical data from the REMEDEE trial at 12 months shows non-inferiority to paclitaxel drug-eluting stents, no evidence of late stent thrombosis, and a low rate of adverse clinical events.

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