Next-generation DES: the COMBO dual therapy stent with Genous endothelial progenitor capturing technology and an abluminal sirolimus matrix

Abstract

In contrast to the use of cytotoxic or cytostatic drugs, a ‘pro-healing’ approach may have an effect that is beneficial on clinical outcomes. The endothelial progenitor cell capturing stent (ECS) technology accelerates re-endothelialization after implantation in animal models and in the human arteriovenous shunt model. Several clinical studies have shown its safety in non-complex lesions. However, in the prevention of in-stent restenosis in complex lesions, the ECS is less effective compared with drug-eluting stents. The novel COMBO dual therapy stent is the first stent to combine accelerated endothelial coverage and control of neo-intimal proliferation using a pro-healing technology with an abluminal elution of sirolimus. In the randomized REMEDEE trial, the COMBO dual therapy stent showed similar angiographic and clinical outcomes compared to the paclitaxel-eluting stent. The REMEDEE-OCT study showed equal vascular healing as assessed by optical coherence tomography of the COMBO dual therapy stent compared to the Xience-V stent.

Keywords::

• endothelial progenitor cells
• percutaneous coronary intervention
• restenosis
• sirolimus
• stent
• stent thrombosis

Financial & competing interests disclosure

The department of cardiology, Academic Medical Center – University of Amsterdam received an unrestricted research grant from OrbusNeich.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The endothelial progenitor cell capturing stent (ECS) technology has shown to be safe and feasible.

• The ECS technology alone does not sufficiently prevent in-stent restenosis compared with the second-generation drug-eluting stent (DES).

• The ECS technology is an attractive alternative to DES in patients with an increased contraindication or suspected non-compliance for dual antiplatelet therapy.

• The novel COMBO dual therapy stent, combining the ECS technology with an abluminal seroloimus-eluting coating, showed a rapid re-endothelialization compared with DES in preclinical studies.

• In a first-in-human study, clinical outcomes and angiographic late lumen loss of the COMBO stent were comparable with a paclitaxel-eluting stent.

• The novel COMBO dual therapy stent received CE mark in May 2013, warranting further clinical studies to investigate the safety and efficacy of the device.

Notes