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MINERVA CARDIOANGIOLOGICA

A Journal on Heart and Vascular Diseases


Official Journal of the Italian Society of Angiology and Vascular Pathology
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Minerva Cardioangiologica 2018 Jan 29

DOI: 10.23736/S0026-4725.18.04612-1

Copyright © 2018 EDIZIONI MINERVA MEDICA

language: English

Current evidence for the safety and efficacy of the bio-engineered dual therapy COMBO stent

Deborah N. KALKMAN 1, 2, Jaya CHANDRASEKHAR 1, Robbert J. de WINTER 2, Roxana MEHRAN 1

1 Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA; 2 Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands


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The novel dual-therapy COMBO stent aims to promote vessel healing after percutaneous coronary intervention (PCI) in patients with coronary artery disease. The pro-healing technique consists of an anti-CD34+ antibody layer that attracts circulating endothelial progenitor cells (EPCs), which bind to the stent surface and allow rapid endothelialization by differentiation of the EPCs into normal endothelial cells. The COMBO stent combines this pro-healing technique with an abluminal drug elution of sirolimus. The promise of this dual-therapy stent is that it may safely allow a shortened duration of dual-antiplatelet therapy (DAPT) after stent placement. Moreover, with a mature endothelial layer, lower rates of in-stent restenosis may be expected. Clinical outcomes after COMBO stent implantation have been recently evaluated in both randomized trials and large, prospective, multicenter registries, showing low clinical event rates of in-stent restenosis and stent thrombosis. Randomized clinical trials (HARMONEE and RECOVERY) have demonstrated the non-inferiority of COMBO versus “first in class” second generation and newer generation drug-eluting stents. Safety and efficacy of 3 months of DAPT after COMBO stent placement in patients presenting with acute coronary syndrome has been evaluated in the large REDUCE randomized controlled trial, showing non-inferiority to standard duration of 12 months DAPT. In this review we provide an overview of the current pre-clinical and clinical evidence for the performance of the COMBO stent.


KEY WORDS: Percutaneous coronary intervention - Drug-eluting stent - Endothelial progenitor cell

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Publication History

Article first published online: January 29, 2018
Manuscript accepted: January 19, 2018
Manuscript received: January 9, 2018

Cite this article as

Kalkman DN, Chandrasekhar J, De Winter RJ, Mehran R. Current evidence for the safety and efficacy of the bio-engineered dual therapy COMBO stent. Minerva Cardioangiol 2018 Jan 29. DOI: 10.23736/S0026-4725.18.04612-1

Corresponding author e-mail

Roxana.Mehran@mountsinai.org