Introduction
Innovations in the field of drug-eluting coronary stent (DES) therapy are rapidly evolving. First-generation DES improved outcomes in terms of reduced rates of restenosis compared with bare metal stenting.1 2 Subsequently, second-generation DES, with thinner stent struts, limus analogue drugs and more biocompatible polymers, were designed to reduce the increased risk of late clinical events of DES.3–5 The controversial term ‘third-generation’ DES is attributed to DES with newer (fully) biodegradable polymers and polymer-free DES. These stents and also the bioabsorbable scaffolds try to minimise adverse outcomes.6–8 However, no device has been able to eliminate in-stent neointimal hyperplasia, neoatherosclerosis and/or (very) late stent thrombosis (ST).
The COMBO stent (OrbusNeich Medical, the Netherlands) is the first dual-therapy stent (DTS), which combines the ‘traditional’ drug-eluting therapy (sirolimus in a biodegradable polymer) with an immobilised CD34 antibody that captures endothelial progenitor cells (EPCs) from the circulation (figure 1). These EPCs can differentiate into endothelial cells on the luminal surface of the stent.9 The hypothesis of this ‘pro-healing’ technique is that it may offer not only improved clinical outcomes, but also safe short use of dual-antiplatelet therapy (DAPT).10 11
The REMEDEE Registry (all acronyms are presented in the online supplementary file 1) aims to provide more insight into the clinical outcomes with the COMBO stent in routine clinical practice and in an all-comer setting. Currently only limited long-term data are available on clinical results with the COMBO DTS exceeding 1 year.12 In this paper, we evaluate 2-year clinical results of the REMEDEE Registry and analyse outcomes in different patient subgroups.