Introduction: In Europe, Ischaemic Heart Disease (IHD) causes 1.8 million deaths per year and is the leading cause of death among persons aged under 65 years. According to theWorld Health Organisation report, in 2012 IHD was the leading cause of Disability-Adjusted Life Years (DALY) and Years of Potential Life Lost (YPLL). Currently, the principal treatment for de novo coronary lesions is percutaneous coronary intervention using bare-metal stents (BMSs) or drug-eluting stents (DESs). In recent years it has developed a new concept of stent which attempt to reduce the DES-related thrombosis rate, as the endothelial progenitor cell (EPC) capture stent, i.e. the GENOUS™ bio-engineered EPCC stent, and the COMBO™ dual therapy stent. The mechanism of action of these stents is characterised by a technology based on the capture of circulating bone marrow-derived EPCs from peripheral blood by means of a surface coating of anti-CD34+ antibodies, which then serves to accelerate re-endothelialisation of the stent.
Objective: The aim of this report was to assess the clinical utility of EPCC stents in the treatment of de novo coronary lesions as compared to routine clinical practice, in terms of safety (technique-related adverse events), efficacy/effectiveness (mortality rate, acute myocardial infarction, restenosis and thrombosis post-implantation), and the economic and organisational impact of implementing this technology in Spanish National Health System (NHS).
Methods: We made a systematic review of the literature in different sources: such as biomedical databases, e.g. the Centre for Reviews and Dissemination (CRD) database (Health Technology Assessment-HTA and Database of Abstracts of Reviews of Effectiveness-DARE), Cochrane Library Plus, Medline (PubMed), Embase (OVID), Web of Science (Web of Knowledge) and Scopus, databases of ongoing studies, e.g., ClinicalTrials.gov., and economic evaluations, e.g., the Economic Evaluation Database of the National Health Service (NHS EED), as well as the web page of the Institute of Health Economics (IHE). The search strategy was conducted in April 2016, with monthly updates until date ofreport's edition. Two independent reviewers selected the papers in accordance with pre-established inclusion/exclusion criteria. The data were summarised, and the methodological quality of the studies was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. In the case of randomised clinical trials (RCTs), we performed a meta-analysis, if appropriate, using the Review Manager programme version 5.3 to obtain a pooled assessment of the variables of interest. In case series, means and SDs weighted by sample size were calculated using the SPSS statistics programme (version 19).
Result and conclusion: See pdf below.