BACKGROUND: Several multicenter national and international post-marketing surveillance registries have been conceived and operationalized in the last 5 years to assess the safety and efficacy of different brands and models of drug-eluting stents approved for use in the clinical practice. This registry is aimed at documenting the results of consecutive patients undergoing percutaneous coronary intervention (PCI) with the NoboriTM drug-eluting stent (Terumo Corporation, Tokyo, Japan), treated in public and private hospitals in Brazil, at 30 days, 12 and 24 months. METHODS: Five hundred and six patients over 18 years of age will be included, with clinical and angiographic criteria for PCI with drug-eluting stents recommended by the current guidelines. The primary endpoint is to assess the device oriented composite endpoint, defined as cardiac death, myocardial infarction (Q-wave and non-Q-wave not clearly attributable to non-target vessel) and clinically driven target lesion revascularization at 12 months. Patient inclusion started in December 2010 in 37 Brazilian sites and completion is estimated for December 2011 CONCLUSIONS: The results of this multicenter registry and its pre-specified subgroups will allow the assessment of the performance of the NoboriTM drug-eluting stent in interventional clinical practice in Brazil.
Drug-eluting stents; Thrombosis; Coronary restenosis; Myocardial revascularization
