EvaluatioN of ApiXaban in strOke and systemic embolism prevention in patients with non-valvular atrial fibrillation in clinical practice Setting in France, rationale and design of the NAXOS: SNIIRAM study

Non-vitamin K antagonists oral anticoagulants (NOACs) have recently challenged vitamin-K antagonists (VKAs) for stroke and systemic embolism prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Nevertheless, little information is available in routine clinical practice for France. The aim of this study is to describe the effectiveness and safety of apixaban, rivaroxaban, dabigatran or VKAs in routine clinical practice in adult NVAF patients for the prevention of stroke and systemic embolism in France. The NAXOS study is a nationwide observational retrospective cohort generated from the French national healthcare insurance database (SNIIRAM-a comprehensive in- and outpatient healthcare consumption database), consisting of eight distinct sub-cohorts of anticoagulant-naive or anticoagulant-experienced patients diagnosed with NVAF, newly initiated with either NOACs (dabigatran, rivaroxaban or apixaban) or VKAs. Patients will be included if initiating a new anticoagulant treatment for AF during the study period from 1 January 2014 to 31 December 2016. Primary effectiveness outcome will be the incidence of stroke or systemic thromboembolic events; primary safety outcome will be the incidence of major bleeding during the exposure period. The NAXOS study will provide routine clinical practice data on the effectiveness and safety profiles of apixaban vs other NOACs and VKAs in the prevention of stroke and systemic embolism in adult patients with NVAF in clinical practice conditions in France.