Abstract
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.
Highlights
Atrial fibrillation (AF) can lead to significant mortality, morbidity, and cost.[1,2] Long-term prophylaxis with anticoagulation therapy is recommended to prevent stroke and systemic embolization in patients with AF presenting an independent risk factor for stroke.[3]
Four non vitamin-K antagonists oral anticoagulants (NOACs) are currently available: the direct factor Xa inhibitors and the direct factor IIa inhibitor. These four NOACs have demonstrated, in randomized clinical trials, a consistent favorable risk-benefit profile across a wide range of patients with reductions in stroke or systemic embolism, intracranial hemorrhage, and mortality but increased gastrointestinal bleeds when compared with warfarin.[4,5,6,7,8]
While recommending the reimbursement of apixaban in this indication, HAS requested clinical practice data documenting the therapeutic benefit of apixaban under actual conditions of use, compared with the standard oral anticoagulant treatment recommended in France
Summary
Atrial fibrillation (AF) can lead to significant mortality, morbidity, and cost.[1,2] Long-term prophylaxis with anticoagulation therapy is recommended to prevent stroke and systemic embolization in patients with AF presenting an independent risk factor for stroke.[3] Four non vitamin-K antagonists oral anticoagulants (NOACs) are currently available: the direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban) and the direct factor IIa inhibitor (dabigatran). These four NOACs have demonstrated, in randomized clinical trials, a consistent favorable risk-benefit profile across a wide range of patients with reductions in stroke or systemic embolism, intracranial hemorrhage, and mortality but increased gastrointestinal bleeds when compared with warfarin.[4,5,6,7,8]. In OAC-naive patients only: To compare baseline characteristics, outcomes (stroke and systemic thromboembolic events, major bleeding, and all-cause mortality), and healthcare resource utilization rates between patients initiated with apixaban vs patients initiated with each of the other anticoagulant treatments in anticoagulant-naive patients
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
