Prospective observational study in elderly patients with non-valvular atrial fibrillation: Rationale and design of the All Nippon AF In the Elderly (ANAFIE) Registry

Abstract

The ANAFIE Registry will provide a valuable database for the clinical status, management, and outcomes of mortality, stroke, systemic embolism, and hemorrhagic events with/without anticoagulation in the increasing population of elderly NVAF patients, and will identify risk factors associated with these clinical events.

Age-Related Differences in the Clinical Characteristics and Treatment of Elderly Patients With Atrial Fibrillation in Japan ― Insight From the ANAFIE (All Nippon AF In Elderly) Registry ―

“…Invasive procedures (except those related to AF) and other clinical events were also recorded. 32 Registry UMIN000024006) is a multicenter, prospective, observational (non-interventional) registry of elderly NVAF patients (aged ≥75 years) from across Japan; full details of the registry have been reported previously. 32, 33 Patient enrollment in the registry started in October 2016 (target, 30,000 patients), and follow-up data were collected at month 12 and month 24.…”

Baseline Demographics and Clinical Characteristics in the All Nippon AF in the Elderly (ANAFIE) Registry

“…The 2-year follow-up observation and planned subcohort studies, 16 including data on biomarkers, ECG, heart rate, hypertension, cognitive function, frailty, and treatment adherence, will further illuminate real-world clinical practices for the treatment of NVAF in the era of DOAC therapy.…”

“…The study design and ethical considerations have been reported previously. 16 Briefly, patients eligible for the study included those aged ≥75 years with a definitive diagnosis of NVAF based on ECG. Patients who were currently partici-Registry in Atrial Fibrillation) study demonstrated that the absolute benefit of oral anticoagulants was higher in patients with AF aged ≥85 years than in those aged <85 years.…”

“…4- 6 To disseminate and implement this recommendation in clinical practice, surveys and registries are needed to verify whether real-world clinical practice is in keeping with current guidelines. The aims of the present study, the All Nippon AF In the Elderly (ANAFIE) Registry, 16 is therefore to collect information regarding the actual clinical status of elderly patients with NVAF aged ≥75 years, to elucidate the current status of anticoagulant therapy and its clinical outcomes, to identify risk factors for death, thromboembolism, and major bleeding, as well as their interrelationships, and to establish a database for this specific patient population to aid in the development of therapeutic strategies. The analysis of these data may provide information on what is required or recommended in clinical practice when treating elderly patients with NVAF, which involves not only of cardiologists, but also of clinicians of various specialties.…”

University hospitals, general hospitals, private clinics: Place-based differences in patient characteristics and outcomes of AF—A SAKURA AF Registry Substudy

“…We note, however, that patient selection and regional enrollment biases are limitations of all prospective observational studies. The largest prospective observational study in elderly patients with non-valvular atrial fibrillation will provide important insights into understanding the clinical outcomes among Japanese AF patients [22]. Nevertheless, as noted in other registry-based studies in Japan, similarity exists within patient groups, depending on the type of facility at which they are being treated.…”