Current Status and Outcomes of Direct Oral Anticoagulant Use in Real-World Atrial Fibrillation Patients　― Fushimi AF Registry ―

Abstract

practice, DOAC have prevailed all over the world. After the release of DOAC, several national guidelines for the management of AF were updated, and now recommend DOAC as broadly preferable to VKA in the vast majority of patients with non-valvular AF. 6 RCT, however, are conducted under idealized and rigorously controlled conditions. Thus, RCT patients are highly selected, and hence are not broadly representative of real-world patients. Also, not many studies have investigated the real-world effectiveness and safety of DOAC in unselected patients; and, according to studies involving general practice settings, the outcomes of DOAC in real-world clinical practice do not necessarily coincide with the RCT outcomes. 7, 8 The aim of this study was therefore to evaluate the change in OAC status over time and the clinical outcomes O ral anticoagulants (OAC) are essential for stroke prevention in patients with atrial fibrillation (AF). The use of conventional OAC, such as a vitamin K antagonist (VKA), reduces stroke by 64%, compared with non-VKA users. 1 Until recently, VKA were the only available OAC but direct oral anticoagulants (DOAC; dabigatran, rivaroxaban, apixaban, and edoxaban) have been introduced for stroke prevention in patients with AF. Recent large-scale randomized clinical trials (RCT) demonstrated the similar efficacy and safety of DOAC, compared with VKA.

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

“…In the present study, 42.7% of the patients received 2.5 mg BID apixaban. This frequency was similar to that in Japanese registration studies (40.4% and 44%), but lower than that in a Japanese claims database study (60.6%).…”

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”

“…However, these recommendations are not uniform worldwide, hampering the selection of the preferable posology and the identification of DOAC suboptimal use. Indeed, the approved doses and dose adjustment criteria defined by European Medicine Agency (EMA) and Food and Drugs Administration (FDA) are summarized in Table while the recommendations reported by Health Canada regulatory agency, European Society of Cardiology and Japanese guidelines, regarding DOAC dose adjustment in patients with AF, are presented in Table . Note that Japanese guidelines mention some differences in relation to EMA and FDA, particularly related to the smaller body size, different pharmacokinetic and genetic profiles of Asian populations when compared with European or American patients.…”

The influence of frailty under direct oral anticoagulant use in patients with atrial fibrillation

“…Bleeding history was an indicator of major bleeding, but not stroke or SE 7. This could explain why major bleeding was not a predictor of composite end points.…”

“…In our study, bleeding history was a predictor of major bleeding in the univariate analysis (HR: 4.70, 95% CI: 1.00 to 22.1). Stroke or TIA history is also a predictor of stroke, but not a significant predictor of major bleeding 7. Moreover, our hospital actively performs emergent endovascular treatment of acute ischaemic stroke (about 60 cases a year).…”