The safety of NOACs in atrial fibrillation patient subgroups: A narrative review

Abstract

Four non-vitamin K oral anticoagulants (NOACs) have been evaluated in clinical trials for the prevention of stroke in patients with atrial fibrillation (AF). Although each of the NOACs have been shown to be at least non-inferior to warfarin for efficacy and safety outcomes, controversy remains over the relative safety of each NOAC in patient subgroups. This narrative review provides an overview of phase III data on NOAC trials for the prevention of stroke in AF, with a focus on reporting the safety of each agent in key patient subgroups based on age, gender, accumulated risk factors, and primary or secondary prevention of stroke. Methods: A comprehensive literature search was completed and, where data permit, analyses of phase III trials of the NOACs are presented for each patient subgroup. Results: Analyses of key safety outcomes from NOAC trials were completed using primary trial data, including major bleeding and all-cause mortality. The safety of NOACs was generally consistent and favourable compared to warfarin according to patient age, gender, previous history of stroke, and the presence of risk factors for stroke. Conclusions: The safety of the NOACs compared to warfarin was generally favourable across different patient subgroups, including those perceived to be at 'high risk' for adverse outcomes. However, certain NOACs may be preferable to warfarin in some subgroups, based on indirect analyses.

Safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in real-world patients with non-valvular atrial fibrillation: a retrospective analysis of contemporary Japanese administrative claims data

“…Consequently, a number of observational, real-world evidence studies have emerged to provide supportive evidence of the safety and/or effectiveness of NOACs in clinical practice 11–18. However, there remain several unmet knowledge gaps in the literature regarding the clinical outcomes of NOAC treatment in patients with NVAF, particularly in patient subgroups at high risk of adverse outcomes 19 20…”

Real-world evaluation of perception, convenience and anticoagulant treatment satisfaction of patients with atrial fibrillation switched from long-term vitamin K antagonist treatment to dabigatran

“…13 14 Currently, four NOACs, namely, apixaban, dabigatran, edoxaban and rivaroxaban, are licensed for use in the USA and Europe for this indication. 15 The use of NOACs for stroke prevention in NVAF is recommended by several international guidelines, [16][17][18] and is also a well-established clinical practice across the world. 19 It has been reported that NVAF patients who are initiated on oral anticoagulants are increasingly being treated with NOACs when compared with the VKAs.…”

A rare case of acquired factor V inhibitor, during treatment with dabigatran for chronic atrial fibrillation, successfully treated with bypassing agents

“…Prevention of thromboembolic complications represents the cornerstone of atrial fibrillation treatment and is based on oral anticoagulation therapy. With the development of NOACs, like dabigatran, rivaroxaban, apixaban, and edoxaban, direct thrombin, or factor X inhibitors, the use of vitamin K antagonists is in decline 11,12 . However, over the last decade, percutaneous closure of left atrial appendage closure (LAAC) proved effective in reducing thromboembolic complications in patients with oral treatment contraindications 13,14 .…”