AIM: 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. This article is protected by copyright. All rights reserved.
- Administration, Oral
- Age Factors
- Anticoagulants/administration & dosage
- Atrial Fibrillation/complications
- Clinical Trials, Phase III as Topic
- Dabigatran/administration & dosage
- Hemorrhage/chemically induced
- Pyrazoles/administration & dosage
- Pyridines/administration & dosage
- Pyridones/administration & dosage
- Risk Factors
- Rivaroxaban/administration & dosage
- Thiazoles/administration & dosage
- Warfarin/adverse effects