Effectiveness and safety of self-managed oral anticoagulant therapy compared with direct oral anticoagulants in patients with atrial fibrillation

Erik Lerkevang Grove,Thomas Decker Christensen,Torben Bjerregaard Larsen,Peter Brønnum Nielsen,Flemming Skjøth

doi:10.1038/s41598-018-33531-7

Erik Lerkevang Grove, Thomas Decker Christensen + Show 3 more

Open Access

https://doi.org/10.1038/s41598-018-33531-7

Copy DOI

Abstract

We compared the effectiveness and safety of direct oral anticoagulants (DOAC) vs patient self-managed warfarin therapy (PSM) in patients with atrial fibrillation. We linked prospectively registered data from university hospital clinics to nationwide Danish health registries. Primary effectiveness and safety outcomes were ischaemic stroke (incl. systemic embolism) and major bleeding. All-cause mortality and all-cause stroke were secondary outcomes. An inverse probability of treatment propensity-weighted approach was applied to adjust for potential confounding. The study cohorts included 534 patients treated with PSM and 2,671 patients treated with DOAC. Weighted rates of ischaemic stroke were 0.46 and 1.30 percent per year with PSM vs DOAC, hazard ratio (HR) 0.27 (95% confidence interval 0.11–0.68) with 2.5 years follow-up. Rates of major bleeding were 2.32 and 2.13 percent per year (HR 1.06 [0.69–1.63]). All-cause mortality was not statistically different (HR 0.67 [0.39–1.17]), whereas the incidence of all-cause stroke was significantly lower among patients treated with PSM with rates of 0.61 vs 1.45 percent per year (HR 0.36 [0.16–0.78]). In patients with atrial fibrillation, self-managed oral anticoagulant treatment was associated with a significantly lower risk of all-cause and ischaemic stroke compared to treatment with DOAC, whereas no significant differences were observed for major bleeding and mortality.

Highlights

Atrial fibrillation (AF) increases the risk of stroke by a factor of 4–5 and accounts for almost 15% of all ischaemic strokes[1]
We studied AF patients assigned to Patient self-management (PSM) at Center for Self-Managed Oral Anticoagulation, Department of CardioThoracic and Vascular Surgery, Aarhus University Hospital enrolled between 1 June 1996 and the June 2012, and at Center of Thrombosis, Aalborg University Hospital enrolled between the 1 April 2008 and December 2012
In the PSM group, the number of patients switching to direct oral anticoagulants (DOAC) was low, mainly as the end of 2.5 years of follow-up was reached before introduction of DOACs for AF

Summary

Introduction

Atrial fibrillation (AF) increases the risk of stroke by a factor of 4–5 and accounts for almost 15% of all ischaemic strokes[1]. Patients on VKA are regularly monitored, and their doses adjusted to ensure that the International Normalised Ratio (INR) scores remain in the therapeutic range. This is often challenging due to variation in individual responses and the narrow therapeutic window of warfarin. Patient self-management (PSM) is a model empowering trained patients to monitor and adjust their treatment in home settings. This strategy has proved effective and convenient www.nature.com/scientificreports/.

Objectives

Methods

Results

Conclusion