Abstract

BackgroundCurrent guidelines recommend non-vitamin‑K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF). The use of drugs in a clinical trial setting differs from that in real-world populations. Real-world data are important to accrue more heterogeneous patient populations with respect to co-morbidities and co-medication use. The aim of this study was to evaluate the use of NOACs in daily practice in a large tertiary hospital in the Netherlands.MethodsA single-centre prospective study was conducted among all patients with AF using a NOAC in the St. Antonius Hospital between 2013 and June 2017. The outcomes were the rates of any bleeding, stroke/transient ischaemic attack, mortality, discontinuation rate and adverse drug reactions.ResultsIn total, 799 patients were enrolled with a mean follow-up of 1.7 years. Mean age was 69.8 (SD ± 11) and 61.2% were male. Mean CHA2DS2-VASc score was 2.8 (SD ± 1.6) and mean HAS-BLED score was 1.4 (SD ± 0.9). Bleeding occurred in 6.0, major bleeding in 1.8, stroke in 1.2 patients per 100 patient-years, and 87 patients (10.9%) died during the follow-up period. Adverse drug reactions were reported by 59 patients (7.4%). Finally, 249 patients (31.2%) reported a temporary interruption and 132 (16.5%) permanent discontinuation of NOAC treatment, of whom 33 (25%) patients switched to a vitamin‑K antagonist.ConclusionsWe observed low rates of bleeding and adverse drug reactions. However, rates of mortality and discontinuation were relatively high. These results could possibly be explained by the real-world nature of the data including higher-risk patients.Electronic supplementary materialThe online version of this article (10.1007/s12471-019-01330-y) contains supplementary material, which is available to authorized users.

Highlights

  • Current guidelines recommend non-vitamin-K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF) [1,2,3,4]

  • This is the first report on real-world use of all four non-vitamin-K oral anticoagulants (NOACs) in atrial fibrillation (AF) patients in a large cardiology centre in the Netherlands

  • acetylsalicylic acid (ASA) was discontinued after initiation of NOAC therapy, since in our centre we use NOAC monotherapy in patients with AF and coronary or peripheral artery disease

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Summary

Introduction

Current guidelines recommend non-vitamin-K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF) [1,2,3,4]. This is the first report on real-world use of all four non-vitamin-K oral anticoagulants (NOACs) in atrial fibrillation (AF) patients in a large cardiology centre in the Netherlands. We found rates of stroke and bleeding that were similar to those of phase III randomised controlled trials (RCTs) of NOACs in AF patients. All-cause mortality was higher and discontinuation rates were lower than in these RCTs. This study confirms that the use of NOACs in everyday clinical practice is safe and efficacious. Management and outcomes of real-world use of non-vitamin-K oral anticoagulants (NOACs) in patients. K oral anticoagulants (NOACs) as the firstchoice therapy for stroke prevention in patients with atrial fibrillation (AF).

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