Non‐vitamin K antagonist oral anticoagulants (NOACs) in patients with concomitant atrial fibrillation and heart failure: a systemic review and meta‐analysis of randomized trials

Abstract

Background No pooled analysis has been undertaken to assess the efficacy and safety of the non‐vitamin K antagonist oral anticoagulants (NOACs) compared with warfarin in the subgroup of patients with atrial fibrillation (AF) and heart failure (HF), including edoxaban data from recent randomized controlled trials (RCTs). Methods Comprehensive literature searches were conducted using the Cochrane Library, MEDLINE, and Scopus databases from inception to April 2015. Statistical analyses were performed using RevMan 5.3 software. Results Four RCTs were included: 19 122 of 32 512 AF patients with HF were allocated to a NOAC (13 384 receiving single‐/high‐dose NOAC regimens), and 13 390 to warfarin. Among AF patients with HF, single/high‐dose NOACs significantly reduced the risk of stroke/systemic embolic (SE) events by 14% [odds ratio0.86, 95% confidence interval (CI) 0.76–0.98), and had a 24% lower risk of major bleeding(OR 0.76, 95% CI 0.67–0.86). For low‐dose NOAC regimens, comparable efficacy to warfarin for stroke or SE events (OR 1.02, 95% CI 0.86–1.21) and a non‐significant trend for lower major bleeding was observed. Regardless of high‐ or low‐dose NOAC, the incidences of both major bleeding and stroke/SE in AF patients with HF were similar to those without HF. Atrial fibrillation patients with HF on NOACs had a 41% lower risk of intracranial haemorrhage compared with those without HF (OR 0.59, 95% CI 0.40–0.87). Conclusion Among AF patients with HF, single‐/high‐dose NOAC regimens have a better efficacy and safety profile, but low‐dose regimens had similar efficacy and safety to warfarin. NOACs were similarly effective or even safer (less intracranial haemorrhage) in AF patients with HF compared with those without HF.

Atrial Fibrillation and Heart Failure: Approaches to Antithrombotic Therapy

“…Значительный интерес представляют результаты двух недавно проведенных мета-анализов для оценки эффективности и безопасности ПОАК у пациентов с ФП в сочетании с СН, а также влияния наличия СН на эффект ПОАК у пациентов с ФП в сочетании с СН и без СН [42,43]. В первом мета-анализе [42] при оценке результатов первичной эффективности и без-опасности было проведено разделение на две под-группы: I -режим единственной дозировки (рива-роксабан 20 мг 1 раз/день или апиксабан 5 мг 2 раза/ день) или высокой дозировки (дабигатран 150 мг 2 раза/день или эдоксабан 60 мг 1 раз/день) и II -режим низкой дозировки (дабигатран 110 мг 2 раза/день или эдоксабан 30 мг 1 раз/день).…”

“…В первом мета-анализе [42] при оценке результатов первичной эффективности и без-опасности было проведено разделение на две под-группы: I -режим единственной дозировки (рива-роксабан 20 мг 1 раз/день или апиксабан 5 мг 2 раза/ день) или высокой дозировки (дабигатран 150 мг 2 раза/день или эдоксабан 60 мг 1 раз/день) и II -режим низкой дозировки (дабигатран 110 мг 2 раза/день или эдоксабан 30 мг 1 раз/день).…”

Untitled

“…Pre-specified subgroup analyses of the four randomized phase III trials on stroke prevention in non-valvular AF (RE-LY, Rocket-AF, ARISTOTLE and ENGAGE AF-TIMI 48) on the safety and efficacy of non-vitamin K-dependent oral anticoagulants (NOACs) compared to the VKA warfarin showed a similar efficacy and safety profile in patients with and without HF, respectively [20]. However, the definition of HF in these phase III trials varied and (serial) LVEF assessment was not regularly done at baseline or during follow-up [10].…”

Management of atrial fibrillation in specific patient populations

“…Oral anticoagulation is essential in HF patients with AF. One recent meta-analysis showed that in this group of patients standard-dose NOAC regimens have a better efficacy and safety profile than warfarin, while low-dose regimens are similarly effective and safe as warfarin, and therefore should be preferred [49]. …”