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The focus on careful management of patients with atrial fibrillation (AF) and co-morbidities, such as renal impairment and diabetes, has recently intensified. 2019 has seen an accumulation of real-world data on the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with AF who also have renal impairment and/or diabetes, as well as data on the effect of NOACs on preserving renal function in these patients. These data have been published and/or presented at various congresses throughout the year.1-5
Release of new data for NOACs in stroke prevention in patients with AF and renal impairment and/or diabetes, as well as data on the effect of NOACs on preserving renal function in these patients in 2019
The high risk of renal decline and its associated adverse outcomes in patients with AF has gained increasing attention over the past year. Several studies have investigated the effect of NOACs, in particular rivaroxaban, on renal outcomes in patients with AF,1,2,6-8 and a guideline update has been published acknowledging that the choice of anticoagulation can have an impact on renal function.9
Results from a subanalysis of the retrospective database study RELOAD showed that rivaroxaban was associated with a lower incidence of ischaemic stroke and intracranial haemorrhage versus phenprocoumon in patients with AF and renal impairment.3 The favourable safety profile of rivaroxaban versus phenprocoumon in patients with renal impairment was further confirmed in the RELOADED study.1 In addition, a retrospective analysis of US Truven MarketScan claims data reported a reduced risk of major bleeding with rivaroxaban versus warfarin in patients with AF and advanced kidney disease.4
Analyses from three studies suggested that some NOACs, in particular rivaroxaban, may reduce renal function worsening compared with vitamin K antagonists (VKAs) in patients with AF regardless of whether their renal function is already impaired.1,6,7 This effect was also observed in patients with co-morbid diabetes,2,7,8 which is a particularly important result considering the increased risk of renal decline in these patients.
New data on the efficacy and safety of NOACs in patients with AF and diabetes have also been released. In the RELOADED study, NOACs were associated with a similar risk of ischaemic stroke and systemic embolism compared with phenprocoumon in patients with both AF and diabetes, with a trend towards better effectiveness for rivaroxaban.2 The study also reported a numerical benefit in the risk of intracranial haemorrhage for NOACs compared with phenprocoumon.2 Results from a US Truven MarketScan data analysis of a similar population of high-risk patients indicated that rivaroxaban was associated with lower risks of major adverse cardiovascular events and major adverse limb events versus warfarin in patients with AF and diabetes.5 This is significant because diabetes itself increases a patient’s risk of stroke by 1.7-fold.10 In addition, an alarming 20–40% of patients with diabetes are likely to suffer from chronic kidney disease,11 which puts these patients at increased risks of stroke and bleeding.12,13
The increased risks of bleeding and fatal strokes, renal decline and co-morbid diabetes become important considerations when treating patients with AF. The new data indicate that rivaroxaban provides improved protection against life-changing strokes and embolic events in these high-risk patients with AF, not only by reducing the risk of stroke and bleeding but also by preserving renal function.
Overall, 2019 has highlighted the importance of providing full protection for patients with AF and co-morbidities, including renal impairment and diabetes. By using a NOAC, such as rivaroxaban, it is possible to protect your patients from the devastating consequences of stroke, while preserving their renal function. This is an important consideration in patient care, particularly with the growing number of patients with diabetes, who are not only at increased risk of stroke and bleeding but also renal function decline.
The importance of reducing renal function decline and the potential impact of the choice of anticoagulant in patients with AF has been recognized in the 2019 update to the American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) guidelines on the management of AF, stating that ‘Over time, NOACs (particularly dabigatran and rivaroxaban) may be associated with lower risks of adverse renal outcomes than warfarin in patients with AF.’9
Managing stroke prevention in patients with AF and co-morbidities can be challenging, primarily, because of their increased risk of stroke and/or bleeding.10,14 Because of their close interconnection, co-morbid renal impairment and diabetes are of particular concern in patients with AF, a topic which was also highlighted at the Bayer-sponsored satellite symposium at ESC this year entitled ‘The bigger picture in stroke prevention and anticoagulation: Think Beyond Atrial Fibrillation’. Diabetes is one of the leading causes of chronic kidney disease and has been identified as a strong and independent risk factor for stroke in patients with AF.10,15 Renal impairment is prevalent in patients with AF12 and is associated with an increased risk of stroke, bleeding and mortality.14 The risk of mortality is even higher in patients who have both kidney disease and type II diabetes than those with either condition alone.16 Therefore, it is important to consider the adverse outcomes associated with co-morbidities when managing patients with AF.