Stroke prevention in patients with AF in 2019: A year in review
Advancements in stroke prevention in patients with AF and co-morbidities
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
For more information on diabetes, renal impairment and the importance of preserving renal function in patients with AF, please see our newsletters on: diabetes; renal impairment; co-morbid diabetes and renal impairment; and preserving renal function.
What does the new real-world data show?
Patients with AF and renal impairment
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.
Patients with AF and diabetes
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.
Summary
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.
Guideline updates in 2019
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
Why is the management of patients with AF and co-morbidities challenging?
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.
References
- Bonnemeier H, Kreutz R, Kloss S et al. Comparative safety and effectiveness of non-vitamin-K oral anticoagulants vs phenprocoumon in patients with non-valvular atrial fibrillation and renal disease - results from the RELOADED study. 5th European Stroke Organisation Conference. Milan, Italy, 22–24 May 2019, Abstract AS25-066. Available at: https://journals.sagepub.com/toc/esoa/4/1_suppl [accessed 20 November 2019]. Bonnemeier H, Kreutz R, Kloss S et al. Comparative safety and effectiveness of non-vitamin-K oral anticoagulants vs phenprocoumon in patients with non-valvular atrial fibrillation and renal disease - results from the RELOADED study. 5th European Stroke Organisation Conference. Milan, Italy, 22–24 May 2019, Abstract AS25-066. Available at: https://journals.sagepub.com/toc/esoa/4/1_suppl [accessed 20 November 2019]. Return to content
- Bonnemeier H, Kreutz R, Kloss S et al. Comparative safety and effectiveness of non-vitamin-K oral anticoagulants vs phenprocoumon in patients with non-valvular atrial fibrillation and diabetes - results from the RELOADED study. 5th European Stroke Organisation Conference. Milan, Italy, 22–24 May 2019, AS25-069. Available at: https://journals.sagepub.com/toc/esoa/4/1_suppl [accessed 20 November 2019]. Bonnemeier H, Kreutz R, Kloss S et al. Comparative safety and effectiveness of non-vitamin-K oral anticoagulants vs phenprocoumon in patients with non-valvular atrial fibrillation and diabetes - results from the RELOADED study. 5th European Stroke Organisation Conference. Milan, Italy, 22–24 May 2019, AS25-069. Available at: https://journals.sagepub.com/toc/esoa/4/1_suppl [accessed 20 November 2019]. Return to content
- Bonnemeier H, Huelsebeck M, Kloss S. Comparative effectiveness of rivaroxaban versus a vitamin K antagonist in patients with renal impairment treated for non-valvular atrial fibrillation in Germany - A retrospective cohort study. Int J Cardiol Heart Vasc 2019;23:100367. Return to content
- Coleman CI, Kreutz R, Sood NA et al. Rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and severe kidney disease or undergoing hemodialysis. Am J Med 2019;132:1078–1083. Return to content
- Baker WL, Beyer-Westendorf J, Bunz TJ et al. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab 2019;21:2107–2114. Return to content
- Coleman CI, Kreutz R, Sood N et al. Rivaroxaban's impact on renal decline in patients with nonvalvular atrial fibrillation: A US MarketScan claims database analysis. Clin Appl Thromb Hemost 2019;25:1076029619868535. Return to content
- Vaitsiakhovich T, Coleman CI, Kleinjung F et al. Worsening of renal function in atrial fibrillation patients with stage 3 or 4 chronic kidney disease treated with warfarin or rivaroxaban - evidence from the real-world CALLIPER study in the US claims. European Society of Cardiology Congress. Paris, France, 31 August–5 September 2019, Poster P4746. Return to content
- Hernandez AV, Bradley G, Khan M et al. Rivaroxaban versus warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes 2019: doi:10.1093/ehjqcco/qcz047. Return to content
- January CT, Wann LS, Calkins H et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in collaboration with the Society of Thoracic Surgeons. Circulation 2019;140:e125–e151. Return to content
- The Stroke Risk in Atrial Fibrillation Working Group. Independent predictors of stroke in patients with atrial fibrillation: a systematic review. Neurology 2007;69:546–554. Return to content
- Gheith O, Farouk N, Nampoory N et al. Diabetic kidney disease: world wide difference of prevalence and risk factors. J Nephropharmacol 2016;5:49–56. Return to content
- Boriani G., Laroche C., Diemberger I. et al. Glomerular filtration rate in patients with atrial fibrillation and 1-year outcomes. Sci Rep. 2016;6:30271. Return to content
- Fanikos J., Burnett A.E., Mahan C.E. et al. Renal function considerations for stroke prevention in atrial fibrillation. Am J Med. 2017;130(9):1015–23. Return to content
- Olesen J.B., Lip G.Y., Kamper A.L. et al. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med. 2012;367(7):625–35. Return to content
- Jha AK, Larizgoitia I, Audera-Lopez C et al. The global burden of unsafe medical care: analytic modelling of observational studies. BMJ Qual Saf 2013;22:809–815. Return to content
- Afkarian M, Sachs MC, Kestenbaum B et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol 2013;24:302–308. Return to content
- Mahmoodi BK, Yatsuya H, Matsushita K et al. Association of kidney disease measures with ischemic versus hemorrhagic strokes: pooled analyses of 4 prospective community-based cohorts. Stroke 2014;45:1925–1931. Return to content
- Boehme AK, Esenwa C, Elkind MS. Stroke risk factors, genetics, and prevention. Circ Res 2017;120:472–495. Return to content
- Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988. Return to content
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Updated date 10/10/2022
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