Protecting elderly patients with atrial fibrillation
Monica is 82 years old, loves to travel and has been planning her dream holiday in the Caribbean with her new partner, Lionel. She leads a busy life, regularly volunteering at a suicide prevention helpline and frequently visiting family and friends.
She was diagnosed with type 2 diabetes last year after routine blood tests performed by her GP found a high serum glucose. While at her primary care centre for a diabetes review, she mentioned occasional palpitations to the practice nurse who performed a 12-lead ECG, diagnosing atrial fibrillation (AF).
Considering her age and comorbid diabetes, how would you approach Monica from the perspective of managing her AF?
Diabetes and AF are common comorbidities in older patients
Management of comorbid diabetes and AF is a frequent clinical scenario and one that warrants additional care on the part of treating clinicians.1 Both diseases become more frequent with age: AF affects nearly 1 in 5 people aged ≥85 years,2 while up to one quarter of people >60 years have diabetes.3,4
Older age and diabetes are both associated with an increased risk of stroke in patients with AF.5 The consequences of stroke can be severe – especially in older patients, making effective protection essential in this vulnerable population.6 Further information on the risks of AF and management of older patients with AF can be found here.
In spite of their increased risks, studies show that older patients are less likely to receive anticoagulation than younger patients, despite evidence supporting its use.5,7 A clearer understanding of the risks and benefits of anticoagulation in this patient group can help to address this.
Older and younger patients with NVAF receive a consistent benefit from anticoagulation with rivaroxaban compared with warfarin9
RIVA-DM found that elderly patients with diabetes were just as likely to benefit from rivaroxaban as younger patients
Real-world data, especially from large datasets like the Optum HER database, can illustrate how interventions are protecting patients in the everyday setting.8 RIVA-DM is a large observational study that was carried out using US claims data, exploring outcomes with rivaroxaban or warfarin in a population of patients with both AF and diabetes;9,10 Professor Craig Coleman provided detail on the overall population and outcomes at ESC 2021.
A subanalysis of RIVA-DM, presented at ASH 2021, aimed to determine whether there was any difference in the effectiveness or safety of rivaroxaban between patients with non-valvular atrial fibrillation (NVAF) who are <80 or ≥80 years of age.11 The ≥80 age group made up 27.5% of the overall population in RIVA-DM, comprising nearly 32,000 patients. Patients in the ≥80 years group were considerably less likely to have been prescribed rivaroxaban (20.7%) than the <80 years group (30.3%).11
Older patients with NVAF receive a similar safety benefit to younger patients from anticoagulation with rivaroxaban rather than warfarin9
The risk of bleeding for patients on rivaroxaban compared with warfarin was similar between older and younger patient groups14
Patients ≥80 years old received a consistent level of protection from rivaroxaban compared with warfarin, similar to patients <80 years.11 Patients aged ≥80 years receiving rivaroxaban had a significantly lower risk of cardiovascular death and major adverse limb events compared with those receiving warfarin, while experiencing significantly fewer major bleeding events and intracranial haemorrhages.11 This demonstrates that rivaroxaban can be used confidently in high-risk older patients with AF and diabetes, providing an effective treatment option to reduce the sequelae of AF, with low risks of bleeding.11
RIVA-DM reinforces findings from the phase III trial and other observational studies of rivaroxaban in patients with NVAF
RIVA-DM is not the first study to show that older patients with AF can benefit from treatment with rivaroxaban. The phase III ROCKET AF study comprised 14,264 patients with NVAF randomized to either warfarin or rivaroxaban for the prevention of stroke and systemic embolism.12,13 Of that population, just under half (44%) were aged ≥75 years at the time of treatment initiation.12,14 The investigators performed an additional analysis, finding that for all clinical endpoints, including stroke prevention, incidence rates for patients on rivaroxaban compared with warfarin were similar between older and younger patients. Although older patients in ROCKET AF experienced a higher rate of bleeding events overall, there was no difference in the treatment effect of rivaroxaban versus warfarin between older and younger patients.14
The risk of bleeding for patients on rivaroxaban compared with warfarin was similar between older and younger patient groups
CI, confidence interval; HR, hazard ratio.
Observational studies prior to RIVA-DM have also found low rates of adverse events and good rates of efficacy in older patient populations. The prospective XANTUS study featured a population with a mean age of 71.5 years and found low rates of stroke and bleeding events.15 Additionally, the prospective SAFIR observational study compared rivaroxaban with vitamin-K antagonists (VKA) in patients aged ≥80 years, also finding rivaroxaban had a significantly improved safety profile in terms of bleeding events compared with VKAs.16
Rivaroxaban has demonstrated it is an effective treatment with a good safety profile for the management of AF in high-risk groups
Older patients with AF and diabetes can benefit from treatment with rivaroxaban, with consistent data supporting its use in this patient group; RIVA-DM is the latest large-scale study building the case that age should not be a limiting factor for access to effective treatments against the complications of AF. In the case of Monica, she can be confident that she is protected from consequences of AF that could prevent her continuing to live a rich and fulfilled life, on a treatment that has been well-tested in patients like her.
- Nichols GA, Reinier K, Chugh SS. Independent contribution of diabetes to increased prevalence and incidence of atrial fibrillation. Diabetes Care 2009;32:1851–1856. Return to content
- Heeringa J, van der Kuip DAM, Hofman A et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J 2006;27:949–953. Return to content
- DECODE Study Group. Age- and sex-specific prevalences of diabetes and impaired glucose regulation in 13 European cohorts. Diabetes Care 2003;26:61–69. Return to content
- Centers for Disease Control and Prevention. National diabetes statistics report. 2020. Available at: https://www.cdc.gov/diabetes/data/statistics-report/index.html [accessed 28 January 2022]. Centers for Disease Control and Prevention. National diabetes statistics report. 2020. Available at: https://www.cdc.gov/diabetes/data/statistics-report/index.html [accessed 28 January 2022]. Return to content
- Hindricks G, Potpara T, Dagres N et al. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2021;42:373–498. Return to content
- Baumann M, Le Bihan E, Chau K, Chau N. Associations between quality of life and socioeconomic factors, functional impairments and dissatisfaction with received information and home-care services among survivors living at home two years after stroke onset. BMC Neurol 2014;14:92. Return to content
- Steffel J, Collins R, Antz M et al. 2021 European Heart Rhythm Association practical guide on the use of non-vitamin k antagonist oral anticoagulants in patients with atrial fibrillation. Europace 2021;23:1612–1676. Return to content
- Radawski CA, Hammad TA, Colilla S et al. The utility of real-world evidence for benefit-risk assessment, communication, and evaluation of pharmaceuticals: case studies. Pharmacoepidemiol Drug Saf 2020;29:1532–1539. Return to content
- Coleman CI, Costa OS, Brescia CW et al. Thromboembolism, bleeding and vascular death in nonvalvular atrial fibrillation patients with type 2 diabetes receiving rivaroxaban or warfarin. Cardiovasc Diabetol 2021;20:52. Return to content
- Bayer AG. A study using electronic health information to learn about rivaroxaban compared to warfarin in participants with non-valvular atrial fibrillation (NVAF) and diabetes (RIVA-DM). 2021. Return to content
- Coleman C, Brescia C, Vardar B et al. Thromboembolism, bleeding, and vascular death among older and younger nonvalvular atrial fibrillation patients with type 2 diabetes receiving rivaroxaban or warfarin. American Society of Hematology Annual Meeting. Atlanta, USA, 11–14 December 2021. Poster & Abstract 3234. Return to content
- Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883–891. Return to content
- Johnson & Johnson Pharmaceutical Research & Development LLC, Bayer. An efficacy and safety study of rivaroxaban with warfarin for the prevention of stroke and non-central nervous systemic embolism in patients with non-valvular atrial fibrillation. 2014. Available at: http://www.clinicaltrials.gov/show/NCT00403767 [accessed 28 January 2022]. Johnson & Johnson Pharmaceutical Research & Development LLC, Bayer. An efficacy and safety study of rivaroxaban with warfarin for the prevention of stroke and non-central nervous systemic embolism in patients with non-valvular atrial fibrillation. 2014. Available at: http://www.clinicaltrials.gov/show/NCT00403767 [accessed 28 January 2022]. Return to content
- Halperin JL, Hankey GJ, Wojdyla DM et al. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation 2014;130:138–146. Return to content
- Camm AJ, Amarenco P, Haas S et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 2016;37:1145–1153. Return to content
- Hanon O, Vidal JS, Pisica-Donose G et al. Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation. Heart 2021;107:1376–1382. Return to content
See Also
Bayer symposium highlights from the ESC congress 2021
See Also
Anticoagulation in high risk patients with atrial fibrillation - Episode 2
See Also
Patients with AF and diabetes
See Also
Older Patients with AF
See Also
ESC 2020 AF Diabetes Symposium
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Updated date 10/10/2022
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