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Archie is 70 years old and has recently retired after working for 33 years as a civil engineer. For several years he has been eagerly looking forward to spending more time with his four young grandchildren. He has a history of hypertension but is otherwise well. Following several recent episodes of feeling faint and dizzy, he was diagnosed with non-valvular atrial fibrillation (NVAF). After discussion with his doctor, the decision was made to start anticoagulation.
At the age of 70, it is likely that Archie will be on anticoagulation for many years to come; although he is not in a vulnerable population now, he may well be in the future. How would you treat Archie to ensure that he receives the best possible protection against the complications of atrial fibrillation (AF)?
Patients with AF frequently suffer from co-morbid diseases, which can complicate treatment and worsen prognosis. Several often-encountered challenges facing patients with AF are: diabetes (found in around 22% of patients with AF), renal impairment (found in around 10% of patients with AF) and cardiovascular disease (of which coronary artery disease alone is found in around 20% of patients with AF).1 All of these co-morbidities can influence the likelihood of stroke or alter bleeding risk.2-4
Co-morbidities are frequently encountered in patients with AF1
AF, atrial fibrillation
Opting for the most appropriate anticoagulant for a patient with AF can provide the best chance of protection from the potentially life-threatening or debilitating consequences of stroke.5
It is important that clinical trials are conducted in patient populations that are representative of those who will ultimately be prescribed the treatment. The ROCKET AF trial studied rivaroxaban in vulnerable patients with AF, its population had the highest mean CHADS2 score of the phase III non-vitamin K antagonist oral anticoagulant (NOAC) studies.6 Around 40% of patients in ROCKET AF had diabetes, 21% had moderate renal impairment, 63% had heart failure and 55% had experienced a prior stroke or a transient ischaemic attack (TIA).6,7 Of the phase III NOAC trials, this was the greatest proportion of patients with these conditions, with results that consistently demonstrated a reliable treatment effect.7-11
ROCKET AF had the most vulnerable patient population of the phase III NOAC studies8-11
CHADS2, Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke or transient ischaemic attack (2 points); NOAC, non-vitamin K oral anticoagulant. The results are not intended for direct comparison.
Extensive data can help to build confidence in a treatment. In addition to the vulnerable patient population assessed in ROCKET AF, a broad range of data have been generated from studies of patients on rivaroxaban in the real-world setting. For example, RIVA-DM is a large, retrospective electronic health records analysis study that has shown that patients in the real-world setting with diabetes and AF experience a similar benefit from rivaroxaban compared with warfarin as seen in the ROCKET AF study.6,12 RIVA-DM also showed that there were lower rates of cardiovascular death in this high-risk group than with warfarin, which was consistent with a subanalysis of ROCKET AF.13,14 The RELOAD and ANTENNA studies have also provided reassuring data. The RELOAD study demonstrated reduced incidence of stroke and intracranial haemorrhage in patients with impaired renal function versus phenprocoumon.15 Results from ANTENNA showed that patients with preserved renal function experienced a safety profile consistent with phase III clinical trial findings, and also showed a benefit in terms of worsening kidney function versus warfarin.16
For many patients with AF, there is a breadth of data available for rivaroxaban that can provide reassurance that it has been thoroughly tested in patients just like themselves.
Modern AF management strategies, like those encouraged by the European Society of Cardiology (ESC), emphasize integrated, patient-centred management, and can provide a way to improve adherence.17 Placing your patient at the centre of their management means considering all options for medication, given both their current health status and an awareness of any possible complicating factors that may develop over time.
For vulnerable patients at high risk of stroke, it is not enough to just prescribe an anticoagulant, the patient must stick to their treatment. Around one-third of patients are not adherent to stroke prevention therapy, and those patients have twice the risk of stroke compared with patients who adhere to their treatment.18
The factors that influence medication adherence can be broken down into patient factors, physician factors and healthcare system factors.17 Physicians influence adherence through effective reduction of polypharmacy and by working with patients to improve their understanding of their condition and treatment.17
Factors influencing adherence can be divided into three groups17
Dr Yassir Javaid highlighted how important it was to encourage adherence to anticoagulation therapy: “It’s a really good opportunity to reinforce that significant increase in stroke risk, and the tremendous importance and opportunity of reducing that risk with compliance with a good quality anticoagulation therapy”.
Promoting a patient’s understanding of their condition is an important way to optimize their adherence and subsequent protection from anticoagulation.17 In addition, studies have found that reducing pill burden increases the likelihood of adherence to treatment.19 Selecting a treatment regimen with only one daily dose, such as rivaroxaban, may provide a solution to further optimize adherence.
For patients who are likely to be on anticoagulation in the long-term, such as Archie, the decision of which is the most appropriate treatment selection should be multifactorial and should consider their current situation while looking towards the longer-term challenges of increasing age and the likelihood of developing co-morbidities. Putting patients at the centre of the decision-making process will provide them with the best opportunity to benefit from stable, long-term continuous treatment, regardless of any future complications.