Dr Matthew Fay explains why the NICE quality standard for atrial fibrillation in adults was needed to encourage the use of anticoagulation therapy and help reduce the risk of stroke
Atrial fibrillation (AF), defined as an irregular and often rapid cardiac rhythm that highlights pathological changes in the atrium, is the most common, sustained cardiac dysrhythmia. In the UK, it is estimated that AF affects approximately 900,000 people, or 1.74% of the general population.1 These atrial changes lead to a prothrombotic state in the atria allowing for thrombus formation. It is the embolisation of this thrombus to the cerebral circulation that leads to a five-fold increase in stroke and, in the UK, it is estimated that 12,500 strokes are directly attributable to AF annually.2,3
The majority of AF-related stroke can be prevented through effective anticoagulation treatment. Appropriately anticoagulating AF delivers a 60% reduction in the risk of stroke for an individual.4 However, appropriate treatments are not always offered, with intervention rates suggesting that over 40% of individuals diagnosed with an increased risk of having a debilitating and potentially fatal stroke are left untreated.5
Improving current practice with respect to stroke prevention in AF is a clear and important priority within the emerging cardiovascular outcomes strategy.7
The AF Association found that 8000 AF-related strokes could be prevented every year with the use of a risk stratification tool in primary care known as GRASP-AF (guidance on risk assessment and stroke prevention for atrial fibrillation)8 and appropriate anticoagulation. Moreover, it could save the NHS £124 million.1
NICE updated guideline on atrial fibrillation
In June 2014, NICE issued its updated guideline, Clinical Guideline (CG) 180, on Atrial fibrillation: management.3 Publication of this guideline met with some reaction from the medical profession, as it was the first national AF guideline to distance itself from antiplatelet agents in stroke risk reduction. Although the main emphasis of CG180 was on stroke risk reduction, it also focused on interventions for the symptoms of AF.
The guideline included a patient decision aid (and user guide), the first to be endorsed by NICE, to assist the clinician in supporting patients to make decisions for the prevention of AF-related stroke (see www.nice.org.uk/guidance/cg180/resources).9
NICE CG180 also has a series of technical appraisals of the available non-vitamin K oral anticoagulants (NOACs, i.e. apixaban, dabigatran etexilate, and rivaroxaban), which influence the way these medications are referenced within the guideline. Furthermore, NICE Diagnostics Guidance (DG) 14 on Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers,10 became available shortly after CG180 was published.
Quality standard for the treatment and management of AF in adults
The six statements that comprise NICE Quality Standard (QS) 93 on Atrial fibrillation: treatment and management are listed in Table 1 (see below) and are discussed in detail below.12
|1||Adults with non-valvular atrial fibrillation and a CHA2 DS2 -VASc stroke risk score of 2 or above are offered anticoagulation|
|2||Adults with atrial fibrillation are not prescribed aspirin as monotherapy for stroke prevention|
|3||Adults with atrial fibrillation who are prescribed anticoagulation discuss the options with their healthcare professional at least once a year|
|4||Adults with atrial fibrillation taking a vitamin K antagonist who have poor anticoagulation control have their anticoagulation reassessed|
|5||Adults with atrial fibrillation whose treatment fails to control their symptoms are referred for specialised management within 4 weeks|
|6||(developmental) Adults with atrial fibrillation on long-term vitamin K antagonist therapy are supported to self-manage with a coagulometer|
Developmental quality statements set out an emergent area of cutting-edge service delivery or technology currently found in a minority of providers and indicating outstanding performance. They will need specific, significant changes to be put in place, such as redesign of services or new equipment.
|NICE (2012). QS93. Quality standard for the treatment and management of atrial fibrillation in adults. Available at: www.nice.org.uk/guidance/qs93|
Reproduced with permission
NICE QS93 on AF in adults is designed so that the key points of NICE CG180 are implemented. The overall emphasis is to ensure that:
- people are offered high-quality stroke prevention services
- interventions chosen by patients are appropriate and effective
- clinicians respond to patients' symptoms promptly.
Anticoagulation to reduce stroke risk—statement 1
This statement reflects the paradigm shift of stroke assessment in NICE CG180. The prevailing approach is that all people with AF have an increased risk of stroke and only those at low risk should not be offered oral anticoagulation.
The NICE guideline for the management of AF issued in 200613 also emphasised the need to protect people from AF-related stroke and introduced an algorithm to assist in the decision-making process; however, despite this and the subsequent addition of AF to the QOF,11 levels of anticoagulation therapy in people at risk remained at approximately 50%.5
When assessing the CHA2 DS2 -VASc score6,5,15 it is important to recall that males with a score of 1 are also at risk of AF-related stroke and should be considered for anticoagulation therapy.12 Consideration should also be given to what risk factor has scored the point, because some factors are more significant than others, for example hypertension carries a greater risk than congestive heart failure.14
It is important to highlight that people with metallic heart valves or valvular AF (defined as haemodynamically significant rheumatic mitral stenosis), should not be risk assessed using CHA2 DS2 -VASc because anticoagulation with a vitamin K antagonist (VKA) is obligated in these individuals.16
Use of aspirin and discussing options for anticoagulation—statements 2 and 3
The removal of any recommendation for aspirin monotherapy is an important development in stroke prevention. The ineffectiveness of aspirin in preventing the cardioembolic stroke of AF has long been established; the use of aspirin, however, has maintained its position in national and international guidelines due to its role in the primary prevention of cardiovascular disease. NICE CG180 removed any recommendations for the use of aspirin for the prevention of AF-related stroke. Individuals with occlusive vascular disease, such as coronary artery disease, who decline oral anticoagulation therapy should maintain aspirin monotherapy. If they choose to receive an oral anticoagulant, aspirin monotherapy can be discontinued unless there has been an acute event in the previous 12 months.16
The recommendation about stopping aspirin monotherapy reflects the evidence of the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (ACTIVE)-A study.17 ACTIVE-A compared aspirin monotherapy with aspirin and clopidogrel (NB clopidogrel is not licensed for use in the prevention of AF-related stroke). The study cohort was made up of patients with AF in whom oral anticoagulation therapy was considered inappropriate, had previously been declined, or had previously been discontinued. The results of the ACTIVE-A study showed an increased effectiveness of dual antiplatelet therapy (DAPT) compared with aspirin monotherapy; however, this was at the expense of increased bleeding.
When considering the results of the ACTIVE-A study,17 the ACTIVE-W study should also be discussed.18 This study, which compared controlled VKA with DAPT in patients at high risk of AF-related stroke who did not have contraindications to oral anticoagulants, was terminated early not only because the oral anticoagulant was superior in preventing stroke but also because it substantially reduced the severity of the vascular events.
More recently, the apixaban versus acetylsalicylic acid to reduce the rate of embolic stroke (AVERROES) trial,19 which had a patient cohort similar to the ACTIVE-A study, compared aspirin monotherapy with the NOAC apixaban. The AVERROES trial also demonstrated the clear superiority of the anticoagulant, necessitating the discontinuation of the study. At the point of study termination, there was no significant difference in the bleeding rates in the two cohorts.
When reviewing this evidence regarding DAPT, one must consider in what situations use of antiplatelet agents would be considered over use of an oral anticoagulant when the antiplatelet agents are inferior to oral anticoagulants for the same bleeding risk.
Anticoagulation control—statement 4
The anticoagulation options currently available to clinicians and patients have changed dramatically in the last few years. NICE guidance specifies that options available to patients should include VKAs (such as warfarin) and the NOACs apixaban, dabigatran etexilate, and rivaroxaban, within their respective marketing authorisations and NICE technology appraisal guidance. For people who are taking warfarin, the potential risks and benefits of switching to a NOAC should be considered in light of their level of international normalised ratio (INR) control. Only VKAs can be used in people with valvular atrial fibrillation, and this should be explained to the patient.3,12
- the choice of anticoagulant should be made by the patient and supported by the treating clinician. NICE does not specify order of treatment from the list of licensed VKAs and NOACs—patient personal preferences and comorbidities should be taken into account
- warfarin control is important to reduce risk of stroke and of having a major bleed. NICE CG180 and QS93 specify that, for those individuals taking a VKA, poor anticoagulation control can be shown by any of the following:3,12
- two INR values higher than 5 or one INR value higher than 8 within the past 6 months
- two INR values less than 1.5 within the past 6 months
- time in therapeutic range (TTR) less than 65%
- therapeutic range should be measured at each visit and at least annually, and healthcare professionals should:3,12
- use a validated method of measurement such as the Rosendaal method for computer-assisted dosing or proportion of tests in range for manual dosing
- exclude measurements taken during the first 6 weeks of treatment
- calculate TTR over a maintenance period of at least 6 months
- if poor control is noted in individuals taking a VKA, then the following factors should be assessed and addressed if they are contributing to poor anticoagulation control:
- cognitive function
- adherence to therapy
- interacting drug therapy
- lifestyle factors including diet and alcohol consumption
- if poor anticoagulation control is not improved as a result of this reassessment the use of an alternative anticoagulant should be considered
- if anticoagulation is contraindicated or not tolerated, left atrial appendage occlusion should be considered.
Referral for specialised management—statement 5
Although much of CG180 is dedicated to stroke prevention, it is clear that AF can affect the quality of life in many people who experience the dysrhythmia.3 The guideline highlights that, as there is no established prognostic benefit between rate and rhythm management, rate control should always be considered first in those with symptomatic AF.3 Treatment for rate control should be commenced with a standard beta-blocker or a rate-limiting calcium-channel blocker.3 If monotherapy does not control the symptoms within 4 weeks, however, or if the side-effects of the intervention are significant, then a prompt referral to a cardiologist with a specific interest in dysrhythmia (an electophysiologist or nurse with an interest in arrhythmia) is recommended.12 This respects the adage that AF begets AF and the longer someone is in persistent AF, the less likely they are to experience a return to sinus rhythm.20
Self-monitoring of anticoagulation—statement 6 (developmental)
This statement refers to NICE Diagnostics Guidance 1410 on the use of self-monitoring for patients who choose or require a VKA (e.g. people with metallic heart valves or valvular AF). Once a patient is stabilised on their VKA, they should be offered self-monitoring and possibly self-management (i.e. self-adjusting the dosage of their anticoagulant medication according to an agreed care protocol).
Statement 6 is the first developmental quality statement; NICE says that developmental quality statements 'set out an emergent area of cutting-edge service delivery or technology currently found in a minority of providers and indicating outstanding performance'.12 Such statements will need specific, significant changes to be put in place (e.g. redesign of services or new equipment).12
In the author's opinion, as the environment of anticoagulation changes and if the use of NOACs increases, then it is possible there may be a reduction in the availability of local clinics for VKA monitoring. This developmental quality statement reflects this potentially changing environment.
Atrial fibrillation is the most prevalent sustained dysrhythmia in the general population with an increasing prevalence in the elderly. The changes to the atria that facilitate the propagation of the dysrhythmia also make a prothrombotic environment, which allows clot formation that can subsequently cause cardioembolic stroke.
NICE QS93 on AF reflects the importance of anticoagulation therapy for individuals at risk of AF-related stroke to prevent thrombus formation. It also highlights the need to promptly refer those individuals with symptomatic AF to specialists to ensure rhythm options are considered before the changes to the atria become too advanced for successful intervention.21
- Atrial fibrillation is the most common, sustained cardiac dysrhythmia and if left untreated is a significant risk factor for stroke
- Most AF-related strokes can be prevented through effective anticoagulation treatment
- People with AF should not be prescribed aspirin as monotherapy to prevent stroke
- Anticoagulation treatment options available to patients with AF should include VKAs (e.g. warfarin) and NOACs
- If warfarin is used for stroke prevention, the quality of anticoagulation control is crucial to reduce the risk of stroke and of a major bleed
- People with AF whose symptoms do not respond to treatment or who experience side-effects should be referred promptly for specialised management.
AF=atrial fibrillation; NOAC=non-vitamin K oral anticoagulants
- Proportion of adults with:
- non-valvular AF and a CHA2 DS2 -VASc stroke risk score of 2 or above who receive anticoagulation
- AF who are prescribed aspirin as monotherapy for stroke prevention
- AF who are prescribed anticoagulation who discuss the options with their healthcare professional at least once a year
- AF taking a VKA who have their TTR recorded at each visit for INR assessment
- poor anticoagulation control who have it reassessed
- AF whose treatment fails to control their symptoms who are referred for specialised management within 4 weeks
- AF on long-term VKA therapy who are supported to self-manage with a coagulometer.
AF=atrial fibrillation; VKA=vitamin K antagonist; TTR=time in therapeutic range; INR=international normalised ratio
NICE (2015) QS92.Quality standard for the treatment and management of atrial fibrillation in adults. Available at: www.nice.org.uk/guidance/qs93
Reproduced with permission.
GP commissioning messages
written by Dr David Jenner, NHS Alliance GMS contract/PBC Lead
- AF is a major risk factor for ischaemic stroke; however, this risk can be effectively mitigated for individuals through anticoagulation treatment
- Anticoagulation rates remain at around 50% so CCGs should identify through QOF, hospital admission, and prescribing data the incidence of stroke, AF, and anticoagulant prescription per practice
- Where there are concerns about unexplained low prevalence of diagnosed AF or anticoagulation rates, or high levels of exception reporting, investigating the reasons why with practices is advisable
- Anticoagulation with VKAs is often delivered through an enhanced service and the relevant commissioner (CCG or NHS England) could build in quality requirements to that enhanced service to report the TTR for patients and review those with poor control
- CCGs will be concerned about the costs of the NOACs on prescribing budgets (NOACs are now recommended as an option for treatment in non-valvular AF by NICE) and may wish to issue local guidance to GP practices indicating where their use is most beneficial and cost effective.
AF=atrial fibrillation; QOF=quality and outcomes framework; VKA=vitamin K antagonist; TTR=time in therapeutic range; NOACs=novel anticoagulants
- NHS Improving Quality. Costs and benefits of antithrombotic therapy in atrial fibrillation in England: an economic analysis based on GRASP-AF. NHS Improving Quality, 2014. Available at: www.nhsiq.nhs.uk/media/2566025/af_economic_analysis_final.pdf↩
- Atrial Fibrillation Association. Atrial fibrillation and anticoagulation—challenges and considerations. Atrial Fibrillation Association, 2012. Available at: www.atrialfibrillation.org.uk/files/file/130911-cjw-FINAL-AF&Anticoagulation-Challenges&Consids.pdf↩
- NICE. Atrial fibrillation: management. Clinical Guideline 180. NICE, 2014. Available at: www.nice.org.uk/guidance/cg180↩
- Hart R, Pearce L, Aguilar M. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007 19; 146 (12): 857–867. ↩
- Cowan C, Healicon R, Robson I et al. The use of anticoagulants in the management of atrial fibrillation among general practices in England. Heart 2013; 99 (16):1166–1172. ↩
- Camm A, Lip G, Caterina R et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Eur Heart J 2012; 33: 2719–2747. ↩
- Department of Health. Cardiovascular Disease Outcomes Strategy. Improving outcomes for people with or at risk of cardiovascular disease. DoH, 2013. Available at: www.gov.uk/government/uploads/system/uploads/attachment_data/file/217118/9387-2900853-CVD-Outcomes_web1.pdf↩
- Atrial Fibrillation Association, Anticoagulation Europe. The AF report atrial fibrillation: preventing a stroke crisis. AF Association, 2012. Available at: www.atrialfibrillation.org.uk/files/file/Publications/130322-jf-FINAL-AF%20report.pdf↩
- NICE. Patient decision aid. Atrial fibrillation: medicines to help reduce your risk of a stroke—what are the options? NICE, 2014. Available at: www.nice.org.uk/guidance/cg180/resources↩
- NICE. Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor). Diagnostic Guidance 14. NICE, 2014. Available at: www.nice.org.uk/guidance/dg14 (accessed 11 November 2015). ↩
- NHS Employers website. Quality and outcomes framework. www.nhsemployers.org/your-workforce/primary-care-contacts/general-medical-services/quality-and-outcomes-framework (accessed 19 November 2015). ↩
- NICE. Atrial fibrillation: treatment and management. Quality Standard 93. NICE, 2015. Available at: www.nice.org.uk/guidance/qs93 (accessed 11 November 2015). ↩
- NICE. Atrial fibrillation: the management of atrial fibrillation. Clinical Guideline 36. NICE, 2006. ↩
- Lip G, Nieuwlaat R, Pisters R et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro Heart Survey on atrial fibrillation. Chest 2010; 137 (2): 263–272. ↩
- American College of Cardiology. Atrial fibrillation toolkit. Available at: www.acc.org/tools-and-practice-support/clinical-toolkits/atrial-fibrillation-afib (accessed 19 November 2015). ↩
- Heidbuchel H, Verhamme P, Alings M et al. Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 2015; 17:1467–1507. ↩
- ACTIVE Writing Group on behalf of the ACTIVE Investigators, Connolly S, Pogue J. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet 2006; 367 (9526): 1903–1912 ↩
- The ACTIVE investigators. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009; 360 (20): 2066–2078. ↩
- Connolly S, Eikelboom J, Joyner C et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364 (9): 806–817. ↩
- Atrial Fibrillation Association website. Fitzpatrick A. Diagnosis of PAF. www.atrialfibrillation.org.uk/medical-professionals/docs/diagnosis-of-paf.html (accessed 2 December 2015) ↩
- Uijl D, Bax J. Left atrial size as a predictor of successful radiofrequency catheter ablation for atrial fibrillation. Europace 2009; 11: 1255–1256. ↩G