Editorial

Updated NICE guideline: management of atrial fibrillation (2014) Expert Review of Cardiovascular Therapy Downloaded from informahealthcare.com by Nyu Medical Center on 01/10/15 For personal use only.

Expert Rev. Cardiovasc. Ther. 12(9), 1037–1040 (2014)

Keitaro Senoo‡ University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Dudley Road, Birmingham, B18 7QH, UK

Yee Cheng Lau‡ University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Dudley Road, Birmingham, B18 7QH, UK

Gregory YH Lip Author for correspondence: University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Dudley Road, Birmingham, B18 7QH, UK Tel.: +44 121 507 5080 Fax: +44 121 554 4083 [email protected]

Authors contributed equally

There is significant progress made in the field of atrial fibrillation, especially regarding stroke stratification, novel pharmacological agents and interventions for improving symptom control. The Updated NICE Guideline for management of 2014 reflects that and provided an up-to-date appraisal regarding atrial fibrillation treatment, management with consideration to overall healthcare cost economics. It emphasizes the need for individualized, patient-centered package of care, and an robust stroke and bleeding risk before decision regarding choice of oral anticoagulation to be made.

Atrial fibrillation (AF) is the most common cardiac arrhythmia and contributes to significant mortality and morbidity, from stroke, heart failure, cognitive dysfunction and impaired quality of life. To improve the management of AF, the National Institute of Health and Clinical Excellence (NICE) in conjunction with the Royal College of Physicians (RCP London) collaborated to release the first AF guideline in 2006 [1]. The purpose of the guideline was to educate clinicians and to recommend up-to-date, evidencebased AF management strategies, with the ultimate aim of breaking down barriers to the provision of effective clinical care. Since the 2006 guideline, major advances in the field of AF have been made, through the introduction of new classes of pharmaceutical agents (such as the non-vitamin K antagonist oral anticoagulants [NOACs]), increasing experience with AF ablation and left atrial appendage occlusion strategies, as well as a greater focus on patient-centered and symptom-directed AF management. In June 2014, NICE (now called the National Institute for Health and Care Excellence) published a detailed and comprehensive update spanning 420 pages [2]. Steps were taken by the Guideline Development Group to appraise the quality of evidence in the scientific data when

considering clinical and cost effectiveness. This editorial will attempt to briefly summarize the NICE Guideline: management of AF (2014) and provide some comparisons with recent guidelines from North America and Europe [3,4]. First and foremost, the updated 2014 NICE guideline (similar to its European and American contemporaries) highlights the importance of offering AF patients an individualized package of care that is patient centered and symptom directed. Treatment and care should be tailored to individual needs and accounting for patient’s preferences, including the provision of comprehensive patient education and information regarding cause, effect and complications of AF, discussions regarding AF symptoms to guide rate-control or rhythm-control strategy, personalized stratification of stroke versus bleeding risk and subsequent anticoagulation choice, etc. Each step delivered in this fashion will empower individual patient’s understanding of their condition and treatment plan, contributing to an improved patient experience and hopefully culminating to better compliance and clinical outcomes [5]. Second, the guideline advocates use of new risk stratification tools for stroke and bleeding risk, which are the CHA2DS2VASc [6] and HAS-BLED scores [7], respectively. The CHA2DS2-VASc is now

KEYWORDS: atrial fibrillation • guideline • ischaemic stroke prevention • risk stratification • symptom management

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10.1586/14779072.2014.943189

 2014 Informa UK Ltd

ISSN 1477-9072

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Editorial

Senoo, Lau & Lip

the recommended stroke risk assessment score, as prior studies in AF patient groups designated as ‘low risk’ by (say) the older risk scores such as CHADS2 score still included many patients with elevated stroke risk [8]. In keeping with the European guideline, the management focus has now shifted toward identifying ‘truly low-risk’ patients who will not benefit from antithrombotic therapy (that is CHA2DS2-VASc score = 0 for men or score = 1 for females), as the first decision step. Subsequent to this step, effective stroke prevention (that is, oral anticoagulation) can be offered to patients with ‡1 additional stroke risk factors. Stroke prevention should be considered in all AF patients regardless of symptoms, type or duration of AF, and also for patients suffering from atrial flutter. Emphasis is also made regarding patients who are in sinus rhythm postelectrical cardioversion, as the risk of recurrence of arrhythmia in this group is significant and thus continual use of stroke prevention will be needed. On the other hand, as bleeding risk is a legitimate concern amongst those who are about to be initiated on oral anticoagulant, the guideline also recommends the use of the HAS-BLED score, to assess bleeding risk and ‘flag up’ the patients potentially at risk of bleeding, for more careful review and/or followup. This simple score also helps identify and address modifiable bleeding risk factors such as harmful alcohol use, concurrent aspirin/NSAID therapy in an anticoagulated patient or labile INRs. Rather than withholding oral anticoagulation due to a high HAS-BLED score, the benefit of stroke reduction with oral anticoagulation usually outweighs the risk of serious bleeding in most AF patients with ‡1 stroke risk factors, resulting in a positive net clinical benefit [9,10]. Third, relating to stroke prevention, the new guideline recommends initiation of oral anticoagulant after prior risk stratification, and with consideration of clinical features and patient’s preference. The NICE guideline recommends effective stroke prevention with oral anticoagulation, whether delivered as a NOAC (with dabigatran, rivaroxaban and apixaban already previously evaluated by NICE as cost–effective) or well-controlled vitamin K antagonists (e.g., warfarin) with focus on good-quality anticoagulation, with a high average individual time in therapeutic range (TTR) of >65%. NOACs clearly have many advantages and, with the many choices available, we can fit the drug to the patient (and vice versa) [11]; the NICE guidance does not recommend one NOAC over another; although various indirect comparisons have been published [12,13], they are no substitute for head-tohead trials. Indeed, translation of the NOAC data and new guideline to clinical practice has been modeled to have a positive net clinical benefit in the presence of ‡1 stroke risk factors [14] and make a substantial impact on reducing strokes and bleeding [15]. For those who are started on VKAs, regular assessment of quality of anticoagulation is recommended. This is done by calculating the patient’s TTR. Poor TTRs are related to increasing the risk of hemorrhage and ischemic stroke [16,17].

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The guideline clearly state that aspirin monotherapy should not be offered for stroke prophylaxis due to its lack of efficacy, increased propensity for bleeding and lack of cost–effectiveness [18]. Among those few patients who are intolerant or where oral anticoagulant is contraindicated, the use of dual antiplatelet therapy with aspirin and clopidogrel may be considered, if at low bleeding risk – as such combination therapy carries the same bleeding risks as warfarin. Otherwise, a left atrial appendage (LAA) occlusion device may be considered, and this interventional device has already been subject to a NICE technology appraisal. Thus, the NICE guidance does allow for consideration of percutaneous LAA occlusion in the few highly selected patients for who oral anticoagulants are not eligible or contraindicated, though with strong emphasis that LAA occlusion is not an alternative to oral anticoagulation treatment. Due to the high variability in techniques and success rate, surgical closure of LAA [19] has not been discussed in the current NICE guideline. The stroke prevention algorithm from the 2014 NICE guideline is shown in FIGURE 1. When comparing rate-control versus rhythm-control strategies, the guideline recommends rate control as first-line strategy for all patients with AF, guided by the results of randomized trials which demonstrated no clinical benefits relating to mortality, heart failure or stroke. The use of a rhythm-control strategy is further hindered by its inherent risk of ventricular arrhythmia and sudden cardiac death; therefore it is only recommended for those who remain symptomatic of AF despite adequate rate control, especially where AF is reversible or those with concomitant heart failure. The NICE guidance makes no preference for beta-blocker or rate-limiting calcium channel blocker when used as initial monotherapy for those patients who requiring rate-control strategy. Conversely, the new guideline only recommends using digoxin as monotherapy only for non-paroxysmal AF patients who are sedentary. The role of amiodarone for long-term rate control is not recommended, given the significant risk of side effects associated with longterm use. Thus, amiodarone treatment is now relegated to those with significant structural heart disease, or pre- and postelectrical cardioversion to enhance the success of maintenance of sinus rhythm. Among those who remain symptomatic despite optimized pharmacological treatment (regardless of rate control or rate plus rhythm control) for paroxysmal AF, percutaneous AF ablation is recommended by the new guidance (aligned with both European and American guidelines); however, it does emphasize the need for careful discussion regarding the risk and benefit of ablation strategy, as repeated ablation procedures may be needed to achieve ‘success’. Despite the use of percutaneous AF ablation strategy, it does not eliminate the need for long-term oral anticoagulation as the rate of asymptomatic AF actually increases by over three-fold after ablation treatment [20]. Thus, it is not to be if the AF will recur but how hard clinicians look for those recurrences post-ablation.

Expert Rev. Cardiovasc. Ther. 12(9), (2014)

Updated NICE guideline

Stroke risk stratification (CHA2DS2-VASc score) Bleeding risk stratification (HAS-BLED score)

Discuss risks and benefits of anticoagulation

Expert Review of Cardiovascular Therapy Downloaded from informahealthcare.com by Nyu Medical Center on 01/10/15 For personal use only.

Identify low risk patients CHA2DS2-VASc=0 (men) or 1 (women)

CHA2DS2-VASc=1 (in men) Consider oral anticoagulant

People who choose not to have treatment

Low risk

CHA2DS2-VASc≥2 Offer oral anticoagulant

Editorial

No anti-thrombotic therapy

Anticoagulation contraindicated

Discuss the options for anticoagulation with patient (based on their clinical features and preferences)

Vitamin K antagonists (VKA)

Poor control

Non-VKA oral anticoagulant

Non VKA contraindicated or not tolerated

Left atrial appendage occlusion

Annual review for all patients

Figure 1. Stroke prevention algorithm.

The NICE guideline also includes key priorities for implementation, as well as research recommendations. There are accompanying documents that include a patient decision aid, NICE pathways and a NICE NOAC Implementation Collaborative Consensus document. All will help implementation of the guidance. In conclusion, the latest update to the AF guideline by NICE has addressed pressing issues surrounding the modern treatment of AF, especially by appraising and incorporating the latest evidence for the prevention of AF-related ischemic stroke. There is now reasonably good alignment between the UKderived NICE guideline, and its European and American counterparts. The challenge now is to publicize and implement its guidance, and all of us should help do this. Further reading

NICE version of guideline: • http://guidance.nice.org.uk/CG180/NICEGuidance/pdf/ English • Full guideline:http://guidance.nice.org.uk/CG180/Guidance

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• The guideline has been published alongside a Patient Decision Aid: http://guidance.nice.org.uk/CG180/PatientDecisionAid/pdf/English and a web-based NICE pathway: • http://pathways.nice.org.uk/pathways/atrial-fibrillation • There is also a NOAC implementation document to complement the NICE guidelines:http://guidance.nice.org.uk/CG180/ NICConsensusStatement/pdf/English Financial & competing interests disclosure

K Senoo holds a NIHON KOHDEN/St. Jude Medical Arrhythmia Fellowship. GYH Lip has served as a consultant for Bayer, Astellas, Merck, Sanofi, BMS/Pfizer, Daiichi-Sankyo, Biotronik, Medtronic, Portola and Boehringer Ingelheim, and has been on the speakers bureau for bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic and Sanofi Aventis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

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factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010;137: 263-72

References

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National Institute for Health and Clinical Excellence(NICE). NICE CG(36), atrial fibrillation: the management of atrial fibrillation. 2006. Available from: http:// publications.nice.org.uk/atrial-fibrillationthe-management-of-atrial-fibrillation-cg36 [Last accessed 18 June 2014]

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Olesen JB, Torp-Pedersen C, Hansen ML, Lip GY. The value of the CHA2DS2-VASc score for refining stroke risk stratification in patients with atrial fibrillation with a CHADS2 score 0-1: a nationwide cohort study. Thromb Haemost 2012;107:1172-9

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January CT, Wann LS, Alpert JS, et al. 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 Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014. [Epub ahead of print]

9.

Olesen JB, Lip GY, Lindhardsen J, et al. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: a net clinical benefit analysis using a ‘real world’ nationwide cohort study. Thromb Haemost 2011;106: 739-49

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Expert Rev. Cardiovasc. Ther. 12(9), (2014)

Updated NICE guideline: management of atrial fibrillation (2014).

There is significant progress made in the field of atrial fibrillation, especially regarding stroke stratification, novel pharmacological agents and i...
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