the imminent nice guidelines for af – what are the implications? david hargroves, consultant...
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The imminent NICE guidelines for AF
– what are the implications?David Hargroves,
Consultant Physician,Clinical Lead for Stroke Medicine,
East Kent Hospitals University NHS Foundation Trust.
29th April 2014
Pulse Live event 2014:Novotel London West One
Disclosures
• I am principle investigator for 2 industry funded NOAC compliance studies.
• I have received sponsorship / speaker fees / and or consultancy fees from: BI, Bayer, BMS, Pfizer.
Atrial fibrillation: the management of atrial fibrillation
NICE guideline
Draft for consultation, January 2014
This guidance is an update of NICE clinical guideline 36 (published June 2006) and will replace it when
published 11th June 2014
4
Atrial fibrillation (AF)
• AF is the most common heart rhythm disturbance1
• It is estimated 1 in 4 individuals aged 40 years will develop AF1
• Due to the aging population, this number is expected to double within 30 years3
1. Lloyd-Jones DM, et al. Circulation 2004;110:1042-1046. 2. Decision Resources. Atrial Fibrillation Report. Dec 2008. 3. Go AS, et al. JAMA 2001;285:2370-2375.
The prevalence of AF is estimated at 1.3% of the general
population and increases sharply with age
The average GP:
• Will have 20–25 cases on their personal list
• Can expect to diagnose at least 3 new cases per annum
In press- Lip G, Heath R. 10 steps before you refer for: ATRIAL FIBRILLATION. British journal of cardiology.
Atrial Fibrillation (AF) and Stroke
• Stroke is the most serious ongoing risk associated with AF1
• In patients with AF, blood clots tend to form in the atria, particularly within the left atrial appendage, due to abnormal blood flow and pooling2
• These clots may travel to the brain, causing an ischaemic stroke2
1. Wolf PA et al. Stroke 1991;22:983–988; 2. Fuster V et al. Circulation 2006;114:700–752; 3. Paciaroni M et al. Stroke 2007;38:423–430
AF increases the risk of stroke
• AF is associated with a pro-thrombotic state– ~5 fold increase in stroke risk 1
• Risk of stroke is the same in AF patients regardless of whether they have paroxysmal or sustained AF 2,3
• Cardio embolic stroke has a 30-day mortality
of 25% 4
• AF-related stroke has a 1-year mortality of ~50% 51. Wolf PA, et al. Stroke 1991;22:983-988; 2. Rosamond W et al. Circulation. 2008;117:e25–146; 3.Hart RG, et al. J Am Coll Cardiol
2000;35:183-187; 4. Lin H-J, et al. Stroke 1996; 27:1760-1764; 5. Marini C, et al. Stroke 2005;36:1115-1119.
Common Causes of Stroke
Atrial Fibrillation
Myocardial Infarct
Valve Disease
ThrombosisAtherosclerosis
Embolism
Large vessel disease-30%
Cardioembolic-35%
Small vessel disease-35%
England Overview
Publically available HES data 2012
Percentage of Ischaemic Strokes that have a diagnosis of AF
36.2%
36.4%
36.6%
36.8%
37.0%
37.2%
37.4%
37.6%
37.8%
38.0%
2009 2010 2011
37.9%
37.7%
36.8%
Sentinel Stroke National Audit Programme of the Royal College of Physicians*
Jan- March 2013England, Wales, Northern Ireland
11,939 stroke admissions
OAC; An-tirhtombotics; 36;
36%
Antiplatelet; An-tirhtombotics; 38;
38%
Nothing; An-tirhtombotics; 26;
26%
OAC 36%
Nothing 26%
Antiplatelets 38%
5,969 in AF
*www.rcplondon.ac.uk
11
How are AF patients at risk of stroke currently being managed?
Gladstone DJ et al. Stroke 2009;40:235–240.
Preadmission medications in patients with known atrial fibrillation who were admitted with acute ischemic
stroke (high-risk cohort, n=597)Sub- therapeuticwarfarin, 29%
Therapeutic warfarin, 10%
Single antiplateletagent, 29%
Dual antiplatelettherapy, 2%
No antithrombotic29%
Only 60 are diagnosed
Of the 60, 58 have moderate or high
stroke risk
http://www.preventaf-strokecrisis.org/files/files/AF%20Report%208%20Feb%2012.pdf Accessed Jan 2012
For every 100 patients with AF…
Of the 58, only 31 are
anticoagulated
Of the 31, only 18 have INRs in
range regularly
New oral anticoagulants
CommonPathway
IXX
TF VIIa
VIII
Xa
Thrombin
Fibrin
Thrombinactivity
Initiationphase
AmplificationPropagation
phase
PlateletSurface
XII
XI
Contact
Fibrinogen
RivaroxabanApixaban
Warfarin
Dabigatran etexilate
Continued symptoms?
Personalised package of care and information
Diagnosis of AF
Stroke prevention
Rate control
strategies
Rhythm control
strategies
Ablation strategiesMonitoring
NICE AF draft guidance (January 2014)
Personalised package of care and information
NICE AF draft guidance (January 2014)
Measures to prevent stroke
Rate control
Assessment of symptoms for rhythm control
Psychological support if needed
Up-to-date and comprehensive education and information on:
Cause, effects and possible complications of atrial fibrillation Management of rate and rhythm control Anticoagulation Practical advice on anticoagulation in line with
recommendation 1.3.1 in ‘Venous thromboembolic diseases’ (NICE clinical guideline 144)
Support networks. [new 2014]
Stroke risk assessment with CHA2DS2-VASc
CHA2DS2-VASc criteria Score
Congestive heart failure/left ventricular dysfunction
1
Hypertension 1
Age 75 yrs 2
Diabetes mellitus 1
Stroke/transient ischaemic attack/TE
2
Vascular disease(prior myocardial infarction, peripheral artery disease or aortic plaque)
1
Age 65–74 yrs 1
Sex category (i.e. female gender)
1
CHA2DS2-VASc total score
Rate of stroke/other TE (%/year)*
0 0.78
1 2.01
2 3.71
3 5.92
4 9.27
5 15.26
6 19.74
7 21.50
8 22.38
9 23.64
1 Lip GYH et al. Stroke 2010;41:2731–2738.2 Olesen JB et al BMJ 2011, 342: d124NICE AF draft guidance (January 2014)
ESC 2012 AF stroke prevention guidelines
Consideraspirin +
clopidogrel or aspirin only‡
Consider LAAO, or LAA excision
CHA2DS2-VASc:1 and not suitable for, or refusing, NOAC or VKA
CHA2DS2-VASc: 2 refusing OAC
Consideraspirin +
clopidogrel or aspirin only‡
Non-valvular
CHA2DS2-VASc
No antithrombotic
therapy
Aged <65 years, no cardiovascular disease
CHA2DS2-VASc: 2 unsuitable for OAC
Dose-adjusted VKA
(INR 2.0–3.0)
NOAC drugs§
ApixabanDabigatran
Rivaroxaban
1† ≥2
OAC therapy
Assess bleeding risk (HAS-BLED)Consider patient values
and preferences
Suitable for OAC therapy
Dose-adjusted VKA
(INR 2.0–3.0)
Valvular* AFparoxysmal, persistent
or permanent
Camm AJ et al. Europace 2012;14(10):1385–413, European Heart Journal (2012) 33, 2719–2747. Page 2726 – 4.4 fig 1
Options not well validated
Less preferable or less validated
Preferred option
Offer first line anticoagulation to all patients with CHADsVaSc ≥2 and consider in males ≥1 [new 2014]
Anticoagulation may be with apixaban, dabigatran etexilate, rivaroxaban or a vitamin K antagonist [new 2014]
Recommendations for use of NOACs are in line with the relevant Technology Appraisals [new 2014]
Do not withhold anticoagulation solely because the person is at risk of having a fall [new 2014]
Anticoagulation for stroke prevention
Do not offer aspirin monotherapy solely for stroke prevention to people with atrial fibrillation [new 2014]
Only consider dual antiplatelet therapy with aspirin and clopidogrel for stroke prevention if anticoagulation is contraindicated or not tolerated and the person has a CHA2DS2-VASc score of 2 or above [new 2014]
NICE AF draft guidance (January 2014)
NICE AF stroke prevention guidelines (draft 2014)
Consideraspirin +
clopidogrel
CHA2DS2-VASc:1 and not suitable for, or refusing, NOAC or VKA
CHA2DS2-VASc: 2 refusing OAC
Consideraspirin +
clopidogrel
Non-valvular
CHA2DS2-VASc
No antithrombotic
therapy
Aged <65 years, no cardiovascular disease
Dose-adjusted VKA
(INR 2.0–3.0)
NOAC drugs§
ApixabanDabigatran
Rivaroxaban
1† ≥2
OAC therapy
Assess bleeding risk (HAS-BLED)Consider patient values
and preferences
Suitable for OAC therapy
Dose-adjusted VKA
(INR 2.0–3.0)
Valvular* AFparoxysmal, persistent
or permanent
Options not well validated
Less preferable or less validated
Preferred option
NICE AF draft guidance (January 2014)
OAC benefits outweigh bleeding risk for most people
For people with an increased risk of bleeding the benefit of anticoagulation may not always outweigh the bleeding risk, and careful monitoring of bleeding risk is important [new 2014]
uncontrolled hypertension poor control of INR (‘labile INRs’) concurrent medication, for example concomitant use
of aspirin or an NSAID harmful alcohol consumption [new 2014]
Correct and monitor:
HAS-BLED bleeding risk score
Assess bleeding risk
NICE AF draft guidance (January 2014)
Friberg L, Rosenqvist M, Lip GY.. Circulation 2012;125:2298–307
Balancing risk using theCHA2DS2-VASc and HAS-BLED scores
0
0.2
0.4
0.6
0.8
1.0
HA
S-B
LE
D ≥
3 p
0
0.2
0.4
0.6
0.8
1.0
0 1 2 3 4
0
0.2
0.4
0.6
0.8
1.0
0
0.2
0.4
0.6
0.8
1.0
0 1 2 3 4Years
HA
S-B
LE
D 0
–2 p
CHA2DS2–VASc 0–2 p CHA2DS2–VASc ≥3 p
Ris
k fo
r in
trac
ran
ial
ble
edin
g
Risk for embolic stroke
P<0.00001(n=1.787)
P<0.00001(n=43.395)
P<0.00001(n=59.817)
P<0.00001(n=53.797)
No OAC
No OAC
OAC
OAC
No OAC
No OAC
OAC
OAC
Assessing anticoagulation control with VKAs
Calculate the person’s time in therapeutic range (TTR) at each visit
When calculating TTR: 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 [new 2014]
NICE AF draft guidance (January 2014)
2 INRs >5 or 1 INR >8 in past 6/12
2 INRs <1.5 in past 6 months
TTR less than 65%. [new 2014]
Reassess anticoagulation for a person with poor anticoagulation control shown by any of the following:
Assessing anticoagulation control with VKAs
NICE AF draft guidance (January 2014)
Reassessing anticoagulationTake into account and if possible correct the following factors:
Cognitive function Adherence to prescribed therapy Illness Interacting drug therapy Lifestyle factors including diet and alcohol
consumption. [new 2014]
If poor anticoagulation control cannot be improved, evaluate the risks and benefits of alternative stroke prevention strategies and discuss these with the person. [new 2014]
NICE AF draft guidance (January 2014)
Diabetes
Heart failure
Peripheral arterial disease
Coronary heart disease
Stroke, transient ischaemic
attack or systemic
thromboembolism [new 2014]
People with AF not taking an anticoagulant
Review stroke risk when they reach age 65 or if they develop any of the following at any age:
NICE AF draft guidance (January 2014)
Rate and rhythm control
Assess and offer rate control as the first line strategy for all people with AF
Initial monotherapy with β-blocker or rate-limiting CCB
Digoxin monotherapy only for non-paroxysmal AF in sedentary patients [new 2014]
If monotherapy does not control symptoms, combine 2 of : β-blocker Diltiazem Digoxin [new 2014]
Do not offer amiodarone for long term rate control [new 2014]
[new 2014]
NICE AF draft guidance (January 2014)
Offer rhythm control to people with or without continuing symptoms if they have any of the following:
AF with a reversible cause
Heart failure thought to be primarily caused by AF
New-onset AF [new 2014]
Rate and rhythm control
NICE AF draft guidance (January 2014)
Rate and rhythm control
Consider pharmacological and/or electrical rhythm control for people with atrial fibrillation whose symptoms continue after heart rate has been controlled or a rate-control strategy has not been successful
Electrical Cardioversion (ECV) if AF persisted > 48hrs
Consider amiodarone 4 weeks before and 12 months after ECV to maintain sinus rhythm
TOE guided and conventional ECV considered equally effective
Offer β-blocker (e.g. sotalol) for long-term rhythm control if needed
NICE AF draft guidance (January 2014)
Rate and rhythm control
Consider pharmacological and/or electrical rhythm control for people with atrial fibrillation whose symptoms continue after heart rate has been controlled or a rate-control strategy has not been successful
LV impairment or heart failure
Consider amiodarone
If β-blockers unsuccessful or contraindicated…..
Structural heart disease
Do not offer flecainide or
propafenone*
*increased risk of ventricular arrhythmiasNICE AF draft guidance (January 2014)
Refer people promptly at any stage if treatment fails to control the symptoms of atrial fibrillation and referral for more specialised management is needed. [new 2014]
Referral for specialised management
NICE AF draft guidance (January 2014)
If drug treatment has failed to control symptoms of atrial fibrillation or is unsuitable: offer left atrial catheter ablation to
people with paroxysmal atrial fibrillation consider left atrial surgical or catheter
ablation for people with persistent atrial fibrillation
discuss the risks and benefits with the person [new 2014]
Left atrial ablation
NICE AF draft guidance (January 2014)
Atrial fibrillation: the management of atrial fibrillation
NICE guideline
Draft for consultation, January 2014
This guidance is an update of NICE clinical guideline 36 (published June 2006) and will replace it when
published 11th June 2014
NICE AF stroke prevention guidelines (draft 2014)
Consideraspirin +
clopidogrel
CHA2DS2-VASc:1 and not suitable for, or refusing, NOAC or VKA
CHA2DS2-VASc: 2 refusing OAC
Consideraspirin +
clopidogrel
Non-valvular
CHA2DS2-VASc
No antithrombotic
therapy
Aged <65 years, no cardiovascular disease
Dose-adjusted VKA
(INR 2.0–3.0)
NOAC drugs§
ApixabanDabigatran
Rivaroxaban
1† ≥2
OAC therapy
Assess bleeding risk (HAS-BLED)Consider patient values
and preferences
Suitable for OAC therapy
Dose-adjusted VKA
(INR 2.0–3.0)
Valvular* AFparoxysmal, persistent
or permanent
Options not well validated
Less preferable or less validated
Preferred option
NICE AF draft guidance (January 2014)