The imminent NICE guidelines for AF – what are the implications? David Hargroves, Consultant Physician, Clinical Lead for Stroke Medicine, East Kent Hospitals.

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

[email protected]

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


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 stroke prevention guidelines (draft 2014)

Consideraspirin +

clopidogrel



Consideraspirin +

clopidogrel

Non-valvular

CHA2DS2-VASc

No antithrombotic

therapy


Dose-adjusted VKA

(INR 2.0–3.0)

NOAC drugs§

ApixabanDabigatran

Rivaroxaban

1† ≥2

OAC therapy


and preferences


Dose-adjusted VKA

(INR 2.0–3.0)


or permanent



Preferred option


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


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]


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


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]


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:


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]


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]




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



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


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


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



Consideraspirin +

clopidogrel

Non-valvular

CHA2DS2-VASc

No antithrombotic

therapy


Dose-adjusted VKA

(INR 2.0–3.0)

NOAC drugs§

ApixabanDabigatran

Rivaroxaban

1† ≥2

OAC therapy


and preferences


Dose-adjusted VKA

(INR 2.0–3.0)


or permanent



Preferred option


[email protected]

The imminent NICE guidelines for AF

– what are the implications?

The imminent NICE guidelines for AF – what are the implications? David Hargroves, Consultant Physician, Clinical Lead for Stroke Medicine, East Kent Hospitals.

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