AF AND NOACSAN UPDATE JULY 2014

Helen WilliamsConsultant Pharmacist for CV Disease

South London

AF is the leading - and most preventable - cause of embolic stroke

Risk increases with age

Without preventive treatment, approximately 1 in 20 patients (5%) with AF will have a stroke each year

0

5

10

15

20

25

50-59 60-69 70-79 80-89

% of strokes attributable to AF

Kannel WB et al. Am J Cardiol 1998; 82 (8A): 2N–9N.

AF and stroke risk

Age (years)

%

NICE Guidance 2014

NICE Priorities (CG180)

Personalised package of care Assessment of stroke and bleeding risk

Use of CHA2DS2-VASc and HASBLED

Anticoagulation with warfarin or a NOAC Stop using aspirin for stroke

prevention in AF Rate and rhythm control Specialist referral and interventions

where first line options fail to manage symptoms adequately

CHA2DS2-VASc

Score Annual stroke rate, %

0 0

1 1.3

2 2.2

3 3.2

4 4.0

5 6.7

6 9.8

7 9.6

8 6.7

9 15.2

•Congestive heart failure/1

LV dysfunction•Hypertension

1•Age 75

2•Diabetes mellitus

1•Stroke/TIA/TE

2•Vascular disease

1(CAD, CArD, PAD)

•Age 65-741

•Sex category (female)1

Score 0 – 9Validated in 1084 NVAF patients not on OAC with known TE status at 1 year in Euro Heart SurveyOR for stroke if: Female: 2.53 (1.08 – 5.92), p=0.029; Vascular disease: 2.27 (0.94 – 5.46), p=0.063

Assessment of risk of bleeding - HAS-BLED

Pisters R, et al. Chest 2010;138:1093-100

ScoreBleeds per 100 patient-

years

0 1.13

1 1.02

2 1.88

3 3.74

4 8.70

•Hypertension (current)

1

•Abnormal renal/liver function

1/2

•Stroke

1

•Bleeding

1

•Labile INR

1

•Elderly (age > 65 years)

1

•Drugs or alcohol

1/2

Score 0 – 9

Validated in 3978 NVAF patients with known TE status at 1 year in Euro Heart Survey

c-statistic 0.72 (similar to HEMORR2HAGES)0.91 vs 0.85 for patients on ASA or no therapy

Low

Inter-mediate

High

c-statistic 0.72

Myths and Misconceptions…

Aspirin is as effective as oral anticoagulation

Aspirin is safer than oral anticoagulation

Falls are a C/I to anticoagulant therapy

Prior GI bleeds are a C/I to anticoagulation

So, where are we now?

Up to 15% of patients cannot take warfarin due to allergy, contraindication or inability to manage the monitoring requirements.

Up to 40% are not controlled within therapeutic range on warfarin

Up to 45% with atrial fibrillation at high stroke risk are not currently anticoagulated – see QOF!

Where are we now?

50%

55%

60%

65%

70%

75%

80%

85%

90%

95%

100%

Warfarin vs NOACs share (DOT)

WARFARIN NOAC

1. Data on file: Bristol-Myers Squibb Pharmaceuticals Limited

~4% uptake of NOACs in the UK market

DOT = Days on therapy

NOACs: Prioritizing Patients

HIGH PRIORITY

MEDIUM PRIORITY

LOWER PRIORITY

Patients unable to take warfarin due to allergies / CI and patients unable to comply with monitoring of warfarin (n=207)

Patients out of range (n =252 – 501)

New Patients (n=261)

Patients on aspirin or nothing (n= 629-1257)

Patients currently stable on warfarin (n=756 – 1005)£425-

£565k

£147k

£505 - £1,010k

£141 -£282k

£166k

What about costs?** Annual costs based on a CCG in South London, population 300k (prevalence = 0.9%)

= 7 strokes prevented

= 8 -16 strokes prevented

= 20 - 40 strokes prevented

= 3 – 5 strokes

prevented

…. And return on investment?

Plus... up to £915k for currently undetected AF

Novel oral anticoagulantsSW London Positioning 2014/15

An alternative to warfarin for SPAF in patients with CHADS2 ≥ 1 who: have a warfarin allergy, warfarin specific-

contraindication or are unable to tolerate warfarin therapy

are unable to comply with the specific monitoring requirements of warfarin

are unable to achieve a satisfactory INR after an adequate trial of warfarin

have had an ischaemic stroke whilst stable on warfarin therapy

are unwilling to take warfarin after a full discussions of the risks and benefits

SWL Positioning 2014/15

Warfarin is a suitable first-line option for many patients

Initiation by clinicians with ‘expertise in initiating anticoagulation’

Initiating clinician responsible for at least first 3 months of therapy:

Address side effects Emphasise importance of adherence

Transfer to patients own GP when ‘stable’ and in line with approved indications

Prescribing NOACs

Check indication – AF, VTE treatment or prophylaxis Check patient age – dose adjustment at 80 years

with dabigatran Check renal function

Not just eGFR Calculate creatinine

clearance Check for adverse effects

Dabigatran dyspepsia in up to 10% patients Rivaroxaban / apixaban: headache / dizziness

Check adherence No monitoring of bloods (except annual renal function) therefore

possible increased risk of non-adherence over time