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AF and NOACs An UPDATE JULY 2014. Helen Williams Consultant Pharmacist for CV Disease South London. AF and stroke risk. % of strokes attributable to AF. AF is the leading - and most preventable - cause of embolic stroke Risk increases with a ge
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AF and NOACsAn UPDATE JULY 2014 Helen Williams Consultant Pharmacist for CV Disease South London
AF and stroke risk % of strokes attributable to AF • 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 % Age (years) Kannel WB et al. Am J Cardiol1998; 82 (8A): 2N–9N.
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 • 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 65-74 1 • Sex category (female) 1 Score 0 – 9 Validated in 1084 NVAF patients not on OAC with known TE status at 1 year in Euro Heart Survey OR 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 • Hypertension (current) 1 • Abnormal renal/liver function 1/2 • Stroke1 • Bleeding 1 • Labile INR 1 • Elderly (age > 65 years) 1 • Drugs or alcohol 1/2 Low Inter- mediate High Score 0 – 9 c-statistic 0.72 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 Pisters R, et al. Chest 2010;138:1093-100
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 controlledwithin therapeutic range on warfarin • Up to 45% with atrial fibrillation at high stroke risk are not currently anticoagulated – see QOF!
Where are we now? • ~4% uptake of NOACs in the UK market Data on file: Bristol-Myers Squibb Pharmaceuticals Limited DOT = Days on therapy
NOACs: Prioritizing Patients …. And return on investment? Patients unable to take warfarin due to allergies / CI and patients unable to comply with monitoring of warfarin(n=207) HIGH PRIORITY = 7 strokes prevented £166k = 8 -16 strokes prevented £141 -£282k Patients out of range (n =252 – 501) MEDIUM PRIORITY = 20 - 40 strokes prevented Patients on aspirin or nothing (n= 629-1257) £505 - £1,010k £147k New Patients (n=261) = 3 – 5 strokes prevented LOWER PRIORITY Patients currently stable on warfarin (n=756 – 1005) £425- £565k Plus... up to £915k for currently undetected AF * Annual costs based on a CCG in South London, population 300k (prevalence = 0.9%) What about costs?*
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