New Oral Anticoagulants (NOACs)Dabigatran and Rivaroxaban

for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation

Educational Event23rd & 24th January 2013

West Suffolk Hospital Education Centre

WSCCG NOACs in AF Prescribing Guidelines

Linda LordHead of Medicines Management (GP Prescribing)

West Suffolk Clinical Commissioning Group

WSCCG NOAC Guidelines

• Detailed advice on use of NOACs for prevention of stroke and systemic embolism in nonvalvular AF

• Based on NICE TA 249 and 256

• Includes expert advice of local clinicians

• Core guidance: 15 pages

• Appendices

• Manufacturers’ Summaries of Product Characteristics

GP Responsibilities1 Initiating a NOAC

2 Converting from warfarin to a NOAC

3 Prescribing a NOAC as on-going treatment

4 Referring to hospital for possible NOAC initiation

Please refer to WSCCG guidelines

Page number

Initiating a NOAC

1. Ensure NICE criteria metDabigatran

One or more of following risk factors:

•Previous stroke or TIA

•Left ventricular ejection fraction <40%

•Symptomatic heart failure NYHA ≥ class 2

•Age ≥ 75 years

•Age ≥ 65 years with one of following: diabetes mellitus, coronary artery disease, hypertension

1. Ensure NICE criteria met

Rivaroxaban

One or more risk factors such as:

•Congestive heart failure

•Hypertension

•Age ≥ 75 years

•Diabetes mellitus

•Prior stroke or TIA

2. Consider further points (strong recommendations)

• CHADS2 or CHA2DS2-VASc ≥ 2

• eGFR

> 40 for dabigatran

> 25 for rivaroxaban

• No history of significant peptic ulcer disease

p.3-4

2. Consider further points (strong recommendations)

At least one of these:• Warfarin contraindicated• Venous access for INR not possible• Insurmountable difficulties with safe

compliance of INR monitoring and dose adjustments, e.g. cognitive decline

• HAS-BLED ≥ 3• Warfarin has been stopped due to

intolerance, poor response or significant bleed while taking warfarin

2. Consider further points (strong recommendations)

• No significant ischaemic heart disease

• No other contraindications

• Special warnings, precautions and drug interactions have been considered (appendices 6,7,8)

p.4-5

2. Consider further points (strong recommendations)

• Informed discussion with patient has taken place: disadvantages/ advantages

p.9-10

3. Record details in patients’ notes

• Which NICE criteria satisfied

• Why a NOAC (name and dose) has been selected rather than warfarin*

* Use of checklist 4a recommended

p.21

4. Perform baseline blood tests

• FBC (platelet count must be >100 x 109/L & stable)

• U&Es

• Clotting screen

• LFTs

• eGFR

5. Counsel patient• Indication

• Treatment schedules and duration

• Side effects

• Common interactions, including OTC medicines

• Avoid pregnancy and breast feeding

• Importance of compliance

• More… p.18

6. Issue alert card

Available free from stores

7. Provide on-going treatment and monitoring

Discussed later

Converting from warfarin to a NOAC

Converting from warfarin to a NOAC

1. Ensure NICE criteria met – as before

2. Consider further points (strong recommendations) – as before

3. Record details in patients’ notes: Which NICE criteria met Why warfarin converted to a NOAC

(name and dose)*

*Use of checklist 4b recommendedp.23

Converting from warfarin to a NOAC

4. Counsel patient – as before

5. Issue alert card – as before

Converting from warfarin to a NOAC

6. Implement conversion safely:

Step 1 – Stop warfarinStep 2 – Wait for 3 days Step 3 – Check INR. Dabigatran can be given as soon as INR <2. Rivaroxaban should be initiated when INR ≤ 3

Converting from warfarin to a NOAC

7. Inform anticoagulant services that warfarin has been stopped

8. Provide on-going treatment and monitoring (discussed later)

Prescribing a NOAC as on-going treatment

On-going treatment and monitoring

• At least annual clinical review• At least annual eGFR if renal

function normal, more frequent if impaired

• Twice yearly FBC, LFT and U&E if renal function normal, more frequent if impaired

• Close clinical surveillance (looking for signs of bleeding or anaemia)

p.15

On-going treatment and monitoring

• Being alert to: Risks if acute decline in renal

function, e.g. due to dehydration, shock, initiation of nephrotoxic medicines such as NSAIDs, ACEIs, aminoglycosides

Possibility of discharge on extended prophylaxis to reduce risk of VTE

p.15

Referring to hospital for possible initiation of a

NOAC

Referral is appropriate if:• Patient has complex co-morbidities

• GP does not know what to do/ cannot weigh up pros and cons of anticoagulation in whatever form

• Criteria and strong recommendations for NOAC satisfied but GP does not feel competent to prescribe a NOAC

Referral – further information • Referral not normally expected

• No specific NOAC clinic at WSH

• Referral to general medical or cardiology clinics in exceptional cases

• Use of checklist 4a (initiation of NOAC) or 4b (conversion from warfarin) recommended

p.21-22

SummaryWarfarin is suitable for most patients

and is the preferred option if:

•eGFR <40

(eGFR 40-50: beware of risk of progressive/acute renal dysfunction)

•History of significant peptic ulcer disease

•Significant ischaemic heart disease

Please keep a vigilant eye on medication safety literature regarding NOACs. Potentially life-threatening side effects

New Oral Anticoagulants (NOACs)Dabigatran and Rivaroxaban

for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation

Educational Event23rd & 24th January 2013

West Suffolk Hospital Education Centre

WSCCG NOACs in AF Prescribing Guidelines

Linda LordHead of Medicines Management (GP Prescribing)

West Suffolk Clinical Commissioning Group