New Oral Anticoagulants Pathway Guidance - Adult Leeds

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1. Background Information / Scope of Pathway

Quick info:
This guidance is intended to aid high quality, cost-effective care and improve clarity of understanding between primary and secondary care. It is recommended for use in primary care for Leeds patients age 18 years and over.

Recommendations assume the absence of established contraindications or cautions and that  other established interventions are also considered. Refer to the BNF, relevant NICE guidance and summaries of product characteristics for more information.  Legal and clinical responsibility lies with the prescriber.

Objectives
1. A reduction in cases of stroke and systemic embolic events. 2. Reduce the risk of and incidence of adverse events with warfarin treatment. 3. Reduce the number of patients attending LTHT for management of INR>8 4. Compliance with NICE TAs for the New Oral Anticoagulants (NOACs) Dabigatran, Rivaroxaban and, when published, Apixaban.

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2.  Information Resources for Patients and Carers

Quick info:
Anticoagulation and AF Patient Information Leaflet

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3.  Development and Updates to this Pathway

Quick info:
Approved 2.7.2013 by Leeds APC
Review date 31.3.2016 Written by Tony Jamieson

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4.  Referral Forms

Quick info:
For Referral Procedure Information please contact the NOAC Clinic:

NOAC Clinic Referral Form
Haematology Dept
Level 4 Bexley Wing
Leeds Teaching Hospital Trust Beckett Street, Leeds, LS9 7TF
Tel: 0113 2067684

Fax: 0113 2067716

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5.  Is patient suitable for anticoagulant therapy for non-valvular atrial fibrilliation?

Quick info:
Patients with confirmed AF with a CHADs 2 score of  1 who do not have a contraindication to warfarin or NOAC

CHADS2 Scoring Scheme
Condition
Points
C : Congestive heart failure 1 Point
H : Hypertension 1 Point
A : Age > 75 years 1 Point
D : Diabetes Mellitus 1 Point
S2 : Prior Stroke or TIA 2 Points

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7.  Patient is not suitable for warfarin

Quick info:
Patients who are not suitable for Warfarin
NOAC will be considered before a trial of warfarin for patients who are suitable for anticoagulation only in the following circumstances:

  • Previous confirmed allergy or alopecia with warfarin.
  • Previous history of unsuccessful treatment with warfarin for which the contributing factors still exist.
  • Major difficulty with venous access.

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10. Warfarin treatment unsuccessful

Quick info:
“Unsuccessful treatment” with warfarin
The following indicators must be present before treatment with warfarin is considered unsuccessful in patients whose adherence has been assessed and judged to be adequate:

INR>8 on one occasion in 6 months or INR>5 on two occasions in 6 months which are unexplained following clinical review of the contributing factors

Or

Confirmed allergic reaction or alopecia drug reaction.

Or

Treatment time in range (TTR) <65% after at least 9 months of taking warfarin regularly and have one or more of the risk factors:

  • Previous stroke/ TIA, systemic embolism
  • Left ventricular ejection fraction < 40%
  • Age ≥  75 years
  • Diabetes Mellitus, Coronary Artery Disease, Hypertension

(See NICE TA's for Apixaban, Dabigatran and Rivaroxaban for drug specific risk factors).

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13. Patient meets inclusion criteria for NOAC

Quick info:
NOAC inclusion criteria
Patients will be considered for NOAC if the following conditions apply: Warfarin treatment has been unsuccessful

Or

Patients whose management of warfarin puts them at unacceptable risk of harm.

And

The patient meets the NICE criteria and has given informed consent.

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14. Patient has exclusion criteria for NOAC

Quick info:
NOAC exclusion criteria
Patients who meet the inclusion criteria will be excluded from NOAC treatment if the following conditions apply:
Presence of contraindications
Age <18 years
Unresolved problems with adherence
Current injecting drug use/misuse
Women of childbearing age without adequate contraception.
Presence of interactions that lead to unmanageable risk
Patients with swallowing difficulties which prevent them from taking the unaltered formulation.

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16. Patient initiated on NOAC

Quick info:
This may be

  • Apixaban
  • Dabigatran
  • Rivaroxaban

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24. DEVELOPMENT OF CONTRAINDICATION - AT ANY TIME: Stop NOAC and Fast-track referral to NOAC Clinic

Quick info:
CONTRAINDICATIONS OF RIVAROXABAN

  • Hypersensitivity to the active substance or to any of the excipients
  • Clinically significant bleeding
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
  • Pregnancy and breast-feeding
  • eGFR <15 ml/min/1.73m2,
  • Patients on concomitant azole-antimycotics such as ketoconazole, itraconazole, voriconazole and posaconazole, dronedarone or HIV protease inhibitors. These are strong CYP and P-glycoproein (P-gp) inhibitors and can increase the levels of rivaroxaban.

(Source: Leeds Rivaroxaban Amber Drug Guidance, approved 19th June 2013)

Leeds Rivaroxaban Amber Drug Guidance

For Referral Procedure Information please contact the NOAC Clinic:
NOAC Clinic Referral Form
Haematology Dept
Level 4 Bexley Wing
Leeds Teaching Hospital Trust Beckett Street, Leeds, LS9 7TF
Tel: 0113 2067684
Fax: 0113 2067716

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27. Face to Face Review at 3 months in GP Practice with FBC U+E LFT

Quick info:
Check for drug interactions / adherence / signs of bleeding / emergence of contraindications or complicating co-morbidities
Ensure adequate contraception in women of child-bearing age
Consider management of co-morbidities which increase risk of bleeding e.g. hypertension
Reinforce safe alcohol limits
Check FBC U+E LFT
Investigate abnormal FBC LFT and refer if necessary
Follow pathway per U+E (eGFR results)

The following PIL on anticoagulation and AF may be useful to inform discussions with patients:

Anticoagulation and AF Patient Information Leaflet

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28. Face to Face Review at 3 months in GP Practice

Quick info:
Check for drug interactions / adherence / signs of bleeding / emergence of contraindications or complicating co-morbidities
Ensure adequate contraception in women of child-bearing age
Consider management of co-morbidities which increase risk of bleeding e.g. hypertension
Reinforce safe alcohol limits
Blood tests only if clinically indicated

The following PIL on anticoagulation and AF may be useful to inform discussions with patients:

Anticoagulation and AF Patient Information Leaflet

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29. Review at 12 months in GP practice with FBC U&E and LFT

Quick info:
Check for drug interactions / adherence / signs of bleeding / emergence of contraindications or complicating co-morbidities
Ensure adequate contraception in women of child-bearing age
Consider management of co-morbidities which increase risk of bleeding e.g. hypertension
Reinforce safe alcohol limits
Check FBC, U+E, LFT
Investigate abnormal FBC LFT and refer if necessary
Follow pathway per U+E (eGFR results)

The following PIL on anticoagulation and AF may be useful to inform discussions with patients:

Anticoagulation and AF Patient Information Leaflet

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30. eGFR 30-60 ml/min Declining trend

Quick info:
If eGFR trend declining then

- Manage as per NICE CKD guidelines
- Consider bleeding risk may be increased
- Review at NOAC Clinic

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31. eGFR 30-60 ml/min Stable

Quick info:
If other biochemical parameters are normal and no interactions, evidence of bleeding or problems with adherence then
6 monthly Notes review with FBC U+E LFT
If concerns investigate and refer if necessary

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32. Manage as per NICE CKD Guidelines Continue NOAC Routine referral to NOAC Clinic

Quick info:
For Referral Procedure Information please contact the NOAC Clinic:

NOAC Clinic Referral Form
Haematology Dept
Level 4 Bexley Wing
Leeds Teaching Hospital Trust Beckett Street, Leeds, LS9 7TF
Tel: 0113 2067684
Fax: 0113 2067716

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33. 6 monthly Notes review with FBC U+E LFT

Quick info:
Manage as per pathway if concerns or contraindications develop.
Investigate abnormal FBC LFT and refer if necessary
Follow pathway per U+E (eGFR results)
Note :if eGFR > 60 ml/min for > 12 months follow the 'eGFR > 60 ml/min' stem

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34. If eGFR 30-60 ml/min follow alternate stem

Quick info:
Note:
If eGFR drops to between 30-60 ml/min then the 'eGFR 30-60 ml/min' stem should be followed

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35. Annual Notes Review if: Bloods normal No new interactions No bleeding No adherence problems

Quick info:
Manage as per pathway if concerns or contraindications develop.
Annual FBC U+E LFT
Investigate abnormal FBC LFT and refer if necessary
Follow pathway per U+E (eGFR results)

Key Dates

Published: 19-Mar-2014, by Leeds
Valid until: 31-May-2016

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References

This is a list of all the references that have passed critical appraisal for use in the care map Anticoagulation

ID Reference
1.  Contributors representing the Royal College of Physicians. 2010.
2. Contributors representing the Royal College of Physicians. 2013.
3. Practice-informed recommendation. 2010.
4.

Scottish Intercollegiate Guidelines Network (SIGN). Antithrombotics: indications and management. SIGN Publication no. 129. Edinburgh: SIGN; 2012. http://www.sign.ac.uk/guidelines/fulltext/129/index.html

5. Scottish Intercollegiate Guidelines Network (SIGN). Prevention and management of venous thromboembolism. SIGN Publication no. 122. Edinburgh: SIGN; 2012. http://www.sign.ac.uk/guidelines/fulltext/122/
6. Watson H Davidson S Keeling K. Guidelines on . diagnosis and management of heparin-induced thrombocytopenia - second edition. Br J Haematol 2012; 159: 528-540.
7.

Keeling D Baglin T Tait C et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol 2011; 154: 311-324.

8. National Institute for Health and Clinical Excellence (NICE). Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation. Technical appraisal guidance 249. London: NICE; 2012. http://guidance.nice.org.uk/TA249
9.

 Garcia DA Baglin TP Weitz JI et al. Parenteral anticoagulants: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141: e24S-43S.

10.

Medicines and Healthcare products Regulatory Agency (MHRA). Dabigatran (Pradaxa): risk of serious haemorrhage - contraindications clarified and reminder to monitor renal function. Drug Safety Update. London: MHRA; 2012. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON175429

11.

National Institute for Health and Clinical Excellence (NICE). Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism. Technical appraisal guidance 261. London: NICE; 2012. http://guidance.nice.org.uk/TA261

12.

Douketis JD Spyropoulos AC Spencer FA et al. Antithrombotic therapy and the prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based guidelines. Chest 2012; 141: e326S-350S. http://chestjournal.chestpubs.org/content/141/2_suppl

13.

National Institute for Health and Clinical Excellence (NICE). Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing. London: NICE; 2012. http://guidance.nice.org.uk/CG144

14. National Institute for Health and Clinical Excellence (NICE). Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation. Technical appraisal guidance 256. London: NICE; 2012. http://guidance.nice.org.uk/TA256/Guidance/pdf/English
15.

Heneghan C Alonso-Coello P Garcia-Alamino JM et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006; 367: 404-411. http://www.ncbi.nlm.nih.gov/pubmed/16458764

16. British National Formulary (BNF). BNF 64. London: BMJ Group and RPS Publishing; 2012. http://www.bnf.org/bnf/index.htm
17.

Institute for Clinical Systems Improvement (ICSI). Antithrombotic therapy supplement. Bloomington, MN: ICSI; 2012.
https://www.icsi.org/guidelines    more/catalog_guidelines_and_more/catalog_guidelines/catalog_card iovascular_guidelines/antithrombotic/

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