Appendix C Factors to consider when choosing between anticoagulant options and FAQs

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1 Appendix C Factors to consider when choosing between anticoagulant options and FAQs Choice of anticoagulant for non-valvular* atrial fibrillation: Clinical decision aid Patients should already be screened for an absolute contraindication to oral anticoagulation. This is a guide to the suitability of the patient for a NOAC versus warfarin and an indication to a preferred drug. Each of the following 10 factors should be considered and each drug rated using the key below to give the clinician a pointer to a preferred drug. Clinically suitable options must then be discussed with the patient before a drug is selected, taking into account patient preferences. Always refer to the current SPC for up to date prescribing information. 1-4 Key Symbol Definition Example ++ Strongly favours drug W++strongly favours warfarin + Favours drug R+ favours rivaroxaban - Not preferred agent D- dabigatran not preferred agent () Contraindicated (C/I) (A) apixaban contraindicated Absolute contraindications to NOACs (consider warfarin instead) 5,6 *Significant mitral valve stenosis or prosthetic valve (NB other valve pathology are not a C/I) Clinically significant active bleeding or acute haemorrhagic stroke in the previous 14 days Known hypersensitivity, Pregnancy (any stage) In ischaemic stroke within 2 weeks post stroke, in view of risk of haemorrhagic transformation, risks and benefits of early anticoagulation need to be considered by determining the size of infarct and disability Check SPC of individual drugs for other specific contraindications

2 1. Renal function >50ml/min Any agent Few patients with CrCl <50 ml/min have been studied in clinical trials; all NOACs have dose adjustments for varying 30-49ml/min W++, R+, A+, D- degrees of renal impairment. Monitor renal function closely in situations where it may deteriorate (e.g. elderly, heart failure). Switch before thresholds for C/I are reached ml/min W++, R+, A+, (D) <15ml/min W++, (R, A, D) 2. Liver function LFTs > 2x ULN: W, R+, A- (D) Dabigatran is not recommended and apixaban should be used with caution in patients with elevated liver enzymes > 2 x ULN. Apixaban is not recommended in patients with severe hepatic impairment. No anticoagulant is safe in the presence of a coagulopathy (any cause). 3. Elderly and frail Patient >75 years W+, R+, A-, D- The elderly and frail have an increased bleeding risk. adjustments are required for dabigatran and apixaban depending on age & weight (see SPC). Patient <75 years Any agent 4. Ability/compliance with dosing Good Any agent Compliance may be easier if o.d. (warfarin or rivaroxaban) vs. b.d. (dabigatran, apixaban) but a missed dose may have more consequence for rivaroxaban. NB. if patient has poor medication compliance this can best be identified and monitored with warfarin. Poor W+, R-, A-, D- 5. Ability/compliance with monitoring Good Any agent Warfarin requires regular INR monitoring. None of the NOACs require routine anticoagulation testing but do require renal function monitoring at least yearly. % Time in Therapeutic Range* 65% Continue warfarin <65% Favours any NOAC * INR 2-3, assess over 6/12 but ignore first 6/52 of initiation. NICE recommend considering a NOAC if TTR < 65% or the patient has had extreme INRs (e.g. two > 5, one > 8 or two < 1.5 in last 6/12). 7 NB. Provided reason for range deviation is not correctible; review cognition, adherence, illness, drugs and lifestyle. Poor Favours any NOAC

3 6. History of major GI disease + GI bleeding event in past year Appendix C: AF anticoagulation clinical decision aid Yes W+, A+, R-, D- Both SPCs for dabigatran and rivaroxaban indicate increase risk for GI bleeding compared to warfarin. In addition, dabigatran has an increased incidence of dyspepsia. 7. Ongoing need for concomitant medications that interact with a NOAC** Yes Favours warfarin Warfarin has many drug interactions, but has the INR as a means of monitoring and making dose adjustments. The NOACs have fewer drug interactions but no means of monitoring and little data on how to or whether to make dose adjustments. Consult SPC for up to date list of drug interactions 1-4 ** Depending on NOAC, to varying degrees: verapamil, diltiazem, quinidine, amiodarone, dronedarone, some antifungals, antivirals and antibiotics. NB. list not exhaustive or specific to one NOAC. 8. Ongoing need for concomitant single or dual antiplatelet therapy No Any agent Patients taking OAC + aspirin + clopidogrel or higher dose aspirin were generally excluded from NOAC clinical Single Favours warfarin trials. Antiplatelets combined with any anticoagulant will increase bleeding risk. NICE recommend avoiding triple Dual Only warfarin and consider therapy, i.e. just warfarin + one antiplatelet if patient has had an MI or stent in the last 12/12 (clopidogrel if dropping one antiplatelet stented, otherwise aspirin). 8 NICE also recommends avoiding NOACs post MI or post-pci. 8 ASAP 9. Ongoing variable intake of excess alcohol or medications that interact with warfarin Yes Favours NOAC e.g. antibiotics for exacerbations of COPD, courses of steroids or patient is prone to binge drinking. Warfarin has many drug interactions, but has the INR as a means of monitoring and making dose adjustments. If frequent courses of medication upset control and they are not known to interfere with a NOAC, the NOAC may provide more stable anticoagulation. 10. Need for monitored dosing system (MDS) Yes A+, R+, (W, D) Only rivaroxaban and apixaban can be put in an MDS. 9 Warfarin and dabigatran must be kept separate.

4 AF dosing information APIXABAN - factors affecting dose Standard dose (no dose modifying factors present) Two or more of the following factors present: Creatinine >133μmol/l, Age > 80 yrs, weight < 60 kg CrCl ml/min CrCl < 15 ml/min DABIGATRAN - factors affecting dose Standard dose (no dose modifying factors present) Age > 80yrs or taking verapamil CrCl 30-50ml/min, or age 75-80yrs, or risk factors for bleeding CrCl < 30ml/min RIVAROXABAN - factors affecting dose CrCl >50ml/min CrCl ml/min CrCl ml/min CrCl <15ml/min Appendix C: AF anticoagulation clinical decision aid 5mg BD 2.5mg BD 2.5mg BD 150mg BD 110mg BD Consider 110mg BD instead of 150mg BD 20 mg OD 15 mg OD Caution Switching anticoagulants Warfarin to a NOAC - For dabigatran and apixaban, start the drug once INR is < 2. F or rivaroxaban, start when INR 3. One NOAC to another NOAC - Take usual dose(s) of first drug on day prior to switch and usual doses of the new drug from the following morning. NOAC to warfarin - For dabigatran, the duration of concurrent treatment is based on renal function: CrCl 50 ml/ min: Start warfarin 3 days prior to stopping dabigatr an. CrCl ml/min: Start warfarin 2 days prior to stopping dabigatran. CrCl ml/min: Start warfarin 1 day prior to stopping dabigatran. For rivaroxaban, warfarin should be given concurrently until INR 2.0, with INR-guided dosing of warfarin used from day 3 of the transition period. NB. Rivaroxaban raises INR levels so test INR just before next dose of rivaroxaban. For apixaban, continue apixaban for at least 2 days after starting warfarin. Check INR just prior to next dose of apixaban and continue apixaban until INR 2.0. Peri-operative management In general, NOACs should be stopped before invasive or surgical procedures and restarted promptly when haemostasis has been restored. Many minor operations that can be performed with concomitant warfarin may be safe to perform if a NOAC is taken (e.g. dental extraction). For dabigatran, stopping distance is based on renal function: CrCl 80 ml/ min: Stop dabigatr an 24 hours pre-procedure. CrCl ml/min: Stop dabigatran 1-2 days pre-procedure. CrCl ml/min: Stop dabigatran 2-3 days pre-procedure. NB. Also add 1-2 days to above if there is a high risk of bleeding or major surgery planned. For rivaroxaban, stop at least 24 hours pre-procedure. For apixaban, stop at least 48 hours prior to procedures with moderate-high risk of unacceptable/significant bleeding and 24 hours prior to low risk procedures. Management of bleeding Standard measures to control bleeding and maintain haemostasis should be used. Fresh frozen plasma (FFP) has no role and there is no licensed or well researched antidote. The short half-life of NOACS is in their favour. Activated prothrombin complex concentrate may have some effect. Monitoring requirements: 1. ALL patients on long term anticoagulants require a general review at least once a year: Check risks and benefits are unchanged Assess if dose change is required Check compliance Check patient understanding of risks etc. see patient information. 2. Patients on NOACs should have renal function checked: Annually if CrCl > 60ml/min 6 monthly if CrCl 30-60ml/min 3 monthly if CrCl < 30ml/ min, 75 years or expected decline in renal function: During acute illness (dose many need to be modified- see above) 3. Patients on warfarin require checks as per local INR protocol and a check for time in therapeutic range every 6/12

5 References 1. Summary of Product Characteristics - Eliquis 2.5 mg film-coated tablets, Bristol-Myers Squibb-Pfizer. Updated 30/07/14, accessed 28/10/14. https://www.medicines.org.uk/emc/medicine/ Summary of Product Characteristics - Xarelto 15mg film-coated tablets, Bayer plc. Updated 15/08/14, accessed 28/10/14. https://www.medicines.org.uk/emc/medicine/ Summary of Product Characteristics - Pradaxa 110 mg hard capsules, Boehringer Ingelheim Limited. Updated 15/08/14, accessed 28/10/14. https://www.medicines.org.uk/emc/medicine/ Summary of Product Characteristics - Marevan 1mg Tablets, Amdipharm Mercury Company Limited. Updated 26/05/14, accessed 28/10/14. https://www.medicines.org.uk/emc/medicine/ Hankey GJ, Norrving B, Hacke W, Steiner T. Management of acute stroke in patients taking novel oral anticoagulants. International Journal of Stroke 2014;9(5): doi: / ijs National clinical guideline for stroke, Prepared by the Intercollegiate Stroke Working Party, Fourth edition 2012 https://www.rcplondon.ac.uk/sites/default/files/national-clinicalguidelines-for-stroke-fourth-edition.pdf 7. NICE Clinical guideline 180. Atrial fibrillation: the management of atrial fibrillation. Published June NICE Clinical guideline 172. MI secondary prevention: Secondary prevention in primary and secondary care for patients following a myocardial infarction. Published November recommendations#drug-therapy-2 9. UKMi Medicines compliance aid database, accessed 07/11/14.

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