P a g e 1 Dorset Cardiac Centre Patients with Atrial Fibrillation/Flutter undergoing DC Cardioversion or Ablation procedures- Guidelines for Novel Oral Anti-coagulants (NOACS) licensed for this use February 2015 1. Background / rationale for implementation of guideline There are no agreed national guidelines for the use of NOACS in patients undergoing elective DC Cardio version (DCCV) or ablation procedures. Where DCCV is indicated in the text, ablation can also be read. These guidelines have been developed locally and agreed by the Cardiology Consultants throughout Dorset. The guidelines have been ratified through Dorset Cardiology sub group. The justification for using NOACs in these patients is to enable their procedure to take place in a more timely manner and to reduce the issues that occur with weekly warfarin testing. When patients are commenced on NOAC s they should be able to undergo DCCV 4 weeks later, thus improving the access time to their procedure and avoiding unnecessary delays due to sub therapeutic anticoagulation levels. Patients will remain on NOAC s until seen in the Atrial fibrillation/ Atrial flutter (AF/Aflutter) clinic by the Arrhythmia Nurse Specialist 4-6 weeks post procedure. If patients are to remain anti- coagulated at this point, a further discussion should occur to decide on continuation of NOAC or a change to warfarin. This decision will be made with the Cardiology Consultant. At present there are three licensed NOAC s available in the UK. Dabigatran is a direct thrombin inhibitor; Rivaroxaban and Apixaban are factor Xa inhibitors. All three drugs are licensed to be continued in patients undergoing cardioversion. 2. Process of identification of suitable patients to be managed on NOAC therapy Patients reviewed in the clinic, who are deemed suitable for DCCV, will be risk assessed according to their CHA2DS2-Vasc score (table 1) (NICE clinical guidance 2006 & European Heart Journal 2012). The score outcome will be discussed with the Cardiology Consultant/registrar. Table 1 CHA2DS2VASC Risk Factor Score Congestive Heart Failure/LV Dysfunction 1 Hypertension 1 Aged > 75 years old 2 Diabetes mellitus 1 Stroke/TIA/Thromboembolism 2 Vascular disease (prior myocardial infarction, peripheral artery disease or aortic plaque 1 Age 65-74 years old 1
P a g e 2 Sex category - Female 1 Patients who are identified for DCCV who have been unstable on warfarin with TTR < 65% will be converted from warfarin to a licensed NOAC (unless contraindicated). If warfarin has not yet been initiated in Primary Care, this will be discussed with the cardiology consultant and it may be decided to initiate NOAC as the first line anti-coagulant. Patients need to be informed that further discussion regarding long term anticoagulation will occur 4 6 weeks post DCCV. 3.Management of patients identified as suitable for NOAC therapy prior to DCCV Patients MUST have up to date U&E's, HB, LFTs, baseline clotting and TFTs 4-6 weeks prior to DCCV and again prior to DCCV (see below). The patient s medication history will be checked prior to the initiation of NOAC in clinic to check for interactions (refer to SPC for individual NOAC). Patients will be counselled regarding the reasons for the initiation of NOAC the importance of taking it, and its side effects. It will be explained to them that if they miss a single dose of NOAC their protection is reduced and therefore their Stroke risk is increased. Patients will be issued with a yellow warning card to carry, and a NOAC use in Cardioversion information leaflet Patients will be issued with an outpatient prescription for the first 28 s of NOAC with counselling on initiation and a letter for their GP to confirm this. On-going prescriptions around the cardio version period should be provided by primary care. The Arrhythmia Nurse Specialist or DCCV co-ordinator will contact the patient to arrange the date for the procedure and she will discuss the necessary preparations the patient needs prior to DCCV. This includes ensuring that the patient will receive a further blood test prior to the procedure, in order to check U&Es (ensuring potassium is above 4mmol/L). 4. Management of patients taking NOAC on of DCCV procedure At the pre assessment appointment and on the of the DCCV patient compliance with NOAC MUST be checked prior to proceeding. If the patient has missed one dose of NOAC leading up to the DCCV date, the procedure will be postponed and the patient will be placed on the waiting list for the following month. A NOAC does not have a long half-life. If a dose or two is missed this may mean the patient is insufficiently anti-coagulated If DCCV is repeatedly postponed because of missed single doses then warfarin would be deemed more appropriate. Patients may be asked to sign an additional declaration on the consent form to confirm that they have been fully compliant with the NOAC dosing for the 4 weeks prior to the DCCV procedure and verified on the of the procedure by the Arrhythmia Nurse. If patients have side effects when taking a NOAC then these patients will be discussed with the Cardiology Consultant.
P a g e 3 5. Management of patients taking NOAC following DCCV procedure Post DCCV patients will remain on NOAC until their follow up appointment with the Arrhythmia Nurse in clinic 4-6 weeks following their procedure. At this time the patient will be reviewed with regard to maintenance of sinus rhythm and to assess the need for continuing anticoagulation following discussion with the Cardiology Consultant / Registrar. The choice of anti-coagulation will then be considered with the patient 4-6 weeks post DCCV, if they are to remain on anti-coagulation long term. 6. DOSING The dose of NOAC will depend on the drug chosen and the clinical condition of the patient. Brief details of the recommended dosages can be found below. Prescribers are advised to check the summary of product characteristics for the latest information (available from www.medicines.org.uk/emc): NOAC Dabigatran: Dose reduction in: Patients > 80 years Patients taking Verapamil Consider reduced dose in: Patients between 75 80 years of age (where thromboembolic risk is low and bleeding risk is high) Patients with moderate renal impairment (CrCL 30-50ml/min) Patients with gastritis, esophagitis or gastroesophageal reflux Patients at increased risk of bleeding Recommended dose 150mg Twice a Reduced Dose 110mg twice a Rivaroxaban: Dose reduction in : Patients with reduced renal function with Creatinine clearance between 15 49ml/min 20mg Once a 15mg Once a Apixaban: Dose reduction in patients with 2 of the following: Age 80 years Body weight 60kg 5mg Twice a 2.5mg Twice a
P a g e 4 Serum Creatinine 133 micromol/l Where patients are noted to have CrCL 15-29ml/min a reduced dose of apixaban should be offered. Contra Indications to NOAC s Hypersensitivity Severe renal impairment (CrCL <15 for apixaban and rivaroxaban and <30 for dabigatran) Active clinically significant bleeding Concomitant treatment with other anticoagulants Hepatic disease associated with coagulopathy and clinically relevant bleeding risk Pregnancy and breast feeding Not recommended in patients with prosthetic heart valves Further information regarding the dose, cautions, contra-indications and drug interactions can be found in the drug SPC. 7. Follow up clinic At 4-6 weeks post DCCV those patients remaining on anticoagulation may be switched to warfarin therapy. Patients will be switched by referral to the anticoagulation clinic via their GP. Patients will be given a letter in clinic for their G.P to confirm choice of anti-coagulation with clear instructions and guidance. 8. Audit Data for the Arrhythmia Nurse to collect at DCCV & at the patients 4-6 week follow up clinic appointment. Any side effects with NOAC. Any missed doses or issues with adherence Time to DCCV from referral CHA2DS2VASc score and success of procedure
P a g e 5 References National Collaborating Centre for Chronic Conditions. Atrial Fibrillation: National Clinical Guidelines for management in primary and secondary care. NICE clinical guideline CG36 full guidance 2006. European Society of Cardiology. ACC/AHA/ESC 2012 updated guidelines for the\ management of patients with atrial fibrillation executive summary. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Riccardo Cappato et al. Eur Heart J. 2014; doi: 10.1093/eurheartj/ehu367. https://www.medicines.org.uk/emc/medicine/24839- Pradaxa 150mg hard capsules- https://www.medicines.org.uk/emc/medicine/27220 - Eliquis 5mg film coated tablets https://www.medicines.org.uk/emc/medicine/25586 - Xarelto 20mg film coated tablets DMAG Approval Date Review date Contact for this Policy Nick Bolton, Pharmacist Dorset CCG nick.bolton@dorsetccg.nhs.uk