Consulted With; Post/Committee/Group Date Haematology Dr Shereen Elshazly (Lead for Anticoagulation) January 2016 Department of Anaesthesia

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1 Peri-procedural anticoagulation in Adult patients taking Warfarin and novel oral anti-coagulants (NOACS) Clinical Guideline Register No: Status: Public Developed in response to: Contributes to CQC Regulation 9, 12 Provide a simple hospital wide protocol for assessing and managing patients with chronic anticoagulants who may need to stop these for procedures. Consulted With; Post/Committee/Group Date Haematology Dr Shereen Elshazly (Lead for Anticoagulation) January 2016 Department of Anaesthesia Dr Ben Maddison (Lead Pre-assessment) January 2016 Professionally Approved By Dr Chris Wright, Clinical Director Anaesthesia, Theatres and Intensive Care. January 2016 Version Number 1.0 Issuing Directorate Ratified by: Anaesthesia and Diagnostics Document Ratification Group Ratified on: 25 th February 2016 Trust Executive Sign Off Date March 2016 Implementation Date 1 st March 2016 Next Review Date February 2019 Author/Contact for Information Policy to be followed by (target staff) Distribution Method Related Trust Policies (to be read in conjunction with) Dr Joseph Hussey Consultant Anaesthetist Medical, Nursing and Pharmacy staff Intranet, Website and internal department distribution Clinicians and Nursing Staff. n/a Document Review History Version No Authored/Reviewed by Active Date 1.0 Dr Joseph Hussey Consultant Anaesthetist 1 st March

2 1. Purpose 2. Scope 3. Exclusions 4. Warfarin, assessment of peri-procedural risk 5. Discontinuation of Warfarin 6. Resumption of Warfarin 7. Regional Anaesthesia and Warfarin 8. Management of Novel Oral Anticoagulants (NOACs) 9. Regional Anaesthesia and NOACs 10. Communication and Implementation 11. Audit and Monitoring of Policy 12. References Appendix A Assessing Peri-Procedural Risk Appendix B Warfarin Bridging Regimen Appendix C Post-Procedural Bleeding Risk of Individual Procedures for guidance only Appendix D Anticoagulation and Regional Anaesthesia risks Appendix E Peri-procedural management of Novel Oral Anticoagulants Appendix F Example letter to GP & Patient 2

3 1.0 Purpose 1.1 This guideline incorporates the current published evidence to provide a simple, hospitalwide protocol for the management of peri-operative anticoagulation. It is applicable to the majority of chronically anti-coagulated patients undergoing elective surgery at Mid Essex Hospitals NHS Trust. 1.2 Peri-operative management of patients taking oral anticoagulants must balance the risk of a thrombotic event associated with interruption of anticoagulation and the risk of haemorrhage associated with the procedure. This balance of risks will vary between individual patients and hence there is considerable variation in practice between individual clinicians. This guideline aims to standardise anticoagulant management across the trust in line with published guidance and in so doing to minimise morbidity and mortality from thrombosis or haemorrhage. 2.0 Scope 2.1 This guideline applies to adult patients, 18 years and over, taking oral anticoagulant drugs that require interruption. This may be for any elective invasive procedure that involves a significant bleeding risk. 3.0 Exclusions 3.1 Urgent or emergency surgery- seek specialist advice. 3.2 Paediatric patients under 18 years- seek specialist advice. 3.3 Certain procedures may be able to be carried out whilst continuing oral anticoagulants, however the final decision on suitability is the responsibility of the operating consultant. Examples include: Some opthalmic surgery / procedures Minor dermatological procedures Biopsy of compressible Site Joint aspiration or Injection Diagnostic Endoscopy +/- minor procedures (See British Society for Gastroenterology guidance) Minor Dental Surgery (See NPSA guidance) 4.0 Warfarin Assessment of Peri-procedural Risk 4.1 Patients who receive Warfarin are assessed according to the bleeding risk of the procedure and the thrombotic risk of stopping therapy (see appendix 1). Patients stratified into the increased thrombotic risk group should receive an individualised, therapeutic dose, Enoxaparin bridging regimen. This can be managed in the community, however adequate time prior to surgery will be needed to co-ordinate provider services. 4.2 Assessment of thrombotic risk is based on the current best evidence and expert opinion. Recent key evidence from the BRIDGE trial 10 showed non-inferiority in support of not bridging patients with non-valvular atrial fibrillation. In addition there was a significantly higher rate of peri-operative bleeding in bridged patients. The trial however 3

4 did have very small numbers of patients with the highest thrombotic risk (CHADS2 4) or patients with active cancer, therefore it remains our recommendation to bridge these patients 5.0 Discontinuation of Warfarin 5.1 Warfarin should be discontinued 5 days prior to procedure. Enoxaparin should be administered 3 days prior to procedure (see appendix B). Administration should occur before 10am in order to minimise residual anticoagulant effect at the time of surgery. Patients with significant thrombotic risk should receive a therapeutic dose (i.e. 1.5mg/kg Enoxaparin) regimen. Note, A half therapeutic dose (i.e. 0.75mg/kg Enoxaparin) can be considered the day before procedure to minimise the risk of residual anticoagulation at the time of operation, particularly for high bleeding risk procedures (e.g. Vascular, Major GI with epidural). A reduced Enoxaparin dose (1mg/kg) is also recommended for patients with renal impairment (CrCL<30mls/min). 5.2 The patient should have their INR tested prior to surgery. Please be aware of laboratory turnaround time. Patients with an INR of may benefit from low dose Vitamin K, however this will take a number of hours to take effect. For patients with an INR of 1.9 or over, consideration should be given to delaying non-urgent surgery. For urgent surgery Haematology advice should be sought. 6.0 Resumption of Warfarin 6.1 Postoperatively, patients should have their Warfarin re-introduced at the earliest safe opportunity, according to their pre-procedure regimen. This will usually be 24 hours after low bleeding risk procedures and hours after high bleeding risk procedures, however this should be decided by the responsible operator (see appendix C). Patients should not be re-loaded with Warfarin unless directed by a Haematologist. Importantly, Enoxaparin must be continued alongside Warfarin until the INR is therapeutic (Usually 3-7 days post resumption). 6.2 Prophylactic dose Enoxaparin should be administered post operatively on the day of procedure (Unless the bleeding risk is extremely high) and this should be replaced by therapeutic dose (with Warfarin), once bleeding risk from the procedure has reduced to an acceptable level. The timing of Enoxaparin administration post-procedure is less important, and can be given at the same time as warfarin (see appendix B). 7.0 Regional Anaesthesia & Warfarin 7.1 Central neuraxial blocks & deep plexus / paravertebral / deep peripheral nerve blocks should not be performed whilst a patient is anti-coagulated with Warfarin. INR should be 1.4 or less when performing these blocks. 7.2 Therapeutic dose Enoxaparin should be avoided whilst an epidural catheter is in Situ- in this case Prophylactic dose should be administered a minimum of 6 hours after insertion. Prior to insertion of epidural / spinal / deep block, it is recommended that a minimum of 24 hours should have elapsed since the last dose of therapeutic Enoxaparin or 12 hours since the last dose of prophylactic Enoxaparin. Therapeutic Enoxaparin can be administered 6 hours post removal of catheter / performance of block, however this may need to be extended to 24 hours if there has been a history of traumatic (bloody) insertion tap. 4

5 7.3 Peripheral nerve blocks usually cause less serious complications and are devoid of the risk of spinal epidural haematoma. Nevertheless, there have been case reports of morbidity and mortality associated with the performance of deep plexus block. Amongst various societies, there is a consensus that deep peripheral nerve blocks, plexus blocks and paravertebral blocks have a high risk of bleeding complication. For these, perioperative anticoagulation / antiplatelet therapy should be guided in the same way as central neuraxial blocks. 7.4 Guidance is less clear with superficial nerve blocks. The AAGBI have issued a document (See appendix D), which aims to classify blocks according to bleeding risk profile. It would not be unreasonable to perform blocks in the lower risk categories in anti-coagulated patients if they are not required to stop anticoagulation for the surgery itself. In this case it is advised to utilise ultrasound guidance especially if a peri-vascular technique (e.g. Axillary brachial block) is being considered and to observe for the development of haematoma. The excess risk of haematoma should also be discussed with the patient when consenting. 8.0 Management of Novel Oral Anticoagulants (NOACs) 8.1 The peri-procedural management of NOAC-treated patients aims to interrupt anticoagulant therapy so there is no (or reduced) residual anticoagulant effect at the time of procedure, and to ensure timely but careful resumption after procedure so as not to incur an increased risk for post-procedural bleeding. 8.2 NOACs are fast acting (peak onset within 2 hours) drugs with a relatively short half-life compared to Warfarin. They rely on renal function for their elimination. Reliable or widely available laboratory tests to measure anticoagulant activity are often lacking. In the absence of laboratory tests the peri-procedural management of NOACs should take into account: The bleeding risk associated with the surgery/procedure type and whether patient will receive central neuraxial anaesthesia The drug elimination half-life (with normal renal function) The effect of renal function on drug elimination half-life For guidance on individual drugs - see Appendix E 8.3 For minor procedures, where some residual anticoagulant activity (12-25%) is acceptable a delay, corresponding to two elimination half-lives of the drug can be planned (usually the day before procedure with unimpaired renal function). 8.4 For high bleeding risk procedures or where central neuraxial anaesthesia is being considered the drug will need to be stopped for the equivalent of 4 to 5 half-lives (usually 2 days before procedure with unimpaired renal function). This will ensure minimal (3-6%) residual anticoagulant activity. 8.5 Bridging with therapeutic Enoxaparin pre-operatively is not usually recommended 8.6 Post-procedure, NOACs should be reintroduced as soon as is safe, typically 24 hours after low bleeding risk procedure and 48 hours post major procedure. Until reintroduction, prophylactic dose Enoxaparin should be considered daily. There is no 5

6 need to bridge the reintroduction of NOACs with therapeutic dose Enoxaparin because of the speed of peak onset. 9.0 Regional Anaesthesia and NOACs 9.1 Patients receiving NOACs are in the high bleeding risk category if they are to receive a Central-neuraxial / deep plexus / deep peripheral nerve block and their pre-operative management should reflect this. NOAC s can be restarted a minimum of 6 hours after removal of Epidural catheter or performance of spinal anaesthetic / high bleeding risk peripheral nerve block. 9.2 For peripheral blocks there is little guidance available for this class of drug. However, it would be reasonable to follow the recommendations as outlined in Appendix B Communication & Implementation 10.1 It is a corporate responsibility for ensuring that this document is uploaded to the intranet and website, and notified to all staff in Focus It is the author s responsibility to ensure that this document is notified to all appropriate clinical staff. This will be achieved by the cascading of policy by contributors Audit and Monitoring of Policy 11.1 Where there has been non-compliance with this policy which has resulted in patient harm, the risk event must be recorded on a Datix There will be an ongoing audit process to investigate the safety of and compliance with the policy. This will be completed by the author and senior members of nursing staff in the pre-operative preparation clinic Results of audit will be presented at departmental audit meetings Patients who develop problems at home and/or require readmission will have their individual cases investigated by Consultant Anaesthetic staff References 1. Perioperative Management of Antithrombotic Therapy: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines (9 th Edition). Douketis J et al, Chest 2012; 141: e326s-e350s. 2. Perioperative Management of Antithrombotic Therapy: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines (8 th Edition). Douketis J et al, Chest 2008; 133: Guidelines on Oral Anticoagulation with Warfarin (4 th Edition). British Haematological Society Venous thromboembolism: Reducing the risk; NICE, January Regional Anaesthesia in the Patient Receiving Antithrombotic or Thrombolytic therapy: ASRA evidence based guidance (third edition): Regional Anesthesia and Pain Medicine; 2010;35:

7 6. Regional Anaesthesia in Patients with Abnormalities in Coagulation: AAGBI, RA-UK, OAA guidance document Regional Anaesthesia and antithrombotic agents: recommendations of the European Society of Anaesthesiology. Gogarten et al, European Journal of Anaesthesiology 2010:27: Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. European Society of Cardiology How I treat anti coagulated patients undergoing elective procedure of surgery. Spyropoulos AC, Dockets JD, Blood 2012;120: Preoperative Bridging Anticoagulation in Patients with Atrial Fibrillation. Douketis et al, New England Journal of Medicine 2015;373:

8 APPENDIX A ASSESSING PERI-PROCEDURAL RISK 8

9 APPENDIX B WARFARIN BRIDGING REGIMEN 9

10 Appendix C Post-Procedural Bleeding Risk of Individual Procedures for guidance Only. 9 10

11 Appendix D Anticoagulation and Regional Anaesthesia risks. 6 11

12 Appendix E Peri-procedural management of Novel Oral Anticoagulants TIME TO LAST INTAKE OF DRUG BEFORE INCREASED BLEEDING RISK PROCEDURE Creatine Clearance Cockcroft-Gault Low Bleeding Risk Dabigatran Apixaban - Edoxaban - Rivaroxaban High Bleeding Risk Low Bleeding Risk High Bleeding Risk 80 ml/min 24 Hours 48 Hours 24 Hours 48 Hours ml/min 36 Hours 72 Hours 24 Hours 48 Hours ml / min a 48 Hours 96 Hours 24 Hours 48 Hours ml / min a Not Indicated Not Indicated 36 Hours 48 Hours < 15 ml /min NO OFFICIAL INDICATION FOR USE a Many of these patients will be on a reduced dose of drug THERE IS NO NEED FOR BRIDGING WITH HEPARIN NOAC SHOULD BE RESUMED WHEN IT IS DEEMED SAFE TO DO SO, TYPICALLY; 24 HOURS POST LOW BLEEDING RISK PROCEDURE 48 HOURS POST HIGH BLEEDING RISK PROCEDURE NOAC SHOULD NOT BE ADMINISTERED IF SURGICAL DRAINS / EPIDURAL CATHETER ARE IN SITU. PEAK EFFECT AFTER 2 HOURS OF ADMINISTRATION 12

13 Appendix F Example letter to GP & Patient. 13