CLINICAL GUIDELINE FOR MANAGEMENT OF ANTICOAGULATION IN INTERVENTIONAL CARDIOLOGY 1. Introduction

Transcription

1 CLINICAL GUIDELINE FOR MANAGEMENT OF ANTICOAGULATION IN INTERVENTIONAL CARDIOLOGY 1. Introduction 1.1. Although of proven benefit in a range of indications, antithrombotics are associated with adverse effects, principally abnormal bleeding. When patients on anticoagulation require an invasive procedure, the risks and benefits of stopping or continuing anticoagulation must be considered. To maximise benefit over risks, the selection of patients for treatment with antithrombotics and their management should be evidence based. 2. Purpose of this Guideline 2.1. This guideline applies to patients taking oral anticoagulation or antiplatelet drugs who require an invasive procedure. It is designed to safely manage the discontinuation of the following medications and where appropriate the prescription of reversal agents or substitutes such as bridging therapy. It aims to standardise management across the cardiac wards in line with international guidelines and in so doing, to minimise morbidity and mortality from thrombosis or haemorrhage. 3. Scope 3.1. This document applies to all doctors (regardless of grade) and nurses who have the responsibility to identify patients (elective and inpatient) on medications that will increase the risk of bleeding during/after a cardiac procedure. 4. Roles and responsibilities 4.1. To identify patients (elective and inpatient) on medications that will increase the risk of bleeding during/after a cardiac procedure and use the RCHT Discontinuation of antiplatelet and anticoagulation medications in pacing and intervention chart to stop these medications in a timely fashion to minimise the risk of bleeding whilst considering if substitute bridging medication is required to prevent thromboembolic complications To identify patients (elective and inpatient) on medications that were stopped prior to surgery with the aim to reduce the risk of bleeding during/after a procedure and use the RCHT Restarting Of Antiplatelet/Anticoagulation Medications In Pacing And Intervention chart to begin the reintroduction of these medications in a timely fashion to minimise the risk of and prevent thromboembolic complications To provide information and explain the reasons for these alterations to patients and carers. 5. Thrombotic risk 5.1. The risk-benefit ratio of interrupting VKA therapy requires individual consideration. Continuation of anticoagulation during invasive procedures is likely to increase the bleeding risk. Whilst discontinuation is associated with a temporary

2 increase in thrombosis risk. There is debate over the optimal approach to management in this situation and whether VKA therapy should be interrupted and, if so, whether there is a need for bridging therapy with the temporary introduction of an alternative antithrombotic, usually heparin. THROMBOTIC RISK SCORE Risk Mechanical Heart Atrial Fibrillation Valve High 1 Any mitral prosthesis CHA2DS2-VASc score of or 6 Moderate 2-4 Any caged-ball or tilting disc aortic prosthesis Recent (within 6 months) stroke or TIA Bileaflet aortic prosthesis and one or more of the of following risk factors: atrial fibrillation, prior stroke or TIA, hypertension, diabetes, congestive heart failure, age>75 year Recent (within 3 months) stroke or TIA Rheumatic valvular heart disease CHA2DS2-VASc score of 2 to 4 VTE within the past 3-12 months VTE Recent (within 3 months) VTE Severe thrombophilia (eg, deficiency of protein C, protein S, or antithrombin; antiphospholipid antibodies; multiple abnormalities) VTE within the past 3-12 months Non-severe thrombophilia (eg, heterozygous factor V Leiden or prothrombin gene mutation) Low 0-1 Bileaflet aortic prosthesis without AF and no other risk factors for stroke CHA2DS2-VASc score of 0 or 1 (assuming no prior stroke or TIA) Recurrent VTE Active cancer (treated within 6 months or palliative care) VTE >12 months previous and no other risk factors CHA2DS2-VASc score for stroke risk in atrial fibrillation Feature Score Congestive Heart Failure 1 Hypertension 1 Age >75 years 2 Age between 65 and 74 years 1 Stroke/TIA/TE 2 Vascular disease (previous MI, peripheral artery 1 disease or aortic plaque) Diabetes mellitus 1 Female 1 High-risk patients may also include those with a prior stroke or TIA occurring >3 months before the planned surgery and a CHADSVASC score <5, those with prior thromboembolism during temporary interruption of VKAs

3 6. Guidance 6.1. ASPIRIN Antiplatelet Indication low doses of aspirin administered once daily significantly reduce platelet aggregability and is indicated in: Primary prevention - risk of heart attack, stroke or vascular occlusion but have not had one. This will include patients over age 50 with hypertension, diabetes or other cardiovascular risk factors Secondary prevention - patients with significant cardiovascular disease. This includes patients with previous Unstable angina, Heart attack, Angioplasty or Coronary artery stents, Angina, Stroke, Peripheral vascular disease and renovascular disease. Intervention Can be continued for angiograms and is a necessity for any procedure where stenting is considered. Pacing EPS & ablation Where an allergy is present, discussion with the consultant Cardiologist is required. Discontinuation is not required prior to invasive pacing procedures. Discontinuation is not required prior to these procedures CLOPIDOGREL, TICAGRELOR, PRASUGREL Antiplatelet Indication Reduce platelet aggregation. Used in conjunction with aspirin as part of the ACS treatment regimen for the prevention of atherothrombotic events and post stent insertion to reduce stent thrombosis Intervention Can be continued for angiograms and is a necessity for any procedure where stenting is considered. Pacing EPS & ablation Where an allergy is present, discussion with the consultant Cardiologist is required. Discontinuation is not required prior to invasive pacing procedures. Discontinuation is not required prior to these procedures WARFARIN Anticoagulant Indication Vitamin K antagonist (VKA). Used for thromboembolic prophylaxis in patients with mechanical heart s, atrial fibrillation, recurrent DVT and/or PE and hypercoagulable disorders. Used also as treatment for first time DVT and/or PE. Intervention Moderate to high Can be continued for angiograms. Target INR <4 4 CHA2DS2-VASc Where any stenting is indicated the patient will score or any metal require bridging therapy. For guidance on bridging refer to Appendix 2, Page 69 of the RCHT clinical guideline for thrombosis prevention investigation Low and management of anticoagulation. Can be continued for angiograms. Target INR <4 Where any stenting is indicated stop 5 days before

4 procedure. Target INR of <1.7. Pacing EPS & ablation Moderate to high 4 CHA2DS2-VASc score or any metal Low Moderate to high 4 CHA2DS2-VASc score or any metal Low Restart warfarin evening of procedure with usual daily dose. Check INR one week later to ensure adequate anticoagulation. Continue warfarin. Target INR <4 Stop 5 days before. Target INR <1.5. Restart warfarin day after procedure with usual daily dose. Check INR one week later to ensure adequate anticoagulation. For radiofrequency ablation the decision is made on an individual basis. Please consult the operator for guidance. For VT stimulations, atrial flutter ablations, AV node ablation with PPM implant in same sitting and AV node ablations with PPM insitu continue warfarin. Target INR <4 For radiofrequency ablation and AV node ablation with PPM implant in same sitting stop 5 days before. Target INR <1.5. Restart warfarin evening of procedure with usual daily dose. Check INR one week later to ensure adequate anticoagulation. For VT stimulations, atrial flutter ablations and AV node ablations with PPM insitu continue warfarin. Target INR < DALTEPARIN/FRAGMIN ENOAPARIN/CLEANE LMWH Indication Treatment and prevention of thrombosis Intervention Treatment dose Stop 24hrs before. Recommence day after procedure. Prophylactic dose Continue. Pacing Treatment dose Stop 24hrs before. First dose 24hrs after procedure. Prophylactic dose Continue. EPS & ablation Treatment dose Stop 24hrs before. Recommence day after procedure. Prophylactic dose Continue.

5 6.5. FONDAPARINU Antithrombotic - Indirect factor a inhibitor Indication Treatment and prevention of thrombosis Intervention Omit day of procedure. Pacing EPS & ablation Restart at least 6 hours post-operatively provided haemostasis has been achieved. Omit day of procedure. Restart at least 6 hours post-operatively provided haemostasis has been achieved. For radiofrequency ablation and AV node ablation with PPM in same sitting omit day of procedure. Restart at least 6 hours post-operatively provided haemostasis has been achieved. For VT stimulations, atrial flutter ablations and AV node ablations with PPM insitu continue RIVAROABAN (ARELTO) / APIABAN (ELIQUIS) Direct oral anticoagulant - Direct factor a inhibitor Indication Direct oral anticoagulants (DOACs) are an alternative for vitamin K antagonists (VKAs) for prevention of VTE after hip and knee replacement surgery, treatment of DVT and prevention of recurrent VTE and the prevention of thromboembolism in AF. They were previously known as NOACs, but as these medications are no longer novel, DAOC is going to be the future adopted term for practice Intervention Moderate to high Can be continued for angiograms. 4 CHA2DS2-VASc Where any stenting is indicated the patient will score or any metal require bridging therapy. For guidance on bridging refer to Appendix 2, Page 69 of the RCHT clinical guideline for thrombosis prevention investigation Low and management of anticoagulation. Can be continued for angiograms. Where any stenting is indicated stop 48hrs before procedure. Pacing Moderate to high 4 CHA2DS2-VASc score or any metal Low Resume 48 hrs post-procedure. Continue. Stop 48hrs before.

6 EPS & ablation Moderate to high 4 CHA2DS2-VASc score or any metal Low Resume 48 hrs post-procedure. Continue. For radiofrequency ablation and AV node ablation with PPM implant in same sitting stop 48hrs before procedure. Resume 48 hrs post-procedure. For VT stimulations, atrial flutter ablations and AV node ablations with PPM insitu continue DABIGATRAN (PRADAA) Anticoagulant - Direct thrombin inhibitor Indication Direct oral anticoagulants (DOACs) are an alternative for vitamin K antagonists (VKAs) for prevention of VTE after hip and knee replacement surgery, treatment of DVT and prevention of recurrent VTE and the prevention of thromboembolism in AF. They were previously known as NOACs, but as these medications are no longer novel, DAOC is going to be the future adopted term for practice Intervention Moderate to high Can be continued for angiograms. 4 CHA2DS2-VASc Where any stenting is indicated the patient will score or any metal require bridging therapy. For guidance on bridging refer to Appendix 2, Page 69 of the RCHT clinical guideline for thrombosis prevention investigation Pacing Low Moderate to high 4 CHA2DS2-VASc score or any metal Low and management of anticoagulation. Can be continued for angiograms. Where any stenting is indicated stop: Renal function (egfr) hours before 50-< days before 30-< days before (> 48 hours) Resume 48 hrs post-procedure. Continue. Stop: Renal function (egfr) hours before 50-< days before

7 30-< days before (> 48 hours) EPS & ablation Moderate to high 4 CHA2DS2-VASc score or any metal Low Resume 48 hrs post-procedure. Continue. For radiofrequency ablation and AV node ablation with PPM implant in same sitting stop: Renal function (egfr) hours before 50-< days before 30-< days before (> 48 hours) Resume 48 hrs post-procedure. For VT stimulations, atrial flutter ablations and AV node ablations with PPM insitu continue. 7. Switching between anticoagulant regimes VKA to DOAC When switching patients from warfarin to DOAC for stroke and/or systemic embolism, discontinue warfarin and start DOAC as soon as the International Normalized Ratio (INR) <3.0, DOAC to VKA Parenteral anticoagulation to DOAC: Intravenous unfractionated heparin (UFH) Low molecular weight heparin (LMWH) When switching patients from warfarin to DOAC for DVT/PE and prevention of recurrence of VTE discontinue warfarin and start DOAC as soon as the International Normalized Ratio (INR) <2.5 Administer concomitantly for at least two days until INR in appropriate range. After 2 days of coadministration measure INR just before next intake of DOAC. Re-test 48hr after last dose of DOAC. Continue coadministration until the INR is 2, Monitor INR in first month until stable values ( ) achieved Discontinue the parenteral anticoagulant and start DOAC 0-2 hours prior to the time that the next dose of the alternate therapy would be due.

8 DOAC to parenteral anticoagulant Intravenous unfractionated heparin (UFH) Low molecular weight heparin (LMWH) DOAC to DOAC DOAC to dual antiplatelet therapy (Aspirin + Clopidogrel/Prasugrel/Ticagrelor) Dual antiplatelet therapy (Aspirin + Clopidogrel/Prasugrel/Ticagrelor) to DOAC Triple therapy DOAC or VKA with aspirin plus clopidogrel/prasugrel For unfractionated heparin being administered by continuous infusion, stop the infusion and start DOAC at the same time Initiate when next dose of DOAC was due. It is recommended to wait 12 hours after the last dose before switching from DOAC to a parenteral anticoagulant. Initiate when next dose is due except where higher plasma concentrations expected (e.g. renal impairment) Switch immediately. Discontinue DOAC and give the first dose of the other antiplatelet at the time that the next DOAC dose would have been taken unless combination therapy needed Unless combination therapy is needed, start DOAC 0 to 2 hours prior to the next scheduled evening administration of the drug and omit administration of the other antiplatelet. Combined oral anticoagulant and antiplatelet therapy is generally discouraged in atrial fibrillation (AF) outside of ACS or stenting because of increased bleeding, hence the decision to use triple therapy is made on an individual basis in consultation with a consultant Cardiologist 8. Monitoring compliance and effectiveness Element to be monitored Lead Tool Guidance continues to comply with national guidelines and practice updates. Sian Pelton - Quality and Innovation Facilitator Audit of patients both inpatient and elective who are cancelled or delayed going to the cardiac catheter lab due to incorrect anticoagulation work-up

9 Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Regular feedback from the booking team, wards, junior medical team and consultant body on the usability and successful implantation of the guidelines. A short report will be completed on a monthly basis and shared at the Cardiology Quality Summit held monthly Completed reports will be submitted to the Cardiology Quality Summit held monthly. Each report will be submitted prior to quality summit meetings and discussed during the meetings to identify the required actions, the outcomes and resulting actions minuted and recorded as an action for completion. The Quality and Innovation Facilitator will undertake subsequent recommendations and action planning for any or all deficiencies and recommendations within reasonable timeframes. Required changes to practice will be identified and actioned within one month of implementation. The cardiac ward and catheter lab managers, alongside the cardiology consultant body will be responsible for implementation of the change in practice. Lessons learned will be shared with all the relevant stakeholders during the monthly cardiology MDT meetings 9. Equality and Diversity 9.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2.

10 Appendix 1. Governance Information Document Title Date Issued/Approved: 30 th January 2015 clinical guideline for management of anticoagulation in interventional cardiology Date Valid From: 30 th January 2015 Date Valid To: 30 th January 2018 Directorate / Department responsible (author/owner): Cardiology Quality and Innovation Facilitator, Cardiology Contact details: or Brief summary of contents Suggested Keywords: Target Audience Executive Director responsible for Policy: Date revised: This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Guidance on the management of anticoagulation in interventional cardiology Anticoagulation Antiplatelet Cardiology antithrombotic RCHT PCH CFT KCCG Rob Parry New Document Debra Shields Not Required {Original Copy Signed} Internet & Intranet Intranet Only

11 Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Clinical/Cardiology No RCHT clinical guideline for thrombosis prevention investigation and management of anticoagulation. No Version Control Table Date Versio n No V1.0 Initial Issue Summary of Changes Changes Made by (Name and Job Title) Sian Pelton Quality and Innovation Facilitator All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager.

12 Appendix 2. Initial Equality Impact Assessment Form Clinical Guideline For Management Of Anticoagulation In Interventional Cardiology Guidance on the management of anticoagulation in interventional cardiology for both electives and inpatients awaiting a cardiac procedure Directorate and service area: Is this a new or existing Policy? New Cardiology Name of individual completing Telephone: assessment: Sian Pelton 1. Policy Aim* This policy is aimed at all medical and nursing staff caring for patients Who is the strategy / awaiting interventional cardiology who require management of their policy / proposal / anticoagulation. service function aimed at? 2. Policy Objectives* To standardise clinical practice in the management of anticoagulation in patients awaiting cardiac procedures. To inform and educate all medical and nursing staff to ensure the management of anticoagulation for patients awaiting cardiac 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? procedures is evidence based. To reduce the number of patients cancelled or delayed in having their cardiac procedures due to incorrect/inconsistent management of anticoagulation. All clinical staff working in cardiology are knowledgeable and confident in their understanding of anticoagulation management in interventional cardiology Regular feedback from the booking team, wards, cardiac catheter labs and consultant body. Audit of the number of patients who are cancelled or delayed in having their cardiac procedure due to incorrect/inappropriate management of their anticoagulation. Both elective and inpatients on anticoagulation awaiting a cardiac procedure. Yes b) If yes, have these *groups been consulted? C). Please list any groups who have Yes, clinical leads for intervention and pacing have reviewed the guidelines and they have been presented at the Cardiology Audit Meeting. Cardiology Consultants

13 been consulted about this procedure. 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. No 9. If you are not recommending a Full Impact assessment please explain why. NA

14 Signature of policy developer / lead manager / director Sian Pelton (RN) Quality and Innovation Facilitator Names and signatures of 1. Sian Pelton members carrying out the Screening Assessment Date of completion and submission 30 th January 2015 Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date