Warfarin and Novel Anti-Coagulants: Management Before and After the Cath Lab

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1 Warfarin and Novel Anti-Coagulants: Management Before and After the Cath Lab Drew Baldwin, MD Virginia Mason Seattle, Washington NCVH May 28, :30 pm

2 I have no disclosures.

3 Stroke risk reduction in non-valvular atrial fibrillation Prevention of DVT after hip or knee surgery Risk reduction for recurrent DVT Treatment of DVT and PE aspirin warfarin (Coumadin) dabigatran (Pradaxa) rivaroxaban (Xarelto) apixaban (Eliquis) FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved edoxaban (Savaysa) FDA approved FDA approved betrixaban Not yet FDA approved Not yet FDA approved Not yet FDA approved Not yet FDA approved

4 Warfarin Radial access; INR < 3.0 Avoids enoxaparin bridging Femoral access; INR < 1.7 Vitamin K for reversal in case of bleeding complications

5 NOACs in the cath lab Planned procedures for a patient on a NOAC Emergency procedures (STEMI) for a patient on a NOAC Antiplatelet and anticoagulant therapy for a patient with PCI and atrial fibrillation

6

7 How long should NOACs be held before cardiac procedures? CrCl < 15 CrCl CrCl Cr Cr 80 Direct Xa inhibitors for a procedure with low bleeding risk Direct Xa inhibitors for a procedure with high bleeding risk N/a > 36 hrs > 24 hrs > 24 hrs > 24 hrs N/a > 48 hrs > 48 hrs > 48 hrs > 48 hrs DTI (dabigatran) for a procedure with low bleeding risk DTI (dabigatran) for a procedure with high bleeding risk N/a N/a > 48 hrs > 36 hrs > 24 hrs N/a N/a > 96 hrs > 72 hrs > 48 hrs Procedures with low bleeding risk: coronary angiogram, pacemaker/icd implant, EP study, SVT ablation. Procedures with high bleeding risk: PCI, AF ablation, VT ablation, TAVR Based on: Baker N and Jennings HS. Novel Anticoagulants: Management in the Periprocedural Setting and During Complications. SCAI website, March 25, 2015.

8 When should NOACs be restarted after cardiac procedures? Procedures with low bleeding risk: resume hours after the procedure Procedures with high bleeding risk: resume hours after the procedure Procedures with low bleeding risk: coronary angiogram, pacemaker/icd implant, EP study, SVT ablation. Procedures with high bleeding risk: PCI, AF ablation, VT ablation, TAVR Based on: Baker N and Jennings HS. Novel Anticoagulants: Management in the Periprocedural Setting and During Complications. SCAI website, March 25, 2015.

9 Measuring NOAC levels Rivaroxaban PT can provide a qualitative assessment Chromogenic anti-xa level calibrated for rivaroxaban Trough levels 4-96 ng/ml Usual lower level of measurable is < 50 ng/ml Apixaban PT can provide a qualitative assessment Chromogenic anti-xa level calibrated for apixaban Trough levels ng/ml Usual lower level of measurable is < 20 ng/ml Dabigatran aptt can provide a qualitative assessment Plasma dilute thrombin time (dtt, Hemoclot) dtt > 65 seconds indicates increased risk for bleeding Gehrie E, Tormey C. Arch Pathol Lab Med 2015; 139:

10 Managing non-life threatening bleeding complications Apply local hemostasis if possible Provide hemodynamic support (IV fluids, packed RBCs, vasopressors) Assess compliance and timing of the last dose Get early consultation with a hematologist or blood bank physician Consider platelet transfusions for thrombocytopenia (platelet count < 60,000) Consider desmopressin for coagulopathy or thrombopathy For dabigatran, maintain diuresis (unless hypotensive or volume depleted) For dabigatran, consider hemodialysis Wait

11 Additional measures for life-threatening bleeding Oral charcoal for recent doses DTI (dabigatran) May be effective Factor Xa inhibitors Hemodialysis Effective in CKD Not likely to be effective Andexanet alfa Off-label therapies: Unactivated prothrombin complex concentrate (Kcentra, Profilnine) No effect FDA-approved for bleeding complications in patients taking rivaroxaban or apixaban Highly effective in experimental models Activated prothrombin complex concentrate (Feiba NF) Recombinant factor VIIa Factor II, IX, X concentrates Effective in experimental models Effective in experimental models Effective in experimental models Effective in experimental models Effective in experimental models

12 Andexanet alfa Factor Xa decoy Recombinant engineered form of factor Xa produced in CHO cells Serine alanine change eliminates catalytic activity, prevents cleavage of prothrombin Complete correction of coagulation parameters within 2 minutes of bolus; effects last 1-2 hours Approved for reversal of rivaroxaban (ANNEXA-R study) Approved for reversal of apixaban (ANNEXA-A study) Undergoing evaluation for reversal of edoxaban, betrixaban

13 Reversal agents in development Idarucizamab (adabi-fab) Antibody fragment against dabigatran Aripazine (ciraparantag, PER977) Small molecule binds to heparin, LMWH, oral factor Xa inhibitors

14 Antiplatelet and anticoagulant therapy for the patient with atrial fibrillation who also has ACS or a PCI procedure WOEST trial bleeding events: 19.4% in patients taking clopidogrel + OAC 44.4% in patients taking aspirin + clopidogrel + OAC Dewilde WJM, et al. Lancet 2013;381:

15 Antiplatelet and anticoagulant therapy for the patient with atrial fibrillation who also has ACS or a PCI procedure Rivaroxaban Apixaban Edoxaban Dabigatran PIONEER AUGUSTUS EVOLVE RE-DUAL

16 Antiplatelet and anticoagulant therapy for the patient with atrial fibrillation who also has ACS or a PCI procedure Triple therapy (aspirin 81 mg daily + clopidogrel 75 mg daily + anticoagulant) for 1-3 months, then stop aspirin Individualize according to risk for bleeding and stent thrombosis.

17 NOACs in the cath lab Planned procedures for a patient on a NOAC: Hold NOAC according to institutional protocols and individual patient situations Emergency procedures (STEMI) for a patient on a NOAC: Use radial access Notify hematology/blood bank and prepare to manage any bleeding complications Antiplatelet and anticoagulant therapy for a patient with PCI and atrial fibrillation Individualize according to patient s risk for bleeding complications and stent thrombosis

18 Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation Drew Baldwin, MD Virginia Mason Seattle, Washington NCVH May 29, :15 pm

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