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Warfarin and Novel Anti-Coagulants: Management Before and After the Cath Lab
Drew Baldwin, MDVirginia Mason
Seattle, WashingtonNCVH | May 28, 2015 | 2:30 pm
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)
FDA approved FDA approved FDA approved FDA approved
dabigatran(Pradaxa)
FDA approved FDA approved FDA approved
rivaroxaban(Xarelto)
FDA approved FDA approved FDA approved FDA approved
apixaban(Eliquis)
FDA approved FDA approved FDA approved FDA approved
edoxaban(Savaysa)
FDA approved FDA approved
betrixabanNot yet FDA
approvedNot yet FDA
approvedNot yet FDA
approvedNot yet FDA
approved
Warfarin
• Radial access; INR < 3.0
– Avoids enoxaparin bridging
• Femoral access; INR < 1.7
• Vitamin K for reversal in case of bleeding complications
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
How long should NOACs be held before cardiac procedures?
CrCl < 15 CrCl 15-29 CrCl 30-49 Cr 50-79 Cr ≥ 80
Direct Xa inhibitors for a procedure with low bleeding risk
N/a > 36 hrs > 24 hrs > 24 hrs > 24 hrs
Direct Xa inhibitors for a procedure with high bleeding risk
N/a > 48 hrs > 48 hrs > 48 hrs > 48 hrs
DTI (dabigatran) for a procedure with low bleeding risk
N/a N/a > 48 hrs > 36 hrs > 24 hrs
DTI (dabigatran) for a procedure with high bleeding risk
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.
When should NOACs be restarted after cardiac procedures?
• Procedures with low bleeding risk: resume 12-24 hours after the procedure
• Procedures with high bleeding risk: resume 48-72 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.
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 41-230 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: 687-692.
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
Additional measures for life-threatening bleeding
DTI (dabigatran) Factor Xa inhibitors
Oral charcoal for recent doses May be effective
Hemodialysis Effective in CKD Not likely to be effective
Andexanet alfa FDA-approved for bleeding complications in patients taking rivaroxaban or apixaban
Off-label therapies:
Unactivated prothrombin complex concentrate (Kcentra, Profilnine)
No effect Highly effective in experimental models
Activated prothrombin complex concentrate (Feiba NF)
Effective in experimental models
Effective in experimental models
Recombinant factor VIIa Effective in experimental models
Effective in experimental models
Factor II, IX, X concentrates Effective in experimental models
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
Reversal agents in development
• Idarucizamab (aDabi-Fab)
– Antibody fragment against dabigatran
• Aripazine (ciraparantag, PER977)
– Small molecule binds to heparin, LMWH, oral factor Xa inhibitors
Antiplatelet and anticoagulant therapy for the patient with atrial fibrillation who also has ACS or a PCI procedure
Dewilde WJM, et al. Lancet 2013;381:1107-1115.
WOEST trial bleeding events:• 19.4% in patients
taking clopidogrel+ OAC
• 44.4% in patients taking aspirin + clopidogrel + OAC
Antiplatelet and anticoagulant therapy for the patient with atrial fibrillation who also has ACS or a PCI procedure
• Rivaroxaban PIONEER
• Apixaban AUGUSTUS
• Edoxaban EVOLVE
• Dabigatran RE-DUAL
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.
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