Anticoagulation Bridging Decision Support Click here to begin Click here for references Oral Anticoagulants What oral anticoagulant does the patient take? Warfarin (Coumadin®, others) Dabigatran (Pradaxa®) Rivaroxaban (Xarelto®) Is surgery or procedure elective or emergent? Elective Emergent Thromboembolism Risk • This risk classification is an initial guide for decisionmaking that should be adapted to individual patient circumstances. If you are unsure of your patient’s risk of thromboembolism, continue with decision support here. • If you already know your patient’s risk of thromboembolism, choose management plan below: – High Thromboembolic Risk Perioperative Bridging – Moderate Thromboembolic Risk Perioperative Bridging – Low Thromboembolic Risk – no bridging therapy Is patient having any of the following (very low bleeding risk procedures): 1) Dental extraction? 2) Cataract extraction/IOL? 3) Upper GI endoscopy? 4) Carpal Tunnel Release? 5) Needle Breast Biopsy? 6) Cutaneous procedure (Mohs, excisions)? Yes No HIGH RISK: Does patient have any of the following? 1) Any mitral valve prosthesis? 2) Caged-ball or tilting disc valve prosthesis? (Types of Mechanical Valves) 3) Stroke, TIA, or VTE in last 3 months? 4) Stroke or TIA with mechanical valve in last 6 months? 5) Severe thrombophilia? (examples) 6) CHADS2 score of 5 or 6 with atrial fibrillation? (CHADS2 Scoring Tool) 7) Rheumatic valvular heart disease with atrial fibrillation? Yes No MODERATE RISK: Does patient have any of the following? 1) Bileaflet aortic valve prosthesis with at least one risk factor? (risk factors) 2) CHADS2 score of 3 or 4 with atrial fibrillation? 3) Prior thromboembolism with atrial fibrillation during interruption of warfarin? 4) VTE within past 3-12 months? 5) Recurrent VTE? 6) Active cancer (treated within 6 months or palliative)? 7) Non-severe thrombophilia? (examples) Yes No Patient does not meet criteria for moderate or high risk of thromboembolism. Consider no bridging therapy during interruption of warfarin unless patient’s history indicates otherwise. Exit No need to stop warfarin before surgery or procedure. Exit Types of Mechanical Valves Return to previous slide Valve Type Valve Name(s) Bileaflet St. Jude; CarboMedics; ATS Open Pivot; On-X; Conform-X Tilting Disc (single leaflet) Bjork-Shiley (now discontinued); Medtronic Hall; Omnicarbon; Monostrut Caged-Ball Starr-Edwards (only one FDA approved) Bioprosthetic (does not require anticoagulation) Carpentier-Edwards (porcine); Hancock II and Mosaic (both by Medtronic, porcine); Edwards Prima Plus, Medtronic Freestyle, and Toronto SPV (by St. Jude) are pericardial porcine valves. Prosthetic Heart Valves. Author: Eric M Kardon, MD, FACEP, Attending Emergency Physician, Georgia Emergency Medicine Specialists; Physician, Division of Emergency Medicine, Athens Regional Medical Center. CHADS2 Scoring Tool Return to previous slide Characteristic Points Recent CHF exacerbation 1 Hypertension (treated or untreated) 1 Age > 75 years 1 Diabetes 1 Prior Stroke or TIA 2 Examples of Severe Thrombophilia Return to previous slide • • • • • Protein C Deficiency Protein S Deficiency Antithrombin Deficiency Antiphospholipid Syndrome Multiple abnormalities Risk Factors Return to previous slide • • • • • • Atrial fibrillation Prior stroke or TIA Hypertension Diabetes Congestive heart failure Age > 75 Examples of Non-severe Thrombophilia Return to previous slide • Heterozygous factor V Leiden mutation • Factor II (prothrombin) mutation Patient is at HIGH risk for thromboembolism Consider bridging patient with therapeutic enoxaparin if bleeding risk acceptable. Consider use of heparin infusion for patients with mechanical valve. Click here for suggested bridging plan. Patient is at MODERATE risk of thromboembolism If patient is undergoing a major cardiac surgery or carotid endarterectomy surgery, consider no bridging therapy. If patient is undergoing a surgery or procedure with low risk for bleeding, consider bridging with heparin infusion, therapeutic enoxaparin, or lowdose enoxaparin based on patient's history. For all other patients with moderate risk, bridging therapy should be chosen based on patient’s history. Click here for suggested bridging plans. Patient is at LOW risk of thromboembolism Consider no bridging therapy during interruption of warfarin based on patient’s history. Exit High Thromboembolism Risk Perioperative Bridging Day Anticoagulation Plan Pre-op Day 5 Stop warfarin (last dose on Pre-op Day 6). Pre-op Day 3 Start therapeutic enoxaparin bridging (1 mg/kg SC q12h) or heparin infusion when INR < goal range. Pre-op Day 1 Check INR, give vitamin K 1.25-2.5 mg orally if INR > 1.5. Last dose of therapeutic enoxaparin (if using) must be > 24 hours prior to surgery. Day of Surgery Check INR, consider additional vitamin K if INR > 1.5. Stop heparin infusion (if using) 4-6 hours prior to surgery. Assess hemostasis postoperatively. May resume warfarin evening of surgery if patient taking fluids. Post-op Day 1 Standard bleeding risk: Resume therapeutic enoxaparin or heparin infusion 24 hours after surgery if hemostasis achieved. High bleeding risk: Consider no bridging or low-dose enoxaparin (40 mg SC daily) 24 hours after surgery if hemostasis achieved. Post-op Day 2 High bleeding risk: Resume therapeutic enoxaparin or heparin infusion 48-72 hours after surgery if hemostasis achieved. Post-op Day 4+ Discontinue bridging when INR in goal range. Exit Moderate Thromboembolism Risk Perioperative Bridging Day Anticoagulation Plan Pre-op Day 5 Stop warfarin (last dose on Pre-op Day 6). Pre-op Day 3 Start low-dose enoxaparin (40mg SC daily), therapeutic enoxaparin (1 mg/kg SC q12h), or heparin infusion based on patient’s bleeding risk when INR < goal range. Pre-op Day 1 Check INR, give vitamin K 1.25-2.5 mg orally if INR > 1.5. Last dose of any enoxaparin (if using) must be > 24 hours prior to surgery. Day of Surgery Check INR, consider additional vitamin K if INR > 1.5. Stop heparin infusion (if using) 4-6 hours prior to surgery. Assess hemostasis postoperatively. May resume warfarin evening of surgery if patient taking fluids. Post-op Day 1 Standard bleeding risk: Resume low-dose enoxaparin, therapeutic enoxaparin, or heparin infusion 24 hours after surgery if hemostasis achieved. High bleeding risk: Consider no bridging or low-dose enoxaparin 24 hours after surgery if hemostasis achieved. Post-op Day 2 High bleeding risk: Continue low-dose enoxaparin (if started post-op day 1) or resume therapeutic enoxaparin or heparin infusion 48-72 hours after surgery if hemostasis achieved. Post-op Day 4+ Discontinue bridging when INR in goal range. Exit Emergency Surgery When rapid reversal is required for any INR: 1) Discontinue warfarin temporarily 2) Administer vitamin K1 2-5mg by slow IV infusion** 3) Supplement with fresh frozen plasma (at least 15ml/kg) 4) Recheck INR and administer additional vitamin K1 in 4-8 hrs, if necessary ** Intravenous vitamin K should be diluted in 50mg Dextrose 5% and administered over 60 minutes to decrease risk of anaphylaxis. Return to Anticoagulation Bridging Decision Support Exit High Bleeding Risk Examples • Urologic surgery and procedures consisting of TURP, bladder resection, or tumor ablation; nephrectomy; or kidney biopsy • Pacemaker or implantable cardioverter-defibrillator device implantation • Colonic polyp resction, typically of large (1-2 cm long) sessile polyps • Surgery and procedures in highly vascular organs (kidney, liver, spleen) • Bowel resection • Major surgery with extensive tissue injury (cancer surgery, joint arthroplasty, reconstructive plastic surgery) • Cardiac, intracranial, or spinal surgery Return to High Thromboembolism Risk Perioperative Bridging Return to Moderate Thromboembolism Risk Perioperative Bridging Dabigatran “Bridging” • Emergent Surgery: – – – • Stop dabigatran. If appropriate, consider delaying surgery until aPTT is normal or appropriate amount of time has passed for drug to have cleared (see table below). INR is not a reliable indicator. There is no reversal agent for dabigatran. Transfuse FFP, PRBC and platelets as indicated. Consider use of recombinant factor VIIa or hemodialysis. PCC is not available at St. Mary’s Hospital. Consider Hematology Consult. Elective Surgery: Creatinine Clearance (mL/min) Dabigatran Half-life (hours) Last dose of dabigatran prior to surgery Standard Bleeding Risk High Bleeding Risk > 80 13 (11-22) 24 hours 2-4 days > 50 to ≤ 80 15 (12-34) 24 hours 2-4 days > 30 to ≤ 50 18 (13-23) At least 2 days (48 hours) 4 days ≤ 30* 27 (22-35) 2-5 days > 5 days *dabigatran is contraindicated when CrCl ≤ 30 mL/min Restart dabigatran post-operatively when hemostasis achieved and wound is stable. Bridging anticoagulation is not necessary due to rapid onset of dabigatran, but use of an alternate route anticoagulant (e.g. LMWH) may be appropriate if the patient cannot take medications by mouth. Exit Rivaroxaban “Bridging” • Emergent Surgery: – Stop rivaroxaban. If appropriate, consider delaying surgery until PT (not INR) is normal or appropriate amount of time has passed for drug to have cleared (see below). – There is no reversal agent for rivaroxaban. Transfuse FFP, PRBC and platelets as indicated. Consider use of recombinant factor VIIa. Rivaroxaban is not dialyzable. PCC is not available at St. Mary’s Hospital. – Consider Hematology consult. • Elective Surgery: Hold rivaroxaban for 1-2 days prior to surgery based on elimination half-life (5-9 hours in healthy adults, 11-13 hours in elderly adults). Restart rivaroxaban post-operatively when hemostasis achieved, at least 6-10 hours. Bridging anticoagulation is not necessary due to rapid onset or rivaroxaban, but use of an alternate route anticoagulant (e.g. LMWH) may be appropriate if the patient cannot take medications by mouth. Exit References Return to Anticoagulation Bridging Decision Support • Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, et al. Perioperative management of antithrombotic therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest. 2012;141:e326S-e350S. • Douketis JD. Perioperative management of patients who are receiving warfarin therapy: an evidence-based and practical approach. Blood. 2011;117(19):5044-5049. • Garcia DA. Update in bridging anticoagulation. J Thromb Thrombolysis. 2011;31(3):259-264. • Lexi-comp OnlineTM , Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; September 20, 2011. • Guidelines for testing and perioperative management of dabigatran. New Zealand Government PHARMAC. • DeLoughery TG. Practical aspects of the oral new anticoagulants. Am J Hematol. 2011;86:586-590. Updated May 14, 2012 Katherine Rotzenberg, PharmD; Dr. Roy Kim; Dave Pauly, RPh