9/28/15. Dabigatran. Rivaroxaban. Apixaban. Edoxaban. From the AC Forum Centers of Excellence website: Dabigatran, Rivaroxaban, & Apixaban

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1 Identify the FDA approved direct oral anticoagulants (DOACs) Linda Kelly, PharmD, PhC, CACP Presbyterian Healthcare Services Distinguish the differences in the dosing of DOACs for various indications Describe the differences between switching from a DOAC and switching to a DOAC Explain the differences in bridging a patient on warfarin versus a patient on a DOAC Discuss transitions of care issues with the DOACs Dabigatran Rivaroxaban Apixaban Edoxaban From the AC Forum Centers of Excellence website: Resource Center Drug Therapy Management Comprehensive Management of TSOACs TSOAC Comparison Chart for Dabigatran, Rivaroxaban, & Apixaban 1

2 Marge is a 72 year old female with non-valvular atrial fibrillation (NVAF). She has been taking warfarin for stroke prevention. Her history also includes hypertension. Her CHA 2 DS 2 -VASc score is Marge arrives at her anticoagulation clinic visit with the news she saw her PCP yesterday. She is going to stop warfarin and start dabigatran. She picked up her prescription for dabigatran 150mg capsules this morning Marge kept her appointment with you to say goodbye and drop off the souvenir she bought for you on her latest excursion Her PCP instructed her to stop warfarin after tonight s dose and start the dabigatran tomorrow morning Is Marge a candidate for dabigatran? Diagnosis CHA 2 DS 2 -VASc score CrCl/hepatic disease Drug Interactions Adherence History GI disease/gi bleeding All bleeding history Fall history Cost Per the prescribing information, start DOAC when INR is: Dabigatran-less than 2 Apixaban-less than 2 Edoxaban- less than or equal to 2.5 Rivaroxaban- less than 3 2

3 9/28/15 Protocol 1 Start warfarin and continue DOAC Check INR frequently Check just before dose of DOAC due Avoid use of point of care INR Protocol 2 Stop DOAC and start low molecular weight heparin (LMWH) at the next scheduled dose Start warfarin and overlap with LMWH until INR is greater than 2 Stop DOAC and start LMWH when the next dose is due Stop LMWH and start DOAC when next dose is due Stop DOAC 1 and start DOAC 2 when the next dose is due Stop heparin drip and start DOAC immediately Start DOAC 1 hour before stopping heparin drip in patients with high risk of thrombosis and DOAC with longer Tmax (rivaroxaban) 3

4 9/28/15 Black hole All DOACs affect the aptt All DOACs except dabigatran affect the antixa level Evidence-free recommendation: Assess clotting and bleeding risks for patient Stop the DOAC and start weight based heparin drip when next DOAC dose is due NO baseline lab Draw first lab (aptt or anti-xa level) 12 hours after drip has started This is the first question to ask when bridging is contemplated. Summary of Recommendations for the Interruption of Anticoagulation or Antiplatelet Therapy for Elective Invasive Procedures or Surgery Polypectomy is considered a high bleeding risk procedure Most gastroenterologists want to have the option of polypectomy so request patients withhold anticoagulant therapy prior to colonoscopy Per the Savaysa Prescribing Information: 2.5 Discontinuation for Surgery and Other Interventions Discontinue SAVAYSA at least 24 hours before invasive or surgical procedure because of the risk of bleeding 4

5 Similar to resuming treatment-dose LMWH, it is generally recommended to resume DOACs 2-3 days (48 to 72 hour) post-operatively Longer period if hemostasis has not been achieved Consider absorption of oral products, particularly post bowel surgery Low bleeding risk procedures-consider resumption after 24 hours Was the primary indication for the anticoagulant clearly documented Was an assessment of fall risk clearly documented Did documentation indicate whether the patient was new to anticoagulation therapy or a previous user If new (within 30 days), was the start date of anticoagulation therapy provided Did documentation indicate whether treatment is intended to be short-term or long-term If short-term, was total duration of therapy provided Date, time, and strength of last dose given documented Date, time, and strength of next dose provided If on warfarin: Was the target INR or INR range provided Were the last 2 INR results provided Was the date for the next INR provided Was the most recent serum creatinine or creatinine clearance evaluation provided Was the patient provided with educational material Was an assessment of patient/caregiver understanding of the education documented Was the patient referred to an anticoagulation management service 5

6 One source recommends At 1 month, assess for: Medication adherence Tolerance (e.g. dyspepsia) Monitor for bleeding Consider first visit no more than 7 days and add patient education, dose assessment, and duration of therapy to above list Every 6 months for 2 years, and every 6 to 12 months thereafter: Assess for medication adherence and tolerance Monitor for bleeding Monitor kidney/hepatic function Assess concomitant medications Plan for treatment interruptions for elective procedures or surgery Douketis Can Family Physician 2014 Douketis Can Family Physician Comprehensive Management of TSOACs. Excellence.ACForum. AC Forum, n.d. Web. 1Sept Pradaxa [package insert]. Ridgefield, Ct: Boehringer Ingelheim Pharmaceuticals, Inc.; January CT, et. al AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. Journal of the American College of Cardiology.2014;64(21):e1-e Xarelto [package insert]. Titusville NJ; Janssen Pharmaceuticals, Inc.; Eliquis [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; Savaysa [package insert]. Parsippany, NJ:Daiichi Sankyo, Inc.; Abo-Salem E, Becker R. Transitioning to and from the novel oral anticoagulants: a management strategy for clinicians. J Thromb Thrombolysis. 2014;37: Mahan CE. Practical aspects of treatment with target specific anticoagulants: initiation, payment and current market, transitions, and venous thromboembolism treatment. J Thromb Thrombolysis. 2015;39: Spyropoulos A, Douketis J. How I treat anticoagulated patients undergoing an elective procedure or surgery. Blood. 2012;120: "Summary of Recommendations for the Interruption of Anticoagulation or Antiplatelet Therapy for Elective Invasive Procedures or Surgery." ThrombosisCanada. Thrombosis Canada, n.d. Web. 31 Aug "Anticoagulation Discharge Communication (AC-DC) Audit Tool." IPRO.org. IPRO, Oct Web. 31 Aug Douketis J, et. al. Approach to the new oral anticoagulants in family practice. Can Family Physician. 2014; 60 (11):