Oral anticoagulants new and old: bleeding risk and management strategies. Logan Tinsen Pharm.D. Benefis Hospitals

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1 Oral anticoagulants new and old: bleeding risk and management strategies Logan Tinsen Pharm.D. Benefis Hospitals

2 Disclaimer! I am not receiving any compensation from any drug company! Any opinions I may state are my own and may not necessarily represent the views and opinions of Benefis Hospitals

3 Learning Objectives! Distinguish how FDA approved oral anticoagulants function in the body! Understand the trial data that expresses bleeding risk with oral anticoagulants! Comprehend management strategies for oral anticoagulant induced bleeding

4 The Impact of Atrial Fibrillation! AF will affect 6 million Americans by ! >70% us NVAF! Leads to 100, ,000 embolic strokes/ year! AF related stroke leads to:! Chronic disability! Bedridden patients! Constant nursing care! > 20% are fatal

5 The Impact of Venous Thromboembolism! VTE affects up to 900,000 people/ year in US! ½ have long-term complications! Up to 1/3 will die within one month of diagnosis! Up to 1/3 will have a recurrence within 10 years! PE! Leading preventable cause of death in hospitalized patients! Sudden death is 1 st symptom in ¼ of patients! Mortality rate without treatment 30%

6 Goals of Anticoagulation Therapy

7 Clinical Decision Aid

8

9

10

11

12 TSOA vs warfarin for AF

13 TSOA vs warfarin for AF

14 Selecting among available TSOA

15 TSOA vs warfarin for VTE

16 TSOA vs warfarin for VTE

17 TSOA selection for VTE prevention and treatment

18 Managing Bleeding Events: Risk Stratification

19 Managing Bleeding Events: Risk Stratification! Minor bleeding! Withdraw TSOA for 1 day; provide definitive interventions! Restart TSOA at lower dose for a short period! Moderate bleeding! Stop anticoagulant and monitor closely! Consider activated charcoal! Identify and treat bleeding source! Consider extended TSOA withdrawal! Low dose parenteral anticoagulant???! Transfuse PRBC for symptomatic anemia

20 Managing Bleeding Events: Risk Stratification! Major and life-threatening bleeding! Immediate withdrawal of anticoagulant, antiplatelet agents! Verify timing of last dose! Aggressive clinical monitoring (vitals, CBC, CMP, etc.)! Transfuse PRBCs in response to proven/anticipated severe anemia! Consider 4-factor PCC (Kcentra)! Aggressively identify and treat bleeding source! Supportive therapies! Inotropes, ventilation, and ICU admission as needed

21 Clinical Evaluation: Warfarin Reversal 2012 Chest Guidelines For patients with VKA-associated major bleeding, we suggest the rapid reversal of anticoagulation with four-factor prothrombin complex concentrate rather than with plasma (Grade 2C) PCC vs FFP FFP increased risk of volume overload, requires a cross-match if group-specific plasma is used, takes a prolonged period of time to thaw and administer, clotting factor concentrations vary, effect is transient PCC does not require a cross-match, does not pose a risk of volume overload, can be infused in minutes, effect is transient rfviia- evidence supporting its use in VKA-associated bleeding is limited; use cannot be recommended unless more effective agents are NOT available We suggest the additional use of vitamin K 5-10 mg administered by slow IV injection rather than reversal with coagulation factors alone (Grade 2C)

22 Clinical Evaluation: Rivaroxaban Reversal! Guidelines:! FFP: no data for rivaroxaban reversal and the use of FFP in animal or human studies, supportive measure! Kcentra (4-PCC):! Study in rats 50 U/kg effective for reversing rivaroxaban, 25 U/kg was not! Feiba (a4pcc):! Animal studies partially reverse high-dose rivaroxaban! No human data! rviia:! Animal studies decreased BT, mixed effects on lab tests! No human studies! Increased risk of arterial thrombosis

23

24

25 Kcentra Dosing Warfarin [Coumadin] Major or life-threatening bleeding: Kcentra IV x1 according to chart below. Administer at a rate over 30 min. DO NOT REPEAT KCENTRA. Administer vitamin K 5-10 mg IV x 1 with Kcentra (Kcentra MUST BE administered with vitamin K). Dosing is based on body weight AND pre- treatment INR: Pre- treatment INR 2 to < > 6 Dose in units/kg total body weight Maximum doseǂ 25 units/kg 2500 units max 35 units/kg 3500 units max 50 units/kg 5000 units max ǂRound the dose to the nearest vial size (variable based on lot #) Apixaban [Eliquis], Rivaroxaban [Xarelto] Major or life-threatening bleeding: Kcentra 50 units/kg (max 5000 units) IV at a rate over 30 mins

26 Antidotes in Development

27 Summary! Renal impairment! CrCl >30: consider warfarin or Xa agent! CrCl 15-29: consider warfarin! CrCl <15: choose warfarin! Liver impairment! Moderate to severe: avoid TSOA! Adherence issues! Missed doses, consider warfarin! Cost, consider warfarin! Labile INR, consider TSOA! Elderly! All indications: consider apixaban

28 Summary! Specific indication! Hip/knee: apixaban or rivaroxaban! VTE treatment/prevention: all agents! Non-valvular afib: all agents! Valvular afib/ mechanical valve: warfarin! Drug and food interactions! Alteplase (tpa)! Over-anticoagulation

29 Questions???

30 References! Pradaxa (dabigatran etexelate) package insert and patient information, Novartis, NJ. January 2011.! Xarelto (rivaroxaban) package insert and patient information, Janssen Pharmaceuticals, NJ. November 2011.! Eliquis (apixaban) package insert and patient information, Bristol- Myers Squibb, NJ. December 2012.! January CT, Alpert JS, Calkins H, et al AHA/ACC/HRS guideline for management of patients with atrial fibrillation: executive summary. JACC 2014;64: ! Connolly SJ et al. N Engl J Med. 2009;363: ! Patel MR et al. N Engl J Med. 2011;365: ! Granger CB et al. N Engl J Med 2011; 365: ! van der Hulle T et al. J Thromb Haemost. 2014;12:

31 References 1. Kcentra [package insert]. Kankakee, IL. CSL Behring: Sarode R, Milling TJ, Refaai MA, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation Sep 10;128(11): Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation Oct 4;124(14): Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G; American College of Chest Physicians. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e44S-88S. 5. Holbrook A, Schulman S, Witt DM, et al. American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e152S-184S.

32 References cont. 6. Charles V. Pollack. Managing bleeding in anticoagulated patients in the emergency care setting. J Emerg Med Sep;45(3): Davis S. Personal communication. CSL Behring. November 5, Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost Apr;6(4): King CS, Holley AB, Moores LK. Moving toward a more ideal anticoagulant: the oral direct thrombin and factor Xa inhibitors. Chest Apr;143(4): Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol Jul;87(7):S141 S Magee G, Zbrozek A. Fluid overload is associated with increases in length of stay and hospital costs: pooled analysis of data from more than 600 US hospitals. Clinicoecon Outcomes Res Jun 26;5:

33 Cost! Kcentra $635.00/vial (500 units)! FFP $132.00/ unit + $84.00 thawing= $216.00/ unit (~250 ml)! Cost comparison:! Maximum 5000 units (100 kg) Kcentraà $6350! ml/kg of FFP may be requiredà maximum 16 units (100 kg)à $3456! Cost of fluid overload???! Study: 11! 4,138 patients received at least 1 unit of FFP during hospital stay! 3.2% experienced fluid overload! Results:! Fluid overload associated w/ a 29% increase in LOS and a $14,062 increase in hospital costs per visit

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