Oral Anticoagulants & Reversal Strategies

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1 Oral Anticoagulants & Reversal Strategies ISHP Spring Conference Boise 2015 April 12 th, 2015 Rob Wills, Pharm.D., BCPS Sr Clinical Manager of Pharmacy St. Luke s Treasure Valley Objectives 1. Discuss current updates related to the new oral anticoagulants 2. Describe the indications and differences between agents 3. Evaluate the differences between reversal agents 4. Identify the complications associated with the use of the new oral anticoagulants 2 1

2 J Am Coll Cardiol. 2012;59(16): doi: /j.jacc Wisconsin Sweet Clover & Rodenticide ISCONSIN LUMNI ESEARCH OUNDATION 4 Wardrop & Keeling. British Journal of Haematology, 2008:141;

3 What s Wrong With WARFARIN? 5 Chest. 2008;133(6_suppl):160S-198S Well Established Guidelines 6 3

4 What s Wrong With WARFARIN? 7 Reversibility with Phytonadione Slow on/off Food Interactions 8 4

5 Year in the life of a Warfarin patient 9 Year in the life of a Warfarin patient 6 INR Trend Stomach bug Antibiotic INR INR Reading New diet Trip to Europe Thanksgiving 0 January March September December 10 5

6 11 ACC/AHA/ESC guidelines: Fuster V et al. Circulation 2006;114:e and Eur Heart J 2006:27: Time in Therapeutic Range (TTR) Taiwan Mexico Peru Romania India Columbia Russia Brazil China Korea Greece Thailand Malaysia Poland Japan South Africa France Slocakia Portugal Israel Czech Republic Philippines Bulgaria Hungary Hong Kong Turkey Belgium Austria USA Spain Germany Switzerland Singapore Argentina Netherlands Norway Canada Italy Ukraine UK Denmark Austrailia Finland Sweden USA Wallentin L, et al. Lancet Sep 18;376(9745): PMID: Preventing Afib Related Strokes. Boston University Anticoagulation Forum. Accessed

7 What s Wrong With WARFARIN? 13 7

8 Question: What are the ideal characteristics of an oral anticoagulant? a) Rapid onset-offset b) Predictable pharmacokinetics/pharmacodynamics c) Low risk of bleeding d) Low risk of drug-drug or drug-food interactions e) All of the above 15 National warfarin and dabigatran treatment visits, 2007 to Kirley K et al. Circ Cardiovasc Qual Outcomes. 2012;5: Copyright American Heart Association, Inc. All rights reserved. 8

9 Quarterly prescription expenditures for warfarin and dabigatran (retail value), 2007 to Kirley K et al. Circ Cardiovasc Qual Outcomes. 2012;5: Copyright American Heart Association, Inc. All rights reserved. Dabigatran (Pradaxa ) Approved 2010 Use 4-fold FDA - reports of serious and fatal bleeds McConeghy KW, et al. Pharmacotherapy. 2014;34(6): Southworth et al. N Engl J Med 2013; 368: Pradaxablood.com 18 9

10 Dabigatran (Pradaxa ) Warfarin Dabigatran (Pradaxa ) Adverse Reports Bleeding Events (32%) 2347 (26%) Fatal outcomes 46 (7.1%) 348 (15%) Lower bound est 150 bleeding fatalities per 100,000 dabigatran patient years McConeghy KW, et al. Pharmacotherapy. 2014;34(6): Southworth et al. N Engl J Med 2013; 368: NOAC FDA Approval Status Indication Dabigatran Pradaxa Rivaroxaban Xarelto Apixaban Eliquis Edoxaban Savaysa Atrial fibrillation FDA approved FDA approved FDA approved FDA approved VTE Treatment FDA approved FDA approved FDA approved FDA approved VTE Prevention, Ortho surgery No FDA activity FDA approved FDA approved No FDA activity Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference

11 Atrial Fibrillation - Stroke Stroke Epidemiology - CDC 22 11

12 Mary Age yr hx of afib HTN CHADS 2 2 Currently on wafarin INR TTR ~ 50% Minor complaints of bruising and nose bleeds SCr 1.6, Wt 81 kg

13 2014 AHA/ACC/HRS Atrial Fibrillation Guidelines Risk Category CHA 2 DS 2 -VASc = 0 Recommendation No Therapy CHA 2 DS 2 -VASc = 1 OAC or ASA or no therapy CHA 2 DS 2 -VASc 2 OAC Unstable INR Dabigatran, Rivaroxaban or Apixaban January CT et al. J Am Coll Cardiol Mar _hasbled.ashx 13

14 27 BLED%20Bleeding%20risk.png HAS-BLED vs. CHADS-VASc

15 Drug Feature Warfarin Dabigatran Pradaxa Rivaroxaban Xarelto Apixaban Eliquis Edoxaban Savaysa Target Vitamin K Thrombin Factor Xa Factor Xa Factor Xa Dose Freq Daily Twice Daily Daily Twice daily Once Daily Onset Slow Rapid Rapid Rapid Rapid Peak effect 4 to 5 days 1 to 2 hours 2 to 3 hours 1 to 2 hours 1 to 2 hours Offset Long Short Short Short Short Half-life 40 hours 12 to 17 hrs 7 to 11 hours 12 hours 10 to 14 hrs Renal clearance None 80% 33% active (70% total) 25% 50% Interactions Many P-gp CYP3A4;P-gp CYP3A4;P-gp P-gp Monitoring Yes No No No No Dialyzable No Yes No No No Antidote Vitamin K, 4PCC None None None None Cost $0.36 tab $3.16 day $4 per tab $6.80 day? Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference 2014 Drug Feature Warfarin Dabigatran Pradaxa Rivaroxaban Xarelto Apixaban Eliquis Edoxaban Savaysa Target Vitamin K Thrombin Xa Xa Xa Dose Freq Daily or Twice Daily? Daily Onset Slow Rapid Rapid Rapid Rapid Peak effect 4 to 5 days 1 to 2 hours 2 to 3 hours 1 to 2 hours 1 to 2 hours Offset Long Short Short Short Short Half-life 40 hours 12 to 17 hrs 7 to 11 hours 12 hours 10 to 14 hrs Renal clearance None 80% 33% active (70% total) 25% 50% Interactions Many P-gp CYP3A4;P-gp CYP3A4;P-gp P-gp Monitoring Yes No No No No Dialyzable No Yes No No No Antidote Vitamin K, 4PCC None None None None Cost $0.36 tab $3.16 day $4 per tab $6.80 day? Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference

16 Drug Feature Warfarin Dabigatran Pradaxa Rivaroxaban Xarelto Apixaban Eliquis Edoxaban Savaysa Target Vitamin K Thrombin Xa Xa Xa Dose Freq Daily or Twice Daily? Daily Onset Slow Rapid Rapid Rapid Rapid Peak effect 4 to 5 days 1 to 2 hours 2 to 3 hours 1 to 2 hours 1 to 2 hours Offset Long Short Short Short Short Half-life 40 hours 12 to 17 hrs 7 to 11 hours 12 hours 10 to 14 hrs Renal clearance None 80% 33% active (70% total) 25% 50% Interactions Many P-gp CYP3A4;P-gp CYP3A4;P-gp P-gp Monitoring Yes No No No No Dialyzable No Yes No No No Antidote Vitamin K, 4PCC None None None None Cost $0.36 tab $3.16 day $4 per tab $6.80 day? Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference 2014 Atrial Fibrillation Trials RE-LY (18,113) ROCKET-AF (14,264) ARISTOTLE (18,201) ENGAGE (21,108) Agent Dabigatran Rivaroxaban Apixaban Edoxaban* Design Inclusion Renal impairment (excluded) Dosing Renal Dose Adjustment Open-label Non-inferiority Non-valvular AF CHADS 2 1 Double-blind Non-inferiority Non-valvular AF CHADS 2 2 Double-blind Non-inferiority Non-valvular AF CHADS 2 1 CrCl < 30 ml/min CrCl < 30 ml/min Serum creatinine > 2.5 mg/dl or CrCl < 25 ml/min 150 mg Twice Daily NONE 75 mg dose not studied in patients *Currently not approved in US Double-blind Non-inferiority Non-valvular AF CHADS 2 2 CrCl 30 ml/min 20 mg Daily 5 mg Twice Daily High 60 mg/day Low 30 mg/day CrCl = ml/min 15 mg daily 2.5 mg Twice Daily if 2 or more of the following: Age > 80 yo, weight < 60 kg, SCr > 1.5 mg/dl ½ dose if CrCl ml/min or weight < 60 kg Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference Connolly SJ et al. NEJM. 2009;361: ; Patel MR et al. NEJM. 2011;365: Granger CB et al. NEJM. 2011;365:981-92; GuiglianoRP et al. NEJM.2013;369:

17 Atrial Fibrillation Trials RE-LY (18,113) ROCKET-AF (14,264) ARISTOTLE (18,201) ENGAGE (21,108) Agent Dabigatran Rivaroxaban Apixaban Edoxaban* Design Inclusion Renal impairment (excluded) Dosing Renal Dose Adjustment Open-label Non-inferiority Non-valvular AF CHADS 2 1 Double-blind Non-inferiority Non-valvular AF CHADS 2 2 Double-blind Non-inferiority Non-valvular AF CHADS 2 1 CrCl < 30 ml/min CrCl < 30 ml/min Serum creatinine > 2.5 mg/dl or CrCl < 25 ml/min 150 mg Twice Daily NONE 75 mg dose not studied in patients *Currently not approved in US Double-blind Non-inferiority Non-valvular AF CHADS 2 2 CrCl 30 ml/min 20 mg Daily 5 mg Twice Daily High 60 mg/day Low 30 mg/day CrCl = ml/min 15 mg daily 2.5 mg Twice Daily if 2 or more of the following: Age > 80 yo, weight < 60 kg, SCr > 1.5 mg/dl ½ dose if CrCl ml/min or weight < 60 kg Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference Connolly SJ et al. NEJM. 2009;361: ; Patel MR et al. NEJM. 2011;365: Granger CB et al. NEJM. 2011;365:981-92; GuiglianoRP et al. NEJM.2013;369: Atrial Fibrillation Trials RE-LY (18,113) ROCKET-AF (14,264) ARISTOTLE (18,201) ENGAGE (21,108) Agent Dabigatran Rivaroxaban Apixaban Edoxaban* Design Inclusion Renal impairment (excluded) Dosing Renal Dose Adjustment Open-label Non-inferiority Non-valvular AF CHADS 2 1 Double-blind Non-inferiority Non-valvular AF CHADS 2 2 Double-blind Non-inferiority Non-valvular AF CHADS 2 1 CrCl < 30 ml/min CrCl < 30 ml/min Serum creatinine > 2.5 mg/dl or CrCl < 25 ml/min 150 mg Twice Daily NONE 75 mg dose not studied in patients *Currently not approved in US Double-blind Non-inferiority Non-valvular AF CHADS 2 2 CrCl 30 ml/min 20 mg Daily 5 mg Twice Daily High 60 mg/day Low 30 mg/day CrCl = ml/min 15 mg daily 2.5 mg Twice Daily if 2 or more of the following: Age > 80 yo, weight < 60 kg, SCr > 1.5 mg/dl ½ dose if CrCl ml/min or weight < 60 kg Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference Connolly SJ et al. NEJM. 2009;361: ; Patel MR et al. NEJM. 2011;365: Granger CB et al. NEJM. 2011;365:981-92; GuiglianoRP et al. NEJM.2013;369:

18 NOAC in A.Fib trial results Trial Characteristics Dabigatran (RE-LY) Rivaroxaban (ROCKET AF) Apixaban (ARISTOTLE) Edoxaban (ENGAGE) Participants 18,113 14,264 18,201 21,105 Median age 71 (mean) Mean CHADS Mean TTR 64% 55% 62% 68.4% Median CrCl N/A -- Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference Stroke or Systemic Embolism RR (95% CI) ARISTOTLE apixaban Efficacy results driven by reduction in hemorrhagic stroke 0.79 ( ) non-inferior & superior RE-LY dabigatran 150 MG BID arm 0.66 ( ) non-inferior & superior ROCKET-AF rivaroxaban Intention-to-treat analysis presented 0.88 ( ) non-inferior only Favors NOAC 1.0 Favors Warfarin Connolly SJ et al. NEJM. 2009;361: ; Patel MR et al. NEJM. 2011;365: Granger CB et al. NEJM. 2011;365:981-92; 36 Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference 18

19 Stroke or Systemic Embolism ENGAGE AF-TIMI 48 High Dose Edoxaban (60 mg) RR (95% CI) 0.87 ( ) non-inferior Low Dose Edoxaban (30 mg) GFR ml/min, Wt < 60 kg, potent PG inhibitor 1.13 ( ) non-inferior Favors NOAC 1.0 Favors Warfarin Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference Guigliano RP et al. NEJM.2013;369: Meta-analysis of Efficacy and Safety of New Oral Anticoagulants Dabigatran, Rivaroxaban, Apixaban vs. Warfarin in AF patients All cause stroke/see Ischemic and unspecified stroke Hemorrhagic stroke Favors NOAC 1.0 Favors Warfarin Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Am J Cardiol Aug 1;110(3): Pub Med PMID: Preventing Afib Related Strokes. Boston University Anticoagulation Forum. Accessed

20 Meta-analysis of Efficacy and Safety of New Oral Anticoagulants Dabigatran, Rivaroxaban, Apixaban vs. Warfarin in AF patients Major bleeding Intracranial bleeding GI Bleeding Favors NOAC 1.0 Favors Warfarin 39 Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Am J Cardiol Aug 1;110(3): Pub Med PMID: Preventing Afib Related Strokes. Boston University Anticoagulation Forum. Accessed Lower Major Bleeding Rates Major Bleeding Rate P = P = Dabigatran Warfarin Rivaroxaban Warfarin P < P < Warfarin Edoxaban Warfarin Dabigatran Rivaroxaban Apixaban Edoxaban Apixaban Connolly SJ et al. NEJM. 2009;361: ; Patel MR et al. NEJM. 2011;365: Granger CB et al. NEJM. 2011;365:981-92; Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference 40 20

21 Trial Conclusions Trial NOAC Conclusion RE-LY Dabigatran 150 mg more effective in preventing stroke or systemic embolism without significantly increasing major bleeding ROCKET-AF Rivaroxaban Non-inferior for preventing stroke or major embolism without significantly increasing major bleeding ARISTOTLE Apixaban Superior to warfarin in preventing stroke or systemic embolism, reducing bleeding and mortality ENGAGE Edoxaban 30 mg and 60 mg non-inferior for the prevention of stroke or systemic embolism, reduced the risk of major bleeding and cardiovascualar death AVERROES Apixaban Apixaban 5 mg BID superior to aspirin mg/day in warfarin unsuitable patients Chan NC et al. Thromb Haemost. 2014;111: Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference 41 What s Best For Mary? CrCl ~ 40 ml/min SCr 1.6, Wt 81 kg Age

22 Considerations for Anticoagulation Therapy Cost of therapy Safety (bleeding risks, need for reversal) Management support Adherence Compliance with follow up Drug-Drug or Drug-food interactions Organ dysfunction (renal/liver) Previous experience with anticoagulants 44 Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference 22

23 Managing Patients on NOACs Effects of acute illness, organ system changes, or new medications (or stopping other meds)? Timing/Stopping before invasive procedure Switching between agents Follow-up plans or monitoring? What should be monitored/measured? Reversibility Is there a way to reverse the effects? 45 Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference Patient Case 1 Atrial Fibrillation How To Switch? 84 yo female, 3+ yr hx of afib Changing to Apixaban Which option is the best? a) Start Apixaban and DC warfarin after 5 days b) DC warfarin and start Apixaban now c) DC warfarin and start Apixaban when INR < 2 d) DC warfarin and start Apixaban when INR <

24 ORAL ANTICOAGULANT CONVERSIONS from warfarin to APIXABAN INR is < 2. DABIGATRAN INR is < 2. RIVAROXABAN INR is < 3 EDOXABAN INR is Adapted from NEW ORAL ANTI-COAGULANTS 2013 (Amr A. Soliman, PharmD, BCPS, CGP) ORAL ANTICOAGULANT CONVERSIONS Apixaban: Dabigatran: Rivaroxaban: Edoxaban: from nonwarfarin anticoagulant to d/c non-warfarin anticoagulant & begin the apixaban at the start 0 to 2 hours before the time of the next dose of the non-warfarin anticoagulant or at time of next scheduled discontinuation of dose of the nonwarfarin anti- continuously administered parenteral anti-coagulant coagulant. (ie, heparin infusion). d/c the non-warfarin anticoagulant & begin the rivaroxaban at the next scheduled dose of the nonwarfarin anti-coagulant. From heparin continuous infusion to rivaroxaban: stop heparin infusion & start rivaroxaban at same time. d/c the non-warfarin anticoagulant & begin the edoxaban at the next scheduled dose From heparin continuous infusion to edoxaban: stop heparin infusion & start edoxaban at same time Adapted from NEW ORAL ANTI-COAGULANTS 2013 (Amr A. Soliman, PharmD, BCPS, CGP) 48 24

25 DOSING: RENAL DISEASE APIXABAN (ELIQUIS ) DABIGATRAN (PRADAXA ) RIVAROXABAN (XARELTO ) EDOXABAN (SAVAYSA ) afib 2.5mg BID if has at least 2 of the following: age = 80+, weight < 60kg, SCr > 1.5 CrCl 15-30: 75mg BID. CrCl <15: AVOID USE. (Per ACCP, contraindicated in CrCl < 30; excluded from RE-LY trial). (use actual body weight to calculate CrCl) CrCl 15-50: 15mg daily w/evening meal CrCl <15: AVOID USE. CrCl 15-50: 30mg Daily CrCl <15 or > 95: AVOID USE. Post- Ortho (off-label): 2.5mg BID. (off-label): CrCl <30: AVOID USE; age >75: 150mg daily. (use actual body weight to calculate CrCl) CrCl<30: AVOID USE. (na) VTE Treatment (off label): VTE prevention after initial treatment: 2.5mg BID. (off-label): CrCl 30-50: 75mg x1 then 150mg daily (CrCl <30: AVOID USE). (use actual body weight to calculate CrCl) CrCl<30: AVOID USE. CrCl 15-50: 30mg Daily OR Body wt < 60 kg OR on P-gp inhib Adapted from NEW ORAL ANTI-COAGULANTS 2013 (Amr A. Soliman, PharmD, BCPS, CGP) Drug Interactions Dabigatran Serum conc Serum conc Rivaroxaban Serum conc Serum conc Apixaban Serum conc Serum conc Interacting Agents Amiodarone, quinidine, ketoconazole, verapamil, clopidogrel Antacids, atorvastatin, proton pump inhibitors, rifampin (avoid) Interacting Agents Ketoconazole, ritonavir, clarithromycin, erythromycin Others: conivaptan, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine, itraconazole Carbamazepine, phenytoin, rifampin, St. John s wort Interacting Agents Ketoconazole, diltiazem, naproxen, not recommended with azoles (ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (ritonavir) Carbamazepine, phenytoin, rifampin, St. John s wort 50 Adapted from Dager WE, Kalus JS. Preventing stroke in atrial fibrillation: pharmacist roles in optimizing therapy and ensuring patient safety. ASHP Advantage presentation ISHP Conference 25

26 DOSING: NG Tube Administration administration via tube APIXABAN (ELIQUIS ) may be crushed & given via any GI tubes. DABIGATRAN (PRADAXA ) cannot be given via tube; breaking, chewing or opening capsule = 75% in absorption = adverse reactions likely. RIVAROXABAN (XARELTO ) needs acidic ph; may be crushed & given via GI tubes that end in stomach, but not in intestines. Adapted from NEW ORAL ANTI-COAGULANTS 2013 (Amr A. Soliman, PharmD, BCPS, CGP) John ed_man.jpg 52 26

27 VTE Is a Major Cause of Morbidity and Mortality With a Significant Economic Burden in the United States VTE kills more people each year than breast cancer, HIV, and traffic accidents combined 15,16 Up to 900,000 people are affected by DVT/PE annually 16,51 550,000 hospitalizations annually in the United States for DVT and/or PE 14 Healthcare costs associated with DVT/PE in 2011 were estimated to be up to $10 billion 16 Annual Deaths (x10 3 ) CDC Reported Causes of Annual Deaths in the United States 15,16 41,078 Breast Cancer 9406 HIV 32, ,000 Traffic DVT/PE Accidents 53 PESI Scoring (Pulmonary Embolism Severity Index) Variable Age > 80 PESI Score Age in years Male sex +10 History of Cancer +30 History of heart failure +10 History of chronic lung disease +10 Pulse 110 beats/min +20 SBP < 100 mmhg +30 Respiratory rate 30 breaths/min +20 Altered mental status +60 Arterial oxyhemoglobin saturation +20 level < 90% Aujesky et al. Lancet 2011;378:41-48 Score Risk Level < 66 Class I Class II Class III Class IV >125 Class V 54 27

28 spesi Scoring (Pulmonary Embolism Severity Index) Variable Simplified PESI Point Scale Age > 80 1 History of Cancer 1 History of Heart Failure, 1 Chronic Lung Disease Pulse 110 bpm 1 SBP < 110 mmhg 1 Arterial oxyhemoglobin 1 saturation level 90% Total Points = 55 spesi Scoring (Pulmonary Embolism Severity Index) spesi Score < 1 & no Sx < 1 + Sx 1 Risk Level No Risk (or incidental) Low High Treatment Home Home? Admit 56 28

29 57 Traditional Treatment Approaches for VTE Require Multiple Agents and Close Monitoring 60 Bridging therapy Parenteral Anticoagulation INR monitoring required VKA (INR ) Initial Therapy: 0 to 7 days Long-term therapy: 7 days to 3 months Extended therapy: 3 months to indefinite Rapid-onset parenteral anticoagulants are used concurrently with VKA until therapeutic INR is reached Oral anticoagulants such as warfarin are used for longer-term protection Routine INR monitoring is required to ensure adequate anticoagulation 26 Mean TTR is low in patients receiving warfarin, particularly during the first 3 months of treatment

30 The EINSTEIN DVT and PE Trials Evaluated a Single-Agent Regimen for VTE Treatment Treatment period of 3, 6, or 12 months* EINSTEIN DVT 8 Objectively confirmed proximal DVT without symptomatic PE EINSTEIN PE 11 Objectively confirmed PE with or without DVT R A N D O M I Z E Rivaroxaban 15 mg twice daily Day 1 Day 21 Rivaroxaban 20 mg once daily Enoxaparin followed by VKA Primary efficacy outcome: Symptomatic recurrent VTE Principal safety outcome: Clinically relevant bleeding *Decision to treat for 3, 6, or 12 months made by investigator at time of randomization. Defined as the composite of recurrent DVT, nonfatal PE, or fatal PE. Defined as the composite of major and clinically relevant nonmajor bleeding

31 DVT/PE Trials RECOVER (5144) EINSTEIN (7449) AMPLIFY (5400) Agent Dabigatran Rivaroxaban Apixaban Edoxaban Design Double blind Open label Double blind Double-blind Indication VTE DVT or PE VTE VTE HOKUSAI (7500) Heparin Bridge? Dosing Duration (mo) Yes. LMWH or heparin for 5 days. Dabigatran was started after DC of parenteral anticoagulation. Dose: 150 mg Twice Daily No No Yes. LMWH or heparin for 5 days. Edoxaban was started after DC of parenteral anticoagulation. 15 mg BID x 3 weeks, then 20 mg daily 10 mg bid x 7 days, then 5 mg Twice Daily 6 3,6,12 3,6,12 3,6,12 Dose 60 mg daily (30 mg daily in patients with CrCl ml/min Schulman et al. N ENGL J MED. 2009:361;24. EINSTEIN Investigatros. N ENGL J MED. 2010;363:2499. Agnelli et al. N ENGL J MED. 2013;369:799. Hokusai investigators. N ENGL J MED. 2013;369:1406 Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference DVT/PE Trials RECOVER (5144) EINSTEIN (7449) AMPLIFY (5400) Agent Dabigatran Rivaroxaban Apixaban Edoxaban Design Double blind Open label Double blind Double-blind Indication VTE DVT or PE VTE VTE HOKUSAI (7500) Heparin Bridge? Dosing Duration (mo) Yes. LMWH or heparin for 5 days. Dabigatran was started after DC of parenteral anticoagulation. Dose: 150 mg Twice Daily No No Yes. LMWH or heparin for 5 days. Edoxaban was started after DC of parenteral anticoagulation. 15 mg BID x 3 weeks, then 20 mg daily 10 mg bid x 7 days, then 5 mg Twice Daily 6 3,6,12 3,6,12 3,6,12 Dose 60 mg daily (30 mg daily in patients with CrCl ml/min Schulman et al. N ENGL J MED. 2009:361;24. EINSTEIN Investigatros. N ENGL J MED. 2010;363:2499. Agnelli et al. N ENGL J MED. 2013;369:799. Hokusai investigators. N ENGL J MED. 2013;369:1406 Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference

32 April RIVAROXABAN Days 1-21 Days APIXABAN Days 1-7 Days April EDOXABAN Days 1 5 or 10 Days 5 or

33 Recurrent VTE and VTE-related Death Dabigatran RR (95% CI) 1.10 ( ) Rivaroxaban 0.68 ( ) P < Apixaban 0.86 ( ) P < Edoxaban 0.89 ( ) Favors NOAC 1.0 Favors Warfarin Schulman et al. N ENGL J MED. 2009:361;24. EINSTEIN Investigatros. N ENGL J MED. 2010;363:2499. Agnelli et al. N ENGL J MED. 2013;369:799. Hokusai investigators. N ENGL J MED. 2013;369:1406 Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference Major Bleeds Dabigatran RR (95% CI) 0.82 ( ) Rivaroxaban 0.97 ( ) Apixaban 0.31 ( ) P < Edoxaban 0.81 ( ) Favors NOAC 1.0 Favors Warfarin Schulman et al. N ENGL J MED. 2009:361;24. EINSTEIN Investigatros. N ENGL J MED. 2010;363:2499. Agnelli et al. N ENGL J MED. 2013;369:799. Hokusai investigators. N ENGL J MED. 2013;369:1406 Adapted from Desai Novel Oral Anticoagulants. ISHP Fall Conference

34 Trial Conclusions DVT/PE Trial NOAC Conclusion RECOVER Dabigatran 150 mg twice daily regimen of dabigatran, following an initial tx of parenteral anticoagulation, is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring. EINSTEIN Rivaroxaban Rivaroxaban alone is as effective as standard therapy, with similar safety, for the treatment of acute VTE and that when treatment is continued, rivaroxaban is very effective in preventing recurrences, as compared with placebo, and has an acceptable risk of bleeding. AMPLIFY Apixaban Apixaban alone was as effective as conventional treatment consisting of enoxaparin followed by warfarin and was associated with a clinically relevant reduction of 69% in major bleeding. HOKUSAI- VTE Edoxaban Treatment with heparin followed by oral edoxaban once daily, as compared with standard therapy, was noninferior with respect to efficacy and superior with respect to bleeding. Schulman et al. N ENGL J MED. 2009:361;24. EINSTEIN Investigatros. N ENGL J MED. 2010;363:2499. Agnelli et al. N ENGL J MED. 2013;369:799. Hokusai investigators. N ENGL J MED. 2013;369: Trial Conclusions DVT/PE NOAC Dabigatran Rivaroxaban Apixaban Conclusion Non-Inferior to warfarin Non-Inferior to warfarin Non-Inferior to warfarin - Reduced incidence of bleeding Edoxaban Non-Inferior to warfarin - Reduced incidence of bleeding Schulman et al. N ENGL J MED. 2009:361;24. EINSTEIN Investigatros. N ENGL J MED. 2010;363:2499. Agnelli et al. N ENGL J MED. 2013;369:799. Hokusai investigators. N ENGL J MED. 2013;369:

35 Transition of Care - The Anticoagulation Clinic 69 Timing of discontinuation of TSOAC for Non-urgent Procedures Drug Renal Function Time of Last Dose Before Minor Procedure Dabigatran Rivaroxaban or Apixaban CLcr > 50 ml/min 1 day (24 hrs) 2 days CLcr ml/min 2 days 4 days CLcr 30 ml/min 4 days 6 days CLcr > 50 ml/min 1 day (24 hrs) 2 days Time of Last Dose Before Major Surgery CLcr ml/min 1 to 2 days 3 to 4 days CLcr 30 ml/min 2 days 4 days Nutescu E, et al. Management of bleeding and reversal strategies for oral anticoagulants: Clinical practice considerations. Am J Health-Syst Pharm ;e

36 71 36

37 What is the best treatment option for acute reversal of new oral anticoagulant? a) Watch and wait b) FFP c) Novo 7 d) Prothrombin Complex Concentrate e) Activated PCC f) Dialysis g) All of the above

38 Factor Composition of 4PCC (Kcentra ) Composition per Vial of Prothrombin Complex Concentrate 500 Units 1 Ingredient Quantity Total protein 120 to 280 mg Factor II 380 to 800 units Factor VII 200 to 500 units Factor IX 400 to 620 units Factor X 500 to 1,020 units Protein C 420 to 820 units Protein S 240 to 680 units Heparin 8 to 40 units Antithrombin III 4 to 30 units Human albumin 40 to 80 mg Sodium chloride 60 to 120 mg Sodium citrate 40 to 80 mg Hydrochloric acid small amounts Sodium hydroxide small amounts Kcentra [package insert]. Kankakee, IL: CSL Behring LLC; April Clinical Efficacy Median INR After Start of Infusion of Prothrombin Complex Concentrate or Plasma in Patients Treated with Warfarin 1 Prothrombin Complex Concentrate (n = 98) Plasma (n = 104) Baseline minutes 1.2 a hour 1.3 a to 3 hours 1.3 a to 8 hours 1.3 a hours 1.2 a hours Kcentra [package insert]. Kankakee, IL: CSL Behring LLC; April

39 Adverse Reaction Comparison Adverse Reactions Reported in (3 or more Subjects) Following Administration of Kcentra or Plasma in the Randomized Controlled Trial for the Treatment of Acute Major Bleeding 1 Prothrombin Complex Concentrate (n = 103) Plasma (n = 109) Headache 7.8% 1.8% Hypotension 4.9% 2.8% Nausea/vomiting 3.9% 0.9% Arthralgia 3.9% 0% Tachycardia 2.9% 0.9% Blood pressure increase 2.9% 0% INR increased 2.9% 0% Intracranial hemorrhage 2.9% 0% Mental status changes 2.9% 0% Hypokalemia 1.9% 4.6% Fluid overload 1% 5.5% Breath sounds abnormal/rates 1% 2.8% Chest pain 1% 2.8% Pulmonary edema 0% 3.7% Transfusion reaction 0% 3.7% Kcentra [package insert]. Kankakee, IL: CSL Behring LLC; April Feb

40 New Oral Anticoagulant Effects on Coagulation Assays Lab Measure Dabigatran Rivaroxaban Apixaban aptt to PT/INR to to to Modified PT a to Thrombin time Ecarin Clotting Time a Antifactor Xa a to Heptest a Adapted from McMillian W, Aloi J. Thrombotic and bleeding diatheses in critically ill patients. Critical & Urgent Care PSAP Activated Charcoal Typically given within 2hrs of last dose Apixaban is the exception Can give up to 6hrs post dose Wang X, et al. Effect of Activated Charcoal on Apixaban Pharmacokinetics in Healthy Subjects. Am J Cardiovasc Drugs :

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