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1 Stepping Beyond Warfarin: Working with Novel Oral Anticoagulants (NOACs) in Clinical Practice USAFP 2015 CPT Tyler R Reese, MD US Army, Medical Corps Tripler Army Medical Center

2 Disclosures: Neither I, nor any member of my immediate family, have a significant financial interest in or affiliation with any commercial supporter of this educational activity and/or with the manufacturer(s) of commercial products and/or providers of any commercial services discussed in this educational activity. The content of my material(s)/presentation(s) in this CME activity WILL include discussion of unapproved or investigational uses of products or devices. The views expressed in this presentation are those of the author and do not reflect the official policy or position of Tripler Army Medical Center, the Department of the Army, the Department of Defense, or the US Government.

3 Objectives: Describe mechanisms and uses of the novel oral anticoagulants (NOACs) Compare clinical features and NOAC use limitations Incorporate limitations and risks of novel anticoagulants in patient care.

4 Melnikova, I. Nat Rev Drug Disc. 8( 353), 2009.

5 Melnikova, I. Nat Rev Drug Disc. 8( 353), 2009.

6 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment PE Treatment Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis* Acute Coronary Syndrome Mechanical Valves

7 Meta-analysis for NOACs in VTE

8 Meta-analysis for NOACs in VTE

9 Meta-analysis for NOACs in VTE

10 Meta-analysis for NOACs in VTE

11 Efficacy Data on NOACs in VTE Lower Risk Dabigatran Rivaroxaban Apixaban Edoxaban Higher Risk

12 NOACs in Atrial Fibrillation Senoo et al. Semin in Hemostasis. 1(415) ISSN

13 NOACs in Atrial Fibrillation Senoo et al. Semin in Hemostasis. 1(415) ISSN

14 NOACs in Atrial Fibrillation Senoo et al. Semin in Hemostasis. 1(415) ISSN

15 NOACs in DVT Prophylaxis for Surgery Thrombosis Research 131, Suppl. 1 (2013) S67 S70

16 NOACs in DVT Prophylaxis for Surgery Thrombosis Research 131, Suppl. 1 (2013) S67 S70

17 Other Indications Acute Coronary Syndrome: - APPRAISE, ATLAS, RE-DEEM with respective agents added to standard of care - Consistently underperformed standard of care - Increase rate of bleeding Medically ill DVT prophylaxis: - 3 trials with more DVTs, increased bleeding Mechanical Valves - 2 trials stopped early for increased thrombosis C. Costopoulos et al. / International Journal of Cardiology 167 (2013) Grube et al. Eur Heart J Feb;35(8):490-5.

18 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment PE Treatment Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis* Acute Coronary Syndrome Mechanical Valves

19 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment X (15mg BID x3wks) X ( 10mg BID x7 days) X (after LMWH) PE Treatment Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis Acute Coronary Syndrome Mechanical Valves

20 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment X (15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) PE Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis Acute Coronary Syndrome Mechanical Valves

21 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) PE Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis Acute Coronary Syndrome X X X Mechanical Valves

22 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) PE Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis* Acute Coronary Syndrome X X X X *10mg daily X *2.5mg BID Mechanical Valves

23 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) PE Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis* Acute Coronary Syndrome X X X X *10mg daily X *2.5mg BID No proven evidence of added benefit with proven increased bleeding risk. Mechanical Valves

24 FDA Indications Rivaroxaban (20mg daily) Apixaban (5mg BID) Dabigatran (150mg BID) DVT Treatment X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) PE Treatment Non-valvular Atrial Fibrillation Embolism Prophylaxis Arthroplasty DVT Prophylaxis* Acute Coronary Syndrome Mechanical Valves X(15mg BID x3wks) X( 10mg BID x7 days) X(after LMWH) X X X X *10mg daily X *2.5mg BID No proven evidence of added benefit with proven increased bleeding risk. Non-inferiority trial for rivaroxaban/dabigatran stopped early for increased harm. Cohorts suggested this in all NOACs

25 Objective 1: Describe mechanism and uses of novel oral anticoagulants (NOACs) # Reversible single enzyme inhibitors (Xa Inh are xabans and thrombin inh is tran) # Not inferior to warfarin for VTE, A Fib, Prophylaxis of DVT (except dabigatran) # DO NOT USE in Acute Coronary Syndromes, mechanical valves, or DVT/PE in malignancy.

26 Objectives: Describe mechanism and uses of the novel oral anticoagulants (NOACs) Compare clinical features and NOAC use limitations Incorporate limitations and risks of novel anticoagulants in patient care.

27 Shared Features of NOACs: Renal Excretion: Not used if GFR <30 - Dose adjust GFR (or don t use) CYP/PG interactions - Caution with polypharmacy - Utilize anticoagulation pharmacist Risk of bleeding is present New agents of cost and dubious intent

28 Bleeding Risks for NOACs: Battle of the Meta-Analysis

29 Risks Comparison Bleeding Risk in Atrial Fibrillation Studies

30 Clinically Significant GI Bleeding by Indication GASTROENTEROLOGY 2013;145:

31 Cost Analysis at TAMC Unit Cost $ (Market) Warfarin (6mg) 0.28 (1.59) Rivaroxaban (daily) 4.85 (10.43) Apixaban (BID) 2.17 (5.51) Dabigatran (BID) 2.65 (4.92) System Costs Total Monthly Cost (115.25) Warfarin (337.55) (354.78) (322.56)

32 Objectives: Describe mechanisms and uses of the novel oral anticoagulants (NOACs) Compare clinical features and NOAC use limitations Incorporate limitations and risks of novel anticoagulants in patient care.

33 Case 1: Mrs Vein - 65 year old woman with new DVT after cosmetic surgery and plane travel. - She has CKD Stage 2 and takes HCTZ for HTN - Diagnosis while traveling and she was started on Apixaban. - She hates pills and wants something easier to take. She hears there is a once per day pill she can take. - Your formulary has dabigatran and warfarin only

34 Case 2: Mr D Vertic Mr J is a 75 yo man with A Fib and HTN. He takes lisinopril, metoprolol, and rivaroxaban. He had hemorrhoids in his 50s with some bleeding, but reports some bloody stools without pain for last 12 hours. - His vitals show a HR of 98 and BP 117/64. - Exam is otherwise unremarkable. - How should bleeding be treated?

35 Controlling Bleeding Miller et al. Practical EM of bleeding for NOACs. Am J Emerg Med Apr;32(4):

36 Controlling Bleeding For Minor Bleeding: LOE C -Normal bleeding control measures -Check Creatinine Clearance -Consider options to withhold for acute period

37 Controlling Bleeding For Major Bleeding: LOE C - Activated charcoal if w/i 2 hours of dose - For Xa inhibitors: -4 factor Prothrombin complex conc (50IU/kg) -activated factor 7 (20 U/kg). -For Thrombin inhibitors: -activate prothrombin complex conc (40U/kg), -activated factor 7. -Dialysis considered treatment especially for dabigatran

38 Case 3: Sgt Etsy 25 yo AD army logistics NCO. Was flying from Korea during his ETS. Gets lower extremity DVT. His Tricare ends tomorrow and he will be acquiring insurance coverage through his new job. - He is very healthy and active otherwise. - He dislikes going to hospital or doctors and hopes to get something easy to take. - You have dabigatran, warfarin, and apixaban. - You cannot find his upcoming formulary.

39 Objectives: Describe mechanism and uses of novel oral anticoagulants (NOACs) Compare clinical features and NOAC use limitations Incorporate limitations and risks of novel anticoagulants in patient care.

40 Conclusions: 1- NOACs and warfarin mostly comparable 2- Bleeding is a questionable issue, but GIB is probably higher especially with rivaroxaban 3- NOACs are expensive 4- Remember renal failure and using pharmacists 5- Special agents may or may not improve bleeding complications

41 Atrial Fibrillation Resources From Tools for Practice 2012

42 DVT/PE Resources From Tool for Practice 2013

43 GASTROENTEROLOGY 2013;145:

44 International Journal of Cardiology 179 (2015)

45 Other Indications ACS, medical admission DVT prophylaxis and mechanical valves: No benefit in trials, increased harm. International Journal of Cardiology 179 (2015)

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