Management of VTE: Opportunities in Care. Wm. Semchuk, MSc, PharmD, FCSHP Manager, Pharmacy Practice Regina Qu Appelle Health Region

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1 1 Management of VTE: Opportunities in Care Wm. Semchuk, MSc, PharmD, FCSHP Manager, Pharmacy Practice Regina Qu Appelle Health Region

2 Disclosures: Research Grants: Bayer, BI, Pfizer, BMS, AZ Honoaraia Bayer, BI, Pfizer, BMS, AZ, Sanofi, Novo Nordisk Advisory Boards/Consultancy Bayer, BI, Pfizer, BMS, AZ, Sanofi

3 Session Objectives After participating in this session, participants will be better able to: Describe how to determine the patient s likelihood and confirm the diagnosis of VTE Describe treatment options for the acute and long term management of VTE Determine the duration of therapy for your patient Discuss the need for extended duration of therapy Discuss information you may might discuss with the patient 3

4 Incidence of VTE in Canada An estimated 45,000 patients in Canada are affected by deep vein thrombosis (DVT) each year 1 There are approximately 1-2 cases per 1,000 persons annually 1 Among those who develop DVT 2 : One-third will have long term complications such as chronic lower leg edema, post phlebitic syndrome, pain, pigment changes One-third will develop a recurrent event within 10 years Despite adequate therapy, 1% to 8% of patients in whom pulmonary embolism develops, will die 2 1.Thrombosis Canada, 2013, Clinical Guides, Venous Thromboembolism; 2.Scarvelis et al, CMAJ 2006; 175(9)

5 Patient Profile Millie, a 53-year old lawyer, presents to the ED with left ankle swelling and left calf pain She reports: Left calf discomfort for 4 days Severe pain over the last 2 days, making it difficult to walk Purplish discolouration and swelling in left ankle and calf No H/o pleuritic chest pain, shortness of breath, cough or hemoptysis 5

6 Patient History Past medical history is unremarkable No recent H/o trauma, immobilization or prolonged travel Although she has a sedentary job, she has been active No personal or family history of venous thromboembolism 6

7 Patient History (Cont...) Millie has been taking hormone replacement therapy to treat perimopausal symptoms No other medication Two pregnancies (last one 22 years ago) were uncomplicated 7

8 On Examination Left calf circumference (measured 10 cm below the tibial tuberosity) is 3.2 cm greater than the right Definite duskiness and warmth in left ankle Left calf is tender to touch BP: 124/80 mm Hg Height: 170 cm; weight: 65 kg 8

9 Distal DVT Seen in 20% to 30% of Patients With proximal DVT there is more PE, higher risk of death, and higher rates of post-phlebitic syndrome DVT=Deep-vein thrombosis; PE=Pulmonary embolism Scarvelis D, Wells PS. CMAJ. 2006;175:

10 Approaches to Diagnosis of VTE Patient History Clinical Symptoms and Signs Clinical Probability Score Laboratory Testing Imaging Testing VTE=venous thromboembolism

11 Risk factors from Geerts WH et al. Chest 2004;126:338S 400S Risk Factors for VTE Exposing risk factors (acute conditions or trauma, surgery) Predisposing risk factors (patient characteristics) Surgery Trauma Acute medical illness Acute heart failure* Acute respiratory failure Central venous catheterization Cancer Inflammatory diseases History of VTE Chronic heart failure Advanced age Varicose veins Obesity Immobility or paresis Myeloproliferative disorders Pregnancy/peripartum period Inherited or acquired thrombophilia Hormone therapies Renal insufficiency *New York Heart Association classification III and IV

12 Clinical Signs and Symptoms of DVT Leg pain (90%) Tenderness (85%) Ankle edema (76%) Calf swelling (42%) Dilated veins (33%) Dusky discoloration (30%)

13 Wells Criteria for Deep Vein Thrombosis Probability of DVT: Low, score of 0 Intermediate, score of 1-2 High, score > 3 Qaseem, A. et. al. Ann Intern Med 2007;146:

14 Wells Criteria for Pulmonary Embolism Probability of PE: Low, score of 0-1 Intermediate, score of 2-6 High, score > 7 Qaseem, A. et. al. Ann Intern Med 2007;146:

15 Diagnostic Algorithm for DVT & PE If high or moderate clinical suspicion of VTE, parenteral anticoagulant should be initiated while waiting for test results Goldhaber et al. The Lancet 2012;379:

16 Investigation Ultrasound examination confirms acute deep vein thrombosis involving the popliteal vein

17 Goals of VTE Treatment Prevent fatal PE Prevent recurrent VTE (early and late) Reduce morbidity associated with acute leg or lung thrombus Prevent long-term complications VTE=venous thromboembolism; PE=pulmonary embolism

18 Risk of recurrent VTE Treatment of VTE and Prevention of Recurrent DVT and PE Phases of anticoagulant treatment Active treatment Active treatment phase overlaps with the secondary prevention phase Secondary prevention Time since starting treatment Active treatment phase: treats and turns off acute thrombosis, improves symptoms, prevents extension rapid decrease in the risk of recurrent VTE ~3 months Secondary prevention phase: prevents new episode of VTE as long as patient is on anticoagulant therapy 18 Kearon C. J Thromb Haemost 2012;10:507 11

19 Initial Pharmacologic Therapy of Uncomplicated DVT Unfractionated heparin (UFH) Low molecular weight heparin (LMWH) Fondaparinux Oral factor Xa inhibitors Rivaroxaban Apixaban Oral direct thrombin inhibitors Dabigatran

20 Options in Management Approved in Canada EINSTEIN- DVT 1 EINSTEIN-PE 2 AMPLIFY 3 RECOVER 4 YES YES YES YES No patients 3,449 4,832 5,244 2,579 Drug Warfarin comparator INR 2-3 Lead-in for warfarin arm Rivaroxaban 20 mg OD (15 mg BID for initial 21 days) Rivaroxaban 20 mg OD Apixaban 5 mg BID for (10 mg BID for initial 7 days) Dabigatran 150 mg BID Open label Open label Double blind Double blind Enox Enox Enox 90% LMWH Patients had PE 1% 100% 35% 21% Median followup 3, 6 and 12 months 6 and 12 months 6 months 6 months 20

21 Symptomatic VTE (%) NOACS vs Warfarin: Recurrent VTE 5 EINSTEIN-DVT 1 Rivaroxaban 5 EINSTEIN-PE 2 Rivaroxaban 5 AMPLIFY 3 Apixaban 5 RECOVER 4 Dabigatran 4 Non-inferior Non-inferior Non-inferior Non-inferior p < p = p < p <

22 Major Bleeding (%) NOACS vs Warfarin: 5 EINSTEIN-DVT Rivaroxaban 5 Major Bleeding EINSTEIN-PE Rivaroxaban 5 AMPLIFY Apixaban 5 RECOVER Dabigatran 4 Non-significant Non-inferior Superior Non-significant p = 0.21 p = p < p =

23 Which Agent to Choose? Consider patient's values and preferences Risk tolerance for bleeding versus clotting Ability to afford drug Ability to get labwork done Need to affiliate closely with healthcare providers Consider patient's bleeding risk factors Age, previous bleeding, cancer, renal failure, liver failure, thrombocytopenia, anemia, previous stroke, diabetes, antiplatelet therapy, poor anticoagulant control, co-morbidity and reduced functional capacity, recent surgery, frequent falls, alcohol abuse

24 24 Clinical Trials to Real Life What happens as you move from clinical evidence to clinical practice? Clinical variables that are always under consideration include but are not limited to: Age, Weight, Excretion, Drug interactions - What do patients do. In assessing any antithrombotic therapy we constantly balance the relationship between: Efficacy and Safety In asssessing this relationship, ask yourself what you are most worried about: Clot vs Bleed which will harm the patient more and faster and do you have better options..

25 Canadian cardiovascular pharmacists network: SPAF Tool VTE coming, App available for ios 25

26 Thrombosis Canada App Search Thrombosis for the free app in the itunes store, Google Play and BlackBerry App World or visit 26

27 Initial Doses of Warfarin Factors impacting decision Liver function / Impaired nutrition Concomitant medications (antiplatelets, antibiotics, etc.) Ethnicity Age Concern re: clotting vs bleeding? Urgency to achieve therapeutic anticoagulation?

28 Warfarin Initiation 10mg vs 5mg? Studies show both preferred for initial 2 days.... In practice, generally only need to start <5mg days 1 & 2 with INR Day 3 if high bleed risk or significant liver failure If use same dose (e.g. 5mg) for first 2 days, may help you know if require a lot less or more warfarin e.g. if baseline INR 1.0 and Day 3 INR greater than 1.4, likely need to decrease daily dose Generally best to avoid daily INRs to curb reacting to yesterday s dose alone

29 ACCP 2012 Guidelines: Evidence-Based Management of Anticoagulant Therapy Loading Dose for Initiation of Vitamin K Antagonist (VKA) Therapy - New For patients sufficiently healthy to be treated as outpatients, we suggest initiating VKA therapy with warfarin 10 mg daily for the first 2 days followed by dosing based on international normalized ratio (INR) measurements rather than starting with the estimated maintenance dose (Grade 2C). Outpatient VTE treatment in order to achieve a therapeutic INR within 5 days Initial Dose Selection and Pharmacogenetic Testing- New For patients initiating VKA therapy, we recommend against the routine use of pharmacogenetic testing for guiding doses of VKA (Grade 1B).

30 Warfarin Initiation Protocol Initial Dose Normosensitive Patient Sensitive Patient First INR < mg daily x 2-3 d mg daily x 2-3 d , 5, 5 2.5, 2.5, mg daily x 2-3 d 1.25 mg daily x 2.3 d mg d x 2-3 d 0.5 mg d x 2.3 d >4.0 Hold until INR <3 Hold until INR <3

31 Reviewing the Individual Patient What is the most warfarin they have required? The least? What is their typical maintenance dose? Do they bounce around in the therapeutic range? Can you tell if they are a delayed responder? Do they decay fast? Are they typically stable or not? Are there recurrent issues frequent exacerbations of CHF, ETOH, non-adherence, etc? With the next INR would you rather be high or low? 31

32 Generalities with Maintenance Dosing of Warfarin The full effect of a given dose may not be seen for 3-5 days Tend to reflect on the past 7 to 10 days average dose to guide future change: Delayed effect of warfarin Very common to take different doses on different days Response is not linear if you double the dose, you wont simply see a doubling of the INR Changes in dosing is slight (commonly 5 10%) 32

33 INR Dosing Chart (Maintenance Target 2.5) Action <1.5 Reload 0-2, weekly dose by 5-15% Reload 0 1, weekly dose by 0-10% No change Hold 0 1, weekly dose by 0-10% Hold 0 2, weekly dose by 5-15% Hold warfarin, Vitamin K 1 2.5mg PO x 0-1 >9 Hold Warfarin, Vitamin K 2.5 5mg po Guidelines are to be used as a general framework for dosage adjustment Modify to the clinical situation 33

34 Interacting Medications Drugs used for short duration are the most difficult to manage because of affects both on initiation and discontinuation of interacting agent Antibiotics: if possible choose non-interacting option (e.g. cefuroxime, amoxicillin +/- clavulanate) TMP/SMX (Septra ) - AVOID Metronidazole (Flagyl ) -?Empiric 25-50% warfarin dose reduction Fluoroquinolones (moxifloxacin > ciprofloxacin) Macrolides (erythromycin, clarithromycin > azithro) Rifampin may require 2-3x increase of weekly warfarin dose Voriconazole -?empiric 25-50% warfarin dose reduction

35 Interacting Medications Other commonly prescribed agents which interact with warfarin: INR fluconazole, celecoxib & naproxen (major), amiodarone (major & delayed), allopurinol, SSRIs, fenofibrates (major-may req 30% warf decrease), statins INR Rifampin (major), phenytoin, carbamazepine, cholestyramine No change in INR, but increase risk of bleeding ASA-containing products, clopidogrel, all NSAIDs Multivitamin products containing low dose vitamin K

36 If You Choose a NOAC for VTE Rivaroxaban/Apixaban Recommended dosing includes a higher to lower dose transition at different time points Overlap with a parenteral agent not needed Dabigatran Initiate parenteral therapy first

37 Time to Cmax (hrs) New Oral Agents key considerations Rivaroxaban Apixaban Dabigatran 2.5 to Half-life (hrs) Renal clearance 33% (of active drug) (50% of metabolized inactive drug) 25% 80% Hepatic clearance 33% (of total) 20% Metabolism Oxidation (by CYP3A4 and 2I2) and hydrolysis Oxidation (by CYP3A4) and conjugation) Prodrug No No Yes Bioavailability 80% 50% 5% Antidote? No No No Dilalyzability Unlikely Unlikely Yes Safe in pregnancy? No No No Conjugation (no CYP involvement) Wt Extremes (Δ < 50 kg 24% < 50 kg ~ 30% ~ 48 kg: 25%

38 Dabigatran Rivaroxaban Apixaban Cr Cl > 80 ml/min 13.8 hr 8.3 hr 12 hr Cr Cl ml/min 16.6 hr (AUC 1.5 fold) 8.7 hr (AUC 44%) AUC 16% Cr Cl ml/min 18.7 hr (AUC 3.2 fold) 9 hr (AUC 52%) AUC 29% Cr Cl < 30 ml/min 27.5 hr (AUC 6.3 fold) 9.5 hr (AUC 64%) AUC 44% ESRD (hemodialysis) 34.1 hr Br J Clin Pharmacol 2010;70(5): , Clin Pharmacokinet 2010;49(4): , Eliquis Product Monograph 2011.

39 Key Drug Interactions Dabigatran Rivaroxaban Apixaban P-GP substrate P-GP and CYP 3A4 substrate CYP3A4 and p-gp substrate Pharmacodynami c Antithrombotiic agents Inc risk for bleeding Inc risk for bleeding Inc risk for bleeding Antiplatelet agents Inc risk for bleeding Inc risk for bleeding Inc risk for bleeding Pharmacokinetic interactions CYP3A4 inhibitors (increase in AUC) N/A Ketoconazole 160% Ritonavir150% Clarithromycin 50% Erythromycin 30% Fluconazole 40% Ketoconazole 200% Diltiazem 140% CYP 3A4 inducers (decrease in AUC) N/A Rifampin 50% Rifampin 54% 39

40 Key Drug Interactions (cont) P-GP inhibitors (increasee in AUC) p-gp inducers (decrease in AUC) P-GP substrates Dabigatran Rivaroxaban Apixaban Amiodarone 58% Dronedarone 73-99% Ketoconazole 153% Quinidine 53% Verapamil (given 1 hr before dabigatran) 2.4 fold (negligible if given 2 hours after) Ketoconazole 160% Ritonavir 150% Clarithromycin 50% Erythromycin 30% Rifampin 66% Rifampin 50% Digoxin: no interaction Digoxin: no interaction Naproxen 150% Digoxin: no 40 interaction

41 Dabigatran Drug Interactions Rivaroxaban/Apixaban Contraindicated clinically significant increased plasma levels Potent P-gp Inhibitors: Systemic azole antifungals (except fluconazole), cyclosporine, dronedarone, tacrolimus, simultaneous initiation with verapamil Potent P-gp and /or CYP 3A4 inhibitors: Systemic azole antifungals (except fluconazole), HIV-protease inhibitors Caution avoid use or seek advice, dose change may be warranted Less potent P-gp inhibitors: Amiodarone, clarithromycin, erythromycin, fluconazole, HIV protease inhibitors, quinidine, ticagrelor Less potent P-gp and/or CYP3A4 inhibitors: amiodarone, cyclosporine, clarithromycin, erythromycin, diltiazem, fluconazole, quinidine, tacrolomus, verapamil Potent P-gp/CYP3A4 inducers: carbamazepine, phenobarbitone, phyenytoin, rifampin, St. John s wort Antiplatelet agents/anticoagulants: e.g.. warfarin, clopidogrel, prasugrel, ticagrelor, heparins 41

42 Length of stay (LoS) in EINSTEIN Trials North American Cohort Patient population/length of stay Rivaroxaban (n=189) Enoxaparin/VKA (n=193) Hospitalized patients Median length of stay, days (interquartile range) p-value* 3.0 ( ) 4.0 ( ) Mean length of stay Mean costs per day were $1,842 for PE patients and $295 for DVT patients The pooled mean cost per VTE day was $2137 Reduction in LOS showed a mean cost savings of $3419 per patient $CDN funds referenced 42 Bookhart et al. J Med Econ 2014; 1 5

43 Persistence to Dabigatran vs Warfarin in a Real World Setting Purpose: To compare persistence rates in newly diagnosed AF patients treated with warfarin vs dabigatran Methods: US Department of Defense administrative claims database Propensity score matching used to identify 1745 matched pairs Persistence defined as time on therapy to discontinuation Time Period 6 mo Persist, % 9 mo Persist, % 1 yr Persist, % 30 Day Medication Gap 60 Day Medication Gap Dabi Warf Dabi Warf P value <0.001 <0.001 ZALESAK M ET AL. CIRC CARDIOVASC QUAL OUTCOMES 2013;6:

44 Renal Impairment and NOAC Bleeding Risk Data from AF Trials Renal impairment bleed risk for all NOACs and warfarin Increase in major bleeding with NOAC not greater than warfarin Apixaban less major bleeding than warfarin with Clcr < 50mL/min NOAC Major bleeding with Clcr < 50mL/min Dabigatran: Rivaroxaban: Apixaban: more than 2 fold compared to Clcr > 50mL/min 32% compared to Clcr > 50 ml/min 31% compared to Clcr > ml/min more than 2 fold compared to CrCl > 80 ml/min Eikelboom J Circ 2011;123: Fox K Eur Heart J 2011;32: Hohnloser SH Eur Heart J 2012:33:

45 Effect of Body Weight on NOACs Apixaban Weight 60 kg (in combination with age >80 years old and serum creatinine >133 micromol/l) requires dose reduction Compared to apixaban exposure in subjects with body weight of 65 to 85 kg, body weight >120 kg was associated with approximately 20-30% lower exposure, and body weight < 50 kg was associated with approximately 20-30% higher exposure. Dabigatran Patients < 50 kg: Since limited data are available in these patients, dabigatran should be used with caution 81% of patients in RELY trial were in the 50 kg and < 100 kg category with no clear difference detected Rivaroxaban Extremes in body weight (<50 kg or >120 kg) had only a small influence (increase in maximum concentration by <25%) on rivaroxaban plasma concentrations and pharmacodynamics 45 Xarelto Product Monograph; Pradaxa Product Monograph; Eliquis Product Monograph

46 Duration of Therapy Categories of VTE Isolated distal DVT, DVT or PE provoked by a transient risk factor First unprovoked DVT or PE Second unprovoked DVT or PE. Cancer-associated VTE Duration of Treatment 3 months Minimum of 3 months and then reassess. For patients with no or only minor risk factors for bleeding, long-term therapy with annual review can be offered. Decision to continue anticoagulation should consider patient s values and preferences. Minimum of 3 months and then reassess. For patients with no or only minor risk factors for bleeding, long-term therapy with annual review should be encouraged. Decision to continue anticoagulation should consider patient s values and preferences. Minimum of 3 months and then reassess. Continue if active cancer (overt evidence of cancer) or continuing to receive anti-cancer therapy Schulman S, et al.. N Engl J Med. 1995;332(25):1661.

47 Provoked and Unprovoked VTE Transient/ reversible factors e.g. surgery or hospitalization Continuing/ irreversible factors e.g. cancer No identifiable cause Provoked VTE Unprovoked (idiopathic) VTE ACCP guidelines recommend at least 3 months VKA therapy after provoked VTE or longer after unprovoked (idiopathic) VTE 3 ACCP, American College of Chest Physicians; VKA, vitamin K antagonist 1. Zhu T et al. Arterioscler Thromb Vasc Biol 2009;29; ; 2. Gensini GF et al. Semin Thromb Hemost 1997;23:55 67; 3. Kearon C et al. Chest 2008;133:454S 545S

48 Decisions About Duration of Therapy Must Consider Bleeding and Thrombosis Risk, as well as Patient s Values and Preferences Transient risk factors include: surgery, hospitalization or plaster cast immobilization, all within 3 months, lesser leg injuries or immobilizations more recently (e.g. within 6 weeks), estrogen therapy or pregnancy, prolonged travel (e.g. > 8 hours) Bleeding risk factors include: Age, previous bleeding, cancer, renal failure, liver failure, thrombocytopenia, anemia, previous stroke, diabetes, antiplatelet therapy, poor anticoagulant control, comorbidity and reduced functional capacity, recent surgery, frequent falls, alcohol abuse

49 Longterm Therapy with NOACs EINSTEIN-EXTENSION: compared to placebo, rivaroxaban associated with less recurrent DVT, more clinically relevant nonmajor bleeding, and similar nonfatal major bleeding after 6 to 12 months of therapy AMPLIFY-EXT: compared to placebo, apixaban (prophylactic or therapeutic dose) associated with less recurrent VTE after 6 months of therapy RE-MEDY: compared to warfarin, dabigatran associated with similar rate of recurrent VTE, less major or clinically relevant bleeding, and more acute coronary syndrome after at least 3 months of therapy RE-SONATE: compared to placebo, dabigatran associated with less recurrent VTE, and more major or clinically relevant bleeding after at least 3 months of therapy

50 Extension Trials with NOACs Recurrent VTE HR (95% CI) Major bleeding HR (95% CI) Major or CRB RE-MEDY (Dabigatran vs Warfarin) 1.44 (0, ) 0.52 ( ) RE-SONATE (Dabigatran vs Placebo) 0.08 ( ) Not estimated AMPLIFY EXT (Apixban 2.5 bid, Apixaban 5mg bid vs Placebo) 2.5 mg 0.19 (0.11-0,33) 5 mg 0.20 ( ) RR 0.49 and 0.25 % 5.6 vs vs = 3.2%, 5=4.3%, P=2.7% HR (95% CI) 0.54 ( ) 2.92 ( ) RR (95% CI) 2.5 = 1.20 ( ) EINSTEIN-Ext (Rivaroxaban vs Placebo) 0.18 ( ) 6.0 vs ( )

51 Once started on therapy Ensure we have done everything possible to decrease bleeding risk Counsel Adherence Adverse effects and what to do about them Duration Special situations

52 Don t forget about bleeding risk.. Canadian Journal of Cardiology , DOI: ( /j.cjca )

53 Why Do We Counsel Patients What can we do? Optimize primary and secondary adherence How many new prescriptions don t get filled? 1 ~31% overall! 34% for NEW INDICATIONS (lower for switches ) 35% for cardiovascular drugs Better adherence associated with: 1 Older age Drug plan/coverage or lower costs drugs Less sick (lower co-morbidity index) More visits with prescribing MD (vs other MD) How to deal with adverse effects: minor and major bleeds How to deal with medication challenges 1. Tamblyn et al. Ann Intern Med 2014;160:441

54 Bleeding management in NOAC patients: severity-based approach Bleeding in anticoagulated patient* Minor bleeding Major bleeding 1. Consider delaying or discontinuing next dose # Reconsider concomitant medication 2. Symptomatic and local measures Mechanical compression Surgical intervention/haemostasis (Activated charcoal ) 3. General volume management Maintain diuresis Fluid replacement/haemodynamic support Transfusion (whole blood/packed cells/ffp) [Consider tranexamic acid] Life- threatening bleeding 4. Special haemostatic management Consider coagulation factor products (PCC, apcc, rfviia) (Dabigatran: haemodialyses if feasible) *Assessment of bleeding should also include location; # temporary or permanent discontinuation should always balance the risk of bleeding against the increased risk of thromboembolic events occasioned by the discontinuation; recommendations vary from within 1 2 h to within 6 h 54

55 Effect of NOACs on Laboratory Tests Test Dabigatran Rivaroxaban Apixaban PT or no change (low sensitivity, varies with reagent) or no change (insensitive at low concentratons, varies with reagent)?clinical Use? or no change (other tests more sensitive, may vary with reagents) Low correlation do not use clinically aptt or no change or no change TCT - - ECT - - Hemoclot Assay - Anti-factor Xa Clot Based Chromogenic ND Segal D, Crowther M. Eur Heart J 2012

56 Structure Target Binding Phase II Clinical Studies Specific Antidotes Andexanet Alpha Human rxa Variant Factor Xa Inhibitors Competitive Bolus/infusion: rapid complete reversal Idarucizumab* PER977 Humanized Fab fragment Dabigatran Non-competitive High Affinity Bolus: rapid complete reversal Synthetic Small Molecule Universal (binds Fxa and DT inhibitors, heparin) Covalent hydrogen bonding IV infusion 56

57 Perioperative management Guidelines re: perioperative management of patients on dabigatran or rivaroxaban are based on theoretical considerations of plasma half-life To what extent these drugs increase risk of surgical bleeding is not known Given that spontaneous bleeding rates are similar to warfarin, one might extrapolate that surgical bleeding rates would also be similar Remember: no antidote, yet.

58 Discontinuation before surgery Dabigatran Renal function (CLCR, ml/min) Estimated half life of effect (a) (hours) Timing of discontinuation after last dose of dabigatran before surgery Bleeding Risk Standard Risk High Risk (b) >80 13 (11-22) 24 hours 2 to 4 days 50 to (12-34) 24 hours 2 to 4 days 30 to (13-23) At least 48 hours 4 days <30 (c) 27 (22-35) 2 to 5 days > 5 days From McMaster Hematology Clinical Protocol Website and Schulman and Crowther, Blood 2012 a

59 Bottom Line Management of VTE includes establishment of diagnosis, selection of options and duration and empowerment of patient to achieve best outcomes NOACS are becoming an attractive option NOACs behave in real life as they were advertised in the trials: Efficacious Safe Considerations: drug interactions, age, weight, renal function From a patient perspective, system perspective these are attractive therapeutic options Antidotes likely coming as soon as the end of 2015 (?necessary) 59

60

61 Thrombosis Canada App Search Thrombosis for the free app in the itunes store, Google Play and BlackBerry App World or visit 61

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