Anticoagulation Initiation,Monitoring and Titration. Ng Heng Joo Department of Haematology Singapore General Hospital

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1 Anticoagulation Initiation,Monitoring and Titration Ng Heng Joo Department of Haematology Singapore General Hospital

2 The 3 I s on the Anticoagulated Patient Indication? Intensity? Indefinite?

3 Indications Atrial fibrillation Venous thrombosis Mechanical cardiac valves Dilated cardiomyopathy LV thrombus AV grafts

4 Initiating anticoagulation therapy a working chart Yes Clear Indication? No Reconsider Favourable risk/benefit profile? No Yes How fast do we need to get this patient therapeutically anticoagulated?

5 How fast do we need to get this patient anticoagulated? Determining factors Risk of thrombus extension/embolisation Risk of thrombus recurrence Risk of first thrombosis Risk of bleeding (haemorrhagic conversion)

6 How fast to get this patient therapeutically anticoagulated? As soon as possible Acute clots High risk of extension High risk of further embolisation High risk for primary clot Low risk of bleeding Can take our time No acute thrombus Primary or secondary prophylaxis New DVT/PE Mechanical heart valves Cardiac thrombus Chronic AFs IV Heparin LMWH Fondaparinux New oral agents (for the future) Dabigatran Rivaroxaban Apaxiban Edoxaban Warfarin New oral agents (in future) Should take our time Acute thrombus High risk of bleeding Acute cardioembolic strokes DVT/PE,active bleeding Warfarin New oral agents (in future) when risk

7 Stroke. 2007;38: Recurrent ischemic stroke within 7 to 14 days - odds ratio 0.68, 95% CI: 0.44 to 1.06, P 0.09 Symptomatic intracranial bleeding - odds ratio 2.89; 95% CI: 1.19 to 7.01, P 0.02 Death or disability at final follow up - odds ratio 1.01; 95% CI: 0.82 to 1.24, P 0.9

8 Which anticoagulant for rapid effect? IV heparin (80/18 80U/kg bolus/18u/kg maintenance) S/C low molecular weight heparin e.g enoxaparin 1mg/kg bd S/C fondaparinux 5 mg om Novel oral anticoagulants e.g rivaroxaban, dabigatran

9 IV heparin vs LMWH in mechanical heart valves Clin. Cardiol. 25, (2002)

10 IV heparin vs LMWH in VTE Arch Intern Med Vol 160, Jan 24, 2000

11 IV heparin vs LMWH in PE Ann Intern Med. 2004;140:

12 Once daily vs twice daily LMWH in DVT Couturaud et al. Thromb Haemost 2001; 86: 980 4

13 Once daily vs twice daily LMWH in DVT Couturaud et al. Thromb Haemost 2001; 86: 980 4

14 Fondaparinux for DVT Ann Intern Med. 2004;140:

15 Fondaparinux for PE Matisse PE N Engl J Med 2003;349:

16 Novel oral anticoagulants Current trials in Phase III VTE studies (novel agents vs LMWH/warfarin) EINSTEIN (Rivaroxaban) RECOVER II (Dabigatran) AMPLIFY VTE (Apaxiban) HOKUSAI (Edoxaban)

17 Transitioning to longer term anticoagulant agents Current available oral agent Warfarin Future oral agents Rivaroxaban, dabigatran, apaxiban, edoxaban Parenteral agent Long term low molecular weight heparin

18 Slide coutesy of Dr M Crowther

19 The Ideal Oral Anticoagulant Warfarin Dabigatran Rivaroxaban Apaxiban Edoxaban Rapid onset of action Predictable response with fixed dosing No interactions with drugs or concurrent illnesses Delayed onset of action Individual variability in dose/response Interactions with drugs and concurrent illness

20

21 Understanding warfarin s action Warfarin CYP1A1 CYP1A2 CYP3A4 R-warfarinwarfarin R-warfarin Vitamin K Reductase S-warfarin S-warfarin CYP2C9 Oxidized Vitamin K Calumenin Reduced Vitamin K CO 2 O 2 Hypofunctional F. II, VII, IX, X Protein C, S, Z γ-glutamyl carboxylase Functional F. II, VII, IX, X Proteins C, S, Z Gage BF et al Circulation 2004

22 Initiating warfarin do we need to get it up fast? Yes When there is an indication to use parenterals (IV heparin, LMWH) Reduces patient s discomfort Reduces heparin exposure Reduces hospital LOS Reduces cost No When we would not have used parenterals in the first place

23 Goals in warfarin initiation Achievement of therapeutic INRs, rapidly in some instances Avoidance of supra-therapeutic INRs and the increased risk of bleeding Minimising the duration of subtherapeutic INRs and the risk of thrombosis

24 Warfarin therapy

25 Warfarin initiation fast facts Initial effect on INR occurs within the first 2-3 days Anti-thrombotic effect occurs within the next few days INR Anti-thrombotic effect

26 The mean time in days to reach the therapeutic range (prothrombin complex activity < 35% of normal) was 1.1 days with the dose of 1.5 mg/kg of body weight, 2.7 days with the dose of 15 mg/day, and 5.2 days with 10 mg/day. With the loading dose, factor VII activity was less during the first 48 hr, but there was no other significant difference between the two methods of drug administration in the amount of reduction of any of the four factors.

27 Half-lives of coagulation factors

28 Initiating warfarin therapy practice points to prevent rethrombosis Overlap warfarin and parenteral anticoagulant (IV heparin or LMWH) for at least 5 days Discontinue IV heparin/lmwh only when INR is in therapeutic range for 2 consecutive days

29 Strategies for initial monitoring and titration of warfarin Fixed dose with limited initial monitoring most suitable for outpatients when rapid anticoagulation effect is not essential Warfarin initiation normograms Computer-based programs Pharmacogenomic-based formulas

30 Factors influencing warfarin maintenance dose Age (Gage B et al, Sconce et al) Body surface area (Gage et al) Height (Sconce et al) Pharmacogenetics CYP2C9 VKORC1

31 What should be the initial warfarin dose? Harrison L, Johnston M, Massicotte MP, et al. Comparison of 5 mg and 10 mg loading doses in initiation of warfarin therapy. Ann Intern Med 1997; 126: Crowther MA, Ginsberg JB, Kearon C, et al. A randomized trial comparing 5 mg and 10 mg warfarin loading doses. Arch Intern Med 1999; 159:46 48 dose of 5 mg warfarin usually results in an INR of 2.0 in 4 or 5 days with less excessive anticoagulation compared to that with an initial 10-mg dose.

32 What should be the initial warfarin dose? Kovacs MJ, Rodger M, Anderson DR, et al. Comparison of 10 mg and 5 mg warfarin initiation nomograms together with low molecular weight heparin for outpatient treatment of acute venous thromboembolism. Ann Intern Med 2003; 138: in outpatients who had been treated for venous thromboembolism, an initial 10-mg dose for the first 2 days of therapy compared to a 5-mg dose resulted in a more rapid achievement of a therapeutic INR (1.4 days earlier) without a difference in rates of excessive anticoagulation.

33 What is a reasonable initiating warfarin dose? 5 mg for the majority of patients 5 mg (e.g 3 mg) for elderly patients, patients with impaired nutrition, liver disease, CCF or at high risk of bleeding complications 2-3 mg in patients with heart valve replacement

34 Warfarin initiation normogram

35 Computer-based programs Mitra R, et al Efficacy of Computer-Aided Dosing of Warfarin Among Patients in a Rehabilitation Hospital. American Journal of Physical Medicine & Rehabilitation 2005;84: Ageno W, Turpie AGG. A randomised comparison of a computer-based dosing program with a manual system to monitor oral anticoagulant therapy. Thromb Res Sep 1;91(5): Ageno W. A computer generated induction system for hospitalized patients starting on oral anticoagulant therapy. Thromb Haemost 2000; 83: Wright D, Seal J. Warfarin induction: A comparative study of laboratorybased computerised dosing versus medical staff dosing. British Journal of Haematology, Vol 101; May Green DG, Kelsey PR. Monitoring of anticoagulant therapy in the community using a centralised computer system with remote modules. British Journal of Haematology 1997; 97: 253.

36 Pharmacogenomics - CYP2C9 Warfarin CYP1A1 CYP1A2 CYP3A4 R-warfarinwarfarin R-warfarin Vitamin K Reductase S-warfarin S-warfarin Thromb Haemost 2004; 91: CYP2C9 Oxidized Vitamin K Calumenin Reduced Vitamin K CO 2 O 2 Hypofunctional F. II, VII, IX, X Protein C, S, Z γ-glutamyl carboxylase Functional F. II, VII, IX, X Proteins C, S, Z

37 Pharmacogenomics VKORC1 Warfarin CYP1A1 CYP1A2 CYP3A4 R-warfarinwarfarin R-warfarin Vitamin K Reductase S-warfarin S-warfarin BLOOD, 15 JANUARY 2005 VOLUME 105, NUMBER 2 CYP2C9 Oxidized Vitamin K Calumenin Reduced Vitamin K CO 2 O 2 Hypofunctional F. II, VII, IX, X Protein C, S, Z γ-glutamyl carboxylase Functional F. II, VII, IX, X Proteins C, S, Z

38 CLINICAL PHARMACOLOGY & THERAPEUTICS 2006;80(4):346-55

39 An example of a pharmacogenomics based algorithm

40

41 Pharmacogenomics and warfarin dosing - pros 50% of the variance in warfarin dosing may be accounted for by CYP2C9 and VKORC1 variants Potentially better INR control at initiation of warfarin when using pharmacogenomics based algorithms

42 Pharmacogenomics and warfarin dosing - cons Cost of testing Need for rapid test results which may not be available to all centres No prospective studies showing improved clinical outcomes in comparison to traditional methods

43 Non-urgent initiation of warfarin therapy Commenced without parenterals Given as outpatient Logical starting dose of 3-5 mg/daily depending on age, body size and concomitant medical problems and medications Begin at lower doses if concerns with bleeding and inability to come for frequent monitoring

44 Monitoring warfarin therapy

45 Issues in monitoring Monitoring frequency Dosing regimens Models of anticoagulation care Primary physician-based Anticoagulation clinics Doctor vs pharmacist vs doctor/pharmacist Patient self management/monitoring

46 Monitoring frequency Initiation phase Start monitoring INR after 2 nd or 3 rd dose of warfarin Hospitalised patients usually daily till TTR reached on 2 consecutive readings Outpatients every few days

47 Frequency of monitoring Stable phase Recommended not more than 4 weeks interval ACCP 2008 More frequent testing may increase time within therapeutic range (TTR)

48 Frequency of monitoring practice points Optimal frequency influenced by Patients compliance Co-morbidities Concomitant medications Diet Quality of dose adjustment decisions Individual patient s response

49 Titration of warfarin Causes of fluctuations in INR Inaccuracy in INR testing Changes in vitamin K intake Changes in vitamin K or warfarin absorption Changes in warfarin metabolism Changes in vitamin K-dependent clotting factors synthesis or metabolism Concomitant drug use Non-compliance

50 Titration of warfarin Just outside therapeutic range Small adjustments of 5-20% of weekly dose No change. Increase monitoring frequency High INRs without bleeding (4-10) Stop 1-2 doses and adjust to lower weekly dose Small dose vitamin K (1-2mg) and adjust weekly dose

51 Warfarin regimens Keep it simple! Especially in elderly patients or those with limited understanding

52 Pharmacotherapy 1999;19(12): Patients receiving the same daily dose reported lower rates of confusion (0% vs 7%) and dosing errors (3.3% vs 14%) that those receiving alternate-day dosing, and expressed a stronger preference for their regimen (40% vs 1.5%). When selecting a regimen, consideration must be given to patient-specific risk of confusion and dosing errors, associated costs, practicality and precision of dosing adjustments, and patient preference.

53

54 Models of anticoagulation care Primary physician-based Anticoagulation clinics Doctor vs pharmacist vs doctor/pharmacist Patient self management/monitoring

55 .PSM is a choice made by patients and health-care providers that depends on many factors. In patients who are suitably selected and trained, PST or PSM is an effective alternative treatment model. ACCP 8 th Ed

56 The future of vitamin K antagonist (and the relevance of what we have discussed) Warfarin will Be around for sometime to come Cheap Safe Not too bad after all for a significant proportion of patients

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