Guidelines for the Use of Antithrombotic Agents in Cardiac Patients. Stuart J Smith MD Chief of Cardiovascular Services SMGH / GRH

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1 Guidelines for the Use of Antithrombotic Agents in Cardiac Patients Stuart J Smith MD Chief of Cardiovascular Services SMGH / GRH

2 Disclosure of Potential for Conflict of Interest Speaker: Dr Stuart J Smith, Cardiologist Presentation: Guidelines for the Use of Antithrombotic Agents in Cardiac Patients FINANCIAL DISCLOSURE Grants/Research Support: MOH Speakers Bureau/Honoraria: Servier Pharma Consulting Fees: None Other: Board of Directors, Cardiac Care Network of Ontario

3 Guidelines for the Use of Antithrombotic Agents in Cardiac Patients Objectives for this talk are : 1. Emphasize the importance of understanding the difference between anti-platelet agents and antithrombotic agents. 2. Review the role of anti-thrombotic therapy in cardiac patients, especially after cardiac interventions. 3. Give the role of anti-thrombotic therapy for stroke prevention in atrial fibrillation and other cardiac conditions.

4 Guidelines for the Use of Antithrombotic Agents in Cardiac Patients 4. Recommend the appropriate use and duration of antithrombotic therapies. 5. Advise on the use of the new direct thrombin inhibitors, in atrial fibrillation and other cardiac conditions.

5 February 2012; 141 (2 suppl) Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Gordon H. Guyatt, Elie A. Akl, Mark Crowther, David D. Gutterman, Holger J. Schuünemann, and for the American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel

6 Guidelines or Guidance?

7 Definitions Anti-platelet Agents vs Anticoagulants Anti-platelet agent anti-aggregant ; member of a group of pharmaceuticals that decrease platelet aggregation and inhibit thrombus formation. Anti-coagulants anti-thrombotic ; pertaining to a substance that prevents or delays coagulation of blood. So much for definitions!!! still need a working knowledge of which is which

8 Why? Antithrombotic agents of little value in preventing acute or sub-acute stent thrombosis

9 Formation of Thrombus and Multiple Potential Targets for Inhibition Anti-platelet Agents that You Need to Know Aspirin Clopidogrel Prasugrel Ticagrelor

10 Anti-Coagulant Agents Anticoagulants that You Need to Know Warfarin Dabigatran Rivaroxaban Apixaban Note:a) approved for afib b) reimbursed or limited usage criteria

11 A. Cardiac Conditions where Antithrombotic Therapy REQUIRED Valvular HD with Mechanical Prosthetic Valve a) Aortic Valve aim for INR 2-3 ±ASA 81 mg OD b) Mitral Valve aim for INR ± ASA

12 B. Cardiac Conditions where consideration for Antithrombotic Therapy Recommended Atrial Fibrillation paroxysmal or persistent Atrial flutter New onset atrial fib > 48 hours anticoagulation for 3 weeks prior and 4 weeks post ; then reassess. Post CV Surgery Atrial fib reassessed in 3 months Post MI Left Ventricular Thrombus reassessed after 3-6 months

13 Cardiac Conditions where consideration for Antithrombotic Therapy Recommended Dilated Cardiomyopathy patient in sinus rhythmwith hx of TIA / CVA suggestive of embolic event Valvular HD with bioprosthetic mitral valve - reassess after 3 months Recurrent cryptogenic stroke despite antiplatelet therapy in patient with patent foramen ovale / atrial septal aneurysm.

14 C. Cardiac Conditions where Antithrombotic Therapy controversial Dilated ischemic cardiomyopathy (LVEF < 30%) in sinus rhythm Cryptogenic stroke in patient in sinus rhythm with known patent ovale foramen / atrial septal aneurysm. Patient with recurrent TIA s despite antiplatelet therapy and has suspected but unproven paroxysmal atrial fib.

15 Cardiac Conditions and Therapeutic Challenges with regards to Antithrombotic Therapy When to initiate / not initiate oral anticoagulation for chronic afib Patient with chronic CAD and afib. Patient with PCI/stent and indication for anticoagulation ( triple therapy ) Indications, contraindications and differences between new oral anticoagulants Patient who does not want to take oral anticoagulation for chronic afib

16 67 year old smoker with HBP and type II DM presents with 6 hour hx of chest pain

17 Brought to the Cath Lab for Primary PCI Successful PCI of LAD with drug eluting stent. Complicated by some heart failure.

18 2D transthoracic echocardiogram in the apical 4-chamber view Aboukhoudir F et al. Circulation 2009;120:e8-e10

19 In addition to usual therapy, how would you manage him : A. ASA + Clopidogrel for 1 year B. ASA + Clopidogrel + Warfarin ( INR 2 3 ) for 1 year C. ASA + Clopidogrel + Warfarin for 3 months ; then Clopidogrel + Warfarin for further 9 months. D. ASA + Clopidogrel + Dabigatran 150 mg BID for 3 months ; then stop ASA. E. Empiric therapy based on best estimate of evidence.

20 Annual Bleeding Risks with Single, Dual, Triple Therapy Warfarin 3.9% ASA 3.7% Clopidogrel 5.6% ASA + clopidogrel 7.4% Warfarin + ASA 6.9% Warfarin + clopidogrel 13.9% Warfarin + ASA + clopidogrel 15.7% Hansen et al. Arch Intern Med 2010;170(16):

21 The bleeding risk of patients on triple therapy is grossly time independent, while the risk for stent thrombosis diminishes clearly over time. Schömig A et al. Heart 2009;95:

22 CCS Guidelines for Afib 2011 Use of Antithrombotic Agents in CAD

23 ESC Guideline on AF Hem. Risk Clinical Setting Stent Type Recommendation Low to intermediate Elective DES Triple Rx for 3-6 mo (INR 2,0-2,5+ASA 100+Clopi 75) Dual Rx until 12 mo (INR 2,0-2,5+Clopi or ASA) ACS BMS/ DES Lifelong: warfarin (INR 2,0-3,0) Triple Rx for 6 mo, then Dual Rx until 12 mo, then lifelong warfarin Eur Heart J 2010;31:

24 Hem. Risk ESC Guideline on AF Clinical Setting Stent Type Recommendation High Elective BMS Triple Rx for 2-4 weeks (INR 2,0-2,5+ASA 100+Clopi 75) Dual Rx until 12 mo (INR 2,0-2,5+Clopi or ASA) Lifelong: warfarin (INR 2,0-3,0) ACS BMS Triple Rx for 4 weeks, then Dual Rx until 12 mo, then lifelong warfarin Eur Heart J 2010;31:

25 NOVEL ANTICOAGULANTS AND DUAL ANTIPLATELET THERAPY Conclusions In RE-LY triple therapy (OAC, ASA and clopidogrel) increases major bleeding by 60% irrespective the anticoagulant used The ischemic AND bleeding benefit of dabigatran over warfarin is maintained with antiplatelet therapy The lowest rate of ICH in this study is seen with low dose dabigatran, which is even lower than with warfarin without antiplatelets

26 NOVEL ANTICOAGULANTS AND DUAL ANTIPLATELET THERAPY Conclusions-2 4. Low dose dabigatran seems a good candidate for patients with AF in the need of antiplatelet therapy (e.g, stenting and/or ACS), but this has to be confirmed in a new randomized trial against warfarin. However, it is unlikely, that such a trial will be done

27 Management of Patient with LV Thrombus and DES Stent Patient s risk of bleeding was felt to be low. ASA + Clopidogrel + Warfarin at INR 2-3 for 3 months ; then stopped ASA. Reassess at 1 year. Bisoprolol 5 mg OD, Rosuvastatin 20 mg qhs; Perindopril 4 mg hs ; Pantoprazole 40mg OD; Metformin + Diamicron.

28 Active 66 year old woman with 5 year history of Type II DM Found on routine ECG in family physician s office

29 The Burden of Atrial Fibrillation-Related Strokes Common 1 in 6 overall; 1 in 4 in the elderly Severe Strokes caused by atrial fibrillation are generally more severe than non-af strokes High mortality 24% at 30 days; 50% at 1 year

30 Prevalence of Diagnosed Atrial Fibrillation Stratified by Age and Sex Go, A. S. et al. JAMA 2001;285:

31 Overview of AF Management AF Detected Detection and Treatment of Precipitating Causes Assessment of Thromboembolic Risk (CHADS 2 ) Management of Arrhythmia ASA OAC Rate Control Rhythm Control No antithrombotic therapy may be appropriate in selected young patients with no stroke risk factors

32 Predictive Index for Stroke Risk Factor Congestive Heart Failure CHADS 2 Score Hypertension 1 Age 75 1 Diabetes Mellitus 1 Stroke/TIA/ Thromboembolism Maximum Score Patients (n= 1733) Adjusted Stroke Rate (%/yr) 95% CI CHADS 2 Score (1.2 to 3.0) (2.0 to 3.8) (3.1 to 5.1) (4.6 to 7.3) (6.3 to 11.1) (8.2 to 17.5) (10.5 to 27.4) 6

33 CCS Guidelines for Afib 2011 Use of Antithrombotic for Afib

34 CHADS 2 CHA 2 DS 2 -VASc Risk Factor Score Risk Factor Score Congestive Heart Failure 1 Hypertension 1 Age 75 1 Diabetes Mellitus 1 Stroke/TIA/Thromboembolism Stroke/TIA/Thromboembolism Maximum Score 6 2 Congestive Heart Failure 1 Hypertension 1 Age 75 2 Diabetes Mellitus 1 Vascular Disease 1 Age Female 1 Maximum Score 9 2 CCS Atrial Fib Guidelines 2011

35 European Society of Cardiology Afib Guidelines and Anticoagulant Rx

36 Bleeding Risk HAS-BLED Score Letter Clinical Characteristic Points H Hypertension 1 A Abnormal Liver or Renal Function 1 point each 1 or 2 S Stroke 1 B Bleeding 1 L Labile INRs 1 E Elderly (age > 65 yr) 1 D Drugs or Alcohol 1 point each 1 or 2 Maximum 9 points Pisters R et al. Chest Nov;138:

37 CCS Atrial Fib Guidelines Events/1000 patients/year Risk of Stroke + Non-cerebral Major Bleed among AF Patients

38 Warfarin is Highly Efficacious reduces stroke risk by 64% reduces death by 25% reduces stroke severity in contrast, ASA only reduces stroke risk by 22%

39 Advantages of Warfarin Familiarity (>50 years of experience) In expert clinician hands, TTR can be high INR monitoring Ability to assess good/poor adherence Ability to assess treatment failures PO and IV antidotes available Non-renal clearance; can use in patients with renal failure Slow onset of action often desirable (post-stroke) Long half-life (40 hours) Inexpensive Known benefits in AMI, CAD, mechanical valves, etc.

40 The Challenges with Warfarin Warfarin is underused Patient factors Physician factors Fear of bleeding side effects Drug and food interactions Need for regular INR monitoring Perioperative discontinuation Patients taking warfarin are outside the therapeutic INR range half of the time C. Van Walraven. Chest 2006

41 The Practice Gap

42 Atrial Fib and Stroke Prevention ASA + Clopidogrel vs Warfarin

43

44 The New Oral Anticoagulants Initiation Phase Amplification Propagation Phase Thrombin Activity Contact XII XI Warfarin VIII IX Common Pathway TF Xa VIIa Platelet Surface Thrombin X Rivaroxaban Apixaban Dabigatran etexilate Fibrinogen Fibrin

45 Comparisons of the Properties of the New Oral Anticoagulants Mechanism of action Dabigatran Rivaroxaban Apixaban Direct thrombin inhibitor Direct Factor Xa inhibitor Direct Factor Xa inhibitor Half-Life (hr) h 6 10 h 8 15 h Excretion Kidney 80% Kidney 66%,, Liver 28% Kidney 25% M. Katsnelson et al Circulation.2012; 125: 1577

46 Advantages of New Agents Rapid onset/offset of action No bridging required More stable anticoagulant effect (avoids fluctuations) No routine coagulation monitoring or dosage adjustment needed (no INR monitoring) No food interactions, fewer drug interactions Easier to use/prescribe for patients/physicians Likely that more eligible patients will be treated

47 Comparison of primary outcomes: Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY), Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation (ROCKET AF), Apixaban versus Acetylsalicylic Acid to Prevent Strokes (AVERROES), and Apixaban... Katsnelson M et al. Circulation 2012;125:

48 Common Themes Across the Trials All trials met non-inferiority vs. warfarin All agents reduced intracranial hemorrhage vs. warfarin Major bleeds 2%-4% All trials had short duration follow-up A major challenge with all agents is adherence (1/5 to 1/4 discontinuation rates over 2 years)

49 Disadvantages of the New Limited experience/familiarity No long-term data No antidote Anticoagulants BID dosing (adherence issues?) Short half-life (greater risk of missed doses?) No INR to monitor (how to monitor therapy?) Contraindicated in renal failure; caution with renal impairment (need to monitor renal function) Treated patients ineligible for IV thrombolysis Expensive Potential for inappropriate off-label uses

50 The New Anticoagulants Patient Groups Likely to Benefit 1. Patients with difficult control INR due to inate / genetics for warfarin metabolism 2. Patients with inadequate access to monitoring 3. Patients requiring medication interacting with VKA s 4. Patients who have decided against warfarin despite attempts to educate 5. Patients at low risk of gastrointestinal bleeding and without severe renal insufficiency ( egfr 30 ) 6. Patients who suffered an ischemic stroke on warfarin with adequate INR

51 The New Anticoagulants Less Suitable or Contraindicated Patient Groups 1. Fragile patients with several concomitant diseases and polypharmacy 2. Patients with significant renal dysfunction 3. Patients with hxof GI bleeding 4. Patients with poor compliance with medical therapy 5. Patients at risk of progressing towards severe renal failure eg patients with advanced heart failure 6. Patients with CAD with high likelihood of requiring possible urgent revascularization egpci or CABG 7. Patients with mechanical prosthetic valves

52 New Anticoagulants Remaining Questions: 1. How do the results from the recent studies translate into real world community practice? ( eg safety, efficacy, compliance, acceptance, long term issues) 1. Should patients who are currently on warfarinbe switched to one of these newer agents? 1. How will cost factor into decisions regarding use of these agents? 1. What treatment should be initiated for a newly diagnosed patient with Atrial Fibrillation?

53 Cardiac Conditions and Therapeutic Challenges with regards to Antithrombotic Therapy When to initiate / not initiate oral anticoagulation for chronic afib Patient with chronic CAD and afib. Patient with PCI/stent and indication for anticoagulation ( triple therapy ) Indications, contraindications and differences between new oral anticoagulants Patient who does not want to take oral anticoagulation for chronic afib

54 Resources Canadian Best Practice Recommendations for Stroke Care Canadian Cardiovascular Society AF guidelines Making Choices University of Ottawa AF decision aid Heart and Stroke Foundation patient information Thrombosis Interest Group of Canada warfarin handout for patients Canadian Cardiovascular Pharmacists Network SPAF Tool

55 February 2012; 141 (2 suppl) Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Gordon H. Guyatt, Elie A. Akl, Mark Crowther, David D. Gutterman, Holger J. Schuünemann, and for the American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel

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