The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012

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1 The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era CCRN State of the Heart 2012 June 2, 2012

2 Disclosures I have I have been involved in trials of new anticoagulants and have received consulting fees and honoraria from A-Z, Bayer, BI, BMS, Daiichi-Sankyo, J&J, Pfizer, Portola and Sanofi I work in an anticoagulation clinic at McMaster / Hamilton General Hospital

3 Therapeutic areas of unmet need AF stroke prevention Mechanical heart valves VTE treatment ACS treatment Increasing unmet need VTE prevention (out-of-hospital) VTE prevention (in-hospital)

4 The 50 year quest to replace warfarin Heparin (1936) LMWH (1993) DTI (1998) Penta (2001) Warfarin (1954) Dabigatran Rivaroxaban (2008) Apixaban (2011)

5 Key messages 1. Warfarin has limitations that reduce its uptake and limit its effectiveness 2. The new oral anticoagulants will progressively replace warfarin for stroke prevention in atrial fibrillation 3. The challenge for clinicians is to translate the results of the trials of new oral anticoagulants into benefits for patients

6 Underuse and poor control Based on 15,174 patients presenting to an Emergency Department with AF between Jan and Apr OAC Use in CHADS Time in Therapeu6c Range* % % Appropriate use of OAC continues to remain low. When OAC is used, INR control is suboptimal. *based on 3 most recent INR values Healey JS, et al. Presented at ESC 2011

7 Possible Strategies to Improve Stroke Prevention in Atrial Fibrillation 1. Patient (and physician) education 2. System-wide improvements in VKA management 3. Novel approaches to left atrial appendage closure (surgical, non-surgical) 4. Effective, safe and more convenient alternatives to VKA and aspirin

8 Advantages of new OAC vs. warfarin Feature Warfarin New OAC Onset Slow Rapid Dosing Variable Fixed Routine Monitoring Yes No Food effect Yes No Drug interactions Many Few Offset Longer Shorter Eikelboom and Weitz. Circulation 2010

9 Key messages 1. Warfarin has limitations that reduce its uptake and limit its effectiveness 2. The new oral anticoagulants will progressively replace warfarin for stroke prevention in atrial fibrillation 3. The challenge for clinicians is to translate the results of the trials of new oral anticoagulants into benefits for patients

10 Consider A new OAC for stroke prevention in AF with the following results compared to dabigatran 150 mg bid: Stroke: 1.5-fold increase Major bleeding: similar rates Intracranial bleeds: 2-fold increase Cardiovascular death: 15% increase

11 Antithrombotic guidelines for stroke prevention in AF trial fibrillation ACCP 2012 we suggest dabigatran 150 mg bid rather than adjusted-dose VKA therapy. CCS 2012 we suggest that most patients should receive dabigatran, rivaroxaban or apixaban in preference to warfarin... You JJ, et al. Chest 2012; 141: e531s-575s Skanes AC, et al. Can J Cardiol 2012; 28:

12 Atrial Fibrillation: Stroke Stroke or Systemic Embolism Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Ischemic Stroke Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Superiority p-value 0.29 < HR (95% CI) Comparator better Warfarin better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011

13 Atrial Fibrillation: Mortality All-Cause Mortality Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Cardiovascular Mortality Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Superiority p-value NR HR (95% CI) Comparator better Warfarin better NR: Not Reported Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011

14 Atrial Fibrillation: Bleeding Intracranial Hemorrhage Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID ISTH Major Bleeding Dabigatran 110 mg BID Dabigatran 150 mg BID Rivaroxaban 20 mg QD Apixaban 5 mg BID Superiority p-value <0.001 < < < HR (95% CI) Comparator better Warfarin better Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011

15 Lessons from new OAC trials in AF Main findings: New OAC at least as effective/safe as warfarin and can be given without routine monitoring Unexpected findings: Apparent dissociation of efficacy and safety Increase in gastrointestinal bleeding Marked reduction in intracranial bleeding Increase in myocardial infarction rates Connolly SJ, et al. NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011

16 Warfarin and Risk of Intracranial Bleeding Trial Warfarin Comparator ACTIVE W ~0.6% ~0.3% RE-LY 0.74% % ROCKET-AF 0.74% 0.49% ARISTOTLE 0.80% 0.33% Hart R, et al. Ann Intern Med 2007; Connolly SJ, et al. Lancet 2006, NEJM 2009; Alexander J, et al. NEJM 2011; Mahaffey K, et al. NEJM 2011

17 Dabigatran MI meta-analysis Uchino K, et al. Arch Intern Med 2012

18 Dabigatran and MI in RE-LY Cumulative Hazard Rates Dabigatran 110 Dabigatran 150 Warfarin Net clinical benefit Stroke/SEE/MI/UA/PCI/CABG/ Cardiac arrest/cardiac death MI Years of Follow-up Hohnloser S, et al. Circulation 2012

19 Key message 1. Warfarin has limitations that reduce its uptake and limit its effectiveness 2. The new oral anticoagulants will progressively replace warfarin for stroke prevention in atrial fibrillation 3. The challenge for clinicians is to translate the results of the trials of new oral anticoagulants into benefits for patients

20 Reducing the risk of bleeding Bleeding is the most common complication of antithrombotic therapy Prevention is better than cure Patient, drug and dose selection; careful follow up and safe management of interruption are key

21 Reports of bleeding with dabigatran need to be interpreted in context Eikelboom JW, et al. J Thromb Hemost 2012

22 Emergency hospitalizations for adverse drug events in Americans ,000 emergency hospitalizations/year 21,000 hospitalizations for warfarin-related events Budnitz DS, et al. N Engl J Med 2011; 365:

23 Management of interruption Measure creatinine clearance Assess procedural bleeding risk Standard High Hold 2-3 drug half-lives Hold 4-5 drug half-lives

24 Measurement of drug levels Specific test may not be routinely available Dabigatran aptt, TCT are semi-quantitative Hemoclot is specific and quantitative Apixaban and rivaroxaban PT may be semi-quantitative Anti-Xa is specific and quantitative

25 Overview of bleeding management Patient with bleeding on dabigatran therapy Mild bleeding Moderate to severe bleeding Life-threatening bleeding Delay next dose or discontinue treatment as appropriate Symptomatic treatment Mechanical compression Surgical intervention Fluid replacement and haemodynamic support Blood product transfusion Oral charcoal application* (if dabigatran ingestion <2 hrs before) Haemodialysis Consideration of rfvlla or PCC Charcoal filtration

26 Summary 1. Warfarin has limitations that reduce its uptake and limit its effectiveness 2. The new oral anticoagulants will progressively replace warfarin for stroke prevention in atrial fibrillation 3. The challenge for clinicians is to translate the results of trials of new OACs for stroke prevention in AF into benefits for patients

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