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Dr. MUHAMMAD SYUKRI, Sp JP PUSAT JANTUNG Regional BAGIAN KARDIOLOGI DAN KEDOKTERAN VASKULAR FKUA/PUSAT JANTUNG RS. DR. M DJAMIL, PADANG

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Burden and Management of AF Challenges and limitation of ASA and VKA New Oral Anti Coagulants ( NOACs) Results of the studies with NOACs, RELY and RELY-ABLE Results of RELY among Asian population What the Guideline Says The goal of OAC therapy Summary

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Chowdhury P, et al. Cleve Clin J Med. 2009;76:543550 Thrombus (clot) Affected portion of the brain Atrial fibrillation is a supraventricular arrhythmia characterized by chaotic and uncoordinated contraction of the atrium Sinus Rhytm Atrial Fibriillation

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The Stroke Association: www.stroke.org.uk. Base on: Office of National Statistics Health Statistics Quarterly, Winter 2001 "Stroke incidence and risk factors in a population based cohort study. The Stroke Association estimate that 5,000 people per year have a stroke in Northern Ireland Scottish Stroke Care Audit 2005/2006. David Bloom's silent killer. David Bloom was an American television journalist covering Iraq war who died suddenly in 2003 after a pulmonary embolism.

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Prevention of complications, including thromboembolism (particularly ischaemic stroke) and heart failure Relief of symptoms Choice of antithrombotic therapy should be tailored to the patient based on: Risk of thromboembolismRisk of bleeding ESC guidelines: Camm J et al. Eur Heart J 2010;31:2369429; ACCF/AHA/HRS Focused Update Guidelines: Fuster V et al. J Am Coll Cardiol 2011;57:e1019

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Superior Efficacy Profile of OAC vs ASA to Prevent Stroke in Patients With Non Valvuler AF Hart et al, Ann Intern Med 2007;146:857867

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Friberg, Rosenqvist & Lip Eur Heart J 2012 Similar safety profile of OAC and ASA in intracranial bleeding and major bleeding

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Camm AJ et al. Eur Heart J 2012;33:271947; Aspirin Tablets BP 300 mg: SmPC, 2013; Ansell J et al. Chest 2008;133;160S198S; Nutescu EA et al. Cardiol Clin 2008;26:16987; Umer Ushman MH et al. J Interv Card Electrophysiol 2008;22:12937

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13 At least as effective as warfarin Predictable response Wide therapeutic window Low incidence and severity of adverse effects Oral fixed dose No need for routine anticoagulation monitoring Low potential for food or drug interactions Fast onset and offset of action Lip GY et al. EHJ Suppl. 2005;7:E2125 Requirements ? ? ? ? ? ? ? ? ? Guidelines ? Long term safety profile?

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NOACs approved for prevention of systemic embolism or stroke in patients with non-valvular AF

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17 Dabigatran 150 mg twice daily is proven to provide superior Ischaemic Stroke prevention vs. Warfarin 1 24% risk reduction in Ischaemic Stroke RRR 24% RRR 24% Haemorrhagic Stroke Both dosages of Dabigatran dramatically reduced the risk of haemorrhagic stroke compared with warfarin: 1 RRR 69% RRR 69% RRR 74% RRR 74%

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18 Life-Threatening Bleeding Rates Intracranial Bleeding Both doses of Dabigatran Significantly reduced the risk of life threatening bleeding compared with warfarin 1 Both doses of Dabigatran substantially reduced the risk of intracranial bleeding compared with warfarin 1 RRR 33% RRR 33% RRR 20% RRR 20% RRR 70% RRR 70% RRR 59% RRR 59%

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25 The objective is to reduce Ischemic Stroke The objective is to reduce Ischemic Stroke

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27 and minimizing the risk of Intracranial Haemorrhage and minimizing the risk of Intracranial Haemorrhage

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Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011 Not head-to-head comparison for illustrative purposes only RE-LYROCKET-AFARISTOTLE c c

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RE-LY Asia Stroke or SEE Asia Non-Asia Ischemic stroke Asia Non-Asia Hemorrhagic stroke Asia Non-Asia Myocardial infarction Asia Non-Asia Death from any cause Asia Non-Asia Dabigatran 150mg bid vs. Warfarin Dabigatran 110mg bid vs. Warfarin Rate (%/year) 110mg bid Warfarin Dabigatran 1.02.00 Warfarin better HR (95%CI) Dabigatran better 1.39 1.06 1.12 0.81 0.17 0.09 0.50 0.86 4.01 3.57 3.06 1.48 2.02 0.98 0.75 0.32 0.58 0.65 5.09 3.96 Interaction p value Interaction p value 0.0853 0.1977 0.7590 0.3782 0.4244 150mg bid 2.50 1.37 2.05 1.14 0.11 0.12 0.51 0.88 5.01 3.53 0.5597 0.5959 0.2729 0.3761 0.5929 1.02.00 Dabigatran betterWarfarin better HR (95%CI)

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RE-LY Asia Major bleeding Asia Non-Asia GI major bleeding Asia Non-Asia Life threatening bleeding Asia Non-Asia Intracranial bleeding Asia Non-Asia Minor bleeding Asia Non-Asia Major or minor bleeding Asia Non-Asia Dabigatran 150mg bid vs. Warfarin Dabigatran 110mg bid vs. Warfarin Rate (%/year) 150mg bid110mg bid Warfarin Dabigatran 1.02.00 Warfarin betterDabigatran better HR (95%CI) Interaction p value Interaction p value 2.17 3.52 0.96 1.69 1.28 1.52 0.45 0.29 12.43 15.27 13.99 17.02 3.82 3.53 1.41 1.01 2.20 1.79 1.10 0.71 19.66 15.81 22.03 17.74 2.22 2.99 1.15 1.14 0.91 1.29 0.23 10.12 13.69 11.72 15.27 0.0079 0.0089 0.1749 0.9509