Dr. MUHAMMAD SYUKRI, Sp JP PUSAT JANTUNG Regional BAGIAN
KARDIOLOGI DAN KEDOKTERAN VASKULAR FKUA/PUSAT JANTUNG RS. DR. M
DJAMIL, PADANG
Slide 3
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
Slide 4
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
Slide 5
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.
Slide 6
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
Slide 7
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
Slide 8
Friberg, Rosenqvist & Lip Eur Heart J 2012 Similar safety
profile of OAC and ASA in intracranial bleeding and major
bleeding
Slide 9
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
Slide 10
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?
Slide 11
NOACs approved for prevention of systemic embolism or stroke in
patients with non-valvular AF
Slide 12
Slide 13
Slide 14
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%
Slide 15
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%
Slide 16
25 The objective is to reduce Ischemic Stroke The objective is
to reduce Ischemic Stroke
Slide 17
27 and minimizing the risk of Intracranial Haemorrhage and
minimizing the risk of Intracranial Haemorrhage
Slide 18
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
Slide 19
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)
Slide 20
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