apixaban in SPAF deck

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Anticoagulation for
Atrial Fibrillation
Bradley J. Dibble, MD FRCPC FACC
September 26, 2014
Conflict Disclosure Information
FINANCIAL DISCLOSURE
Grants/Research Support: None
Speakers Bureau/Honoraria: Bayer, Boehringer-Ingelheim,
Pfizer/Bristol-Myers Squibb
Consulting Fees: None
Investments: None
Other: None
AF is a common disorder
The lifetime risk
of developing AF is
 AF is the most common sustained cardiac arrhythmia,
occurring in 1–2% of the general population1
~25%
 Affecting approx 350,000 Canadians2
in those who have
reached the age of
40
years3
 Affects 3% of Canadians over the age of 45 and 6%
over age 652
 Men are more affected than women1,4
 Men have a ~1.4-fold greater risk of developing AF
after adjustment for age and risk factors4
1. Camm AJ et al. Eur Heart J 2010;31:2369–2429
2. Heart and Stroke Foundation. Atrial fibrillation.
Available at http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm. Accessed February 2012.
3. Lloyd-Jones et al., Circulation 2004;11:1042-1049
4. Go AS et al. JAMA 2001;285:2370–2375
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5
The prevalence of AF is projected to grow
3-fold by 2050
Projected number of adults with AF in the USA by 2050
15.2
16
15.9
14.3
13.1
14
Mayo Clinic data
(assuming a continued
increase in AF incidence)
11.7
Patients with AF
(millions)
12
10.2
8.9
10
11.1
9.4
6.7
8.4
5.9
7.5
5.1
6
5.1
4
6.1
6.8
ATRIA study data
2.94
2.26
2.66
3.33
2.44
2000
2005
2010
2015
2020
2
2.08
5.6
12.1
10.3
7.7
8
11.7
Mayo Clinic data
(assuming no further
increase in AF incidence)
3.8
4.34
4.78
5.16
5.42
5.61
2040
2045
2050
0
1990
1995
2025
2030
2035
Year
Projected data from population studies suggest that the prevalence
of AF will grow at least 3-fold by 2050
Adapted from Savelieva I et al. Clin Cardiol 2008;31:55–62
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Atrial Fibrillation
• Atrial fibrillation (AF) is the most common heart rhythm disturbance
• It is estimated that 1 in 4 individuals aged 40 will develop AF
Normal rhythm
AF
Lloyd-Jones DM, et al. Circulation 2004;110:1042-1046
AF=atrial fibrillation
Classification of
Atrial Fibrillation
Terminology
Clinical features
Pattern
Initial event (first detected
episode)
Symptomatic or Asymptomatic
Onset unknown
May or may not reoccur
Paroxysmal
Spontaneous termination <7 days and
most often <48 hours
Recurrent
Persistent
Not self-terminating: Lasting >7 days
or prior cardioversion
Recurrent
Permanent (‘accepted’)
Not terminated, terminated but
relapsed, no cardioversion attempt
Established
Fuster V, et al. ACC/AHA/ESC 2006 guidelines. J Am Coll Cardiol 2006;48:854-906.
AF is a Progressive Disease
Relative
Importance
AF Duration
Trigger
dependent
(Initiation)
Substrate
dependent
(Maintenance)
Paroxysmal
Persistent
Permanent
Khan I.A. Int J Card 2003;87:301-302.
31
Management Issues in Atrial Fibrillation
• Symptom control
§ Rate control
– Pharmacotherapy and non-pharmacotherapy
§ Rhythm Control
– Pharmacotherapy and non-pharmacotherapy
• Treat associated cardiac conditions (if present)
• Determine etiology
Pathophysiology of Stroke
in Atrial Fibrillation
Stroke Due to AF
Stroke from AFib involves multiple branches and frequently affects the cerebral cortex
AF = Atrial fibrillation
Kelley RE, Minagar A. Southern Medical Journal 2003;96(4):343-349
Left Atrial Appendage (LAA)
Left atrial
appendage (LAA) is
the most common
site for thrombus
formation in patients
with AF
AF=atrial fibrillation
Image courtesy of www.strokecenter.org
Albers G, Stanford Stroke Center, Stanford School of Medicine
Ischemic Stroke Associated With AF is Typically More
Severe Than Stroke due to Other Etiologies
50
% bedridden patients
on admission (mRs* = 5)
41.2%
40
30
23.7%
(P < 0.0005)
20
10
0
With AF
Without AF
Odds ratio for bedridden state following stroke due to AF was
2.23 (95% CI, 1.87-2.59; P < 0.0005)
*mRS=modified
Rankin Scale
AF=atrial fibrillation
Dulli DA, et al. Neuroepidemiology. 2003;22:118-123.
AF confers nearly a 5-fold
increased risk of stroke
2-year age-adjusted incidence
of stroke/1000
 AF is thought to cause ~20% of the 700,000 strokes that occur annually in the USA1
 In patients >80 years of age, AF is linked to as many as 1 in every 3 strokes1
50
Framingham study (n=5070)2
Absence of CV condition
Presence of CV condition
40
~5 fold increase
of stroke in patients
with AF compared
with those without AF
30
20
10
0
RISK
RATIO
HTN
CHD
CHF
AF
3.4*
2.4*
4.3*
4.8*
*p<0.001 different from unity
AF, atrial fibrillation; CHD, coronary heart disease; CHF, congestive heart failure;
CV, cardiovascular; HTN, hypertension
1. Caro JJ. Am J Manag Care 2004;10:S451–S461
2. Adapted from Wolf PA et al. Stroke 1991;22:983–988
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Warfarin and stroke prevention
in patients with atrial fibrillation
Adjusted dose warfarin compared with
placebo or control
AFSAK I = Copenhagen Atrial Fibrillation, Aspirin and Anticoagualtion Study
SPAF I = Stroke Prevention in Atrial Fibrillation Study
BAATAF = Boston Area Anticoagulation Trial doe Atrial Fibrillation
CAFA = Canadian Atrial Fibrillation Anticoagulation
SPINAF = Stroke Prevention in Nonrheumatic Atrial Fibrillation
EAFT = European Atrial Fibrillation Trial
Hart RG et al. Ann Intern Med 2007;146:857-867
VKA therapy has several limitations
Narrow therapeutic window
(INR range 2-3)1
Considerable variability
in dose-response
(genetic variations)1
Risk of stroke
Risk of bleeding1
Convenience not optimal:
• Frequent coagulation monitoring1
Interactions
with drugs and diet1
Long half-life
Slow onset and offset of action1,2
• Frequent dose adjustments1
Issue in perioperative anticoagulation
(bridging)2
1. Weitz et al. Eur J Haematol 2010;85 (Suppl 72);1-28.
2. Camm et al. Eur Heart J 2010;31:2369-429.
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The risks of ischaemic stroke or intracranial
bleed are high outside a narrow INR range
Adjusted odds-ratio for ischaemic stroke and intracranial bleeding in relation
to intensity of anticoagulation
Ischaemic
stroke risk
Intracranial
bleeding risk
20
Odds Ratio
Ischaemic stroke risk
Intracranial bleeding risk
15
10
5
0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
INR
Adapted from: Fuster et al. Circulation 2011;123:e269-e367.
Hylek and Singer. Ann Intern Med 1994;120:897-902.
Oden et al. Thromb Res 2006;117:493-9
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Underutilisation of VKA
AF patients considered to be suitable for anticoagulation and admitted
with acute ischaemic stroke (Ontario 2003-2007)
Dual antiplatelet therapy 2%
No antithrombotics 29%
Warfarin–subtherapeutic 29%
Single antiplatelet agent 29%
Warfarin–therapeutic 10%
n=597
Adapted from Gladstone et al. Stroke 2009;40:235-40.
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Underutilisation of VKA
despite prior TIA or stroke
AF patients with previous TIA or ischaemic stroke, considered to be suitable
for anticoagulation and admitted with acute ischaemic stroke (Ontario 2003-2007)
No antithrombotics 15%
Warfarin–therapeutic 18%
Dual antiplatelet therapy 3%
Single antiplatelet agent 25%
Warfarin–subtherapeutic 39%
n=323
Adapted from Gladstone et al. Stroke 2009;40:235-40.
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Aspirin has modest efficacy in reducing
the risk of stroke in AF patients
Relative risk reduction (95% CI)†
ASPIRIN VS. PLACEBO
OR CONTROL
AFASAK I
SPAF I
EAFT
ESPS II
LASAF
Daily
Alternate day
UK-TIA
300 mg/d
1200 mg/d
JAST
ARR
RRR = 19%
(95% CI: –1 to 35%)
All aspirin trials (n=7)
100%
50%
0
Favours aspirin
Primary prevention, 0.8%/y
Secondary prevention, 2.5%/y
-50%
-100%
Favours placebo or control
Horizontal lines represent 95% CIs around point estimates
†RRR for combined ischaemic and haemorrhagic strokes by intent-to-treat analysis
(ESPS trial reported ”on therapy” results)
ARR, absolute risk reduction; RRR, relative risk reduction
Adapted from Hart RG et al. Ann Intern Med 2007;146:857–867
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Anticoagulation Treatment:
Newer Options
Desirable Qualities of a New Anticoagulant
•
•
•
•
•
•
•
•
At least as effective as current agents
At least as safe as current agents
Oral
Simple dosing
Predictable effect
No anticoagulation monitoring
Minimal food and drug interactions
Rapid onset and offset of action
ACTIVE-W: Clopidrogel plus aspirin
versus anticogulant therapy
ACTIVE Writing Group. Lancet 2006;367:1903-1912
Cumulative Incidence
ACTIVE-A: Clopidrogel plus aspirin
versus aspirin alone
Years
The ACTIVE Investigators. N Engl J Med 2009;360:2066-2078
Antithrombotic treatment for prevention of
stroke in patients with atrial fibrillation
Warfarin > Clopidogrel+ASA > ASA
• Oral anticoagulation therapy is superior to clopidogrel plus
ASA for prevention of vascular events in patients with AF at
high risk of stroke, especially in those already taking oral
anticoagulation therapy.1
• In patients with AF fibrillation for whom vitamin K–antagonist
therapy is unsuitable, the addition of clopidogrel to ASA
reduced the risk of major vascular events, especially stroke,
and increased the risk of major hemorrhage.2
1. ACTIVE Writing Group. Lancet 2006;367:1903-1912
2. The ACTIVE Investigators. N Engl J Med 2009;360:2066-2078
New Oral Anticoagulants
in Nonvalvular Atrial
Fibrillation
RE-LY
Randomized
Evaluation of
Long-Term
Anticoagulation
TherapY
TF/VIIa
X
IX
VIIIa
Dabigatran
IXa
Va
Xa
II
Dabigatran
IIa
Fibrinogen
1. Product Monograph Sep 14, 2011. 2. Kubitza et al, Clin Pharmacol Ther 2005.
Fibrin
Adapted from
Weitz et al, 2005; 2008
RE-LY
Stroke or Systemic Embolism (n=18 113)
Cumulative incidence
0.06
(TTR = 64%)
Warfarin
0.05
HR = 0.90 (95% CI 0.74−1.10)
p = 0.29 (superiority)
p < 0.001 (non-inferiority)
0.04
0.03
Dabigatran 110 mg
Dabigatran 150 mg
0.02
HR = 0.65 (95% CI 0.52−0.81)
p < 0.001 (superiority)
0.01
0.00
0
6
12
18
Follow-up (months)
Connolly SJ, et al. N Engl J Med. 2009; 361:1139−1151.
Connolly SJ,
et al. N
J Med alliance
2010; 363(19):1875-1876.
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byEngl
Pfizer-BMS
in response to an unsolicited request – Not for further distribution
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30
New OACs Compared to Warfarin
Dabigatran 110 vs.
Warfarin
Dabigatran 150 vs.
Warfarin
RR
(95% CI)
p
RR
(95% CI)
Stroke/SE
0.91
(0.74−1.11)
0.34
0.66
(0.53−0.82)
Major
Bleed
0.80
(0.69−0.93)
0.003
0.93
(0.81−1.07)
0.31
IC
Bleed
0.31
(0.20−0.47)
< 0.001
0.40
(0.27−0.60)
< 0.001
Total
Death
0.91
(0.80−1.03)
0.13
0.88
(0.77−1.00)
0.051
p
Rivaroxaban vs.
Warfarin
RR
(95% CI)
p
Apixaban vs.
Warfarin
RR
(95% CI)
p
< 0.001
Blue: Statistically significant
Connolly SJ, et al. for the RE-LY Steering Committee and Investigators. N Engl J Med. 2009; 361:1139−51.
Patel MR, et al. and the ROCKET AF Steering Committee for the ROCKET AF Investigators. N Engl J Med. 2011; 365:883−91.
Granger CB, et al. for the ARISTOTLE Committees and Investigators. N Engl J Med. 2011; 365:981−92.
ROCKET AF
Rivaroxaban
Once-Daily
Oral Direct Factor
Xa Inhibition
Compared with
Vitamin K Antagonism
for Prevention of
of Stroke and
Embolism Trial in
Atrial Fibrillation
Rivaroxaban
• Selective, direct Factor Xa inhibitor1
• High oral bioavailability1
• Rapid onset of
action2
TF/VIIa
X
IX
• Half-life:1
VIIIa
§ 5–13 hours
• Dual mode of
elimination:1
IXa
Rivaroxaban
Va
§ 1/3 of active drug excreted unchanged by the
kidneys
§ Remainder of drug metabolized by the liver
to inactive metabolites: 1/3 of drug excreted
by kidneys, 1/3 of drug excreted by the fecal
route
Xa
II
IIa
Fibrinogen
1. Product Monograph Sep 14, 2011. 2. Kubitza et al, Clin Pharmacol Ther 2005.
Fibrin
Adapted from
Weitz et al, 2005; 2008
ROCKET AF
Stroke or Systemic Embolism (n=14 264)
0.06
ITT Analysis HR = 0.88
(95% CI 0.75−1.03)
p = 0.12 (superiority)
p < 0.001 (non-inferiority)
0.05
Cumulative incidence
(TTR = 58%)
Warfarin
0.04
Rivaroxaban
0.03
OT Analysis HR = 0.79
(95% CI 0.66−0.96)
p = 0.02 (superiority)
p < 0.001 (non-inferiority)
0.02
0.01
0.00
0
6
12
18
Follow-up (months)
Patel MR,Prepared
et al. N Engl
J Med. 2011;
365:883−91.
by Pfizer-BMS
alliance
in response to an unsolicited request – Not for further distribution
24
30
New OACs Compared to Warfarin
Dabigatran 110 vs.
Warfarin
Dabigatran 150 vs.
Warfarin
Rivaroxaban vs.
Warfarin
RR
(95% CI)
p
RR
(95% CI)
RR
(95% CI)
p
Stroke/SE
0.91
(0.74−1.11)
0.34
0.66
(0.53−0.82)
0.88
(0.74−1.03)
0.12
Major
Bleed
0.80
(0.69−0.93)
0.003
0.93
(0.81−1.07)
0.31
1.04
(0.90−1.20)
0.58
IC
Bleed
0.31
(0.20−0.47)
< 0.001
0.40
(0.27−0.60)
< 0.001
0.67
(0.47−0.93)
0.02
Total
Death
0.91
(0.80−1.03)
0.13
0.88
(0.77−1.00)
0.051
0.92
(0.82−1.03)
0.15
p
< 0.001
Apixaban vs. Warfarin
RR
(95% CI)
p
Blue: Statistically significant
Connolly SJ, et al. for the RE-LY Steering Committee and Investigators. N Engl J Med. 2009; 361:1139−51.
Patel MR, et al. and the ROCKET AF Steering Committee for the ROCKET AF Investigators. N Engl J Med. 2011; 365:883−91.
Granger CB, et al. for the ARISTOTLE Committees and Investigators. N Engl J Med. 2011; 365:981−92.
ARISTOTLE
Apixaban for
Reduction
in STroke
and Other
ThromboemboLic
Events in
Atrial Fibrillation
TF/VIIa
X
IX
VIIIa
IXa
Apixaban
Va
Apixaban
Xa
II
IIa
Fibrinogen
1. Product Monograph Sep 14, 2011. 2. Kubitza et al, Clin Pharmacol Ther 2005.
Fibrin
Adapted from
Weitz et al, 2005; 2008
ARISTOTLE
Stroke or Systemic Embolism (n=18 201)
0.06
ITT Analysis HR = 0.79
(95% CI 0.66−0.95)
p = 0.01 (superiority)
p < 0.001 (non-inferiority)
Cumulative incidence
0.05
0.04
(TTR = 62%)
Warfarin
Apixaban
0.03
0.02
0.01
0.00
0
6
12
18
Follow-up (months)
Granger CB
et al. NbyEngl
J Med. alliance
2011; 365:981−92.
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Pfizer-BMS
in response to an unsolicited request – Not for further distribution
24
30
New OACs Compared to Warfarin
Dabigatran 110 vs.
Warfarin
Dabigatran 150 vs.
Warfarin
RR
(95% CI)
p
RR
(95% CI)
Stroke/SE
0.91
(0.74−1.11)
0.34
0.66
(0.53−0.82)
Major
Bleed
0.80
(0.69−0.93)
0.003
0.93
(0.81−1.07)
IC
Bleed
0.31
(0.20−0.47)
< 0.001
Total
Death
0.91
(0.80−1.03)
0.13
Rivaroxaban vs.
Warfarin
Apixaban vs. Warfarin
RR
(95% CI)
p
RR
(95% CI)
p
0.88
(0.74−1.03)
0.12
0.79
(0.66−0.95)
< 0.01
0.31
1.04
(0.90−1.20)
0.58
0.69
(0.60−0.80)
< 0.001
0.40
(0.27−0.60)
< 0.001
0.67
(0.47−0.93)
0.02
0.42
(0.30−0.58)
< 0.001
0.88
(0.77−1.00)
0.051
0.92
(0.82−1.03)
0.15
0.89
(0.80−0.99)
0.048
p
< 0.001
Blue: statistically significant
Connolly SJ, et al. for the RE-LY Steering Committee and Investigators. N Engl J Med. 2009; 361:1139−51.
Patel MR, et al. and the ROCKET AF Steering Committee for the ROCKET AF Investigators. N Engl J Med. 2011; 365:883−91.
Granger CB,
et al. by
forPfizer-BMS
the ARISTOTLE
Committees
and
N Engl
J Med.
2011;
365:981−92.
Prepared
alliance
in response to
an Investigators.
unsolicited request
– Not
for further
distribution
New Oral Anticoagulants:
Pharmacology
Apixaban
Dabigatran
Rivaroxaban
Direct factor Xa
inhibitor
Direct thrombin
inhibitor
Direct factor Xa
inhibitor
Renal excretion
~ 27%
~ 85%
~ 33%
Half-life (hours)
~ 12 h
~ 12−14 h
~ 5−13 h
INR monitoring
Not required
Not required
Not required
Action
ELIQUISTM (apixaban). PM, 2012. Bristol-Myers Squibb/Pfizer Canada.
PRADAXTM (dabigatran). PM, 2012. Boehringer Ingelheim Canada Ltd.
XARELTO®Prepared
(rivaroxaban).
PM, 2012.
Bayer
Canada.to an unsolicited request – Not for further distribution
by Pfizer-BMS
alliance
in response
2012 Updated Canadian
Cardiovascular Society
Atrial Fibrillation guidelines:
Recommendations for stroke prevention
Predictive Index for Stroke – CHADS2 score
CHADS2
RISK FACTOR
Congestive Heart Failure
Hypertension*
SCORE
PATIENTS
ADJUSTED STROKE RATE
(n = 1733)
(%/yr) 95% CI
CHADS2
SCORE
120
1.9 (1.2 to 3.0)
0
463
2.8 (2.0 to 3.8)
1
523
4.0 (3.1 to 5.1)
2
337
5.9 (4.6 to 7.3)
3
220
8.5 (6.3 to 11.1)
4
65
12.5 (8.2 to 17.5)
5
5
18.2 (10.5 to 27.4)
6
1
1
Age ≥ 75
1
Diabetes Mellitus
1
Stroke/TIA
Thromboembolism
2
MAXIMUM SCORE
6
Cairns et al., 2011. Canadian Journal of Cardiology;27:74-90.
Skanes et al. Canadian Journal of Cardiology 2012;28:125–136
*One point is given for a history of hypertension, regardless of
whether it is controlled or not
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Predictive index for 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. 2010 Nov;138:1093-100
*One point is given for uncontrolled hypertension only
**antiplatelets, NSAIDS, anti-inflammatory drugs i.e. medications that increase the risk of bleeding
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CCS Recommendation
Assess Thromboembolic Risk (CHADS2)
CHADS2 = 0
CHADS2 = 1
CHADS2 ≥ 2
OAC
Increasing stroke risk
No antithrombotic
No additional
risk factors for
stroke
ASA
OAC*
OAC*
Either
female sex
or vascular
disease
Age ≥ 65 years
or combination
of female sex
and vascular
disease
*ASA is a
reasonable
alternative in some
as indicated by
risk/benefit
Skanes et al. Canadian Journal of Cardiology 2012;28:125–136
CHADS2: Congestive Heart Failure, Hypertension, Age 75, Diabetes Mellitus and Prior Stroke or Transient Ischemic Attack score
OAC: Oral anti-coagulant
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CCS Recommendation – Value and preferences
 “When OAC therapy is indicated, most patients should receive dabigatran,
rivaroxaban or apixaban in preference to warfarin”
 “This recommendation places a relatively high value on comparisons with warfarin showing
that dabigatran and apixaban have greater efficacy and rivaroxaban has similar efficacy for
stroke prevention; dabigatran and rivaroxaban have no more major bleeding and apixaban
has less; all 3 new OACs have less intracranial haemorrhage and are much simpler to use.”
 “The preference for 1 of the new OACs over warfarin is less marked among patients
already receiving warfarin with stable INRs and no bleeding complications.”
APIXABAN
DABIGATRAN
RIVAROXABAN
VS. WARFARIN
VS. WARFARIN
VS. WARFARIN
Stroke
Major
bleeding
Intracranial
hemorrhage
Adapted from Skanes et al. Canadian Journal of Cardiology 2012; 28:125–136
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2014 Canadian Guidelines
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Figure 1
Canadian Journal of Cardiology DOI: (10.1016/j.cjca.2014.08.001)
© alliance
2014 Canadian
Cardiovascular
Society
and
Conditions
Prepared byCopyright
Pfizer-BMS
in response
to an unsolicited
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– Not for
further
distribution
Under-Estimation of the Risk of Stroke and
Over-Estimation of the Risk of Bleeding
•
As physicians, we tend to
underestimate the risk of stroke and
overestimate the risk of bleeding:
– We will only see the bleeds we “cause”
and not the strokes we “prevented”
Copyright © Canadian Heart Research Centre 2013. This presentation may not be reproduced without written authorization from the Canadian Heart Research Centre
Over- and Under-Estimation of Risk
• Among 530 Ontario physicians who had a patient
with a bleeding event and who treated other patients
with atrial fibrillation during the 90 days before and
the 90 days after
– 21% lower odds of prescribing warfarin
• However, there were no significant changes in
warfarin prescribing after a physician had a patient
who had a stroke while not on warfarin
Choudry et al BMJ 2006;doi:10.1136/bmj.38698.709572.55 (10 January 2006)
Copyright © Canadian Heart Research Centre 2013. This presentation may not be reproduced without written authorization from the Canadian Heart Research Centre
Risk of Not Prescribing or Adequately
Monitoring Anticoagulation Therapy
• Of the 117 medico-legal cases closed between
2002-2007 that involved the use of anticoagulants,
antiplatelet agents and thrombolytics
–85 cases (71%) related to anticoagulants, 58 related to
the prescribing and management
45% represented a delay or failure to prescribe an
anticoagulant when indicated (e.g., in atrial fibrillation)
38% related to inadequate INR monitoring
–
–
Copyright © Canadian Heart Research Centre 2013. This presentation may not be reproduced without written authorization from the Canadian Heart Research Centre
CMPA Risk Identification paper June 2009
Balancing Stroke Prevention and
Bleeding Risk
Bleeding risk with
oral
anticoagulation
Stroke
prevention
with oral
anticoagulation
The benefits of oral anticoagulant therapy for stroke prevention in
most cases outweigh the risk of bleeding → elevated bleeding risk
(unless extreme) is not a reason to withhold anticoagulation
Copyright © Canadian Heart Research Centre 2013. This presentation may not be reproduced without written authorization from the Canadian Heart Research Centre
Bleeding Risk Reduction Strategies
• Address the potentially “reversible” components of the HASBLED score
–adequate hypertension control
–optimal INR control if on warfarin or use of a new oral anticoagulant
that doesn’t require INR monitoring and reduces the risk of intracranial
bleeding
avoidance of unnecessary ASA or NSAID; alcohol reduction
–
• Monitor renal function at least yearly
• Use of balance and mobility aids for those with a history of falls
• Consideration of PPI use in patients at risk of GI bleeding
Copyright © Canadian Heart Research Centre 2013. This presentation may not be reproduced without written authorization from the Canadian Heart Research Centre
Management of bleeding complications
Serious bleeding is generally less common with new OACs compared with Warfarin. Studies have
shown that significant blleds require more transfusions and longer stays in hospital with Warfarin
compared with new OACs.
FIRST MEASURES
IF BLEEDING CANNOT BE CONTROLLED
1. Discontinue OAC
2. Investigate source of bleeding
3. Initiate treatment
Consider administration of procoagulants:
• Activated prothrombin complex concentrate
• surgical haemostasis
• blood volume replacement
• fresh whole blood or the transfusion
of fresh frozen plasma should be
considered
4. Administration of activated charcoal
may be useful in the management of
new OAC overdose or accidental
ingestion.
(APCC), e.g., FEIBA
• Prothrombin complex concentrate (PCC)
• Recombinant Factor-VIIa (rFVIIa)
However, there is currently only very limited
experience with the use of new OACs.
Eliquis PM, 2012.
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55
My Guidelines for
OAC in AF
•
•
•
identify those at risk for stroke and anticoagulate them
NOACs are preferred agents over Coumadin,
but all are acceptable
no individual NOAC is favoured over any
other
Thanks for
listening!
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