efficacy and safety of the noac’s - swedish medical center/media/images/swedish/cme1... ·...
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Efficacy and Safety of the NOAC’s
R. Jeffrey Westcott, MD FACC FSCAI
Medical Director
Cardiac Catheterization Laboratory
Swedish Heart and Vascular Institute
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Disclosures
• Medical Advisory Board
– Boston Scientific
– The Medicines Company
• Speakers Bureau
– Bristol-Myers Squibb
– Pfizer
– Daiichi Sankyo
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The risk of stroke is increased ~5-fold in NVAF patients vs those without NVAF1,2
NVAF Is Associated With Significant Morbidity and Mortality
* P<0.001. AF=atrial fibrillation.
1. Wolf PA et al. Stroke. 1991;22:983-988. 2. Go AS et al. Circulation. 2014;129:e28-e292. 3. Marini C et al. Stroke. 2005;36:1115-1119.
Morbidity Mortality Stroke patients with NVAF are at increased
risk of death vs those without AF3
1-year
~52%
Rate of Death
Rate
, %
Incidence of Stroke According to Presence of NVAF (Framingham Heart Study)
Patients Without NVAF
2-Y
ea
r A
ge
-Ad
jus
ted
Inc
ide
nce
of
Str
oke
/10
00
Patients With NVAF
Risk Ratio: 4.8*
3
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The CHADS2 and CHA2DS2-VASc Scoring Systems Assess Stroke Risk in Patients With NVAF
4
CHA2DS2-VASc* Stroke Risk Index2,3
Risk Factor Points
Congestive heart failure/LVD 1
Hypertension 1
Age ≥75 years 2
Diabetes mellitus 1
Stroke, TIA, or thromboembolism (prior) 2
Vascular disease† 1
Age 65 to 74 years 1
Sex category (ie, female gender) 1
Maximum score: 9
CHADS2 Stroke Risk Index1,2
Risk Factor Points
Congestive heart failure 1
Hypertension 1
Age ≥75 years 1
Diabetes mellitus 1
Stroke or TIA (prior) 2
Maximum score: 6
* A patient’s CHA2DS2-VASc score can either be the same as or higher than the CHADS2 score; it cannot be lower. † Prior myocardial infarction, peripheral artery disease, or aortic plaque LVD=left ventricular dysfunction; TIA=transient ischemic attack.
1. Gage BF et al. JAMA. 2001;285:2864-2870. 2. January CT et al. J Am Coll Cardiol. 2014. doi:10.1016/j.jacc.2014.03.022. 3. Lip GYH et al. Chest. 2010;137:263-272.
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Stroke Risk Increases With Higher CHADS2 and CHA2DS2-VASc Scores in Patients With NVAF
5
As CHADS2 score increases, so does the risk of stroke1,2
Stroke Risk in National Registry of NVAF Patients by CHADS2 Score (N=1733)1,2
CHADS2 Score
Adjusted Stroke Rate*
%/year (95% CI)
0 1.9 (1.2–3.0)
1 2.8 (2.0–3.8)
2 4.0 (3.1–5.1)
3 5.9 (4.6–7.3)
4 8.5 (6.3–11.1)
5 12.5 (8.2–17.5)
6 18.2 (10.5–27.4)
CI=confidence interval.
1. Gage BF et al. JAMA. 2001;285:2864-2870. 2. January CT et al. J Am Coll Cardiol. 2014. doi:10.1016/j.jacc.2014.03.022. 3. Lip GY et al. Stroke. 2010;41:2731-2738.
* The adjusted stroke rate is the expected stroke rate per 100 patient-years from the exponential survival model, assuming that aspirin was not taken.
Risk of Stroke in NVAF Patients by CHA2DS2-VASc Score (N=7329)2,3
Better identifies low-risk patients with AF2
CHA2DS2-VASc Score
Adjusted Stroke Event Rate, %/year†
0 0
1 1.3
2 2.2
3 3.2
4 4.0
5 6.7
6 9.8
7 9.6
8 6.7
9 15.2 † Theoretical event rates without therapy; assuming that
oral anticoagulation provides a 64% reduction in risk.
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What Does CHADS2 Really Tell Us?
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CHADS2 Risk Calculator in Clinical Practice
CHADS2 Score Taking Warfarin Not Taking Warfarin
0 (2557) 0.25 (0.11-0.55) 0.49 (0.30-0.78)
1 (3662) 0.72 (0.50-1.03) 1.52 (1.19-1.94)
2 (2955) 1.27 (0.94-1.72) 2.50 (1.98-3.15)
3 (1555) 2.20 (1.61-3.01) 5.27 (4.15-6.70)
4 (556) 2.35 (1.44-3.83) 6.02 (3.90-9.29)
5 or 6 (241) 4.60 (2.72-7.76) 6.88 (3.42-13.84)
64% reduction on warfarin vs no antithrombotic therapy
2/3 of strokes on warfarin were at an INR <2
Event Rate (per 100 person-years) – 95% Confidence Interval
Go AS, Hylek EM, Chang Y, et al. Anticoagulation therapy for stroke pevntion in atrial fibrillation: how
well do randomized trials translate into clinical practice? JAMA. 2003;290:2685.
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Aristotle – Efficacy of Apixaban vs Warfarin
0.00%
0.20%
0.40%
0.60%
0.80%
1.00%
1.20%
1.40%
1.60%
1.80%
Warfarin,n=9081
Apixaban,n=9120
265 1.27%
Stroke / Systemic Embolism Rates E
ve
nt
Rate
(%
/ye
ar)
Apixaban superior, p=0.01
HR (95% CI)
0.79 (0.66-0.95)
21% RRR
1.6%
212
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ARISTOTLE – Major Bleeding Episodes
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Intracranial0.41 (0.30-0.57)
GI0.89 (0.70-1.14)
Fatal0.27 (0.13-0.53)
Intraocular1.42 (0.83-2.45)
Warfarin, n=9052
Apixaban, n=9088
0.93%
0.83%
0.24%
37 0.06%
10 22
0.21%
Event R
ate
s (
%/y
ear)
0.82%
125
Major Bleeding Episodes
0.33%
52
141
128
0.14%
32
HR (95% CI)
Major bleeding: fatal bleeding, critical site bleeding, Hb decrease >=2 g/dl,
transfusion >=2 units packed red cells.
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Clinically Relevant Non-major Bleeding
0
0.5
1
1.5
2
2.5
3
3.5
CRNM
Warfarin
Apixaban
444
HR (95% CI): 0.70 (0.60-0.80)
p<0.0001
Event R
ate
s (
%/y
ear)
3.00 %/year
2.08 %/year
318
CRNM: Does not meet criteria for major bleeding and leads to hospital admission or
physician guided medical or surgical treatment for bleeding or results in a change in
antithrombotic therapy.
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RE-LY Trial – Reduction in Stroke with Dabigatran
0
20
40
60
80
100
120
140
160
180
200
Stroke Ischemic Stroke HemorrhagicStroke
SystemicEmbolism
Warfarin (n=6022)
Dabigatran (n=6076)
Number of Events
186
122
134
103
45
12 21
13
HR: 0.64
95% CI (0.51-0.81)
HR: 0.75
95% CI (0.58-0.97)
HR: 0.26
95% CI (0.14-0.49)
HR: 0.64
95% CI (0.51-0.81)
Connolly SJ, et al. N Engl J Med. 2009;361:1139-1151.
Connolly SJ, et al. N Engl J Med. 2010;363(19):1875-1876.
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RE-LY Trial – Bleeding Rates
0
500
1000
1500
2000
2500
Total Bleeds Major Bleeds Life ThreateningBleeds
Major GI Bleeds
Warfarin (n=6022)
Dabigatran (n=6076)
HR: 0.91
95% CI (0.85-0.96)
HR: 0.93
95% CI (0.81-1.07)
HR: 0.80
95% CI (0.66-0.98)
HR: 1.50
95% CI (1.17-1.85)
2166
1993
421 399
218 179 125 186
Connolly SJ, et al. N Engl J Med. 2009;361:1139-1151.
Connolly SJ, et al. N Engl J Med. 2010;363(19):1875-1876.
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RE-LY – Intracranial Hemorrhages
0
10
20
30
40
50
60
70
80
90
100
Intracranial Hemorrhages
Warfarin (n=6022)
Dabigatran (n=6076)
90 (0.8%)
38 (0.3%)
HR 0.41 (95% CI: 0.28-0.60)
Event Rates Per 100 Patient Years
Connolly SJ, et al. N Engl J Med. 2009;361:1139-1151.
Connolly SJ, et al. N Engl J Med. 2010;363(19):1875-1876.
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ROCKET AF Trial - Outcomes
0
50
100
150
200
250
300
Stroke HemorrhagicStroke
IschemicStroke
UnknownStroke Type
OtherSystemicEmbolism
Warfarin (n=7081)
Rivaroxaban (n=7090)
Primary composite endpoint vs warfarin: HR (95% CI): 0.88 (0.74, 1.03)
281
19 18
253
33 57
206 208
20 27
Patel MR, et al N Engl J Med. 2011;365(10):883-891.
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ROCKET AF – Bleeding Rates
0
200
400
600
800
1000
1200
1400
1600
Major and NonmajorClinically Relevant
Major Nonmajor ClinicallyRelevant
Warfarin (n=7125)
Rivaroxaban 9n=7111)
HR 95% CI
1.03 (0.96, 1.11)
HR 95% CI
1.04 (0.90, 1.20)
HR 95% CI
1.04 (0.96, 1.13)
Patel MR, et al N Engl J Med. 2011;365(10):883-891.
1449 1475
386 395
1151 1185
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TIMI 48 Study – Event Rates with Edoxaban
0
50
100
150
200
250
First stroke orSEE
Ischemic Stroke HemorrhagicStroke
SystemicEmbolism
Warfarin (n=7012)
Edoxaban 60 mg (n=7012)
232
135 144
182
75
13
39
8
97.5% CI
0.79 (0.63,0.99)
P=0.017
95% CI
0.62 (0.26,1.50)
95% CI
0.52 (0.36,0.77)
95% CI
0.94 (0.75,1.19)
Patel MR, et al N Engl J Med. 2011;365(10):883-891.
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ROCKET AF – Major Bleeding
0
50
100
150
200
250
Bleeding Into aCritical Organ
Fatal Bleeding Transfusion GI Bleeding
Warfarin (n=7125)
Rivaroxaban (n=7111)
91
Patel MR, et al N Engl J Med. 2011;365(10):883-891.
133
55
27
221
140
183
149
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Meta Analysis
0
500
1000
1500
2000
2500
3000
Stroke or SystemicEmbolism
Major Bleeding IntracerebralHemorrhage
Warfarin (n=29,285)
NOAC's (n=29,310)
982
2815
2587
419 199
778
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Meta Analysis
982
778
0
200
400
600
800
1000
1200
Stroke or Systemic Embolism
Stroke or Systemic Embolism
Warfarin (n=29,285) NOAC's (n=29,310)
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Meta Analysis
2815
2587
2450
2500
2550
2600
2650
2700
2750
2800
2850
Major Bleeding
Major Bleeding Episodes
Warfarin (n=29,285) NOAC's (n=29,310)
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Meta Analysis
419
199
0
50
100
150
200
250
300
350
400
450
Intracerebral Hemorrhage
Intracerebral Hemorrhage
Warfarin (n=29,285) NOAC's (n=29,310)
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Reversal Agents
• Indications
– Life threatening bleeding
– Uncontrolled bleeding
– Emergency surgery
– Urgent procedures
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Reversal Agents
Coumadin prescribing information
Prothrombin complex concentrate (PCC), fresh frozen plasma, or
activated Factor VII treatment may be considered if the
requirement to reverse the effects of COUMADIN is urgent. A risk
of hepatitis and other viral diseases is associated with the use of
blood products; PCC and activated Factor VII are also associated
with an increased risk of thrombosis. Therefore, these
preparations should be used only in exceptional or life- threatening
bleeding episodes secondary to COUMADIN overdosage.
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Reversal Agents
Swedish Epic order set
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Reversal Agents
Swedish Epic order set
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Reversal Agents
Swedish Epic order set
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Reversal Agents
Swedish Epic order set
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Dabigatran Reversal with Idarucizumab
Idarucizumab (Praxbind)
• Humanized monoclonal antibody fragment (Fab)
• Binds to dabigatran and its acylglucuronide metabolites
• Binding affinity higher to idarucizumab than to thrombin
• 5 gm dose
• Immediate reversal of anticoagulation due to dabigatran
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Dabigatran Reversal with Idarucizumab
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Factor Xa Inhibition Reversal
• Andexanet alpha
• Portola Pharmaceuticals
• Recombinant modified human factor Xa decoy protein.
• Catalytically inactive
• Binds factor Xa inhibitors at their active site with high
affinity
• Restores the activity of endogenous factor Xa
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Anti Xa Agents Currently in Use
• Apixaban (eliquis)
• Rivaroxaban (xarelto)
• Edoxaban (savaysa)
• Low molecular weight heparin (lovenox)
• Fondaparinux (arixtra)
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Factor Xa Inhibition Reversal
N Engl J Med 2015;373:2413-24
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Factor Xa Inhibition Reversal
N Engl J Med 2015;373:2413-24
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Factor Xa Inhibition Reversal
N Engl J Med 2015;373:2413-24
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Factor Xa Inhibition Reversal
N Engl J Med 2015;373:2413-24