1. Update in ESC: Dabigatran among OAC
Department of Cardiology,
Hirosaki University Graduate School of Medicine, Japan
Professor, Ken Okumura 1

2. Age 81 Female (Living alone, ADL: independent )
Chronic AF　HT(-), No heart disease, DM(-), LAD 43mm
dementia
nose bleed
dementia
dementia
Stroke
Warfarin (2002~)
2.5mg
2.5mg
aspirin
2.5mg
1.5mg 4
3.53 3
2.16
2.1
2.15
2.13
PT-INR 2
1.35
1.54
1.16
1.36 1
0.91
0.78
0.81
0.87
0.81
2004
Jan
2005
Jan
Feb
Mar
Apr
May
Oct
Nov
Dec
Feb
Mar
Apr

3. Age 81 Female (Living alone, ADL: independent )
Chronic AF　HT(-), No heart disease, DM(-), LAD 43mm
29th 4,2005
14th 5,2005

4. mRS by subtype of brain infaction (HIROSAKI Stroke and Rehabilitation Center)
n=768 (Oct, 2005~Jan, 2008)
m-Rankin scale
No symptoms
Lacunar
(n=215)
Able to carry out all usual activities 1
Able to look after own affairs without assistance 2
Atherothrombotic
infarction
(n=308)
Requires some help, but able to walk unassisted 3
Unable to walk unassisted
31%
54% 4
Cerebral
embolism
(n=245) 5
Bedridden 6
Dead 20 40 60 80
100
(%)
Ken Okumura, Norihumi Metoki, Jyoji Hagii　Japanese Journal of Electrocardiology 2011;31: 4

5. Prevalence of AF among Cerebral embolism patients:
267 consecutive patients during
(HIROSAKI Stroke and Rehabilitation Center)
Data from previous Dr &
ECG during hospitalization
ECG on admission
AF(-)
n=67
(25%)
AF(-)
n=128
(48%)
AF(+)
n=139
(52%)
Sustained AF
n=120
(45%)
paroxysmal AF
n=80
(30%)
Ken Okumura, Norihumi Metoki, Jyoji Hagii　Japanese Journal of Electrocardiology 2011;31: 5

6. Severity of stroke by AF type
Sustained AF vs Paroxysmal AF vs Not defined AF
(HIROSAKI Stroke and Rehabilitation Center)
Percentage of patients with internal
carotid artery stenosis
(P＝NS)
Percentage of patients with
mRS = 4,5,6
(P＝NS)
Sustained
(n=120) 23 97 57 63
Paroxysmal
(n=80) 12 68 33 47
Not defined AF
(n=67) 9 58 25 42 20 40 60 80
100
(%) 20 40 60 80
100
(%)
*Patients with acute stroke within 3 hours of onset were treated with tPA 6

7. CHADS2 Score and Severity of stroke
CHADS2=0,1 Score (n=41) vs CHADS2=2-6 Score (n=159)
(HIROSAKI Stroke and Rehabilitation Center)
Percentage of patients with internal
carotid artery stenosis
(P＝NS)
Percentage of patients with
mRS = 4,5,6
(P＝NS)
CHADS2=0,1
(n=41) 9 32 17 24
CHADS2=2-6
(n=159) 34
125 73 86 20 40 60 80
100
(%) 20 40 60 80
100
(%) 7

8. J-RHYTHM Registry J-RHYTHM Registry
The Japanese Society of Electrocardiology
J-RHYTHM Registry
CHADS2 Score of registered AF patients (n=7,937)
J-RHYTHM Registry
J-RHYTHM Registry
(%) 35 30 20 40 60 80
100
(cases) 25 20
1.9%
2.8%
4.0%
5.9%
8.5%
12.5%
18.2%
Incidence for stroke
National Registry of AF 15 10 5 1 2 3 4 5 6
CHADS2 Score

9. Net Clinical Benefit in ATRIA Study
(Singer DE, et al. Ann Intern Med 2009;151: )
13,559 adults with non-valvular atrial fibrillation at Kaiser Permanente Northern California
(73 years median age; Male 57%; more than 66,000 person-years
of observation; 53% of patients were receiving warfarin treatment.)
→ 1,092 thromboembolic events, 299 intracranial hemorrhagic events
2.22
4-6
0.58
3.75
2.07 3
1.21
2.79
0.97
CHADS2 score 2
0.43
1.41
0.19
Net clinical benefit of warfarin = 0.68%/yr
Net clinical benefit of patients with Prior Stroke = 2.48%/yr 1
-0.27
0.45
-0.11
-0.44
0.20 -1
-0.5
0.5 1
1.5 2
2.5 3
3.5
Worse with Warfarin
Better with Warfarin
Net Clinical Benefit ＝(TE rate off warfarin −TE rate on warfarin) − 1.5 x (ICH rate on warfarin −ICH rateoff warfarin)

10. Intracranial hemorrhage rate
Intracranial hemorrhage: Hemorrhagic Stroke (Intracerebral hemorrhage), Subdural hematoma and Subarachnoid hemorrhage
RR 0.41 (95% CI: 0.28–0.60)
P<0.001
RR 0.30 (95% CI: 0.19–0.45)
P<0.001
1.0
Event rate (% per year)
0.8
0.76
0.6
RRR
59%
0.4
RRR
70%
0.32
0.2
0.23
Dabigatran
150mg bid
(n=38/6,076)
Dabigatran
110mg bid
(n=27/6,015)
Warfarin
(n=90/6,022)
Connolly SJ, et al: N Engl J Med 361, , 2009
Connolly SJ, et al: N Engl J Med 363, , 2010

11. INR2.0 to 3.0 for < 70 years old
Urgent Statement on Antithrombotic Therapy of
Atrial Fibrillation : JCS Guideline Statement (Aug.2011)
CHADS2 Score
Heart failure 1point
Hypertension 1point
≥75 years old 1point
Diabetes 1point
History of cerebral infarction or TIA 2points
Mitral stenosis or
mechanical valve
1point
≥2points
Other risk factors
　Cardiomyopathy
　65 to 74 years old
　Female patients
　Coronary heart disease
　Thyrotoxicosis
Non-valvular AF
Warfarin
INR2.0~3.0
Recommended
INR2.0 to 3.0 for < 70 years old
INR1.6 to 2.6 for ≥ 70 years old
Dabigatran
Considered
JCS: Urgent Statement 2011