1) Women with atrial fibrillation experience worse quality of life and more symptoms than men despite less advanced forms of the disease. 2) While women receive similar rates of oral anticoagulation as men, they spend less time within the therapeutic range. 3) Despite receiving less optimal anticoagulation treatment, women had lower rates of overall and cardiovascular mortality compared to men in the study.

1. Quality of Care, Symptoms, and 1-Year Outcomes
for Women vs Men with Atrial Fibrillation:
Primary Results from the ORBIT AF Registry
Jonathan P. Piccini, Sunghee Kim, Benjamin A. Steinberg, Rosalia Blanco,
Jack Ansell, Gregg C. Fonarow, Bernard J. Gersh, Alan S. Go, Elaine Hylek,
Peter R. Kowey, Kenneth W. Mahaffey, Laine Thomas, Paul Chang,
Eric D. Peterson on behalf of the ORBIT AF Investigators & Patients
ORBIT AF was funded by a research grant from Janssen.

2. Background
„ The prevalence of AF
is increasing in both
women and men
„ Few data exist on
quality of life and
subsequent outcomes
in women versus men
with AF
Our objective was to test whether women with AF receive
differential treatment and experience worse outcomes
relative to men.
PATH-AF Investigators. Circ Cardiovasc Qual Outcomes. 2012;5:85–93.

3. Outcomes Registry for Better Informed Treatment
of Atrial Fibrillation
„ Study Design
— Prospective, multicenter, outpatient AF registry
— Incident / Prevalent AF
„ Diverse practice settings (primary care, cardiology, EP)
— 184 sites
„ Enrollment period: June 29, 2010 to Aug 9, 2011
„ Follow-up every 6 months to 3 years
— Serial AF-related quality-of-life assessments (n=1339)
„ Adjusted relative rates for 1-year outcomes determined via
Cox proportional hazards modeling
Piccini JP. Am Heart J. 2011;162:606-12.

4. Baseline Characteristics
Men Women
N=5842 N=4290 P-value
Age, years 73 (65,80) 77 (69,83) <0.0001
Race 0.01
White 90 88
Black 5 6
Other 5 5
Private insurance 29 21 <0.0001
Prior/current smoker 58 36 <0.0001

5. Baseline Characteristics
Men, % Women, %
N=5842 N=4290 P-value
Hypertension 81 86 <0.0001
Diabetes mellitus 30 28 0.02
Heart failure 33 31 0.006
Prior stroke or TIA 14 17 <0.0001
Coronary disease 39 23 <0.0001
GI bleed 9 9 0.95
Obstructive sleep apnea 22 14 <0.0001
Family history of AF 14 16 <0.0001

6. Type of AF
60
54 Men Women
50 48
P<0.0001
40
Percent
29
30 26
20 18
16
10
5 5
0
First-detected Paroxysmal Persistent Permanent

7. CHADS2 Distribution
40
36 Men Women
31
P<0.0001
30
25
22 22
Percent
20 18
12
9
10 8
5 5
4
2
1
0
0 1 2 3 4 5 6
CHADS2 Risk Score

8. Symptom Checklist
50
P<0.0001 Men Women
40
40
P=0.02
P<0.0001
29
30 27 27 28
P<0.0001
25
%
23
19
20
P<0.0001
P=0.06 P=0.001
11 11 11
P=0.11 9 9
10 8
4 5
0
Palpi- Syncope Dyspnea- Exercise Light- Dyspnea- Fatigue Chest
tations exertion Intolerance headed rest Discomfort

9. 1-Year Treatment and
Outcomes

10. Rhythm Management
Men, % Women, %
Enrollment N=5842 N=4290 P-value
Rate control 68 68 0.98
Rhythm control 32 32
1-year follow-up
Cardioversion 7 5 0.0003
Antiarrhythmic Rx 20 21 0.30
Amiodarone 8 7 0.01
Catheter ablation 3 2 0.0084
Beta-blocker 50 49 0.002
Ca channel blocker* 11 14 <0.0001
*Nondihyrdopyridine CCB only

11. ACC/AHA/Physician Consortium 2008
AF Performance Measures at 1 Year
Men Women
N=5842 N=4290 P-value
Oral anticoagulation in
those with CHADS2 >1 65% 65% 0.34
& no contraindication
Proportion with mean time
23% 20% 0.002
between INRs >30 days
Estes M. J Am Coll Cardiol, 2008; 51:865-884.

12. Percent Time in Therapeutic INR Range (TTR)
Men Women
N=3531 N=2602
Median time in Median time in
range range
INR (25th, 75th) (25th, 75th) P-value
<2.0 15 (3, 32) 17 (5,35) 0.0021
2.0 to 3.0 (TTR) 68 (49, 84) 65 (47, 81) <0.0001
>3.0 7 (0, 19) 8 (0, 20) 0.0025

13. Cumulative Incidence of TIA, Stroke,
or Systemic Embolism
Adjusted HR 1.24 (95% CI 0.89–1.71)
P=0.2039 1.96
1.28
# at risk:
Women 4038 4022 4005 3439 3415
Men 5446 5425 5410 4606 4595

14. Cumulative Incidence of New Onset HF
Adjusted HR 0.86 (95% CI 0.58–1.27)
2.14
P=0.4434 1.90
# at risk:
Women 4038 4018 3991 3421 3407
Men 5446 5420 5389 4584 4569

15. Cumulative Incidence of Cardiovascular Death
Adjusted HR 0.46 (95% CI 0.32–0.67)
2.15
P<0.0001
1.49
# at risk:
Women 4038 3989 3947 3906 3876
Men 5415 5365 5311 5253 5181

16. Cumulative Incidence of All-Cause Death
4.88
Adjusted HR 0.59 (95% CI 0.48–0.73) 4.06
P<0.0001
# at risk:
Women 4038 4003 3961 3914 3879
Men 5446 5390 5338 5271 5193

17. Major Outcomes at 1 Year
Men Women
# events # events Adjusted
(# events/ (# events/ HR
Outcome 100 pt-yrs) 100 pt-yrs) (95% CI) P-value
All-cause 266 164 0.59
<0.0001
death
(4.99)
(4.14)
(0.48,0.73)
Cardiovascular 117 60 0.46
<0.0001
death
(2.20)
(1.52)
(0.32,0.67)
Non-cardiovascular 118 88
—
—
death
(2.22)
(2.23)
New-onset/ 97 81 0.86
0.4434
HF diagnosis
(1.94)
(2.18)
(0.58,1.27)
Stroke or non-CNS 65 73 1.24
0.2039
embolism or TIA
(1.30)
(1.96)
(0.89,1.71)
1st hospitalization 1657 1306 1.02
0.6535
(all-cause)
(37.26)
(40.06)
(0.95,1.09)
Favors Favors
Women Men

18. Bleeding Outcomes at 1 Year
Men Women
# events # events Adjusted
(#events/ (#events/ HR
Outcome 100 pt-yrs) 100 pt-yrs) (95% CI) P-value
ISTH major 196 161 0.97
0.7552
bleeding
(3.96)
(4.38)
(0.80,1.17)
Fall in 133 103
—
—
hemoglobin
(2.69)
(2.80)
Transfusion of ≥2 U 100 79
—
—
PRBC/whole blood
(2.02)
(2.15)
Bleeding in 46 33
—
—
a critical site
(0.93)
(0.90)
Fatal 12 8
—
—
bleeding
(0.24)
(0.22)
Favors Favors
Women Men

19. Median AFEQT Scores at Baseline*
Men Women
120
P<0.0001
P=0.001 P=0.0138
P<0.0001 96 P<0.0001
100 92 94 92
86 89
81 81 83
80 73
60
40
20
0
Overall Symptoms Daily Tx Concern Tx
Activities Satisfaction
*P-values are unadjusted

20. Median AFEQT Scores at 1 Year*
Men Women
120
P<0.0001 P=0.001 P=0.0127
P<0.0001 100 97 100
100 P=0.0006
92 92 92
88
81 81
80 71
60
40
20
0
Overall Symptoms Daily Tx Concern Tx
Activities Satisfaction
*P-values are unadjusted

21. Limitations
„ Voluntary site participation
„ Potential for residual & unmeasured confounding
„ Underpowered to detect a difference in relatively
uncommon clinical events like stroke
— Prospectively powered for 2 years

22. Conclusions
„ Compared with men, women with AF have —
— Higher stroke risk
— Similar rates of oral anticoagulation
— Less time in therapeutic range
— More symptoms (despite less advanced AF)
— More functional limitation
— Worse quality of life
„ Women experienced lower adjusted overall and CV-related
death rates than men