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.

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

PATH-AF Investigators. Circ Cardiovasc Qual Outcomes. 2012;5:85–93.

Our objective was to test whether women with AF receive differential treatment and experience worse outcomes

relative to men.

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.

Baseline Characteristics

Men N=5842

Women 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

Baseline Characteristics Men, % N=5842

Women, % 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

5

48

18

29

5

54

16

26

0

10

20

30

40

50

60

First-detected Paroxysmal Persistent Permanent

Perc

ent

Men Women

P<0.0001

Type of AF

8

25

31

22

9

4 1

5

18

36

22

12

5 2

0

10

20

30

40

0 1 2 3 4 5 6

Perc

ent

CHADS2 Risk Score

Men Women

CHADS2 Distribution

P<0.0001

27

4

27

9

19

9

25

8

40

5

29

11

23

11

28

11

0

10

20

30

40

50

Palpi- tations

Syncope Dyspnea- exertion

Exercise Intolerance

Light- headed

Dyspnea- rest

Fatigue Chest Discomfort

%

Men Women

P=0.11

P=0.02

P=0.06

P<0.0001

P=0.001

P<0.0001

P<0.0001

Symptom Checklist

P<0.0001

1-Year Treatment and Outcomes

Rhythm Management

Enrollment Men, % N=5842

Women, % 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

Men N=5842

Women N=4290 P-value

Oral anticoagulation in those with CHADS2 >1 & no contraindication

65% 65% 0.34

Proportion with mean time between INRs >30 days 23% 20% 0.002

Estes M. J Am Coll Cardiol, 2008; 51:865-884.

ACC/AHA/Physician Consortium 2008 AF Performance Measures at 1 Year

Percent Time in Therapeutic INR Range (TTR)

INR

Men N=3531

Median time in range

(25th, 75th)

Women N=2602

Median time in range

(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

# at risk: Women 4038 4022 4005 3439 3415 Men 5446 5425 5410 4606 4595

Cumulative Incidence of TIA, Stroke, or Systemic Embolism

Adjusted HR 1.24 (95% CI 0.89–1.71)

P=0.2039

1.28

1.96

# at risk: Women 4038 4018 3991 3421 3407 Men 5446 5420 5389 4584 4569

Cumulative Incidence of New Onset HF

Adjusted HR 0.86 (95% CI 0.58–1.27)

P=0.4434 1.90 2.14

# at risk: Women 4038 3989 3947 3906 3876 Men 5415 5365 5311 5253 5181

Cumulative Incidence of Cardiovascular Death

Adjusted HR 0.46 (95% CI 0.32–0.67)

P<0.0001 2.15

1.49

# at risk: Women 4038 4003 3961 3914 3879 Men 5446 5390 5338 5271 5193

Cumulative Incidence of All-Cause Death

Adjusted HR 0.59 (95% CI 0.48–0.73)

P<0.0001

4.88

4.06

Outcome

Men # events

(# events/ 100 pt-yrs)

Women # events

(# events/ 100 pt-yrs)

Adjusted HR

(95% CI) P-value

All-cause death  

266 (4.99)  

164 (4.14)  

0.59 (0.48,0.73)   <0.0001  

Cardiovascular death  

117 (2.20)  

60 (1.52)  

0.46 (0.32,0.67)   <0.0001  

Non-cardiovascular death  

118 (2.22)  

88 (2.23)   —   —  

New-onset/ HF diagnosis  

97 (1.94)  

81 (2.18)  

0.86 (0.58,1.27)   0.4434  

Stroke or non-CNS embolism or TIA  

65 (1.30)  

73 (1.96)  

1.24 (0.89,1.71)   0.2039  

1st hospitalization (all-cause)  

1657 (37.26)  

1306 (40.06)  

1.02 (0.95,1.09)   0.6535  

Major Outcomes at 1 Year

Favors Women

Favors Men

Outcome

Men # events (#events/

100 pt-yrs)

Women # events (#events/

100 pt-yrs)

Adjusted HR

(95% CI) P-value

ISTH major bleeding  

196 (3.96)  

161 (4.38)  

0.97 (0.80,1.17) 0.7552  

Fall in hemoglobin  

133 (2.69)  

103 (2.80)   —   —  

Transfusion of ≥2 U PRBC/whole blood  

100 (2.02)  

79 (2.15)   —   —  

Bleeding in a critical site  

46 (0.93)  

33 (0.90)   —   —  

Fatal bleeding  

12 (0.24)  

8 (0.22)   —   —  

Bleeding Outcomes at 1 Year

Favors Women

Favors Men

86 96

81

94 92 81

92

73

89 83

0

20

40

60

80

100

120

Overall Symptoms Daily Activities

Tx Concern Tx Satisfaction

Men Women

P<0.0001

P<0.0001

P<0.0001 P=0.001 P=0.0138

Median AFEQT Scores at Baseline*

*P-values are unadjusted

88

100

81

97 100

81 92

71

92 92

0

20

40

60

80

100

120

Overall Symptoms Daily Activities

Tx Concern Tx Satisfaction

Men Women

P<0.0001

P<0.0001

P=0.0006

P=0.001 P=0.0127

Median AFEQT Scores at 1 Year*

*P-values are unadjusted

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

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