acc slides: orbit af elucidates gender disparities for af patients
DESCRIPTION
SAN FRANCISCO—The ORBIT AF registry, presented last week at the American College of Cardiology (ACC) annual scientific session, examined the quality of care, symptoms and one-year clinical outcomes for women vs. men with atrial fibrillation.TRANSCRIPT
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