Quality of Care, Symptoms, and 1-Year Outcomes   for Women vs Men with Atrial Fibrillation:  Primary Results from the ORBI...
Background„  The prevalence of AF    is increasing in both    women and men„  Few data exist on    quality of life and  ...
Outcomes Registry for Better Informed Treatmentof Atrial Fibrillation„  Study Design     —  Prospective, multicenter, ou...
Baseline Characteristics                          Men         Women                         N=5842       N=4290      P-val...
Baseline Characteristics                           Men, %   Women, %                           N=5842    N=4290    P-value...
Type of AF          60                                      54                  Men        Women          50              ...
CHADS2 Distribution          40                                                  36                    Men          Women ...
Symptom Checklist    50         P<0.0001                                                     Men         Women            ...
1-Year Treatment andOutcomes
Rhythm Management                               Men, %   Women, %Enrollment                     N=5842    N=4290    P-valu...
ACC/AHA/Physician Consortium 2008AF Performance Measures at 1 Year                                                 Men    ...
Percent Time in Therapeutic INR Range (TTR)                       Men           Women                      N=3531         ...
Cumulative Incidence of TIA, Stroke,or Systemic Embolism                    Adjusted HR 1.24 (95% CI 0.89–1.71)           ...
Cumulative Incidence of New Onset HF                    Adjusted HR 0.86 (95% CI 0.58–1.27)                               ...
Cumulative Incidence of Cardiovascular Death                    Adjusted HR 0.46 (95% CI 0.32–0.67)                       ...
Cumulative Incidence of All-Cause Death                                                                4.88               ...
Major Outcomes at 1 Year                        Men          Women                       # events       # events      Adju...
Bleeding Outcomes at 1 Year                           Men         Women                           # events      # events  ...
Median AFEQT Scores at Baseline*                                                            Men      Women120             ...
Median AFEQT Scores at 1 Year*                                                            Men      Women120               ...
Limitations„  Voluntary site participation„  Potential for residual & unmeasured confounding„  Underpowered to detect a...
Conclusions„  Compared with men, women with AF have —     —  Higher stroke risk     —  Similar rates of oral anticoagul...
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ACC slides: ORBIT AF elucidates gender disparities for AF patients

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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.

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ACC slides: ORBIT AF elucidates gender disparities for AF patients

  1. 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. 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. 3. Outcomes Registry for Better Informed Treatmentof 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 modelingPiccini JP. Am Heart J. 2011;162:606-12.
  4. 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. 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. 6. Type of AF 60 54 Men Women 50 48 P<0.0001 40Percent 29 30 26 20 18 16 10 5 5 0 First-detected Paroxysmal Persistent Permanent
  7. 7. CHADS2 Distribution 40 36 Men Women 31 P<0.0001 30 25 22 22Percent 20 18 12 9 10 8 5 5 4 2 1 0 0 1 2 3 4 5 6 CHADS2 Risk Score
  8. 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. 9. 1-Year Treatment andOutcomes
  10. 10. Rhythm Management Men, % Women, %Enrollment N=5842 N=4290 P-value Rate control 68 68 0.98 Rhythm control 32 321-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. 11. ACC/AHA/Physician Consortium 2008AF 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 daysEstes M. J Am Coll Cardiol, 2008; 51:865-884.
  12. 12. Percent Time in Therapeutic INR Range (TTR) Men Women N=3531 N=2602 Median time in Median time in range rangeINR (25th, 75th) (25th, 75th) P-value<2.0 15 (3, 32) 17 (5,35) 0.00212.0 to 3.0 (TTR) 68 (49, 84) 65 (47, 81) <0.0001>3.0 7 (0, 19) 8 (0, 20) 0.0025
  13. 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 3415Men 5446 5425 5410 4606 4595
  14. 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 3407Men 5446 5420 5389 4584 4569
  15. 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 3876Men 5415 5365 5311 5253 5181
  16. 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 3879Men 5446 5390 5338 5271 5193
  17. 17. Major Outcomes at 1 Year Men Women # events # events Adjusted (# events/ (# events/ HROutcome 100 pt-yrs) 100 pt-yrs) (95% CI) P-valueAll-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. 18. Bleeding Outcomes at 1 Year Men Women # events # events Adjusted (#events/ (#events/ HROutcome 100 pt-yrs) 100 pt-yrs) (95% CI) P-valueISTH 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. 19. Median AFEQT Scores at Baseline* Men Women120 P<0.0001 P=0.001 P=0.0138 P<0.0001 96 P<0.0001100 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. 20. Median AFEQT Scores at 1 Year* Men Women120 P<0.0001 P=0.001 P=0.0127 P<0.0001 100 97 100100 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. 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. 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

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