Impact of the 2014 Atrial Fibrillation Guideline Revisions on the Proportion of Patients

Recommended for Oral Anticoagulation

Emily C. OBrien1, Sunghee Kim1, Paul L. Hess1, James V. Freeman2, Laine E. Thomas1, Jack E. Ansell3, Peter R. Kowey4, Elaine M. Hylek5, Paul S. Chan6, Kenneth W. Mahaffey7,
Paul Chang8, Alan S. Go9, Gregg C. Fonarow10, Jonathan P. Piccini1, Eric D. Peterson1
1Duke

Clinical Research Institute, Durham, NC; 2Yale School of Medicine, New Haven, CT; 3Hofstra North Shore/LIJ School of Medicine, Hempstead, NY; 4Jefferson Medical College, Wynnewood, PA; 5Boston University School of Medicine, Boston, MA;
6University of Missouri, Kansas City, KS ; 7Stanford University School of Medicine, Stanford, CA; 8Janssen Scientific Affairs, Raritan, NJ; 9Kaiser Permanente Division of Research, Oakland, CA; 10UCLA Division of Cardiology, Los Angeles, CA

BACKGROUND
Since the publication of the 2006
ACC/AHA/ESC atrial fibrillation (AF)
treatment guidelines, the face of AF
management has changed considerably
Minor risk factors for stroke in AF, including
coronary artery disease, age 65-74, and
female sex, have recently been validated in
independent AF cohorts
The 2014 AHA/ACC/HRS AF treatment
guidelines reflect this new emphasis,
supporting the use of CHA2DS2-VASc as
the basis for antithrombotic treatment
recommendations, as well as a revised risk
threshold for treatment
The potential impact of the new guideline
on the proportion of patients recommended
for OAC treatment is unknown.

OBJECTIVES
Assess the magnitude of the potential
impact of the new guideline on the
proportion of AF patients recommended for
OAC treatment
Estimate the potential increase in number
of AF patients treated with OAC expected
with adoption of the new guideline.

The ORBIT-AF Registry

The ORBIT-AF study is the nations largest
outpatient registry of patients with AF who
are managed by primary care providers,
cardiologists, and electrophysiologists
Data collection occurs at 6 month intervals
for a median of 2 years and includes
demographics, medical history,
cardiovascular risk factors, treatment
strategy, and provider information

METHODS

RESULTS

RESULTS

Starting Population: N=10,132 Patients with

baseline data enrolled at 176 sites
Exclusion Criteria:
- N=1 Patient missing information on antithrombotics
Final Population: N=10,131 enrolled at 176 sites
Primary Outcome

Proportion of patients who would be

recommended for OAC based on the
respective stroke risk scores under the 2011
and 2014 treatment guidelines
Statistical Analysis
The percentage of patients in each possible crossclassification of CHADS2 and CHA2DS2-VASc
score were calculated to create OAC
recommendation groups under each guideline
Baseline characteristics at study enrollment were
compared by recommendation group using the
Kruskal-Wallis test for continuous variables and
the Chi-square test for categorical variables
The percentages of patients in each antithrombotic
treatment group (None, OAC alone, aspirin alone,
OAC and aspirin) were calculated for each
combination of the two stroke risk scores (CHADS2
=0 and CHA2DS2-VASc =0-3; CHADS2 =1 and
CHA2DS2-VASc=1-4)
Changes in OAC recommendations and
antithrombotic use were examined by age (<65
and >65) and sex

Table 2. Baseline characteristics of the ORBIT-AF study population by guideline

recommendation.

CHADS2

2011
Guideline

CHA2DS2VASc

2014 Guideline

Aspirin

None

Aspirin or OAC

Consider OAC/APT

>2

OAC

>2

OAC

OAC
Neither
Both
Recommended
Guideline
Guidelines under 2014 but
PRecommended/
Recommended
not 2011
Value*
Optional OAC
(N=7275)
Guideline
(N=930)
(N=1926)

Variable

Demographics
Age, median
(IQR)
White Race
Female
Medical History
Current Smoker
Hypertension
Diabetes
Renal Disease
Anemia
Stroke or TIA
Prior MI
ATRIA bleeding
score, median (IQR)
Currently taking
antithrombotics
OAC
Dabigatran
Warfarin
OAC contraindication

59.0
(52.0, 63.0)
87.9
10.8

78.0
(71.0, 83.0)
89.2
45.2

70.0
(66.0, 74.0)
90.1
46.8

10.1
41.1
2.4
7.5
4.4
0.0
0.5

5.0
93.3
40.0
40.5
21.8
21.0
19.2

6.9
64.4
2.5
23.1
11.7
0.0
10.7

<.0001
<.0001
<.0001
<.0001
<.0001
<.0001
<.0001

1.0
(0.0, 1.0)

3.0
(2.0, 4.0)

1.0
(2.0, 3.0)

<.0001

49.6

43.8

42.7

0.0014

56.6
7.1
49.5

80.1
4.4
75.8

70.7
6.3
64.4

<.0001
<.0001
<.0001

8.5

13.7

11.4

<.0001

<.0001
0.0494
<.0001

Table 3. Estimated change in number of patients* recommended for OAC in the

US population
# Recommended
under 2011
Guideline

# Recommended
under 2014
Guideline

(Column B
Column A)

Overall

3734100

4722600

988500

Men

2046400

2572300

525900

Women

1687800

2150400

462600

<65

452700

636500

183800

>65

3281300

4086300

805000

Table 1. Recommendations by 2011 & 2014 Guidelines.

Figure 1. Antithrombotic treatment patterns* by stroke risk scores.

*Rounded to the nearest hundred

Based on AF prevalence estimates of 5.2 million and similar age/sex distributions to ORBIT-AF
population

*Criteria data are

percentages of the entire
ORBIT-AF population.
Treatment allocation
data are percentages
within each stroke risk
category.

Figure 2. Change in percent of (A) patients

recommended for and (B) not treated with OAC
therapy under new vs. old AF treatment guidelines

CONCLUSIONS
Under the 2014 guideline, 2 out of 3 AF patients who were
not previously recommended for OAC were reclassified as
OAC recommended
Nearly one-third of AF patients newly recommended under
the 2014 guideline were not receiving OAC at baseline
enrollment
Under the 2014 guideline, women and patients over the age
of 65 had near-universal OAC recommendations
Future studies evaluating longitudinal changes in
anticoagulation treatment patterns and barriers to initiation
and persistence among patients reclassified by the new
guideline are warranted.

Acknowledgments and Funding

The authors would like to thank the staff and participants of the ORBIT-AF registry for their important
contributions to this work. The ORBIT-AF Registry is funded by a research grant from Janssen Scientific
Affairs, LLC. Disclosures: ECO, SK, PLH, LET, PSC, ASG: None. DES: Research Grant; Significant;
Johnson and Johnson. Consultant/Advisory Board: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb,
Johnson and Johnson, Pfizer, Daiichi Sankyo. GCF: Consultant/Advisory Board; Ortho McNeil. PRK:
Consultant/Advisory Board; Modest; Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson,
Portola, Merck, Sanofi, Daiichi Sankyo. EMH: Consultant/ Advisory Board: Bayer, Boehringer Ingelheim,
BMS, Daiichi Sankyo, Johnson & Johnson, Pfizer. Research grants from: Bristol-Myers Squibb, OrthoMcNeil-Janssen. Speaker fees for: Boehringer Ingelheim; Bristol-Myers Squibb. JEA: consulting/ advisory
board for Bristol Myers Squibb, Pfizer, Janssen, Boehringer Ingelheim, and Daiichi Sankyo; equity interest
in Perospher. KWM: research support from AstraZeneca, Amgen, Bayer, Boehringer-Ingleheim, BristolMyers-Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Portola,
POZEN, Schering-Plough, and The Medicines Company, and consulting agreements with Amgen,
AstraZeneca, Glaxo SmithKline, Johnson & Johnson, and Merck; PC is an employee of Janssen; JPP:
research support from Boston Scientific and Janssen and consultancies to Forest Laboratories, Janssen,
and Medtronic, EDP: research support from Eli Lilly & Company and Janssen.