orbit guidelines poster aha v2-emilyobrien-sunday - 9am

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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 Statistical Analysis Impact of the 2014 Atrial Fibrillation Guideline Revisions on the Proportion of Patients Recommended for Oral Anticoagulation Emily C. O’Brien 1 , Sunghee Kim 1 , Paul L. Hess 1 , James V. Freeman 2 , Laine E. Thomas 1 , Jack E. Ansell 3 , Peter R. Kowey 4 , Elaine M. Hylek 5 , Paul S. Chan 6 , Kenneth W. Mahaffey 7 , Paul Chang 8 , Alan S. Go 9 , Gregg C. Fonarow 10 , Jonathan P. Piccini 1 , Eric D. Peterson 1 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, Ortho- McNeil-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, Bristol- Myers-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. Table 2. Baseline characteristics of the ORBIT-AF study population by guideline recommendation. 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 CHA 2 DS 2 -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. 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 study is the nation’s 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 The percentage of patients in each possible cross- classification of CHADS 2 and CHA 2 DS 2 -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 (CHADS 2 =0 and CHA 2 DS 2 -VASc =0-3; CHADS 2 =1 and CHA 2 DS 2 -VASc=1-4) Changes in OAC recommendations and antithrombotic use were examined by age (<65 and >65) and sex Variable Neither Guideline Recommended/ Optional OAC (N=930) Both Guidelines Recommended (N=7275) OAC Recommended under 2014 but not 2011 Guideline (N=1926) P- Value* Demographics Age, median (IQR) 59.0 (52.0, 63.0) 78.0 (71.0, 83.0) 70.0 (66.0, 74.0) <.0001 White Race 87.9 89.2 90.1 0.0494 Female 10.8 45.2 46.8 <.0001 Medical History Current Smoker 10.1 5.0 6.9 <.0001 Hypertension 41.1 93.3 64.4 <.0001 Diabetes 2.4 40.0 2.5 <.0001 Renal Disease 7.5 40.5 23.1 <.0001 Anemia 4.4 21.8 11.7 <.0001 Stroke or TIA 0.0 21.0 0.0 <.0001 Prior MI 0.5 19.2 10.7 <.0001 ATRIA bleeding score, median (IQR) 1.0 (0.0, 1.0) 3.0 (2.0, 4.0) 1.0 (2.0, 3.0) <.0001 Currently taking antithrombotics 49.6 43.8 42.7 0.0014 OAC 56.6 80.1 70.7 <.0001 Dabigatran 7.1 4.4 6.3 <.0001 Warfarin 49.5 75.8 64.4 <.0001 OAC contraindication 8.5 13.7 11.4 <.0001 Table 1. Recommendations by 2011 & 2014 Guidelines. CHADS 2 2011 Guideline CHA 2 DS 2 - VASc 2014 Guideline 0 Aspirin 0 None 1 Aspirin or OAC 1 Consider OAC/APT > 2 OAC > 2 OAC # Recommended under 2011 Guideline # Recommended under 2014 Guideline Δ (Column B Column A) Overall 3734100 4722600 988500 Men 2046400 2572300 525900 Women 1687800 2150400 462600 <65 452700 636500 183800 > 65 3281300 4086300 805000 ̵ Proportion of patients who would be recommended for OAC based on the respective stroke risk scores under the 2011 and 2014 treatment guidelines Table 3. Estimated change in number of patients* recommended for OAC in the US population *Rounded to the nearest hundred Based on AF prevalence estimates of 5.2 million and similar age/sex distributions to ORBIT-AF population Figure 1. Antithrombotic treatment patterns* by stroke risk scores. Figure 2. Change in percent of (A) patients recommended for and (B) not treated with OAC therapy under new vs. old AF treatment guidelines 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. *Criteria data are percentages of the entire ORBIT-AF population. Treatment allocation data are percentages within each stroke risk category. 1 Duke Clinical Research Institute, Durham, NC; 2 Yale School of Medicine, New Haven, CT; 3 Hofstra North Shore/LIJ School of Medicine, Hempstead, NY; 4 Jefferson Medical College, Wynnewood, PA; 5 Boston University School of Medicine, Boston, MA; 6 University of Missouri, Kansas City, KS ; 7 Stanford University School of Medicine, Stanford, CA; 8 Janssen Scientific Affairs, Raritan, NJ; 9 Kaiser Permanente Division of Research, Oakland, CA; 10 UCLA Division of Cardiology, Los Angeles, CA BACKGROUND METHODS RESULTS CONCLUSIONS RESULTS OBJECTIVES The ORBIT-AF Registry Acknowledgments and Funding

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  • 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

    Statistical Analysis

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

    Recommended for Oral AnticoagulationEmily 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

    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, Ortho-

    McNeil-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, Bristol-

    Myers-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.

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

    recommendation. 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.

    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 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

    The percentage of patients in each possible cross-classification 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 sex

    Variable

    Neither

    Guideline

    Recommended/

    Optional OAC

    (N=930)

    Both

    Guidelines

    Recommended

    (N=7275)

    OAC

    Recommended

    under 2014 but

    not 2011

    Guideline

    (N=1926)

    P-

    Value*

    Demographics

    Age, median

    (IQR)

    59.0

    (52.0, 63.0)

    78.0

    (71.0, 83.0)

    70.0

    (66.0, 74.0)