Case 1: 75-Year-Old African-American Man With AF

Hypertensive and overweight

Lives alone; family members live several miles away

Long history of hypertension (currently 145/85 mm Hg) and elevated LDL-C (most recently measured at 125 mg/dL)

AF = atrial fibrillation; LDL-C = low-density lipoprotein cholesterol.

Case 1: 75-Year-Old African-American Man With AF (cont’d)

BMI: 26 kg/m2

Smoker, with shortness of breath

History of GI bleeding

Neuropathy as a consequence of successful radiation treatment for male breast cancer

BMI = body mass index; GI = gastrointestinal.

Risk Factor Points Congestive heart failure 1

Hypertension 1 Age ≥75 years 1 Diabetes mellitus 1 Stroke or TIA 2 Maximum Score 6

CHADS2 = Congestive heart failure, Hypertension, Age ≥75 years, Diabetes, and prior Stroke/TIA; TIA = transient ischemic attack. Gage BF, et al. JAMA. 2001;285:2864-2870. van Walraven C, et al. Arch Intern Med. 2003;163:936-943. Nieuwlaat R, et al. Eur Heart J. 2006;27:3018-3026. Go AS, et al. JAMA. 2003;290:2685-2692. Gage BF, et al. Circulation. 2004;110:2287-2292.

CHADS2 Stroke (%/y) 0 1.9

1 2.8

2 4.0

3 5.9

4 8.5

5 12.5

6 18.2

3%/y

CHADS2 Risk Score

Risk Factor Points CHF/LV dysfunction 1 Hypertension 1

Age ≥75 years 2

Diabetes mellitus 1

Stroke/TIA/embolism 2

Vascular disease 1 Age 64-74 years 1 Sex category (female) 1

Maximum Score 9

CHA2DS2-VASc = Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex category (female); CHF = congestive heart failure; LV = left ventricular. ESC Guidelines. Eur Heart J. 2010;31:2369-2429.

CHA2DS2-VASc Score Stroke (%/y)

1 0% 2 1.3%

3 2.2%

4 4.0%

5 6.7%

6 9.8% 7 9.6% 8 6.7%

9 15.2%

Redefining Risk: CHA2DS2-VASc

ESC Guidelines. Eur Heart J. 2010;31:2369-2429.

Letter Clinical Characteristic Points

H Hypertension 1

A Abnormal liver or renal function 1 or 2

S Stroke 1

B Bleeding 1

L Labile INR 1

E Elderly (age >65 years) 1

D Drugs or alcohol 1 or 2

Maximum Score 9

Pisters R, et al. Chest. 2010;138:1093-1100.

HAS-BLED = Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), and Drugs/alcohol concomitantly; INR = international normalized ratio.

0 2 4 6 8

10 12 14 16

0 1 2 3 4 5

Redefining Risk: HAS-BLED

HAS-BLED Score Bl

eeds

per

100

Pat

ient

Ye

ars

Case 2: 80-Year-Old Caucasian Man With AF and Cataracts

Accompanied by his caregiver wife Receiving warfarin as stroke prophylaxis due to AF following

mild stroke the previous year Type 2 diabetes

– A1C >8% for past 6 months; BMI: 28 kg/m2

Blood pressure: 155/100 mm Hg Recently underwent total hip replacement surgery Now needs outpatient cataract surgery requiring frequent

clinician visits to adjust INR

Dabigatran

Xa

X IX

IXa VIIIa Va

II

Fibrin Fibrinogen

Adapted from: Weitz JI, Bates SM. J Thromb Haemost. 2005;3:1843-1853.

Rivaroxaban Apixaban Edoxaban*

Novel Oral Anticoagulants (NOACs)

TF/VIIa

IIa

*Approved January 2015.

Case 3: 84-Year-Old Hispanic Woman With AF and Moderate Dementia

Accompanied by her caregiver daughter Receiving warfarin for stroke prophylaxis for

5 years; TIA 2 years ago Family history of cardiovascular disease; father

died of heart failure at age 64 years Mild osteoarthritis, which limits her ability to

take walks

BMI: 27 kg/m2

Case 3: 84-Year-Old Hispanic Woman With AF and Moderate Dementia (cont’d)

Recently experiencing increasing forgetfulness and memory loss; has difficulty with managing medications and activities of daily living; diagnosed with moderate dementia

Requires help from family caregiver and part-time home health aide

Becoming nonadherent to medications

ICH = intracranial hemorrhage; OAB = oral anticoagulant. Friberg L, et al. Circulation. 2012;125:2298-2307.

Net Clinical Benefit of Warfarin All-Cause Mortality, Ischemic Stroke, and ICH

1.0

0.8

0.6

0.4

0.2

0.0

0 1 2 3 4

P<.00001 (n=1,787) Prop

ortio

n Su

rviv

ing

OAC

No OAC

1.0

0.8

0.6

0.4

0.2

0.0

0 1 2 3 4

P<.00001 (n=59,817) Pr

opor

tion

Surv

ivin

g

OAC

No OAC

1.0

0.8

0.6

0.4

0.2

0.0

0 1 2 3 4

P<.00001 (n=43,395) Pr

opor

tion

Surv

ivin

g

OAC

No OAC

1.0

0.8

0.6

0.4

0.2

0.0

0 1 2 3 4

P<.00001 (n=59,817) Pr

opor

tion

Surv

ivin

g

OAC

No OAC

HAS-

BLED

0-2

p

HAS

-BLE

D ≥3

p

Risk

for I

ntra

cran

ial B

leed

ing

CHA2DS2–VASc 0-2 p CHA2DS2–VASc ≥3 p

YEARS YEARS

YEARS YEARS

Risk for Embolic Stroke

RE-LY (Dabigatran)

ROCKET-AF (Rivaroxaban)

ARISTOTLE (Apixaban)

ENGAGE AF (Edoxaban)

# randomized 18,113 14,264 18,201 21,105 Age, years 72 ± 9 73 [65-78] 70 [63-76] 72 [64-78] Female, % 37 40 35 38 Paroxysmal AF 32 18 15 25

VKA naive 50 38 43 41 Aspirin use 40 36 31 29

Baseline Characteristics

32 35

33 13

87 47 53 34

36

30 CHADS2

2

3-6

0-1

Ruff CT, et al. Lancet. 2014;383:955-962. VKA = vitamin K antagonist.

All-Cause Mortality

Myocardial Infarction

Hemorrhagic Stroke

Ischemic Stroke

0.90 (0.85-0.95)

0.97 (0.78-1.20)

0.49 (0.38-0.64)

0.92 (0.83-1.02)

Risk Ratio (95% CI)

P = 0.0003

P = 0.77

P < 0.0001

P = 0.10

Favors NOAC Favors Warfarin

0.2 0.5 1 2

Secondary Efficacy Outcomes

Heterogeneity P = NS for all outcomes.

Ruff CT, et al. Lancet. 2014;383:955-962.

Comparison of New AF Guidelines

Recommended Therapy

Risk Profile ESC 20121 AHA/ACC/HRS 20142

No risk factors CHA2DS2-VASc = 0 Nothing Nothing

CHA2DS2-VASc = 1 NOAC >VKA Nothing or ASA or OAC

CHA2DS2-VASc ≥2 NOAC >VKA NOAC or VKA

Mechanical valve VKA: INR 2.0-3.0 (AVR) VKA: INR 2.5-3.5 (MVR)

ACC = American College of Cardiology; AHA = American Heart Association; ASA = acetylsalicylic acid; AVR = aortic valve replacement; ESC = European Society of Cardiology; HRS = Heart Rhythm Society; OAC = oral anticoagulant; MVR = mitral valve replacement. 1. ESC Guidelines. Eur Heart J. 2012;33:2719-2747. 2. AHA/ACC/HRS Guidelines. JACC. 2014 [online March 28].

Shared Decision Making: Principles

Clinicians and patients share the best available evidence when making decisions, and clinicians support patients to consider options to achieve informed preferences1,2

– Rather than clinicians making decisions on behalf of patients1

Based on premise that individual self-determination is a desirable goal and that clinicians need to support patients to achieve this goal1

Highlights the importance of probing for/explaining the diagnosis and then explaining how various treatments may work

1. Elwyn G, et al. J Gen Intern Med. 2012;27:1361-1367. 2. Elwyn G, et al. BMJ. 2010;341:c5146.