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Case Study: Diane Leary. Diffuse Vascular Disease (Focus on Peripheral Arterial Disease [PAD]). Learning Objectives. At the end of this session, participants should be able to: Identify patients with peripheral arterial disease (PAD)

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Diffuse vascular disease focus on peripheral arterial disease pad

Case Study: Diane Leary

Diffuse Vascular Disease

(Focus on Peripheral Arterial Disease [PAD])


Learning objectives

Learning Objectives

At the end of this session, participants should be able to:

  • Identify patients with peripheral arterial disease (PAD)

  • Apply Canadian guidelines for the screening and management of PAD

  • Identify patients with diffuse vascular disease and implement strategies for the prevention of atherothrombotic events in these patients


Patient presentation

Patient Presentation

  • Diane is a 65-year-old retired school teacher

  • She complains of left calf pain when walking a couple of blocks; the pain goes away after she rests for 5 minutes

  • No other complaints


History

History

  • NSTEMI 20 months ago

  • Carotid bruit

  • Hypertension

  • Type 2 diabetes (diagnosed 5 years prior)

  • Hyperlipidemia

  • No family history of diabetes or cardiovascular disease

  • Former smoker

NSTEMI: non-ST-elevation myocardial infarction


Medications

Medications

  • ASA 81 mg/day

  • Ramipril 10 mg/day

  • Metformin 500 mg tid

  • Atorvastatin 20 mg/day

  • Metoprolol 25 mg bid

ASA: acetylsalicylic acid


Physical examination

Physical Examination

  • Height: 1.65 m

  • Weight: 81.6 kg

  • BMI: 29 kg/m2

  • Waist circumference: 104 cm

  • BP in-office: 128/72 mmHg

  • Heart rate: 80 bpm

  • Left femoral bruit

  • Carotid bruit

  • Bilateral reduced pedal pulses

BMI: body mass index; BP: blood pressure


Laboratory investigations

Laboratory Investigations

  • FPG: 6.2 mmol/L

  • A1C: 7.5%

  • Lipids at desired values

    • TC < 5.2 mmol/L

    • TG < 2.3 mmol/L

    • HDL-C > 1.20 mmol/L (female)

    • LDL-C < 2.0 mmol/L

    • TC/HDL-C < 4.0

  • Urine ACR: 1.9 mg/mmol

  • Complete blood count within normal limits

  • ECG normal

FPG: fasting plasma glucose; A1C: hemoglobin A1C; TC: total cholesterol; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; TG: triglycerides; ACR: albumin-to-creatinine ratio; ECG: electrocardiogram


Question 1

Question 1

What is your initial diagnosis?


Key points

Key Points

  • Patient presents with typical symptom of PAD (intermittent claudication) and has a number of risk factors for the disease

  • Basic screening should include directed history and physical exam focusing on femoral bruits and pedal pulses

  • Non-invasive evaluation should include an ABI

ABI: ankle-brachial index


Diffuse vascular disease focus on peripheral arterial disease pad

Risk Factors for PAD

  • Risk factors for PAD are similar to those for atherosclerosis in other beds and include:

  • Smoking and diabetes are the most predictive for development of symptomatic claudication

Teo KK. Can J Cardiol. 2005;21(12):997–1006.


Diffuse vascular disease focus on peripheral arterial disease pad

Varied Presentation of PAD

PAD can be silent or cause symptoms ranging from pain to critical limb ischemia

McDermott MM et al. JAMA 2001;286:1599-1606.


Reach registry atherothrombosis overlapping manifestations of disease

REACH RegistryAtherothrombosis: Overlapping Manifestations of Disease

The REACH Registry found overlapping manifestations of disease in patients with CAD, CVD, and PAD

  • 61% of PAD patients also had symptomatic disease in the coronary or cerebral circulation

  • 40% of CVD patients also had symptomatic disease in the coronary or peripheral circulation

  • 25% of CAD patients also had symptomatic disease in the cerebral or peripheral circulation

18.3% of patients in the REACH Registry did not have manifestations of atherothrombosis, but were included based on risk factors

CAD: coronary artery disease; CVD: cerebrovascular disease; PAD: peripheral arterial disease

Bhatt DL, et al; for the REACH Registry Investigators. JAMA. 2006;295:180-189.


Increased risk of pad with diabetes

*

*

*

Prevalence of PAD (%)

Normal glucose

tolerance

Impaired glucose

tolerance

Diabetes

Increased Risk of PAD with Diabetes

Impaired glucose tolerance was defined as oral glucose tolerance test value ≥140 mg/dL <200 mg/dL.

* P≤0.05 vs. normal glucose tolerance.

Lee AJ, et al. Br J Haematol. 1999;105:648–654.


Question 2

Question 2

What additional investigations would you perform?


Key points diagnosis of pad

Key Points: Diagnosis of PAD

  • History

    • Edinburgh Questionnaire

  • Physical examination

    • Bruit

    • Peripheral pulses

  • Non-invasive tests

    • ABI

    • Arterial Duplex

Adapted from Roussin A, et al. Can J Cardiol. 2005;21(12):997–1006.


Diffuse vascular disease focus on peripheral arterial disease pad

CCS Guidelines: Diagnosis of PAD

Roussin A, et al. Can J Cardiol. 2005;21(12):997–1006.


Edinburgh questionnaire

Edinburgh Questionnaire

  • Do you get a pain or discomfort in your leg(s) when you walk?

    • YES (If patient answers no, then stop here)

  • Does this pain ever begin when you are standing still or sitting?

    • NO

  • Do you get it when you walk uphill or hurry?

    • YES

  • Do you get it when you walk at an ordinary pace on level ground?

    • YES(Answer may also be ‘no’ depending on severity of claudication)

  • What happens to it if you stand still?

    • Pain usually disappears in 10 minutes or less (pain continuing for more than 10 minutes is not consistent with PAD)

  • Where do you get this pain or discomfort?

    • Patient marks calf and/or thigh and/or buttock

  • (A positive diagnosis of PAD requires the responses indicated in yellow for all questions)

Leng GC, et al. J Clin Epidemiol. 1992;45:1101–1109.


Measuring abi

Higher right-ankle pressure

Higher arm pressure

RIGHT ABI

Right-arm

systolic

pressure

Left-arm

systolic

pressure

Higher left-ankle pressure

Higher arm pressure

LEFT ABI

INTERPRETATION OF ABI

>1.30

0.91-1.30

0.41-0.90

0.00-0.40

Noncompressible

Normal

Mild-to-moderate peripheral arterial disease

Severe peripheral arterial disease

DP

PT

DP

PT

Left-ankle

systolic pressure

Right-ankle

systolic pressure

Measuring ABI

Adapted from Roussin A, et al. Can J Cardiol 2005;21(12):997-1006.


Question 3

Question 3

What if the patient’s pedal pulses were palpable and there were no bruits? Would this change your diagnosis?


Key point

Key Point

  • Palpable pedal pulses and an absence of femoral bruits do not preclude PAD


Pad regardless of claudication

PAD Regardless of Claudication

  • Value of physical examination relative to presence of PAD

McGee SR, et al. Arch Intern Med. 1998;158:1357–1364.


Case evolution

Case Evolution

  • Based on your clinical examination, you diagnose Diane with PAD. You perform further investigations and find that she has an ABI of 0.65, which confirms your diagnosis.

Significance of ABI values ►


Question 4

Question 4

  • How would you manage this patient’s:

  • claudication?

  • overall vascular risk?


Diffuse vascular disease focus on peripheral arterial disease pad

Key Points: Objectives of PAD Therapy

  • Prevent death and disability

  • Reduce risk of MI (PAD quadruples MI risk)

  • Reduce risk of stroke (PAD triples stroke risk)

  • Relieve symptoms

  • Improve QOL

  • Improve walking ability

  • Save limbs

  • Prevent major amputations

  • Avoid tissue loss

QOL: quality of life


Survival following diagnosis of pad by diabetes status

Survival Following Diagnosis of PAD by Diabetes Status

100

No diabetes

90

80

Proportion alive (%)

Diabetes

70

60

50

40

30

20

10

0

14

6

13

15

7

9

12

3

4

11

5

8

10

1

2

Time (years)

Migliaccio-Walle K, et al. Can J Diabetes. 2007;31(2):140-147.


Diffuse vascular disease focus on peripheral arterial disease pad

CCS Guidelines for PAD: Risk Reduction Strategies

Anand SS, et al. Can J Cardiol. 2005;21(12):997–1006.


Diffuse vascular disease focus on peripheral arterial disease pad

Risk Factor Management

  • Smoking cessation

  • Weight reduction

  • Regular physical activity

  • LDL-C < 2.0 mmol/L

  • Glycosylated hemoglobin < 6.0%

  • BP < 140/90 mmHg; < 130/80 mmHg in patients with diabetes

  • Platelet inhibition

Hiatt WR. N Engl J Med. 2001;344:1608-1621.

McPherson R, et al. Can J Cardiol. 2006;22:913-927.

CDA 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Available at http://www.diabetes.ca/cpg2003

2007 CHEP Recommendations. Available at www.hypertensions.ca


Diffuse vascular disease focus on peripheral arterial disease pad

CCS Guidelines for PAD: Pharmacologic Approach

Medical therapies to reduce cardiovascular events in PAD

Anand SS, et al. Can J Cardiol. 2005;21(12):997–1006.


Diffuse vascular disease focus on peripheral arterial disease pad

CCS Guidelines:Antithrombotic Therapies

*Not available in Canada

Anand SS, et al. Can J Cardiol. 2005;21(12):997–1006.


Diffuse vascular disease focus on peripheral arterial disease pad

Supervised Exercise in the Management of Symptomatic PAD

  • Exercise prescription is fundamental for all patients with claudication

  • Supervised programs have patients walk to the point of moderate pain, followed by rest and repeat exercise

  • Benefit is observed as early as 4 weeks and continues to improve for at least 1 year

Anand SS, Turpie AGG, et al. Can J Cardiol. 2005;21(12):997–1006.


Question 5

Question 5

Could warfarin be added to antiplatelet therapy in patients with PAD?


Wave warfarin antiplatelet vascular evaluation

WAVE: Warfarin Antiplatelet Vascular Evaluation

WAVE Trial Investigators. N Engl J Med. 2007;357(3):217-27.


Question 6

Question 6

Given this patient’s history of ACS and current diagnosis of PAD (ie, diffuse vascular disease), how long should she remain on the prescribed antiplatelet regimen?

Review pathophysiology & epidemiology of polyvascular disease and atherothrombosis ►


Key points1

Key Points

  • High risk of CV death, MI, stroke or hospitalization in patients with diffuse vascular disease1

  • Aggressive risk reduction strategies and dual antiplatelet therapy should be considered for these patients

  • Currently no guideline recommendations on the optimal duration of antiplatelet therapy in patients with diffuse vascular disease; however, many experts would agree that this patient requires lifelong antiplatelet therapy

    • CCS recommends lifelong antiplatelet therapy in PAD2

    • CHARISMA showed that patients with a prior atherothrombotic event (MI, stroke or PAD) benefit from long-term dual antiplatelet therapy (median follow-up 27 months), but at the cost of an increased rate of bleeding3

CHARISMA: Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance

1. Steg PG, et al.; for the REACH Registry Investigators. JAMA. 2007;297:1197-206. 2. Abramson BL, et al. Can J Cardiol. 2005;21(12):997–1006. 3. Bhatt DL, et al.; CHARISMA Investigators. J Am Coll Cardiol. 2007;49(19):1982-8.


Diffuse vascular disease focus on peripheral arterial disease pad

REACHMajor endpoints as a Function of Single vs Multiple and Overlapping Locations

† P<0.001 (ref class: CAD alone)

§ P<0.001 (ref class: PAD alone)

‡ P<0.001 (ref class: CAD + CVD)

Steg PG, et al.; for the REACH Registry Investigators. JAMA. 2007;297:1197-206.


Diffuse vascular disease focus on peripheral arterial disease pad

CCS Guidelines:Antithrombotic Therapies

Anand SS, et al. Can J Cardiol. 2005;21(12):997–1006.


Caprie clopidogrel vs asa in multi bed disease

CAPRIE:Clopidogrel vs. ASA in Multi-bed Disease

15

10.74%

22.7%

10

8.35%

Annual event rate (%)

Relative Risk

Reduction

164 events

196 events

5

0

Clopidogrel

ASA

Events = ischemic stroke, MI or vascular death

CAPRIE Steering Committee. Lancet. 1996;348(9038):1329-39.


Charisma primary endpoint mi stroke cv death in patients with previous mi is or pad

10

Placebo + ASA

8.8 %

Clopidogrel + ASA

7.3 %

8

6

Primary outcome event rate (%)

4

RRR: 17.1 % [95% CI: 4.4%, 28.1%]

P=0.01

2

0

0

6

12

18

24

30

Months since randomization

CHARISMA:Primary Endpoint (MI/Stroke/CV Death) in Patients with Previous MI, IS, or PAD

“CAPRIE-like Cohort”

N=9,478

Bhatt DL, et al.; CHARISMA Investigators. J Am Coll Cardiol. 2007;49(19):1982-1988.


Charisma primary and secondary safety endpoints

CHARISMA:Primary and Secondary Safety Endpoints

Bhatt DL, et al.; CHARISMA Investigators. J Am Coll Cardiol. 2007;49(19):1982-1988.


Charisma timing of severe or moderate bleeding

CHARISMA:Timing of Severe or Moderate Bleeding

0.00008

Placebo + ASA

Clopidogrel + ASA

0.00007

0.00006

0.00005

Hazard Function/d

0.00004

0.00003

0.00002

0.00001

0

135

270

450

630

810

15

60

Days Since Randomization

Bhatt DL, et al.; CHARISMA Investigators. J Am Coll Cardiol. 2007;49(19):1982-1988.


Take home messages

Take-Home Messages

  • Patients with PAD are at increased risk of diffuse vascular disease (ie, CAD and CVD)

  • Screen for PAD through history (Edinburgh Questionnaire) and physical examination (femoral bruits and pedal pulses)

  • Definitive diagnosis of PAD requires an ABI < 0.9

  • Aggressive risk factor management should be considered for patients with diffuse vascular disease

  • Long-term dual antiplatelet therapy can also be considered in selected cases but it is important to weigh the benefits against the higher risk of bleeding


Diffuse vascular disease focus on peripheral arterial disease pad

HYPERLINKS


Diffuse vascular disease focus on peripheral arterial disease pad

Significance of ABI Values


Getabi mortality all cause by abi category

> 1.1

0.9 – 1.1

0.7 – 0.9

0.5 – 0.7

< 0.5

GetABI: Mortality (All-cause) by ABI Category

Diehm C. Presented at ESC Congress. Vienna, Austria. September 4, 2007.


Strong association between decreased abi increased risk for vascular death

60

All-cause mortality

Vascular disease mortality

50

40

Percent (%)

30

20

10

0

<0.60 (n=25)

1.0-<1.10 (n=980)

0.90-<1.0 (n=195)

0.60-<0.70 (n=21)

0.70-<0.80 (n=40)

0.80-<0.90 (n=130)

Strong Association Between Decreased ABI & Increased Risk for Vascular Death

Baseline ABI*

RETURN

*Mean participant follow-up 8.3 years

Resnick HE, et al. Circulation. 2004;109:733-739.


Diffuse vascular disease focus on peripheral arterial disease pad

Pathophysiology, Epidemiology & Burden

of Atherothrombosis


Pathophysiology of atherothrombosis

Smooth muscle cell progression,

plaque progression

Accumulation

of lipids

Inflammation

Normalartery

Pathophysiology of Atherothrombosis

Atherosclerosis

+

Thrombus Formation

Rupture of Fibrous Cap

Erosion of Endothelium

Erosion of Calcium Nodule

Intraplaque Hemorrhage

Atherosclerosis leads to any number of four possible types of thrombus formation

  • Munger MA et al. J Am Pharm Assoc. 2004;44(suppl 1):s5-s13.

  • Libby P et al. Circulation. 2005;111:3481-3488.


Atherothrombosis can manifest in multiple vascular beds

Atherothrombosis Can Manifest in Multiple Vascular Beds

  • Atherothrombosis is a process that includes the following clinical consequences:

    • Ischemic stroke, MI, and PAD

  • Patients with atherothrombosis have thrombus formations that can manifest in multiple vascular beds throughout the body

Munger MA et al. J Am Pharm Assoc. 2004;44(suppl 1):s5-s13.


Diffuse vascular disease focus on peripheral arterial disease pad

Atherothrombosis: Disease Overlap

Coronary artery disease (CAD)

Cerebrovascular disease (CVD)

13%

9%

14%

5%

Peripheral Arterial Disease (PAD)

Patients with > 1 manifestation = 41%

Aronow WS, Ahn C. Am J Cardiol. 1994;74:64-65.


Epidemiology of atherothrombotic manifestations in canada

Epidemiology of Atherothrombotic Manifestations in Canada

Prevalence

(Patients with disease history)

Incidences per year

Mortality

Patients with a history of atherothrombosis are most likely to die of a recurrent atherothrombotic event5,6,7

Stroke

1.0%1

Stroke

40,000 – 50,0001

MI

2.7% (men)2

1.5% (women)2

MI

75,0001

PAD

3.0%

(10.5 million†4

in North America)

PAD

Variable depending on population3

MI=myocardial infarction; PAD=peripheral arterial disease.

†PAD patients in North America (USA and Canada): symptomatic (37.5%) and asymptomatic (62.5%).

1.Heart and Stroke Foundation of Canada.5. Hardie K, et al. Stroke. 2003;34:1842-1846.

2.Manuel DG, et al. Can J Cardiol. 2003;19:997-1004.6. Taneja AK, et al. Eur Heart J. 2004;25:2013-2018.

3.Ouriel K. Lancet. 2001;358:1257-1264.7. Hirsch AT, et al. J Am Coll Cardiol. 2006;47:1239-1312.

4.Weitz JI, et al. Circulation. 1996;94:3026-3049.


Diffuse vascular disease focus on peripheral arterial disease pad

Patients with Previous Atherothrombotic Events are at Increased Risk of Further Events

* Sudden death defined as death documented within one hour and attributed to coronary heart disease (CHD).

† Includes only fatal MI and other CHD death; does not include non-fatal MI.

1. Kannel WB. J Cardiovasc Risk.1994;1:333–339.; 2. Wilterdink JL, et al. Arch Neurol. 1992;49:857–863. 3. Adult Treatment Panel II. Circulation. 1994;89:1333–1363. 4. Criqui MH, et al. N Engl J Med. 1992;326:381–386.


Framingham heart study atherothrombosis reduces life expectancy

Framingham Heart Study:Atherothrombosis Reduces Life Expectancy

  • In the FHS, healthy individuals aged 60 years who did not have atherothrombosis were expected to live a further 20 years to the age of 80

    • Comparatively, patients with a history of MI lived 9.2 fewer years

    • Those with a history of CVA lived 12 fewer years

9.2Feweryears

12

Feweryears

20

Life Expectancy (Years)

MI=myocardial infarction; CVA=cerebrovascular accident.

Adapted from Bakhai A. Pharmacoeconomics. 2004;22(suppl 4):11-18.


Atherothrombosis as a cause of death

Atherothrombosis as a Cause of Death

According to the World Health Organization in 2004 atherothrombosis was the leading cause of death worldwide—more than AIDS and cancer

Mortality (%)

Athero-thrombosis

InfectiousDisease

Cancer

Injuries

PulmonaryDisease

AIDS

Bakhai A. Pharmacoeconomics. 2004;22(suppl 4):11-18.


Economic burden of atherothrombosis

Economic Burden of Atherothrombosis

The annual cost of CVD in 2006 was estimated to be higher than HIV and cancer in 2004

$403.1 billion

Estimated Cost (in billions)

$190 billion

$28.9 billion

RETURN

American Heart Association. Heart Disease and Stroke Statistics—2006 Update. 2006.


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