Amjad AlMahameed, MD Director, Vascular Medicine Research

Amjad AlMahameed, MDDirector, Vascular Medicine Research

Associate Staff, Section of Vascular MedicineDepartment of Cardiovascular Medicine

Cleveland Clinic Foundation

Medical Management of Claudication: Just Walk it Off!!

Objectives

• Recognize the magnitude of PAD as a public health problem

• Review best management strategies

• Reflect on future prospects

Natural History of Intermittent Claudication

Population > 55 y/o

Intermittent Claudication (5%)

Peripheral Vascular Outcomes

Stable Claudication

50-75%

Worsening Claudication

17-25%

Lower Ext Bypass

7%

Major Amputation

4%

Adapted from Weitz JI et al, Circulation 1996, 94:3026 and TASC Working Group J Vasc Surg 2000;31:(suppl 1) S1-296

Cardiovascular Cause75%

Nonfatal CV EventMI/Stroke/other

20%

5 yearMortality

30%

Other Cardiovascular Morbidity/Mortality

Serious, but “not so bad overall”….

PAD Survival* as a Factor of Clinical Severity

*Kaplan-Meier survival curves based on mortality from all causes.*Kaplan-Meier survival curves based on mortality from all causes.††Large-vessel PAD.Large-vessel PAD. Criqui MH et al. Criqui MH et al. N Engl J MedN Engl J Med. 1992;326:381-386.. 1992;326:381-386.

Normal SubjectsNormal Subjects

Asymptomatic LV-PADAsymptomatic LV-PAD††

Symptomatic LV-PADSymptomatic LV-PAD††

Severe Symptomatic LV-PADSevere Symptomatic LV-PAD††

100100

7575

5050

2525

0000 22 44 66 88 1010 1212

Su

rviv

al (

% o

f p

atie

nts

)S

urv

ival

(%

of

pat

ien

ts)

YearYear

The diagnosis of established atherosclerosis in a patient, or identifying that a patient is high risk for atherosclerosis is an:

EVENT

event

event

event

event

Improve Functional Status

Improve Functional Status Save the LimbSave the Limb

Prevent Atherosclerosis

Progression

Prevent Atherosclerosis

Progression

Reduce Cardiac & Cerebrovascular Morbidity/Mortality

Reduce Cardiac & Cerebrovascular Morbidity/Mortality

Decrease the needfor revascularization

Decrease the needfor revascularization

• Improve symptoms

• Improve QOL

• Improve exercise capacity

• Improve symptoms

• Improve QOL

• Improve exercise capacity

Record nonfatalevents (MI/CVA)

Record nonfatalevents (MI/CVA)

Treatment Goals in PADTreatment Goals in PAD

Weitz JI et al. Circulation 1996; 94: 3026

• Systemic Therapy • “Ongoing research”

• Systemic Therapy • “Ongoing research”

Smoking Cessation

• Repeated advice

• Nicotine replacement Rx

• +/- Bupropion

• Behavioral therapy: smoking cessation classes and support groups

• Cessation leads to a reduction in 10 year mortality from 54% to 18%

• Rest pain developed in 0% of quitters compared 16% of continued smokers at seven years

Strategies Benefits

0

5

10

15

20

25

All diabetic patients

Annual event

rate (%)

Insulin-treated

Clopidogrel

Aspirin

12.7%

11.8%

17.7%

15.6%

21.5%

17.7%

* Events=vascular death, MI, stroke, or re-hospitalization for ischemia or bleeding.

Nondiabetic

3821

Events* prevented/

1000 patients

over Aspirin

9

Bhatt DL, et al. Am J Cardiol. 2002;90:625-628.

CAPRIE: Clopidogrel in Diabetes

Statin Therapy

• All pts should be on a statin to achieve a 25% reduction in cholesterol

• Additional treatment may be needed if HDL is low or TG are high

• Remember that HDL and TG (+/- usCRP) are becoming therapeutic targets

• RR=0.81(0.72 to 0.87) for major vascular events (MI, CVA, or revascularization)

• Improved leg functioning, pain-free walking distance, and community-based physical activity independent of cholesterol level

Strategies Benefits of Statin Rx

0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00 1.10 1.20

0

10

20

30

40

50

Baseline ABI

Od

ds

of

MI,

Str

oke

, o

r V

ascu

lar

Dea

th

Intensive BP therapy in PAD

Moderate RxIntensive Rx

ACE-I: HOPE Study

0.6 0.8 1.0 1.2

Relative Risk in Ramipril Group

No. of Patients

Incidence of Composite Outcome in Placebo Group

PAD 4051 22.0

No PAD 5246 14.3

HOPE Study Investigators N Eng J Med, 2000, 342:143

Increasing Walking Distance

Treatment of IC with Exercise Program

• Meta Analysis # 1

• 49 publications, > 600 pts• Statistically significant increase

in:

- Initial claudication distance: 139 meters

- Absolute claudication distance: 176 meters

• Meta analysis # 2:

• 33 publications• Statistically significant increase in:

- Initial claudication distance: 179% from 125.9 +/- 57.3 m to 351.2 +/- 188.7 m

- Absolute claudication distance: 122% (from 325.8 +/- 148.1 m to 723.3 +/- 591.5 m)

Archives of Intern Med 1999, 159: 337 JAMA. 1995 Sep 27;274(12):975-80.

CONCLUSIONS--The optimal exercise program for improving claudication pain distances in patients with peripheral arterial disease uses intermittent walking to near-maximal pain during a program of at least 6 months. Such a program should be part of the standard medical care for patients with intermittent claudication.

Relative Efficacy of Hospital vs. Home-Based Exercise Training (Regensteiner Angiology, 1997, 48:291)

Peak walking time

Pin free walking time

Peak O2 consumption

Functional status evaluated by Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Study SF-20 questionnaire (MOS).

Physical functioning

Walking distance

Improvement in: Unsupervised (N = 10) Supervised (N = 10)

137%

150%

19%

38%

77%

5%

26%

9%

16%

42% (P<0.05)

Indications for Angiography in patients with PAD

• Rest pain

• Non-healing ulcers

• Lifestyle-limiting claudication