Peripheral Arterial Disease Guidelines:

Management of Patients with Lower Extremity PAD

A Collaboration of the American College of Cardiology, the American Heart

Association, the American Association for Vascular Surgery/Society for
Vascular Surgery, Society for Cardiovascular Angiography and Interventions,
Society of Interventional Radiology, Society for Vascular Medicine and
Biology, and the PAD Coalition.

SVMB
The PAD Coalition
Based on the:

ACC/AHA Guidelines on the Management of Patients With Peripheral

Arterial Disease: A Collaborative Report from the American Association
for Vascular Surgery/Society for Vascular Surgery, Society for
Cardiovascular Angiography and Interventions, Society of Interventional
Radiology, Society for Vascular Medicine and Biology, and the ACC/AHA
Task Force on Practice Guidelines.

Endorsed by the American Association of Cardiovascular and Pulmonary

Rehabilitation; National Heart, Lung, and Blood Institute; Society for
Vascular Nursing; TransAtlantic Inter-Society Consensus; and the
Vascular Disease Foundation.
Supported by an educational grant from Bristol-Myers Squibb and Sanofi
Pharmaceuticals Partnership.

Bristol-Myers Squibb and Sanofi Pharmaceuticals Partnership were not

involved in the development of this slide deck and in no way influenced its
contents.
 Applying Classification of
Recommendations and Level of Evidence
Class I Class IIa Class IIb Class III

Benefit >>> Risk Benefit >> Risk Benefit ≥ Risk Risk ≥ Benefit
Additional studies with Additional studies with No additional studies
focused objectives broad objectives needed; needed
needed Additional registry data
would be helpful Procedure/Treatment
Procedure/ Treatment IT IS REASONABLE to should NOT be
SHOULD be perform Procedure/Treatment performed/administered
performed/ procedure/administer MAY BE CONSIDERED SINCE IT IS NOT
administered treatment HELPFUL AND MAY BE
HARMFUL

should is reasonable may/might be considered is not recommended

is recommended can be useful/effective/ may/might be reasonable is not indicated
is indicated beneficial usefulness/effectiveness is should not
is useful/effective/ is probably recommended or unknown /unclear/uncertain is not
beneficial indicated or not well established useful/effective/beneficial
may be harmful
 Applying Classification of
Recommendations and Level of Evidence
Class I Class IIa Class IIb Class III

Benefit >>> Risk Benefit >> Risk Benefit ≥ Risk Risk ≥ Benefit
Additional studies with Additional studies with No additional studies
focused objectives broad objectives needed; needed
needed Additional registry data
would be helpful Procedure/Treatment
Procedure/ Treatment IT IS REASONABLE to should NOT be
SHOULD be perform Procedure/Treatment performed/administered
performed/ procedure/administer MAY BE CONSIDERED SINCE IT IS NOT
administered treatment HELPFUL AND MAY BE
HARMFUL

Level A Multiple (3-5) population risk strata evaluated

General consistency of direction and magnitude of effect
Level B Limited (2-3) population risk strata evaluated

Level C Very limited (1-2) population risk strata evaluated

 Why A PAD Guideline?
• To enhance the quality of patient care
• Increasing recognition of the importance of
atherosclerotic lower extremity PAD:
– High prevalence
– High cardiovascular risk
– Poor quality of life
• Improved ability to detect and treat renal artery
disease
• Improved ability to detect and treat AAA
• The evidence base has become increasingly robust,
so that a data-driven care guideline is now possible
 Peripheral Arterial Disease Guideline:
The Target Audiences Are Diverse

• Primary care clinicians

– Family practice
– Internal medicine
– PA, NP, nurse clinicians
• Cardiovascular/vascular medicine,
vascular surgical, & interventional
radiology trainees and vascular
specialists
This was not intended to be a procedural guideline;
it is intended to provide a guide to optimal lifelong PAD care.
 Defining a Population “At Risk”
for Lower Extremity PAD
• Age less than 50 years with diabetes, and one additional
risk factor (e.g., smoking, dyslipidemia, hypertension, or
hyperhomocysteinemia)
• Age 50 to 69 years and history of smoking or diabetes
• Age 70 years and older
• Leg symptoms with exertion (suggestive of claudication)
or ischemic rest pain
• Abnormal lower extremity pulse examination
• Known atherosclerotic coronary, carotid, or renal artery
disease
The First Tool to Establish the PAD Diagnosis:
The HPI, ROS, and Physical Examination

• Individuals with asymptomatic PAD should be

identified in order to offer therapeutic
interventions known to diminish their increased
risk of myocardial infarction, stroke, and death.
• A history of walking impairment, claudication,
and ischemic rest pain is recommended as a
required component of a standard review of
systems for adults >50 years who have
atherosclerosis risk factors, or for adults >70
years.
The First Tool to Establish the PAD Diagnosis:
The HPI, ROS, and Physical Examination

• Pulse intensity should be assessed and should be recorded

numerically as follows:
– 0, absent
– 1, diminished
– 2, normal
– 3, bounding

Use of a standard
examination should
facilitate clinical
communication
This guideline recognizes that:
Individuals with PAD Present in Clinical
Practice with Distinct Syndromes

Asymptomatic: Without obvious symptomatic

complaint (but usually with a functional impairment).

Classic Claudication: Lower extremity symptoms

confined to the muscles with a consistent (reproducible)
onset with exercise and relief with rest.

“Atypical” leg pain: Lower extremity discomfort that is

exertional, but that does not consistently resolve with
rest, consistently limit exercise at a reproducible
distance, or meet all “Rose questionnaire” criteria.
This guideline recognizes that:
Individuals with PAD Present in Clinical Practice
with Distinct Syndromes

Critical Limb Ischemia: Ischemic rest pain, non-

healing wound, or gangrene

Acute limb ischemia: The five “P’s, defined by the

clinical symptoms and signs that suggest
potential limb jeopardy:
 Pain
 Pulselessness
 Pallor
 Paresthesias
 Paralysis (& polar, as a sixth “p”).
Hemodynamic Noninvasive Tests

• Resting Ankle-Brachial Index (ABI)

• Exercise ABI
• Segmental pressure examination
• Pulse volume recordings

These traditional tests continue to provide a simple, risk-free,

and cost-effective approach to establishing the PAD diagnosis
as well as to follow PAD status after procedures.
 The Ankle-Brachial Index
Lower extremity systolic pressure
ABI = Brachial artery systolic pressure
• The ankle-brachial index is 95% sensitive and 99% specific for PAD
• Establishes the PAD diagnosis
• Identifies a population at high risk of CV ischemic events
• “Population at risk” can be clinically & epidemiologically defined:
 Exertional leg symptoms, non-
healing wounds, age > 70, age > 50
years with a history of smoking or
diabetes.
• Toe-brachial index (TBI) useful in
individuals with non-compressible pedal
pulses
Lijmer JG. Ultrasound Med Biol 1996;22:391-8; Feigelson HS. Am J Epidemiol 1994;140:526-34;
Baker JD. Surgery 1981;89:134-7; Ouriel K. Arch Surg 1982;117:1297-13; Carter SA. J Vasc Surg 2001;33:708-14
 Exercise ABI

• Confirms the PAD

diagnosis

• Assesses the
functional severity of
claudication

• May “unmask” PAD

when resting the ABI
is normal
 Arterial Duplex Ultrasound Testing
• Duplex ultrasound of the extremities
is useful to diagnose anatomic
location and degree of stenosis of
peripheral arterial disease.

• Duplex ultrasound is useful to

provide surveillance following
femoral-popliteal bypass using
venous conduit (but not prosthetic
grafts). However, the data that
might support use of
• Duplex ultrasound of the extremities duplex ultrasound to
can be used to select candidates for: assess long-term
(a) endovascular intervention; patency of PTA is not
(b) surgical bypass, and robust.
(c) to select the sites of surgical
anastomosis.
 Noninvasive Imaging Tests
Duplex Ultrasound
I IIa IIb III
Duplex ultrasound of the extremities is useful
to diagnose the anatomic location and degree
of stenosis of PAD.

I IIa IIb III

Duplex ultrasound is recommended for routine
surveillance after femoral-popliteal or femoral-
tibial-pedal bypass with a venous conduit.
minimum surveillance intervals are
approximately 3,6, and 12 months, and then
yearly after graft placement.
 Noninvasive Imaging Tests
Magnetic Resonance Angiography (MRA)
I IIa IIb III
MRA of the extremities is useful to diagnose
anatomic location and degree of stenosis of
PAD.
I IIa IIb III
MRA of the extremities should be performed
with a gadolinium enhancement.

I IIa IIb III

MRA of the extremities is useful in selecting
patients with lower extremity PAD as candidates
for endovascular intervention.
 Noninvasive Imaging Tests
Computed Tomographic Angiography (CTA)

I IIa IIb III

CTA of the extremities may be considered
to diagnose anatomic location and
presence of significant stenosis in
patients with lower extremity PAD.

I IIa IIb III

CTA of the extremities may be considered
as a substitute for MRA for those patients
with contraindications to MRA.
 Natural History of PAD
Age > 50 years

Limb Cardiovascular
Morbidity /
Morbidity Mortality

Stable Worsening Critical Nonfatal Mortality

Claudication Claudication Limb CV Events 15-30%
10-20% Ischemia 20%
70-80%
1-2%

CV Causes Non CV Causes

75% 25%
Lipid Lowering and Antihypertensive Therapy

I IIa IIb III Treatment with an HMG coenzyme-A reductase inhibitor

(statin) medication is indicated for all patients with
peripheral arterial disease to achieve a target LDL
cholesterol of less than 100 mg/dl.

I IIa IIb III Antihypertensive therapy should be administered to

hypertensive patients with lower extremity PAD to a goal
of less than 140/90 mmHg (non-diabetics) or less than
130/80 mm/Hg (diabetics and individuals with chronic
renal disease) to reduce the risk of myocardial infarction,
stroke, congestive heart failure, and cardiovascular
death.
 Antiplatelet Therapy
I IIa IIb III
Antiplatelet therapy is indicated to reduce the risk of
myocardial infarction, stroke, or vascular death in
individuals with atherosclerotic lower extremity PAD.

I IIa IIb III Aspirin, in daily doses of 75 to 325 mg, is recommended

as safe and effective antiplatelet therapy to reduce the
risk of myocardial infarction, stroke, or vascular death in
individuals with atherosclerotic lower extremity PAD.

I IIa IIb III Clopidogrel (75 mg per day) is recommended as an

effective alternative antiplatelet therapy to aspirin to
reduce the risk of myocardial infarction, stroke, or
vascular death in individuals with atherosclerotic lower
extremity PAD.
 Supervised Exercise Rehabilitation

I IIa IIb III

A program of supervised exercise training is
recommended as an initial treatment
modality for patients with intermittent
claudication.

I IIa IIb III

Supervised exercise training should be
performed for a minimum of 30 to 45
minutes, in sessions performed at least
three times per week for a minimum of 12
weeks.
 Pharmacotherapy of Claudication

I IIa IIb III

Cilostazol (100 mg orally two times per
day) is indicated as an effective therapy
to improve symptoms and increase
walking distance in patients with lower
extremity PAD and intermittent
claudication (in the absence of heart
failure).
Endovascular Treatment for Claudication

I IIa IIb III Endovascular procedures are indicated for

individuals with a vocational or lifestyle-
limiting disability due to intermittent
claudication when clinical features
suggest a reasonable likelihood of
symptomatic improvement with
endovascular intervention and…

a. Response to exercise or pharmacologic

therapy is inadequate, and/or
b. there is a very favorable risk-benefit ratio
(e.g. focal aortoiliac occlusive disease)
Endovascular Treatment for Claudication

I IIa IIb III

Endovascular intervention is recommended as
the preferred revascularization technique for
TASC type A iliac and femoropopliteal lesions.

Iliac Femoropopliteal
TASC A:
(PTA recommended)

TASC B: (insufficient data to recommend)

Endovascular Treatment for Claudication:
Iliac Arteries
I IIa IIb III Provisional stent placement is indicated for
use in iliac arteries as salvage therapy for
suboptimal or failed result from balloon
dilation (e.g. persistent gradient, residual
diameter stenosis >50%, or flow-limiting
dissection).
I IIa IIb III
Stenting is effective as primary therapy for
common iliac artery stenosis and
occlusions.
I IIa IIb III
Stenting is effective as primary therapy in
external iliac artery stenosis and
occlusions.
Endovascular Treatment for Claudication
I IIa IIb III Endovascular intervention is not indicated if
there is no significant pressure gradient
across a stenosis despite flow
augmentation with vasodilators.

I IIa IIb III

Primary stent placement is not
recommended in the femoral, popliteal, or
tibial arteries.

I IIa IIb III

Endovascular intervention is not indicated
as prophylactic therapy in an asymptomatic
patient with lower extremity PAD.
 Surgery for Critical Limb Ischemia

I IIa IIb III Surgery is not indicated in patients with severe

decrements in limb perfusion in the absence of
clinical symptoms of critical limb ischemia.

I IIa IIb III Patients who have significant necrosis of the

weight-bearing portions of the foot, an
uncorrectable flexion contracture, paresis of the
extremity, refractory ischemic rest pain, sepsis,
or a very limited life expectancy due to co-
morbid conditions should be evaluated for
primary amputation.
 Surgery for Critical Limb Ischemia

I IIa IIb III

For individuals with combined inflow and
outflow disease with critical limb ischemia,
inflow lesions should be addressed first.

I IIa IIb III

When surgery is to be undertaken, an aorto-
bifemoral bypass is recommended for patients
with symptomatic, hemodynamically
significant, aorto-bi-iliac disease requiring
intervention.
 Surgery for Critical Limb Ischemia

I IIa IIb III

Bypasses to the above-knee popliteal
artery should be constructed with autogenous
saphenous vein when possible.

I IIa IIb III Bypasses to the below-knee popliteal artery

should be constructed with autogenous vein
when possible.

I IIa IIb III Prosthetic material can be used effectively

for bypasses to the below knee popliteal
artery when no autogenous vein from ipsilateral
or contralateral leg or arm is available.
 Surgery for Critical Limb Ischemia
I IIa IIb III
Femoral-tibial artery bypasses should be
constructed with autogenous vein, including
ipsilateral greater saphenous vein, or if
unavailable, other sources of vein from the leg
or arm.
I IIa IIb III Composite sequential femoropopliteal-tibial
bypass, or bypass to an isolated popliteal
arterial segment that has collateral outflow to
the foot, are acceptable methods of
revascularization and should be considered
when no other form of bypass with adequate
autogenous conduit is possible.
 Acute Limb Ischemia (ALI)

I IIa IIb III Patients with ALI and a salvageable

extremity should undergo an emergent
evaluation that defines the anatomic level of
occlusion, and that leads to prompt
endovascular or surgical intervention.

I IIa IIb III Patients with ALI and a non-viable extremity

should not undergo an evaluation to define
vascular anatomy or efforts to attempt
revascularization.
ACC/AHA Guidelines for the Management of PAD:
Major Contributions to Improved Care Standards

• Population at risk is now defined by

epidemiologic criteria applied to
practice.

• Presentation-specific algorithms will

expedite care (e.g., asx, atypical leg
pain, classic claudication, critical limb
ischemia, & acute arterial occlusion).

• Use of exercise, pharmacologic,

endovascular, and surgical
interventions are emplaced in
care as defined by evidence.
 The PAD Guidelines & the “PAD Coalition”:
An Ideal Health Partnership To Foster
Clinician and Public PAD Education

The PAD Coalition

A public, interdisciplinary Coalition devoted to
creating a national PAD public awareness
campaign and to coordinating
PAD public & physician education.

www.padcoalition.org