Trans-Atlantic Inter-Society

Consensus Document II
• Fourteen societies representing disciplines in
medicine, vascular surgery, interventional
radiology, and cardiology from Europe and
North America came together in 2000 to form
a consensus in the classification and
treatment of patients with PAD.
 epidemiology
• Incidence and prevalence of asymptomatic
peripheral arterial disease

– the range of 3% to 10%, increasing to 15% to 20%

in persons over 70 years
– The most widely used test is the measurement of
the ankle-brachial systolic pressure index (ABI)
• Incidence and prevalence of symptomatic
peripheral arterial disease
– The prevalence of IC would appear to increase
from about 3% in patients aged 40 to 6% in
patients aged 60 years
– r identifying IC in the population, it must be
remembered that while it is the main symptom of
PAD, the measurement of this symptom does not
always predict the presence or absence of PAD
 RISK FACTORS FOR PERIPHERAL
ARTERIAL DISEASE
• Race :
– Survey in the United States found that an ABI 0.90
was more common in non-Hispanic Blacks (7.8%) than
in Whites (4.4%).
• Gender :
– The prevalence of PAD, symptomatic or asymptomatic,
is slightly greater in men than women
• Age :
– The striking increase in both the incidence and
prevalence of PAD with increasing age
• Smoking :
– The relationship between smoking and PAD has
been recognized since 1911, when Erb reported
that IC was three-times more common among
smokers than among non-smokers
• Diabetes mellitus :
– Overall, IC is about twice as common among
diabetic patients than among non-diabetic
patients.
• Hypertension : , the relative risk for developing
PAD is less for hypertension than diabetes or
smoking.

• Dyslipidemia : y, a fasting cholesterol level greater

than 7 mmol/L (270 mg/dL) was associated with
a doubling of the incidence of IC but the ratio of
total to high-density lipoprotein (HDL) cholesterol
was the best predictor of occurrence of PAD.
• Inflammatory markers :
– The risk of developing PAD in the highest quartile of baseline
CRP was more than twice that in the lowest quartile.
• Hyperviscosity and hypercoagulable states :
– Both hyperviscosity and hypercoagulability have also been
shown to be markers or risk factors for a poor prognosis
• Hyperhomocysteinemia :
– It is reported that hyperhomocysteinemia is detected in about
30% of young patients with PAD.
• Chronic renal insufficiency :
– renal insufficiency was independently associated with future
PAD events in postmenopausal women
• Specific categories are assigned treatment
algorithms (surgical vs. endovascular) based
on lesion classification.
• TASC II divides anatomic distribution of
lesions into aorto-iliac and femoral popliteal
• Lesion patterns are grouped into A–D lesions.
Based on this group recommendation,
• TASC A lesions are those that should have excellent
results from endovascular management alone.
• TASC B lesions are those that should have good results
from endovascular management, and endoluminal
interventions should be the first treatment approach.
• TASC C lesions are those for which surgical
management provides superior long-term results and
endovascular techniques should be reserved for
patients who are surgically high risk.
• TASC D lesions should be treated by open surgery
 RISK FACTORS
Modification of atherosclerotic risk factors
• Smoking cessation.
• Weight reduction.
• Hyperlipidemia.
• Hypertension.
• Diabetes.
• Homocysteine.
• Inflammation.
• Antiplatelet drug therapy.
 Recommendation 1
Smoking cessation in peripheral arterial disease
● All patients who smoke should be strongly and
repeatedly advised to stop smoking [B].
● All patients who smoke should receive a
program of physician advice, group counseling
sessions, and nicotine replacement [A].
● Cessation rates can be enhanced by the
addition of antidepressant drug therapy
(bupropion) and nicotine replacement [A].
 Recommendation 2
Lipid control in patients with peripheral arterial disease (PAD)
● All symptomatic PAD patients should have their low-density lipoprotein (LDL)-
cholesterol lowered to 2.59 mmol/L (100 mg/dL) [A].
● In patients with PAD and a history of vascular disease in other beds (e.g. coronary artery
disease) it is reasonable to lower LDL cholesterol levels to 1.81 mmol/L (70 mg/dL)
[B].
● All asymptomatic patients with PAD and no other clinical evidence of cardiovascular
disease should also have their LDL-cholesterol level lowered to 2.59 mmol/L (100
mg/dL) [C].
● In patients with elevated triglyceride levels where the LDL cannot be accurately
calculated, the LDL level should be directly measured and treated to values listed
above. Alternatively, the non-HDL (high-density lipoprotein) cholesterol level can be
calculated with a goal of 3.36 mmol/L (130 mg/dL), and in high-risk patients the level
should be 2.59 mmol/L (100 mg/dL).
● Dietary modification should be the initial intervention to control abnormal lipid levels
[B].
● In symptomatic PAD patients, statins should be the primary agents to lower LDL
cholesterol levels to reduce the risk of cardiovascular events [A].
● Fibrates and/or niacin to raise HDL-cholesterol levels and lower triglyceride levels
should be considered in patients with PAD who have abnormalities of those lipid
fractions [B].
 Recommendation 3
Control of hypertension in peripheral arterial
disease(PAD) patients
● All patients with hypertension should have blood
pressure controlled to 140/90 mmHg or 130/ 80 mmHg
if they also have diabetes or renal insufficiency [A].
● JNC VII and European guidelines for the management of
hypertension in PAD should be followed [A].
● Thiazides and ACE inhibitors should be considered as
initial blood-pressure lowering drugs in PAD to reduce
the risk of cardiovascular events [B].
● Beta-adrenergic-blocking drugs are not contraindicated
in PAD [A]
 Recommendation 4
Control of diabetes in peripheral arterial disease
(PAD)
● Patients with diabetes and PAD should have
aggressive control of blood glucose levels with
a hemoglobin A1c goal of 7.0% or as close to
6% as possible [C].
 Recommendation 5
Use of folate supplementation in peripheral
arterial disease (PAD)
● Patients with PAD and other evidence of
cardiovascular disease should not be given
folate supplements to reduce their risk of
cardiovascular events [B].
 Recommendation 6
Antiplatelet therapy in peripheral arterial disease (PAD)
● All symptomatic patients with or without a history of other
cardiovascular disease should be prescribed an antiplatelet drug
long term to reduce the risk of cardiovascular morbidity and
mortality [A].
● Aspirin/ASA is effective in patients with PAD who also have clinical
evidence of other forms of cardiovascular disease (coronary or
carotid) [A].
● The use of aspirin/ASA in patients with PAD who do not have clinical
evidence of other forms of cardiovascular disease can be
considered [C].
● Clopidogrel is effective in reducing cardiovascular events in a
subgroup of patients with symptomatic PAD, with or without other
clinical evidence of cardiovascular disease [B].
 Recommendation 7
Management of coronary artery disease (CAD) in
peripheral arterial disease patients
● Patients with clinical evidence of CAD (angina, ischemic
congestive heart failure) should be evaluated and
managed according to current guidelines [C].
● Patients with PAD considered for vascular surgery may
undergo further risk stratification and those found to
be at very high risk managed according to current
guidelines for coronary revascularization [C].
● Routine coronary revascularization in preparation for
vascular surgery is not recommended [A].
 Recommendation 8
Use of beta-blocking agents before vascular
surgery
● When there are no contraindications, beta
adrenergic blockers should be given
perioperatively to patients with peripheral
arterial disease undergoing vascular surgery in
order to decrease cardiac morbidity and
mortality [A].
 Recommendation 9
Management of carotid artery disease in
peripheral arterial disease (PAD) patients
● The management of symptomatic carotid
artery disease in patients with PAD should be
based on current guidelines [C].
 Recommendation 10
Management of renal artery disease in
peripheral arterial disease (PAD) patients
● When renal artery disease is suspected in PAD
patients, as evidenced by poorly controlled
hypertension or renal insufficiency, patients
should be treated according to current
guidelines and consider referral to a
cardiovascular physician [C].
 Recommendation 11
History and physical examination in suspected peripheral
arterial disease (PAD)
● Individuals with risk factors for PAD, limb symptoms on
exertion or reduced limb function should undergo a
vascular history to evaluate for symptoms of claudication or
other limb symptoms that limit walking ability [B].
● Patients at risk for PAD or patients with reduced limb
function should also have a vascular examination evaluating
peripheral pulses [B].
● Patients with a history or examination suggestive of PAD
should proceed to objective testing including an ankle-
brachial index [B].
 Recommendation 12
Recommendations for ankle-brachial index (ABI)screening
to detect peripheral arterial disease in the individual
patient. An ABI should be measured in:
● All patients who have exertional leg symptoms [B].
● All patients between the age of 50–69 and who have a
cardiovascular risk factor (particularly diabetes or
smoking) [B].
● All patients age 70 years regardless of risk-factor status
[B].
● All patients with a Framingham risk score 10%–20% [C].
 Recommendation 13
Determining success of treatment for intermittent
claudication. Patient-based outcome assessment
(including a focused history of change in symptoms) is
the most important measure; however, if quantitative
measurements are required the following may be used:
1. Objective measures include an increase in peak
exercise performance on a treadmill [B].
2. Patient-based measures would include an
improvement on a validated, disease-specific health
status questionnaire; or the physical functioning
domain on a validated generic health status
questionnaire [B].
 Recommendation 14
Exercise therapy in intermittent claudication
● Supervised exercise should be made available as
part of the initial treatment for all patients with
peripheral arterial disease [A].
● The most effective programs employ treadmill or
track walking that is of sufficient intensity to bring
on claudication, followed by rest, over the course
of a 30–60 minute session. Exercise sessions are
typically conducted three times a week for 3
months [A].
 Recommendation 16
Clinical definition of critical limb ischemia (CLI)
● The term critical limb ischemia should be used
for all patients with chronic ischemic rest pain,
ulcers or gangrene attributable to objectively
proven arterial occlusive disease. The term CLI
implies chronicity and is to be distinguished
from acute limb ischemia [C].
 Recommendation 17
Cardiovascular risk modification in critical limb
ischemia (CLI)
● CLI patients should have aggressive
modification of their cardiovascular risk
factors [A].
 Recommendation 18
Evaluation of peripheral arterial disease (PAD) in
patients with diabetes
● All diabetic patients with an ulceration should
be evaluated for PAD using objective testing
[C].
 Recommendation 19
Diagnosis of critical limb ischemia (CLI)
● CLI is a clinical diagnosis but should be
supported by objective tests [C].
 Recommendation 20
Indications for evaluation for critical limb
ischemia
● All patients with ischemic rest pain symptoms
or pedal ulcers should be evaluated for CLI [B].
 Recommendation 21
Importance of early identification of peripheral
arterial disease (PAD)
● Early identification of patients with PAD at risk
of developing foot problems is essential for
limb preservation [C]. This can be achieved by
daily visual examination by the patient or their
family and, at every visit, referral to the foot
specialist.
 Recommendation 22
Early referral in critical limb ischemia (CLI)
● Patients with CLI should be referred to a
vascular specialist early in the course of their
disease to plan for revascularization options
[C].
 Recommendation 23
Multidisciplinary approach to treatment of
critical limb ischemia
● A multidisciplinary approach is optimal to
control pain, cardiovascular risk factors and
other co-morbid disease [C].
 Recommendation 24
Optimal treatment for patients with critical limb
ischemia (CLI)
● Revascularization is the optimal treatment for
patients with CLI [B].
 Recommendation 25
Treatment for infections in critical limb ischemia
(CLI)
● Systemic antibiotic therapy is required in CLI
patients who develop cellulitis or spreading
infection [B].
 Recommendation 26
Multidisciplinary care in critical limb ischemia
(CLI)
● Patients with CLI who develop foot ulceration
require multidisciplinary care to avoid limb
loss [C].
 Recommendation 27
Amputation decisions in critical limb ischemia
(CLI)
● The decision to amputate and the choice of
the level should take into consideration the
potential for healing, rehabilitation and return
of quality of life [C].
 Recommendation 28
Use of prostanoids in critical limb ischemia (CLI)
● Previous studies with prostanoids in CLI
suggested improved healing of ischemic ulcers
and reduction in amputations [A].
● However, recent trials do not support the benefit
of prostanoids in promoting amputation-free
survival [A].
● There are no other pharmacotherapies that can
be recommended for the treatment of CLI [B].
 Recommendation 29
Assessment of acute limb ischemia (ALI)
● Due to inaccuracy of pulse palpation and the
physical examination, all patients with
suspected ALI should have Doppler
assessment of peripheral pulses immediately
at presentation to determine if a flow signal is
present [C].