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Diagnosis and management of peripheral arterial disease - Scottish Intercollegiate Guidelines Network (SIGN) 89

Authors:

Abstract

In 2005-6 I was surgical senior editor of the SIGN Guidelines. This guideline was withdrawn in 2015. Peripheral arterial disease (PAD) in the legs, sometimes known as peripheral vascular disease, is caused by atheroma (fatty deposits) in the walls of the arteries leading to insufficient blood flow to the muscles and other tissues. Patients with PAD may have symptoms but can also be asymptomatic. The commonest symptom, intermittent claudication, is characterised by leg pain and weakness brought on by walking, with disappearance of the symptoms following rest. Patients diagnosed as having PAD, including those who are asymptomatic, have an increased risk of mortality, myocardial infarction and stroke. Relative risks are two to three times that of age and sex matched groups without PAD.1,2 Management of PAD provides an opportunity for secondary prevention of cardiovascular events. Both lifestyle changes and therapeutic interventions to reduce risk need to be considered. Patients with claudication can have a significantly reduced quality of life due to their restricted mobility. Careful consideration needs to be given to drug and lifestyle management of claudication so that patients can achieve an optimum quality of life within the limitations of their condition. In the primary care setting, the methods of diagnosis and the criteria for referral to a specialist vary between general practitioners, while in secondary care the use of diagnostic investigations and the routine follow up of patients varies between specialists. These differences in clinical practice suggest that, where feasible, guidance is required on the best approach to managing patients with PAD.
Diagnosis and management of
peripheral arterial disease
A national clinical guideline
1 Introduction 1
2 Cardiovascular risk reduction 3
3 Referral, diagnosis and investigation 7
4 Treatment of symptoms 13
5 Follow up 19
6 Information for discussion with patients and carers 21
7 Development of the guideline 23
8 Implementation, audit and resource implications 26
Abbreviations 28
Annexes 29
References 34
October 2006
89
COPIES OF ALL SIGN GUIDELINES ARE AVAILABLE ONLINE AT WWW.SIGN.AC.UK
89
Scottish Intercollegiate Guidelines Network
SIGN
KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS
LEVELS OF EVIDENCE
1++ High quality meta-analyses, systematic reviews of randomised controlled trials
(RCTs), or RCTs with a very low risk of bias
1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low
risk of bias
1 - Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or
bias and a high probability that the relationship is causal
2+ Well conducted case control or cohort studies with a low risk of confounding or
bias and a moderate probability that the relationship is causal
2 - Case control or cohort studies with a high risk of confounding or bias
 andasignicantriskthattherelationshipisnotcausal
3 Non-analytic studies, eg case reports, case series
4 Expert opinion
GRADES OF RECOMMENDATION
Note: The grade of recommendation relates to the strength of the evidence on which the
recommendation is based. It does not reect the clinical importance of the recommendation.
A At least one meta-analysis, systematic review of RCTs, or RCT rated as 1++
and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable
to the target population, and demonstrating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target
population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target
population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
GOOD PRACTICE POINTS
Recommended best practice based on the clinical experience of the guideline
development group
This document is produced from elemental chlorine-free material and is sourced from sustainable forests
Scottish Intercollegiate Guidelines Network
Diagnosis and management of
peripheral arterial disease
A national clinical guideline
October 2006
© Scottish Intercollegiate Guidelines Network
ISBN 1 899893 54 7
First published 2006
SIGN consents to the photocopying of this guideline for the
purpose of implementation in NHSScotland
Scottish Intercollegiate Guidelines Network
28 Thistle Street, Edinburgh EH2 1EN
www.sign.ac.uk
1
1 Introduction
1.1 THE NEED FOR A GUIDELINE
Peripheral arterial disease (PAD) in the legs, sometimes known as peripheral vascular disease,


         

Patients diagnosed as having PAD, including those who are asymptomatic, have an increased
 
1,2 Management of PAD provides an opportunity
          


3 Careful consideration needs to be given to drug and lifestyle management of


In the primary care setting, the methods of diagnosis and the criteria for referral to a specialist
vary between general practitioners, while in secondary care the use of diagnostic investigations



1.2 REMIT OF THE GUIDELINE



issue of when to refer a patient with PAD for intervention is discussed, as are possible diagnostic


but not to prevention of disease in individuals without evidence of existing vascular disease
nor to individuals with critical limb ischaemia – a severe manifestation of PAD characterised

            
podiatrists, physiotherapists, occupational therapists, nurses, interventional and diagnostic

1
1 INTRODUCTION
2
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1.3 STATEMENT OF INTENT
        
of care are determined on the basis of all clinical data available for an individual case and
     
       
every case, nor should they be construed as including all proper methods of care or excluding

made by the appropriate healthcare professional(s) responsible for clinical decisions regarding
       
following discussion of the options with the patient, covering the diagnostic and treatment

or any local guidelines derived from it should be fully documented in the patient’s case notes

1.4 REVIEW AND UPDATING

to the guideline in the interim period will be noted on the SIGN website: www.sign.ac.uk
3
3
2+
4
2 Cardiovascular risk reduction
2.1 INTRODUCTION
          


 


4-6
Patients shown to have peripheral arterial disease should be referred within primary care
  
  

  
2.2 SMOKING CESSATION

   

7 In another observational study of patients with
           
      


and non-vascular diseases
Scotland provides information on smoking cessation strategies which are as relevant to patients
10
D Patients with peripheral arterial disease should be actively discouraged from
smoking.
Smoking cessation methods, including nicotine replacement therapy and counselling,
  
2 CARDIOVASCULAR RISK REDUCTION
4
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1++
1+
2++
3
4
2++
4
2.3 CHOLESTEROL LOWERING
1112,13
assessed the impact of cholesterol lowering on cardiovascular events in people with peripheral
             
peripheral arterial disease included all cause mortality and/or non-fatal cardiovascular events
14-16




12
        



   
13

reduce the incidence of total fatal and non-fatal cardiovascular events (coronary artery disease

A Lipid lowering therapy with a statin is recommended for patients with peripheral
arterial disease and total cholesterol level > 3.5 mmol/l.
2.4 GLYCAEMIC CONTROL
People with both peripheral arterial disease1,2 and diabetes mellitus are at increased risk of


diabetes, increasing glycaemia (measured as glycosylated haemoglobin, HbA1C) was associated
20 Modelling of data from the
1C has been associated with


21
B Optimal glycaemic control is recommended for patients with peripheral arterial disease
and diabetes in order to reduce the incidence of cardiovascular events.

  22
2.5 WEIGHT REDUCTION
      
2)
has been adversely associated with a number of cardiovascular risk factors (blood pressure,
plasma cholesterol, triglycerides, glucose tolerance and thrombogenesis)23,24 and with an

D Obese patients with peripheral arterial disease should be treated to reduce their
weight.
26
1++
1+
2++
1+
2.6 BLOOD PRESSURE CONTROL
            
            

     
    27 In PAD patients
          
especially beta blockers, may have adverse effects on PAD due to possible drug induced

In a Cochrane systematic review of the treatment of hypertension in PAD, 46 relevant studies
    

    





 In a subgroup analysis, the effects on patients with symptomatic PAD and those with







Hypertensive patients with PAD are also at considerably increased risk of renovascular disease


A Hypertensive patients with peripheral arterial disease should be treated to reduce their
blood pressure.
27
2.7 HOMOCYSTEINE LOWERING
An elevated plasma homocysteine level has been implicated as an independent risk factor
            


a relationship between high homocysteine levels and cardiovascular events30 and all-cause and
vascular mortality,31 no randomised controlled trials have evaluated homocysteine-lowering in

One randomised controlled trial investigated homocysteine-lowering treatment with folic acid
    32 At

demonstrated no apparent effect of vitamin treatment on peripheral arterial abnormalities, as



2 CARDIOVASCULAR RISK REDUCTION
6
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1++
1++
1+
1+
1++



2.8 ANTIPLATELET THERAPY
Studies investigating the risks of major cardiovascular events over time in patients with PAD

 


     

 
 
33
           
claudication and those having peripheral vascular grafting and angioplasty (although the result

34
           
   



  36          

be exercised in the interpretation of this result as the trial was not powered to detect a realistic



  
  

37


In trials comparing different aspirin regimens in patients with cardiovascular disease, doses

33

A Antiplatelet therapy is recommended for patients with symptomatic peripheral arterial
disease.
7
3
3 Referral, diagnosis and investigation
3.1 DEFINITIONS
 describes PAD as follows:
Stage I asymptomatic
Stage II intermittent claudication
Stage III rest pain / nocturnal pain
Stage IV necrosis / gangrene

3.2 DIAGNOSTIC FEATURES OF INTERMITTENT CLAUDICATION
          
  
 



3.3 INVESTIGATIONS IN PRIMARY CARE
 
             
should include:
examination of peripheral pulses: femoral/popliteal/foot

Many patients do not present with a classical history, or present with multiple pathology, which is



for use in patients with intermittent claudication may be useful for determining health status
40
Individuals with a history of intermittent claudication should have an examination of
  
 




will help to differentiate patients with exercise leg pain due to other causes from those with

      
           
41


3 REFERRAL, DIAGNOSIS AND INVESTIGATION
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
3
3
3
2+
42,43 A
common method is to relate the highest pressure at the ankle to the higher systolic pressure of

44
(see Annex 1 for a method of measuring
ankle pressure recommended by the Society of Vascular Technology).
Ankle brachial pressure index should be measured in all patients suspected of peripheral
  
Measurement of ankle brachial pressure index should be taken by properly trained
  




 
    


Imaging may be appropriate to exclude PAD when there is a discrepancy between clinical

 

46 It may be helpful


 



 
As treadmills are not widely available in primary care, largely due to the need for resuscitation
    

discrepancy between history and clinical signs, as it provides objective evidence of a patient’s

 
Despite the increasing availability of pulse oximeters in primary care for the management of

47
 

that they may be able to detect PAD during exercise, 


2++
2+
3.4 REFERRAL
       

   



 

three times faster in the patient with claudication compared to the normal population; however
          



of life, such as hypertension, and chronic knee, hip and back pain, which are unrelated to the

Patients with suspected peripheral arterial disease should be referred to secondary
care if:

necessary to institute and monitor best medical treatment or is concerned that the
symptoms may have an unusual cause, or;
risk factors are unable to be managed to recommended targets, or;
the patient has symptoms which limit lifestyle and objective signs of arterial disease
 

  
3.5 CONDITIONS WITH SIMILAR PRESENTATIONS TO PERIPHERAL ARTERIAL
DISEASE
Symptoms of chronic compartment syndrome, venous claudication, neurogenic claudication

Chronic compartment syndrome causes a tight, bursting pain in the calf muscles, typically in


Venous claudication produces a tight, bursting pain which can affect the entire leg, but is
usually worse in the thigh and groin, typically in people with a past history of iliofemoral deep







relieved by rest, and can occur at rest, but is usually more comfortable if sitting, and the weight

3 REFERRAL, DIAGNOSIS AND INVESTIGATION
10
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
4
3.6 INVESTIGATIONS IN SECONDARY CARE
 
Major technical advances have been made in recent years in the development of non-invasive
              



    
applicable to a minority of patients with intermittent claudication, and then only after risk factors

the small group of patients in whom there is a discrepancy between the history and objective
   
extent of disease in order to determine suitability for intervention and occasionally to differentiate

options for imaging are as follows:
digital subtraction angiography (DSA)
duplex ultrasound
magnetic resonance angiography
computed tomography angiography
 
         
       


           
projections
it may overestimate the length of occlusions

   
   
        

Disadvantages include complications of catheterisation which may occur both within the vessel
 
severe, improvements in catheter and guidewire technology have reduced their incidence




D Digital subtraction arteriography is not recommended as the primary imaging modality
for patients with peripheral arterial disease.
In patients with intermittent claudication the use of subtraction arteriography should
only be necessary as an immediate prelude to intervention during the same
  
11
2+
1++
 

          
waveform are affected by stenoses the peak systolic velocity ratio is the most widely adopted
 A peak systolic velocity ratio of greater than two indicates a stenosis of greater

 A






        



 
             
   
      




 One meta-analysis determined
 Another meta-analysis




           
            
60
          
to ionising radiation and there is no risk of contrast nephropathy when gadolinium is used
   
Magnetic resonance angiography is performed as a fast non-invasive outpatient procedure




to tolerate the examination and the presence of some metallic implants (such as pacemakers)

3 REFERRAL, DIAGNOSIS AND INVESTIGATION
12
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1+
2+
 
            
dramatically improved arterial resolution and a moving tabletop enables examination from aorta

normally represented in maximum intensity projection format producing easily interpretable




61
62
63
Computed tomography angiography is also excellent for assessment of aneurysms and acute


risk of an allergic reaction to contrast, nephrotoxicity and exposure to ionising radiation as for

A Non-invasive imaging modalities should be employed in the rst instance for patients
with intermittent claudication in whom intervention is being considered.
13
1++
4 Treatment of symptoms
4.1 INTRODUCTION
Peripheral arterial disease, and its most common manifestation, intermittent claudication, are
64 Patients with PAD, even in the absence
of myocardial infarction or ischaemic stroke, have approximately the same relative risk of death



66
Patients with PAD have a similar mortality to patients with angina and management of ischaemic
muscle pain in the leg should receive as much attention as the aetiologically similar pain of



and well recognised placebo response in this patient group, only randomised controlled trials



drugs with a UK licence for the treatment of intermittent claudication
drugs/procedures with no licence but which have been studied in research protocols and
published in peer review journals

4.2 LICENSED DRUG THERAPY FOR PERIPHERAL ARTERIAL DISEASE
             
claudication:
cilostazol
naftidrofuryl
oxpentifylline
inositol nicotinate
cennarizine
 
         67 Cilostazol inhibits
phosphodiesterase III and increases the level of cyclic adenosine monophosphate causing
 It also attenuates the proliferative response to a variety of pro-atherogenic






70,71

        

4 TREATMENT OF SYMPTOMS
14
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1+
1++
1-
1+
A Patients with intermittent claudication, in particular over a short distance, should be
considered for treatment with cilostazol.
A If cilostazol is ineffective after three months, or if adverse effects prevent compliance
with therapy, the drug should be stopped.
            
effectiveness of cilostazol is not demonstrated and therefore it is not recommended for use in
72
 

   73
drug is given in a dose of 100 mg three times a day initially, increasing to 200 mg three times

            
number of studies were excluded from consideration because of poor study design (eg lack

 although only one
  76,77 In one study patients who had

74
76,77
A Patients with intermittent claudication and who have a poor quality of life may be
considered for treatment with naftidrofuryl.
 

properties of blood by decreasing its viscosity, A


7 supported
    

A Oxpentifylline is not recommended for the treatment of intermittent claudication.
 

    

     
 and


B Inisitol nicotinate is not recommended for the treatment of intermittent
claudication.

1+
1+
 

    
controlled single dose or short term studies,       


cinnarizine over a period ranging from four weeks to six months but standardised treadmill


It is not possible to make a recommendation for the use of cinnarizine in the treatment of

4.3 UNLICENSED RESEARCH DRUGS AND PROCEDURES


already be prescribed for the patient with intermittent claudication such as statins; compounds
that have been evaluated for critical limb ischaemia and extrapolated to the patient with
intermittent claudication such as prostaglandins; the novel area of growth factor application

            
Procedures include those such as pneumatic compression, chelation therapy and immune

 

    
used a standard test as endpoint in a small number of subjects, (the other evaluated pain free



group of patients (see section 2.3)
A Statins should be given for risk factor management in patients with intermittent
claudication and total cholesterol level > 3.5 mmol/l.
 
It was not possible to consider prostaglandins as a class as individual studies describe different







A The use of oral prostaglandin therapy in patients with intermittent claudication is not
recommended.
4 TREATMENT OF SYMPTOMS
16
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1+
1+
1-
1+
1++
1+
1+
1+
1+
 
  


 In this


rFGF-2 therapy is not recommended for the treatment of intermittent claudication as the evidence
              
       

 

       

 
100101 A single
102
 
One small trial of immune modulation suggested that it may be effective in improving walking
      
     
103
 
       104 which used a complex treatment

 
Chelation therapy involves the administration of a man-made amino acid, ethylenediamine

patients with intermittent claudication, which showed no difference between experimental


4.4 ALTERNATIVE THERAPIES
A number of unlicensed alternative therapies have been evaluated in patients with intermittent
             

 
A meta-analysis of Gingko biloba studies was found to have inconsistency in the endpoints of

106

It is not possible to make a recommendation concerning the Gingkho biloba therapy of the
meta-analysis as the evidence base rests on studies with non-standard endpoints, and the effect

17
1+
1++
1+
4
 

107
    


4.5 EXERCISE THERAPY
In patients suffering from intermittent claudication it has long been thought that increasing




A Cochrane review of seven trials which directly compared supervised with unsupervised
exercise therapy in patients with intermittent claudication showed that supervised exercise
         
walking distance compared with unsupervised exercise therapy regimens, with an overall
   
              

the supervised exercise therapy groups than the unsupervised exercise therapy groups, these



    All the studies were
small and investigated a range of exercise types and regimens including treadmill walking,






A Patients with intermittent claudication should be encouraged to exercise.
4.6 VASCULAR INTERVENTION
              
  





In the absence of a body of good trial evidence for both endovascular and surgical intervention,
           
      116   
Consensus has grouped lesions with similar morphology which are suitable for intervention
into four categories (A to D; see Annex 2
4 TREATMENT OF SYMPTOMS

DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1++
4
1++
4
D
 







   

116,117

or arterial stenting with a reasonable technical success rate but this is not recommended by

 

One trial of 264 patients randomised to vascular intervention, exercise training or no intervention

       

            
intermittent claudication:116
 
endovascular or surgical, the following considerations must be taken into account:
             
 
the patient must have a severe disability, either being unable to perform normal work or
having very serious impairment of other activities important to the patient
absence of other disease that would limit exercise even if the claudication was improved
(eg angina or chronic respiratory disease)
the individual’s anticipated natural history and prognosis
the morphology of the lesion must be such that the appropriate intervention would have
 
Endovascular and surgical intervention are not recommended for the majority of
patients with intermittent claudication.
For those with severe disability or deteriorating symptoms, referral to a vascular
specialist is recommended.
The TransAtlantic Inter-society consensus guidelines should be used when advising
patients about possible interventions.

4
3
4
5 Follow up
5.1 BENEFITS OF FOLLOW UP
Patients with PAD live with a chronic disease which in the main can only be controlled and not

based but the evidence base to guide the establishment of structured long term follow up is

It is generally recognised that structured care and follow up should be offered to patients with


condition
assess the clinical condition for improvement or deterioration
identify if further intervention is appropriate

 

  120    
121
 



to elements of secondary prevention that are already integral to the management of patients with


Primary care staff should ensure that all patients with peripheral arterial disease be
included in systematic disease management arrangements for the optimal management
  
 



 
               

          

122,123 Graft surveillance has been advocated in order

5 FOLLOW UP
20
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
1+
1-


controlled trials,124-126       127  
analysis included heterogeneous studies (including case series) which used different modes

utility of surveillance following infra-inguinal vein graft with one study124 including follow up




 


a multi-centre, prospective randomised controlled trial, all patients received vein grafts and

surgery there was no difference between the groups in terms of graft failure or amputation rate,

whether clinical follow up improves outcome compared to no follow up, this trial suggests


5.2 WHO SHOULD CARRY OUT FOLLOW UP?
        
          


care can usually best be provided by appropriately trained multidisciplinary teams and should
120 Automatic secondary

21
6 Information for discussion with patients and
carers
6.1 SAMPLE INFORMATION LEAFLET
            
Healthcare professionals may wish to adapt this for use in their own departments, remembering

INFORMATION FOR PATIENTS WITH PERIPHERAL ARTERIAL DISEASE
What is Peripheral Arterial Disease (PAD)?
Peripheral arterial disease (PAD), also known as peripheral vascular disease (PVD) or
peripheral arterial occlusive disease (PAOD) causes your legs to be sore, particularly when
you walk. The pain is usually in the calves of the leg but may be in the thigh or buttock. It
usually comes on when you walk and settles when you stop.
Other signs that you have the problem may include:
cold or numb toes or feet
sores on toes, feet or legs that won’t heal
loss of hair from feet, toes or legs.
If your legs do not hurt when you are at rest but you find you cannot walk as far as you used
to without feeling pain in your calves, then you may have PAD or intermittent claudication
as the symptoms are sometimes called.
What causes PAD?
PAD is caused by narrowing of the arteries following the development of fatty patches,
called atheroma or plaques in the artery walls - a bit like the scale forming on the inside of
water pipes. The amount of blood getting to the muscles of the legs is reduced and pain
is the result. The presence of the fatty deposits can also block the artery completely. This
process is exactly the same as can happen to the arteries carrying blood to your heart
(coronary arteries).
Cigarette smoking is a very important contributor to PAD. Other medical problems that can
contribute to PAD are high blood pressure and diabetes.
What can be done?
Your general practitioner may advise you to make some changes to your lifestyle, for example,
by taking more exercise. You will definitely be advised to stop smoking. The doctor may also
suggest taking a drug to reduce the amount of cholesterol in your blood - this is the main
cause of the build up of the fatty deposits. Also the doctor may prescribe a drug, eg aspirin,
to reduce the chance of a blood clot developing.
There are also drugs available which may relieve the pain of intermittent claudication.
If your PAD gets worse and causes a lot of pain your GP may refer you to a specialist -
probably a vascular specialist.
There are many tests to find out the extent of your disease and you may have the blood
pressure measured in your legs (just like having it done in your arm), an ultrasound scan of
the arteries (just like a pregnant mother has in order to visualise the baby, but in this case the
blood vessels, and any blockages, are visualised) or an angiogram (an X-ray examination
of the blood vessels).
6 INFORMATION FOR DISCUSSION WITH PATIENTS AND CARERS
22
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
If you have significant narrowing of the arteries the specialist may talk to you about the
possibility of angioplasty, a method of blowing up a balloon in the narrow area and widening
the artery, or bypass surgery, inserting a piece of a blood vessel or plastic to get round (or
bypass) the narrowed section of the artery. These procedures are usually only carried out
in patients with more severe disease.
One in five people with PAD have diabetes, so it is important that checks are made to see
if you are suffering from diabetes – if so, your GP will help you to keep it under control.
What can you do to help?
PAD is a disease which can usually be stabilised and as with many other problems associated
with the circulation, you will be actively discouraged from smoking. Over 90% of people with
PAD are smokers. That sends out a very clear-cut message. To greatly reduce the chances
of getting the disease or to improve your situation once PAD appears - stop smoking. Regular
exercise, and controlling your weight if you are obese, will also help. Modifying all of these
will also help reduce high blood pressure (as will the drugs prescribed by your doctor if
appropriate) if this is a contributing factor to your PAD.
What is the likely outcome of having PAD?
Most people with PAD who make these changes to their lifestyle either stabilise or improve
their symptoms.
With this reasonable outlook it is very important to follow the advice above and that given
to you by your GP/Nurse in relation to taking medication to decrease the risk factors for
the disease. Importantly, sometimes when you have disease in your leg arteries, you also
have it in the heart or brain vessels, so taking prescribed tablets can prevent heart attacks,
and strokes.
6.2 SOURCES OF FURTHER INFORMATION FOR PATIENTS
British Heart Foundation
4 Shore Place



Circulation Foundation





Patient UK



23
7 Development of the guideline
7.1 INTRODUCTION
SIGN is a collaborative network of clinicians, other healthcare professionals and patient

by multidisciplinary groups of practicing clinicians using a standard methodology based on a

 
www.sign.ac.uk
7.2 THE GUIDELINE DEVELOPMENT GROUP
Professor Gerry Fowkes Professor of Epidemiology, Public Health Sciences
(Chair) University of Edinburgh
Ms Margaret Armitage Vascular Liaison Nurse, Greater Glasgow Primary Care Trust
  Professor of Vascular Medicine, Ninewells Hospital and
Medical School, Dundee
  Lay representative, Penicuik
  Senior Lecturer and Consultant Vascular Surgeon,
  AberdeenRoyalInrmary
Dr Henry Doig Lay representative, Glasgow
Dr Ian Gillespie Vascular (Interventional) Radiologist,
  RoyalInrmaryofEdinburgh
Ms Margaret Greene Vascular Technologist, Southern General Hospital, Glasgow
Ms Alison Howd Consultant Vascular Surgeon,
Queen Margaret Hospital, Dunfermline
Dr Gordon Isbister General Practitioner, Beith
Dr Moray Nairn Programme Manager, SIGN Executive
Dr Jackie Price Clinical Lecturer, Public Health Sciences,
University of Edinburgh
  ClinicalNurseSpecialist,RoyalInrmaryofEdinburgh
   Senior Vascular Physiotherapist,
Raigmore Hospital, Inverness
Ms Helen Scott Superintendent Physiotherapist WESTMAR,
Southern General Hospital, Glasgow
Ms Valerie Sinclair VascularNurse,StirlingRoyalInrmary
Ms Christine Smith Vascular Liaison Nurse, Raigmore Hospital, Inverness
Mrs Ailsa Stein InformationOfcer,SIGNExecutive
Specialist Registrar, Directorate of Public Health and
  Health Policy, Lothian NHS Board
November 2004)
  Specialist Registrar in Public Health, Lothian NHS Board
   Health Economist, Reproductive and Maternal Medicine,
Division of Developmental Medicine, University of Glasgow





7 DEVELOPMENT OF THE GUIDELINE
24
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
7.3 ACKNOWLEDGEMENTS
SIGN is grateful to the following members of the guideline development group for their

Dr John Forbes Health Economist, Public Health Sciences,
University of Edinburgh
Mr John Hamley Chief Pharmacist, Primary Care Division, NHS Tayside
7.4 SYSTEMATIC LITERATURE REVIEW

A systematic review of the literature was carried out using an explicit search strategy devised


          





7.5 CONSULTATION AND PEER REVIEW
 
A national open meeting is the main consultative phase of SIGN guideline development, at



also available on the SIGN website for a limited period at this stage to allow those unable to

 

who were asked to comment primarily on the comprehensiveness and accuracy of interpretation


   General Practitioner, Montrose
   Lay Representative, British Vascular Foundation
  CSO Research Training Fellow, University of Edinburgh
Dr San Chackraverty Consultant in Radiology, Ninewells Hospital and
Medical School, Dundee
  Lecturer in Podiatry, Queen Margaret University
College, Edinburgh
Mr Douglas Forrest Podiatrist, Southern General Hospital, Glasgow
Dr Peter Gaines Consultant Vascular Radiologist,
  NorthernGeneralHospital,Shefeld
Ms Karen Gallacher ChiefVascularScientist,RoyalInrmaryofEdinburgh
Dr Dugald Glen ConsultantRadiologist,StirlingRoyalInrmary
Dr Jeff Hussey ConsultantRadiologist,AberdeenRoyalInrmary
Dr Jon Moss Consultant Interventional Radiologist,
Gartnavel General Hospital, Glasgow
Dr David Nichols Consultant Radiologist, Raigmore Hospital, Inverness
  Vascular Nurse, Queen Margaret Hospital, Dunfermline

  Consultant Interventional Radiologist,
  AberdeenRoyalInrmary
  ConsultantVascularSurgeon,StirlingRoyalInrmary
 
      
the relevant specialty representatives on SIGN Council to ensure that the specialist reviewers’
             
  

Chair of SIGN; Co-Editor
Dr David Alexander General Practitioner, Nethertown Surgery, Dunfermline
Professor Ian Campbell ConsultantPhysician,VictoriaInrmary,Kirkcaldy
Mr Chris Oliver Consultant Trauma Orthopaedic Surgeon,
  RoyalInrmaryofEdinburgh
  SIGN Programme Director; Co-Editor
  Director of SIGN; Co-Editor
7 DEVELOPMENT OF THE GUIDELINE
26
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
8 Implementation, audit and resource
implications
8.1 LOCAL IMPLEMENTATION


every guideline immediately on publication, but mechanisms should be in place to ensure
that the care provided is reviewed against the guideline recommendations and the reasons for





8.2 RESOURCE IMPLICATIONS

resource use in Scotland and the likely impact of the implementation of the recommendations
     

          



A Non-invasive imaging modalities should be employed in the rst instance for patients
with intermittent claudication in whom intervention is being considered.

          


A Patients with intermittent claudication should be encouraged to exercise.
Supervised exercise programmes for patients with intermittent claudication are not currently
          
dedicated staff and facilities to provide structured programmes for all patients with intermittent

8.3 KEY POINTS FOR AUDIT

 

cholesterol lowering, blood pressure control, glycaemic control, weight loss and antiplatelet
 
27
8.4 RECOMMENDATIONS FOR RESEARCH

 
 

 

forms of exercise therapy (supervised vs unsupervised and different forms of supervision)
 

      
 
            
 

 

 
            
 
8 IMPLEMENTATION, AUDIT AND RESOURCE IMPLICATIONS

DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
Abbreviations
ABPI ankle brachial pressure index
ACE angiotensin-converting enzyme
ATA anterior tibial artery
CAPRIE 
CHARISMA        
Management, and Avoidance trial
CHD coronary heart disease
CI 
CIA common iliac artery
CFA common femoral artery
CTA computed tomography angiography
CVD cardiovascular disease
DPA dorsalis pedal artery
DSA digital subtraction angiography
DVT deep vein thrombosis
EDTA ethylenediamine tetraacetic acid
EIA external iliac artery
GP general practitioner
HbA1C glycosylated haemoglobin
HOPE 
LEADER 
MI myocardial infarction
MRA magnetic resonance angiography
OR odds ratio
PAD peripheral arterial disease
PAOD peripheral arterial occlusive disease
PERA peroneal artery
PTA posterior tibial artery
PVD peripheral vascular disease
QoL 
RCT randomised controlled trial
rFGF-2 
RR relative risk
SIGN Scottish Intercollegiate Guidelines Network
TASC 
VEGF vascular endothelial growth factor

Annex 1
A recommended method for measurement of ankle
brachial pressure index

Step 1:

Step 2:
lateral edge of the hand against the patient’s bare skin (which helps to keep the probe absolutely
seegure1
 
and subtle adjustments in both position and angulation of the probe until the Doppler signal

   
seegure2
Figure 1: Location of brachial artery
Figure2:AngulationbetweenDopplerbeamandarterialbloodow
If the signal is not sharp and triphasic but damped, this arm should not be used to measure
            
artery disease, and the pressure maintained will not be a true representation of the systemic

ANNEXES
30
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
Step 3:







Step 4:

   



      
  



Step 5:              

Step 6:


Step1: Place the cuff around the right ankle, just above, but not covering, the malleolus
(seegure3)
Figure 3A: Correct application –
cuff low but not over the malleolus
Figure 3B: Incorrect application - cuff
wrapped too low - covering malleolus
-willgivearticiallyhighreading.
Step 2:
edge of the medial malleolus on a line between the medial malleolus and the heel (seegure4A
Adjust the probe on the skin to achieve the best Doppler signal but remember that, around the
ankle, the arteries may not run parallel to the skin surface and what may look like a poor angle
of interrogation may actually be very good (seegure5
31
Figure4A:Locationofrightposteriortibial
artery.
Figure4B:Dopplerprobetssnuglyinto
soft spot behind medial malleolus. Note
angulation of probe to achieve a good
angle of interrogation.
Figure5:Illustrationofhowskinsurfacesmaybemisleadingwithregardtodirectionofartery.

 

because artery curves away and Doppler beam

Step 3:
       


Step 4:        

Step 5:
Step 6seegure6) usually found either:
in the soft spot between the base of the hallux and the second toe (position a)




ANNEXES
32
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
Figure6:Locationofrightdorsalispedisarteryandanteriortibialartery
Step 7: 

on the lower leg just above the lateral malleolus

             

Step 8: 


Step 9: 

    
formula:
ABPI = Highest pressure obtained from the ankle vessels for that leg / Highest brachial
pressure of the two arms
Adapted from Vascular Laboratory Practice, Part III. Society for Vascular Technology / Institute of Physics and
Engineering. York, 2002.
33
Annex 2


TASC type A iliac lesions


TASC type B iliac lesions



TASC type C iliac lesions




TASC type D iliac lesions






ANNEXES
34
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
References
 


         

 
of life of people with peripheral arterial disease in the community:


          
        

         
   

    


         
claudication with physical training, smoking cessation, pentoxifylline,
        

 
and cardiovascular complications in patients with peripheral vascular


 

 

         
     

 
          
       

        


 


     
measurements over time: statistical analysis of the angiographic
       

 


                 
cardiovascular risk factors on coronary heart disease and mortality
  

                       

 


 

 

 
       


 

 

        

 
the prevention of coronary heart disease, stroke, and diabetes mellitus

 


26 National Obesity Forum Guidelines on Management of Adult Obesity
         

          
         
management of hypertension: report of the fourth working party of
   

 
    

 



           
        
asymptomatic vascular disease in siblings of young patients with
     

 
blinded study of the relationship between plasma homocysteine and
        

       



      
of randomised trials of antiplatelet therapy for prevention of death,


 
therapy for the prevention of myocardial infarction, stroke or vascular


 


 
    
Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of

 

dipyridamole in the secondary prevention of occlusive vascular events:


          
     

         

            

                     
                       

       


        
        


          
        


          
         
coronary heart disease, stroke and preclinical carotid and popliteal


 
Is toe pressure a better parameter of peripheral vascular integrity than
ankle pressure? Comparison of diabetic with nondiabetic subjects in


          


           
saturation (StO2): a new measure of symptomatic lower-extremity

 


 
of ankle brachial pressure index to predict cardiovascular events and

 



         

 

     
prospective comparison of lower limb colour-coded Duplex scanning

 
        

 
     

 
        

        
        

 
resonance angiography for the evaluation of lower extremity arterial

   
        
carotid artery stenosis and peripheral vascular disease: a systematic

                   
       
a prospective comparison with intraarterial digital subtraction

             
        
      

           
         
      
      

 
          

 



           


 



      
of cyclic nucleotide phosphodiesterase isoenzyme type-III and
         

         

 
from eight randomized, placebo-controlled trials on the effect of
          

           

         
with intermittent claudication due to peripheral arterial disease:
       

       



 


 


 



           

 


 
        

           


 

 
          

    

 

                 


              


          
      

                  

                      
     

      
the lower extremities and effects of a vasoactive agent in persons with
        

          
atorvastatin improves walking distance in patients with peripheral

       
         
of intermittent claudication in hypercholesterolemic patients with

 
sodium, a prostaglandin I(2) analogue, for intermittent claudication:
      
      

             
       
orally active prostaglandin I2 analogue: a double-blinded, randomized,

 



REFERENCES
36
DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
 

growth factor in peripheral arterial disease: a phase II randomized,
double-blind, controlled study of adenoviral delivery of vascular
endothelial growth factor 121 in patients with disabling intermittent

         
      
   

          
    

 
 

      
      
         

           
        
    

 
       
    


  
        
intermittent claudication: A controlled double-blind pilot study with
       

 
        
to determine the efficacy of immune modulation therapy in the
treatment of patients suffering from peripheral arterial occlusive
        

          
ability and ankle brachial pressure indices in symptomatic peripheral
vascular disease with intermittent pneumatic foot compression: a
        

 


           
     

         


        
Supervised exercise therapy versus non-supervised exercise therapy
       

          

      

 
         

 



           
maximum walking distance in early peripheral arterial disease:

 

 


          
       
         

 


 
       

            
        
intervention, supervised physical exercise training compared to no
treatment in unselected randomised patients I: one year results of


 
          
 
  

120 10 High Impact Changes for service improvement and delivery: a
          
         


 
       

 


 
fate of autogenous vein implants as arterial substitutes: clinical,
angiographic and histopathologic observations in femoro-popliteal

 
graft patency is improved by an intensive surveillance program: a

            
duplex scanning in infrainguinal vein graft surveillance: results
         

     
completely accomplished duplex-based surveillance prevent vein-graft

                   
results of infrainguinal bypass improved with the widespread
        

           
surveillance of value after leg vein bypass grafting?: principle results
        

 
    



DIAGNOSIS AND MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE
89
Patients with PAD should be actively discouraged from
smoking.
D
SMOKING CESSATION
On diagnosis of PAD, patients should have a full
cardiovascular risk factor assessment.
Patients should be referred to the practice cardiovascular
clinic for monitoring and long term follow up of risk
factor modification.
Patients with intermittent claudication, in particular
over a short distance, should be considered for
treatment with cilostazol.
Cilostazol should be stopped after three months if it is
ineffective, or if adverse effects reduce compliance.
A
Lipid lowering therapy with a statin is recommended
for patients with PAD and total cholesterol level
>3.5 mmol/l.
A
Optimal glycaemic control is recommended for patients with
PAD and diabetes to reduce the incidence of cardiovascular
events.
B
DRUG THERAPY
Patients with PAD have an increased risk of mortality,
myocardial infarction and stroke. Management of PAD is an
opportunity for secondary prevention of cardiovascular
events.
CHOLESTEROL LOWERING
GLYCAEMIC CONTROL
WEIGHT REDUCTION
Obese patients with PAD should be treated to reduce their
weight.
D
BLOOD PRESSURE CONTROL
Hypertensive patients with PAD should be treated to reduce
their blood pressure.
A
ANTIPLATELET THERAPY
Antiplatelet therapy is recommended for patients with
symptomatic PAD.
A
Patients with suspected PAD should be referred to secondary care if:
the primary care team is not confident of making the diagnosis, lacks the resources necessary to institute and monitor best
medical treatment or is concerned that the symptoms may have an unusual cause
risk factors are unable to be managed to recommended targets
they have symptoms which limit lifestyle and objective signs of arterial disease (clinical signs and a low ankle brachial pressure
index).
Young and otherwise healthy adults, presenting prematurely with claudication, should be referred to exclude entrapment syndromes
and other rare disorders.
Patients with intermittent claudication and who have a
poor quality of life may be considered for treatment with
naftidrofuryl.
A
Oxpentifylline is not recommended for the treatment of
intermittent claudication.
A
Inisitol nicotinate is not recommended for the treatment of
intermittent claudication.
B
Statins should be given for risk factor management in
patients with intermittent claudication and total cholesterol
level >3.5 mmol/l.
A
The use of oral prostaglandin therapy in patients with
intermittent claudication is not recommended.
A
EXERCISE THERAPY
Patients with intermittent claudication should be encouraged
to exercise.
A
VASCULAR INTERVENTION
Endovascular and surgical intervention are not
recommended for the majority of patients with
intermittent claudication.
For those with severe disability or deteriorating
symptoms, referral to a vascular specialist is
recommended.
The TransAtlantic Inter-society consensus guidelines
should be used when advising patients about possible
interventions.
D
CARDIOVASCULAR RISK REDUCTION
TREATMENT
Digital subtraction arteriography is not recommended as the primary imaging modality for patients with PAD.D
Non-invasive imaging modalities should be employed in the first instance for patients with intermittent claudication in whom
intervention is being considered.
A
INVESTIGATIONS IN PRIMARY CARE
Individuals with a history of intermittent claudication should have an examination of peripheral pulses and palpation of the
abdomen for an aortic aneurysm.
Ankle brachial pressure index should be measured in all patients with suspected PAD.
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Context Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis that is common and is associated with an increased risk of death and ischemic events, yet may be underdiagnosed in primary care practice.Objective To assess the feasibility of detecting PAD in primary care clinics, patient and physician awareness of PAD, and intensity of risk factor treatment and use of antiplatelet therapies in primary care clinics.Design and Setting The PAD Awareness, Risk, and Treatment: New Resources for Survival (PARTNERS) program, a multicenter, cross-sectional study conducted at 27 sites in 25 cities and 350 primary care practices throughout the United States in June-October 1999.Patients A total of 6979 patients aged 70 years or older or aged 50 through 69 years with history of cigarette smoking or diabetes were evaluated by history and by measurement of the ankle-brachial index (ABI). PAD was considered present if the ABI was 0.90 or less, if it was documented in the medical record, or if there was a history of limb revascularization. Cardiovascular disease (CVD) was defined as a history of atherosclerotic coronary, cerebral, or abdominal aortic aneurysmal disease.Main Outcome Measures Frequency of detection of PAD; physician and patient awareness of PAD diagnosis; treatment intensity in PAD patients compared with treatment of other forms of CVD and with patients without clinical evidence of atherosclerosis.Results PAD was detected in 1865 patients (29%); 825 of these (44%) had PAD only, without evidence of CVD. Overall, 13% had PAD only, 16% had PAD and CVD, 24% had CVD only, and 47% had neither PAD nor CVD (the reference group). There were 457 patients (55%) with newly diagnosed PAD only and 366 (35%) with PAD and CVD who were newly diagnosed during the survey. Eighty-three percent of patients with prior PAD were aware of their diagnosis, but only 49% of physicians were aware of this diagnosis. Among patients with PAD, classic claudication was distinctly uncommon (11%). Patients with PAD had similar atherosclerosis risk factor profiles compared with those who had CVD. Smoking behavior was more frequently treated in patients with new (53%) and prior PAD (51%) only than in those with CVD only (35%; P <.001). Hypertension was treated less frequently in new (84%) and prior PAD (88%) only vs CVD only (95%; P <.001) and hyperlipidemia was treated less frequently in new (44%) and prior PAD (56%) only vs CVD only (73%, P<.001). Antiplatelet medications were prescribed less often in patients with new (33%) and prior PAD (54%) only vs CVD only (71%, P<.001). Treatment intensity for diabetes and use of hormone replacement therapy in women were similar across all groups.Conclusions Prevalence of PAD in primary care practices is high, yet physician awareness of the PAD diagnosis is relatively low. A simple ABI measurement identified a large number of patients with previously unrecognized PAD. Atherosclerosis risk factors were very prevalent in PAD patients, but these patients received less intensive treatment for lipid disorders and hypertension and were prescribed antiplatelet therapy less frequently than were patients with CVD. These results demonstrate that underdiagnosis of PAD in primary care practice may be a barrier to effective secondary prevention of the high ischemic cardiovascular risk associated with PAD. Figures in this Article Peripheral arterial disease (PAD) is a highly prevalent atherosclerotic syndrome that affects approximately 8 to 12 million individuals in the United States and is associated with significant morbidity and mortality.1- 4 Because of its high prevalence, high rates of nonfatal cardiovascular ischemic events (myocardial infarction [MI], stroke, and other thromboembolic events), increased mortality, and diminution of quality of life, the consequences of PAD in US communities are significant.1- 5 A regional pilot study of community screening for PAD demonstrated that patient awareness of the PAD diagnosis was low and associated with low atherosclerosis risk factor, antiplatelet, and claudication treatment intensity.5 There have been no national efforts in the United States to detect PAD in community-based office practice, to assess both physician and patient awareness of the diagnosis, or to assess the intensity of medical treatments. PAD has not emerged as a focus of public health efforts to improve quality of life nor to decrease the associated cardiovascular ischemic risk. The PAD Awareness, Risk, and Treatment: New Resources for Survival (PARTNERS) program was designed as a national investigation to assess the feasibility of detecting PAD using the ankle-brachial index (ABI) in office-based practices. Additional goals were to assess both patient and physician awareness of PAD, to evaluate the magnitude of the associated atherosclerosis risk factor burden, and to assess the intensity of use of risk-reduction strategies in community practice. The program evaluated the following hypotheses: (1) that PAD is prevalent but underdiagnosed in primary care practices and (2) that PAD is undertreated in terms of risk factor modification and use of antiplatelet therapies compared with that in other cardiovascular diseases (CVDs).
Article
Padma 28, a complex herbal formula, has been used successfully in clinical trials to improve pain-free walking distance in patients with intermittent claudication. Using objective, non-invasive techniques of vascular testing, a randomised, 6 month double-blind pilot study assessed the efficacy, safety and tolerance of Padma 28 in patients with peripheral arterial occlusive disease (PAOD), compared to controls. Padma 28 patients displayed a significant mean improvement of 12% in exercise-induced drop of ankle pressure and 0.8 min in pressure recovery time compared to pre-treatment values. An improvement in pressure drops by more than 15%, compared to a deterioration or no change, occurred in 48% of Padma 28 patients compared to 22% of controls. Calculation of the 'ischaemic window', a quantitative expression of post-exercise hyperaemia, showed a significant reduction of 54% following treatment with Padma 28 compared to 18.8% in controls. Self-assessment by patients revealed that perceived improvement in pain-free walking ability in the Padma 28 group correlated significantly with improvement in exercise-induced drop of ankle pressure. Padma 28 was well tolerated, with minimal unwanted side effects and associated with a significant improvement in patient well-being compared to controls. The pilot study demonstrates that following the stress of exercise, changes in ankle systolic pressure and its recovery time are positively affected by Padma 28. While the precise mode of action requires clarification, results suggest that Padma 28 may be an effective treatment for intermittent claudication.
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OBJECTIVE: To assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease. DESIGN: Double blind placebo controlled randomised trial. SETTING: 85 general practices and nine hospital vascular clinics. PARTICIPANTS: 1568 men, mean age 68.2 years (range 35 to 92) at recruitment. INTERVENTIONS: Bezafibrate 400 mg daily (783 men) or placebo (785 men). Main outcome measures: Combination of coronary heart disease and of stroke. All coronary events, fatal and non-fatal coronary events separately, and strokes alone (secondary end points). RESULTS: Bezafibrate did not reduce the incidence of coronary heart disease and stroke. There were 150 and 160 events in the active and placebo groups respectively (relative risk 0.96, 95% confidence interval 0.76 to 1.21). There were 90 and 111 major coronary events in the active and placebo groups respectively (0.81, 0.60 to 1.08), of which 64 and 65 were fatal (0.95, 0.66 to 1.37) and 26 and 46 non-fatal (0.60, 0.36 to 0.99). Beneficial effects on non-fatal events were greatest in men aged <65 years at entry, in whom benefit was also seen for all coronary events (0.38, 0.20 to 0.72). There were no significant effects in older men. There were 60 strokes in those on active treatment and 49 in those on placebo (1.34, 0.80 to 2.01). There were 204 and 195 deaths from all causes in the two groups respectively (1.03, 0.83 to 1.26). Bezafibrate reduced the severity of intermittent claudication for up to three years. CONCLUSIONS: Bezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events, particularly in those aged <65 years at entry, in whom all coronary events may also be reduced.
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A higher prevalence of stroke is found in diabetic patients. Cerebral infarcts are more frequent than hemorrhages, because of an increased of atherogenesis due to chronic hyperglycemia. Some clinical aspects are common in diabetic patients especially the association with hypertension or cardiopathy. Biological and radiological features of diabetic and non- diabetic stroke patients are similar. Diabetic patients have a higher risk of death and sequelae. The therapeutic strategy should not differ in diabetic patients but the glucose level should be maintained within normal range during the acute stage. Antiplatelet drugs should be evaluated in primary prevention in diabetic patients.
Article
Exercise has been shown to improve walking ability in individuals with arterial claudication. This study compared the effects of an on-site supervised exercise program and a home exercise program on quality of life and psychological outcomes in these individuals. Sixty individuals were randomly assigned to a 12-week on-site or a 12-week home-based exercise program. Quality of life, mood and pain symptoms, and walking ability were examined at baseline, posttreatment, and at 6 months follow-up. Individuals in the on-site exercise program showed significantly greater improvements in walking ability. Although sample size limited the ability to detect significant differences between groups on quality of life and psychological measures, both groups were comparable on improvements in quality of life and in mood. These data suggest that a home exercise program with weekly feedback may provide improved quality of life and mood benefits for individuals with arterial claudication but does not provide improvements in walking equivalent to those provided by an on-site exercise program.
Article
Objective: To review the pharmacology and clinical utility of cilostazol, an antiplatelet and vasodilator agent approved for the management of intermittent claudication. Data sources: Primary literature on cilostazol was identified from a comprehensive MEDLINE literature search (1980-February 2000). Selected meeting abstracts and manufacturer literature were also used as source material. Indexing terms included cilostazol, intermittent claudication, platelet inhibitors, and restenosis. Study selection: Human clinical, pharmacokinetic and randomized comparative trials performed in the US and Asia were reviewed. Selected in vitro, ex vivo, and animal studies were evaluated when human data were not available. Data synthesis: Intermittent claudication, defined as reproducible discomfort of a muscle group induced by exercise and relieved by rest, is the most common clinical manifestation of peripheral arterial disease (PAD). Cilostazol, a specific inhibitor of cyclic adenosine monophosphate phosphodiesterase in platelets and vascular smooth-muscle cells, is a potent antiplatelet agent and vasodilator that reduces vascular proliferation and has lipid-lowering effects in vivo. Recent multicenter, randomized, placebo-controlled trials have led to approval of cilostazol by the Food and Drug Administration for relief of intermittent claudication in patients with stable PAD. Cilostazol doubled walking distances and improved quality of life compared with placebo in these studies. One trial found that cilostazol was more effective than pentoxifylline, the only alternative pharmacologic therapy for claudication. Although frequent (approximately 50%) minor adverse effects, including headache, diarrhea, and palpitations, may occur in clinical practice, cilostazol has not been associated with major adverse events or increased mortality. Small, nonblind studies suggest that cilostazol may prove useful in preventing thrombosis and restenosis following percutaneous coronary interventions, although these remain unlabeled uses. Conclusions: The unique combination of antiplatelet, vasodilatory, and antiproliferative effects of cilostazol appear to make it an attractive agent for use in patients with PAD. Clinical trials demonstrating a significant improvement in walking distances with cilostazol therapy suggest that it will be an important tool in improving symptoms and quality of life in patients with intermittent claudication.
Article
Forty-six patients with clinically significant peripheral atherosclerosis were randomly allocated into two groups; one receiving tablets of betapyridyl carbinol, up to 1800 mg daily, the other receiving a placebo. Patients were assessed clinically and their performance on a treadmill measured over intervals for two years. Plasma lipids were also measured. There was a slightly significant improvement in clinical findings after two years in those receiving drug treatment but no difference in symptoms. Treadmill performance appeared to improve equally in both placebo and drug treated groups. The plasma cholesterol fell significantly in the treated group compared the controls but the plasma triglycerides were not altered. Drop-outs from the trial did not differ significantly between the two groups. Two cases of hepatocellular dysfunction were attributable to betapyridyl carbinol.
Article
In epidemiological studies, the indirectly measured ankle pressure is a widely accepted parameter for the assessment of peripheral vascular disease. In diabetics, the value of this parameter is limited if the stiffness of the arterial wall is increased due to Monckeberg calcification. In those cases, a falsely raised ankle/brachial pressure index is found. Because digital arteries are commonly not calcified, the toe pressure should be a better representation of the intra-arterial pressure. In this study, the value of the toe pressure is compared with the ankle pressure in a representative sample of a Dutch Caucasian population stratified with respect to age, sex, and glucose tolerance. The sample contained 173 diabetic and 458 nondiabetic subjects between 50 and 75 years old. Based on qualitative analysis of Doppler velocity waveforms from the leg arteries, subjects were classified with respect to hemodynamically significant arterial obstructions. We found a significantly higher ankle/brachial index in the nondiabetic group; the toe/brachial indices did not differ. Twenty-three percent of the subjects had a high ankle/brachial index (>1.15) without a statistically significant difference in relation to diabetes. In subjects without evidence of severe peripheral vascular disease (normal Doppler waveforms and ankle/brachial index >0.90), the ankle pressure showed a good correlation with the brachial pressure (explained variance >0.72) in contrast to the toe pressure (explained variance <0.14). The superior correlation of the ankle over the toe pressure was also seen at high ankle/brachial indices. It can be concluded that the measurement of toe pressure does not add to the accuracy of indirect blood pressure measurements in epidemiological studies concerning the prevalence of peripheral arterial disease.