CD 000017

Angioplasty (versus non surgical management) for
intermittent claudication (Review)

Fowkes G, Gillespie IN
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2008, Issue 4
http://www.thecochranelibrary.com
Angioplasty (versus non surgical management) for intermittent claudication (Review)

Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Any angioplasty versus any non surgical management at 6 months, Outcome 1 Treadmill
claudication distance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.2. Comparison 1 Any angioplasty versus any non surgical management at 6 months, Outcome 2 Treadmill
walking distance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.3. Comparison 1 Any angioplasty versus any non surgical management at 6 months, Outcome 3 Ankle brachial
pressure index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.4. Comparison 1 Any angioplasty versus any non surgical management at 6 months, Outcome 4 Duplex patent
artery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 2.3. Comparison 2 Any angioplasty versus any non surgical management at 24 months and over, Outcome 3
Ankle brachial pressure index. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 2.4. Comparison 2 Any angioplasty versus any non surgical management at 24 months and over, Outcome 4
Duplex patent artery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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[Intervention Review]
Angioplasty (versus non surgical management) for

intermittent claudication
Gerry Fowkes1 , Ian N Gillespie2
1 Wolfson Unit for Prevention of Peripheral Vascular Diseases, The University of Edinburgh, Edinburgh, UK. 2 Department of Radiology,
New Royal Infirmary of Edinburgh, EDINBURGH, UK

Contact address: Gerry Fowkes, Wolfson Unit for Prevention of Peripheral Vascular Diseases, The University of Edinburgh, Department
of Public Health Sciences, Teviot Place, Edinburgh, EH8 9AG, UK. gerry.fowkes@ed.ac.uk.
Editorial group: Cochrane Peripheral Vascular Diseases Group.
Publication status and date: Edited (no change to conclusions), published in Issue 4, 2008.
Review content assessed as up-to-date: 22 August 2006.
Citation: Fowkes G, Gillespie IN. Angioplasty (versus non surgical management) for intermittent claudication. Cochrane Database of
Systematic Reviews 1998, Issue 2. Art. No.: CD000017. DOI: 10.1002/14651858.CD000017.
ABSTRACT
Background
Intermittent claudication is pain in the legs due to muscle ischaemia associated with arterial stenosis or occlusion. Angioplasty is a
technique that involves dilatation and recanalisation of a stenosed or occluded artery.
Objectives
The objective of this review was to determine the effects of angioplasty of arteries in the leg when compared with non surgical therapy,
or no therapy, for people with mild to moderate intermittent claudication.
Search strategy
Sources searched include the Cochrane Peripheral Vascular Diseases Groups Specialized Trials Register (August 2006), the Cochrane
Central Register of Controlled Trials (CENTRAL, Issue 3, 2006) and reference lists of relevant articles. The review authors also
contacted investigators in the field and handsearched relevant conference proceedings (August 2006).
Selection criteria
Randomised trials of angioplasty for mild or moderate intermittent claudication.
Data collection and analysis
The contact author selected suitable trials and this was checked by the other review author. Both review authors assessed trial quality
independently. The contact author extracted data and this was cross checked by the other review author.
Main results
Two trials with a total of 98 participants were included. The average age was 62 years old with 20 women and 78 men. Participants
were followed for two years in one trial and six years in the other.
At six months follow up, mean ankle brachial pressure indices were higher in the angioplasty groups than control groups (mean
difference 0.17; 95% confidence interval (CI) 0.11 to 0.24). In one trial, walking distances were greater in the angioplasty group, but
in the other trial, in which controls underwent an exercise programme, walking distances did not show a greater improvement in the
angioplasty group. At two years follow up in one trial, the angioplasty group were more likely to have a patent artery (odds ratio 5.5;
95% CI 1.8 to 17.0) but not a significantly better walking distance or quality of life. In the other trial, long term follow up at six years
demonstrated no significant differences in outcome between the angioplasty and control groups.
Authors conclusions
These limited results suggest that angioplasty may have had a short term benefit, but this may not have been sustained.
PLAIN LANGUAGE SUMMARY

Angioplasty versus conservative management of intermittent claudication, leg pain on walking
Intermittent claudication is evident as pain in the leg that becomes apparent when walking and is relieved by rest. The pain is the
result of insufficient blood flow to the calf muscles when exercising, generally because of atherosclerotic changes in the leg arteries so
that a section becomes narrowed or blocked. People with mild disease are advised to stop smoking, exercise, and take low-dose aspirin
to prevent heart attack or stroke. There is no widely accepted medication to treat claudication. Angioplasty involves using a balloon,
laser or mechanical device threaded down a leg artery to widen and open the narrowed or blocked section. Possible side effects of the
procedure include blood clots and movement of blood clots and debri (emboli). The immediate effect may be to relieve the symptoms
but narrowing can reoccur.
The review authors identified two controlled trials from the UK . A total of 98 participants took part. Their average age was 62 years
and only 20 were women. The participants were randomised to have either angioplasty or, in one trial, to follow an exercise program
or, in the other, to receive advice on smoking, aspirin and exercise. Six months later, both trials showed improvements in leg blood flow
in the people who had angioplasty, measured by comparing pressures at the ankle and the arm (mean ankle brachial pressure index). In
one trial, the distance walked on a treadmill improved more with exercise than angioplasty at six months and at one year. No benefits of
angioplasty were evident six years after surgery. In the other trial, blood flow was still improved two years after angioplasty but walking
distance without pain, which had improved at six months, and quality of life were no better than for participants receiving advice only.
Only these two trials with relatively small numbers of participants contributed to the conclusion that angioplasty provides only shortterm benefits.
BACKGROUND
Intermittent claudication is pain in the legs due to inadequate
blood flow to muscles associated with arterial narrowing (stenosis)
or obstruction (occlusion). The diagnosis is based on the classic
symptom of pain on walking relieved by rest. The ankle brachial
systolic pressure ratio is usually less than 0.9 in those with disease.
The patients history is not very accurate as a means of assessing
severity of disease; measuring walking distance to claudication and
to stopping on an exercise treadmill is less variable and is a preferred
measure. Angiography is considered the gold standard method
of measuring the anatomical extent of disease, but the hazards
associated with this technique of injecting dye into the arterial
tree often preclude its use in mild cases. In recent years, duplex
ultrasound scanning has shown promise as a valid noninvasive
measure of the site and extent of disease.
The treatment of claudication in people with severe symptoms is
often arterial reconstructive surgery or percutaneous transluminal
angioplasty (PTA). Those with milder disease are advised to stop

smoking, keep exercising, and to take aspirin for prevention of
major cardiovascular events. A great variety of medications have
been prescribed over the years, but none has been universally accepted as an effective treatment. More recently, angioplasty has
been used to treat milder forms of claudication.
Angioplasty is a technique which involves dilatation and recanalisation of a stenosed or occluded artery (Belli 1993). The most
commonly used technique is balloon dilatation but in recent years
technical developments have included the use of lasers and mechanical devices. Balloon dilatation acts by fracturing and compressing the atheromatous plaque (fatty deposit in the arterial wall)
leading to an increase in the calibre of the arterial lumen. The procedure is carried out in conjunction with angiography and access
is usually via the common femoral artery. Only lesions of limited
length (less than 10 cm) are suitable for angioplasty. The success of

angioplasty depends on the site of the lesion as well as the severity.
Types of interventions
Clinical experience and case series indicate that angioplasty may

have an immediate effect in relieving symptoms but restenosis may
occur (Price 1996). Also, side effects such as haematoma at the
puncture site and thrombosis (clotting) and embolisation (clot
movement) are known to occur. However, the technique has the
potential to be a successful treatment not only in people with
severe disease who would normally be offered major surgery, but
also in those with milder disease for whom there is no universally
accepted medical treatment.
Angioplasty of any type (e.g. balloon, laser) applied to lesions in

the aorto-iliac or femoropopliteal arterial segments. Comparison
interventions included specific nonsurgical interventions, such as
an exercise programme, or no specific intervention. Usual therapies
applied to the angioplasty group, such as antismoking advice, had
also to be applied to the control group.
OBJECTIVES
To determine the effectiveness of angioplasty in the treatment of
mild or moderate intermittent claudication. Comparisons of angioplasty with reconstructive surgery in severe disease are excluded.
The outcomes include clinical measurements of severity, non invasive tests of the extent of disease, complications of the procedure,
use of resources, and quality of life.
Types of outcome measures

In assessing long term effectiveness, those outcomes had to be assessed at least two years after the intervention. Outcome assessment had to include at least one of the parameters detailed under
Primary outcome above.
Primary outcomes
1. Maximum walking distance on treadmill exercise to onset

of claudication or stopping walking; ankle brachial pressure
index; grading of patency on duplex scanning.
The specific hypotheses are:

(1) angioplasty is more effective than no therapy;
Secondary outcomes
(2) angioplasty is more effective than conservative therapy such as

an exercise programme.
1. Complications of angioplasty including local haematoma

and limb loss.
2. Use of resources.
3. Quality of life.
Usual treatments such as aspirin and antismoking advice may or

may not be applied to each group.
METHODS
Criteria for considering studies for this review
Types of studies
The trials in the review include only those in which people with
intermittent claudication were stated to be randomly allocated
to either angioplasty ( usual therapy) or a specific nonsurgical
intervention, or no intervention ( usual therapy).
Types of participants
Males and females of any age who had a diagnosis of intermittent
claudication made by an expert clinician. The severity of the claudication was mild or moderate such that the clinician considered
that reconstructive surgery was not justified. The symptoms were
considered to be due to one or more atherosclerotic lesions which
had been shown on duplex scanning and/or angiography to be
amenable to angioplasty (e.g. stenosis less than 10 cm long).
Search methods for identification of studies
Electronic searches
The Cochrane Peripheral Vascular Diseases (PVD) Group
searched their Specialized Register (last searched 4 August 2006)
and The Cochrane Central Register of Controlled Trials (last
searched The Cochrane Library 2006, Issue 3) for reports of randomised controlled trials of angioplasty compared with a specific
nonsurgical intervention or to no intervention for intermittent
claudication.
The PVD Groups Specialized Register has been constructed from
regular electronic searches of MEDLINE (from 1960 to date),
EMBASE (from 1980 to date), CINAHL (1982 to date) and from
handsearching relevant journals and conference proceedings.
The full list of journals that have been handsearched, as well
as the search strategies used to search databases are described
in the editorial information about the Cochrane PVD Group
in The Cochrane Library http://www.mrw.interscience.wiley.com/
cochrane/clabout/articles/PVD/frame.html.
For details of the search strategy used to search CENTRAL see
Appendix 1.

Searching other resources
RESULTS
The review authors identified additional articles by reviewing the

references of papers resulting from the initial search. We also handsearched relevant conference proceedings and contacted investigators in the field for any unpublished trials.
Description of studies
Data collection and analysis
Selection of trials
The contact author (FGRF) selected trials for inclusion in the
review. These trials were sent to the second author (ING) who
confirmed that they were acceptable for inclusion. The criteria for
selection of trials was as specified in the above section Criteria for
Considering Trials for Review.
Quality of trials
Both review authors assessed independently the methodological
quality of the trials using the checklist recommended by the Peripheral Vascular Diseases Review Group as an aide memoire and
paying particular attention to any concealment of randomisation.
Both authors gave the trial an allocation score of A (clearly concealed), B (unclear if concealed) or C (clearly not concealed) and
also a summary score of A (low risk of bias), B (moderate risk
of bias) or C (high risk of bias). Any discrepancies between the
review authors in the above scores were discussed and consensus
reached. Trials scoring A for concealment or bias were included,
those scoring C were excluded and those scoring B were discussed
in more detail.
See: Characteristics of included studies; Characteristics of excluded

studies; Characteristics of ongoing studies.
Summary details of included studies are given in the Characteristics of included studies table.
Only two randomised controlled trials, one conducted in Oxford
(Oxford) and the other in Edinburgh (Edinburgh) fulfilled the
criteria for consideration in the review. In the Oxford trial, men
and women with intermittent claudication were randomly allocated to balloon angioplasty or a standardised exercise programme.
Follow up was reported up to 15 months (Creasy 1990) and at
six years (Perkins 1996). In the Edinburgh trial, men and women
with intermittent claudication were randomly allocated to balloon
angioplasty plus aspirin and smoking and exercise advice, or this
advice alone. The aspirin advice comprised patients being advised
to take low dose aspirin and that 75 mg daily was sufficient, but
no checks of compliance were carried out. Follow up was reported
at six months (Whyman 1996) and at two years (Whyman 1997).
Results of another study based in Dunedin (Dunedin) on 100 claudicants has been reported briefly in two abstracts (van Rij 1991;
Thomson 1999). Correspondence with the principal investigator
indicated that a full publication is planned (van Rij 2000), whereupon the results will be included in this review.
One study (Chetter 1997) fulfilled the treatment criteria but had
to be excluded as the patients were not randomised.
Risk of bias in included studies
The contact author (FGRF) collected data on each trial including

information on the participants (age and sex distribution, measures
of severity of claudication such as walking distance, ABPI), the
interventions (angioplasty type, control intervention, usual care
in both groups), and the outcomes (as specified in criteria for
considering trials for a review). Data extraction was independently
cross checked by ING.
Two trials met our inclusion criteria. In the Edinburgh trial

(Edinburgh) randomisation was concealed using a telephone computerised random allocation system (score A); in the Oxford trial
(Oxford) randomisation was carried out using sealed envelopes
containing allocations defined on the basis of random numbers
(score A). Due to the nature of the intervention, participants could
not be blinded in the trials. The observers were also not blinded.
In the Oxford trial (Perkins 1996), only 80% of patients were
available for follow up at six years and analysis was not intention
to treat. The two reports of the Oxford trial did not use precisely
the same participants and the reasons for this are not clear. In both
trials, the numbers were relatively small and may not have been
sufficient to allow for clinical heterogeneity.
Statistical analysis
Effects of interventions
The data synthesis comprised a comparison of group results where

feasible. Individual patient data from different trials was not amalgamated. Sensitivity analysis was not performed because of the
sparsity of data.
In the Oxford trial (Creasy 1990), 21 angioplasties on the 20 patients were attempted. Two were unsuccessful; three had a groin
haematoma and one had rupture of external iliac artery. No patients in the Edinburgh trial (Whyman 1997) had major compli-
Data extraction

cations requiring surgical correction or delay in discharge. Compliance with exercise therapy in the Oxford trial was a mean of
0.89 attendances at the physiotherapy department per week compared to a theoretical maximum of 2 attendances per week.
At six months of follow up, in the Oxford trial (Creasy 1990),
mean walking and claudicating distances were lower in the angioplasty than exercise groups (WMD 130 and 50 m respectively),
but in the Edinburgh trial (Whyman 1996), the median claudicating distance was considerably higher in the angioplasty group
(667 m compared with 172 m; P < 0.05). In the Oxford trial
(Creasy 1990), walking and claudicating distances improved up
to 12 months in the exercise group but remained constant in the
angioplasty group.
At six months of follow up, mean ABPIs were higher in the angioplasty groups than in the control groups (WMD 0.17; 95%
confidence intervals (CI) 0.11 to 0.24). Also, the results of duplex
scanning in the Edinburgh trial showed that more patients in the
angioplasty group had patent arteries than in the control group
(OR 12.2; 95% CI 4.1 to 37.0). The median velocity ratio was 2.2
in the angioplasty group and 4.5 in the control group (P < 0.001).
Quality of life was similar between the angioplasty and control
groups except that fewer angioplasty patients reported pain (12
out of 28) compared to controls (21 out of 27; P < 0.05).
At two years of follow up in the Edinburgh trial (Whyman 1997)
the angioplasty group did not have a significantly greater claudication or walking distance on treadmill exercise than the control group. The mean ABPI was slightly higher in the angioplasty
group, but this difference was not statistically significant (WMD
0.06; 95% CI -0.04 to 0.16). More of the angioplasty group had a
patent artery (OR 5.5; 95% CI 1.8 to 17.0), and a lower median
velocity ratio (1.98 compared to 3.55 in the control group; P <
0.004). Quality of life did not differ between the two groups.
At six years of follow up in the Oxford trial (Perkins 1996), onethird of patients were not re-evaluated because of death, illness or
inability to be contacted but the losses were comparable between
the two groups. Among the remaining subjects, no significant differences were found between the angioplasty and exercise groups
in either median walking distance (180 m in angioplasty group
and 130 m in control group; P > 0.05) or median ABPI.
DISCUSSION
The trials included to date are relatively small and the results must
be interpreted with caution. Possible clinical heterogeneity and
the lack of blinding point to the possibility of bias. Also, the lack
of failure or major side effects of angioplasty in the Edinburgh
trial (Whyman 1997), in contrast to previous observational case
series, indicate the possibility that this trial was carried out under
more stringent circumstances than might be experienced in normal practice. Nevertheless both trials showed improvement in the
ABPI six months following angioplasty. Treadmill distances were

improved but in the Oxford trial (Creasy 1990) results were even
better with an exercise programme. After two years of follow up in
the Edinburgh trial (Whyman 1997), the angioplasty group had
less extensive disease as measured by arterial patency and velocity
ratio. However, this was not translated into a significant advantage
in walking distance or quality of life. After six years of follow up,
the Oxford trial (Perkins 1996) showed no evidence of benefits
from angioplasty. Full publication of the methods and results of a
third trial from Dunedin are awaited.
AUTHORS CONCLUSIONS
Implications for practice
The trial data are scant but do confirm findings from case series that
there is a short term clinical benefit from angioplasty. However,
restenosis is known to occur and the apparent lack of clinical
benefit for patients in the Edinburgh trial (Whyman 1997) at
two years and in the Oxford trial (Perkins 1996) at six years casts
considerable doubt on the value of the procedure. The numbers
of patients receiving exercise therapy in the Oxford trial (Perkins
1996) were too small for valid conclusions to be reached on its
value in clinical practice. The effectiveness of exercise therapy has
been evaluated in another Cochrane review (Leng 2000).
Implications for research

Clearly, there are insufficient data to draw firm conclusions about
the cost effectiveness of angioplasty for mild to moderate claudication. The hospital cost of an angioplasty in 2004 is about 2000
in the UK and about $6000 in the USA. Further trials are required
particularly as observational studies suggest that subgroups of patients may benefit. Therefore, these trials should be of sufficient
size to account for clinical heterogeneity in, for example, site of
lesion, and should include at least two years of follow up. Also,
since only a subgroup of patients with peripheral arterial disease are
suitable for angioplasty, any evaluation of cost effectiveness must
include assessment of the costs of identifying those suitable and
not suitable for the procedure. In the UK, the Health Technology
Assessment programme is commissioning a major trial evaluating exercise and angioplasty in the treatment of mild to moderate
claudication.
ACKNOWLEDGEMENTS
We are grateful to Mr JMT Perkins and Mr MR Whyman who provided unpublished drafts of results of the Oxford and Edinburgh
trials, and the Peripheral Vascular Diseases Review Group for their
assistance with the literature searches.

REFERENCES
References to studies included in this review

Edinburgh {published data only}
Whyman MR, Fowkes FGR, Kerracher EMG, Gillespie IN, Lee

AJ, Housley E, et al.Is intermittent claudication improved by
percutaneous transluminal angioplasty? A randomised controlled
trial. Journal of Vascular Surgery 1997;26:5517.
AJ, Housley E, et al.Randomised controlled trial of percutaneous
transluminal angioplasty for intermittent claudication. European
Journal of Vascular and Endovascular Surgery 1996;12:16772.
Oxford {published data only}
Creasy TS, McMillan PJ, Fletcher EWL, Collin J, Morris PJ. Is
percutaneous transluminal angioplasty better than exercise for
claudication? - preliminary results of a prospective randomised
trial. European Journal of Vascular Surgery 1990;4:13540.
Perkins JMT, Collin J, Creasy TS, Fletcher EWL, Morris PJ.

Exercise training versus angioplasty for stable claudication. Long
and medium term results of a prospective, randomised trial.
European Journal of Vascular and Endovascular Surgery 1996;11:
40913.
References to studies excluded from this review

Chetter 1997 {published data only}
Chetter IC, Spark JI, Turton EPL, Kent PJ, Berridge DC, Scott
DJA, et al.Percutaneous transluminal angioplasty for intermittent
claudication:evidence on which to base the medicine. European
Society for Vascular Surgery XI Annual Meeting. Lisbon, 1720
Sept 1997:114.
References to ongoing studies

Dunedin {published data only}
Thomson IA, van Rij AM, Morrison ND, Packer SGK, Christie R.
A ten year randomised controlled trial of percutaneous
femoropopliteal angioplasty for claudication. Australia and New
Zealand Journal of Surgery 1999;69(Suppl):A98.
van Rij AM, Packer SGK, Morrison N. A randomised controlled
study of percutaneous angioplasty for claudicants with
femoropopliteal disease. Journal of Cardiovascular Surgery 1991;32
(Suppl):34.
Additional references
Belli 1993
Belli AM, Jackson JE, Allison DJ. Interventional radiological
procedures. In: Clement DL, Shepherd JT editor(s). Vascular
diseases in the limbs. Mechanisms and principals of treatment. Mosby

Year Book. St Louis: Mosby, 1993:23958.
Creasy 1990
Creasy TS, McMillan PJ, Fletcher EWL, Collin J, Morris PJ. Is
percutaneous transluminal angioplasty better than exercise for
claudication? - preliminary results of a prospective randomised
trial. European Journal of Vascular Surgery 1990;4:13540.
Leng 2000
Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication.
Cochrane Database of Systematic Reviews 2000, Issue 2. [Art. No.:
CD000990. DOI: 10.1002/14651858.CD000990]
Perkins 1996
Perkins JMT, Collin J, Creasy TS, Fletcher EWL, Morris PJ.
Exercise training versus angioplasty for stable claudication. Long
and medium term results of a prospective, randomised trial.
European Journal of Vascular and Endovascular Surgery 1996;11:
40913.
Price 1996
Price JF, Fowkes FGR. Effectiveness of percutaneous angioplasty for
lower limb atherosclerosis. In: Greenhalgh RM, Fowkes FGR
editor(s). Trials and tribulations in vascular surgery. London: WB
Saunders, 1996.
Thomson 1999
Thomson IA, van Rij AM, Morrison ND, Packer SGK, Christie R.
A ten year randomised controlled trial of percutaneous
femoropopliteal angioplasty for claudication (abstract). Australia
and New Zealand Journal of Surgery 1999;69(Suppl):A98.
van Rij 1991
van Rij AM, Packer SGK, Morrison N. A randomised controlled
study of percutaneous angioplasty for claudicants with
femoropopliteal disease. Journal of Cardiovascular Surgery 1991;32
(Suppl):34.
van Rij 2000
van Rij AM. personal communication 2000.
Whyman 1996
AJ, Housley E, et al.Randomised controlled trial of percutaneous
transluminal angioplasty for intermittent claudication. European
Journal of Vascular and Endovascular Surgery 1996;12:16772.
Whyman 1997
AJ, Housley E, et al.Is intermittent claudication improved by
percutaneous transluminal angioplasty? A randomised controlled
trial. Journal of Vascular Surgery 1997;26:5517.
Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Edinburgh
Methods
Study design: RCT.

Method of randomisation: Concealed randomisation using telephone/computer.
Blinding: Unblinded
Intention to treat.
Exclusions post-randomisation: None.
Losses to follow up: 4.
Participants
Country: United Kingdom.

Setting: Hospital.
No. of participants: 62.
Age (mean): 61.6 years.
Gender: 51 males, 11 females.
Inclusion criteria: Unilateral intermittent claudication due to short femoral stenoses (less than 10 cm) or
occlusions and iliac stenoses.
Exclusion criteria: Previous angioplasty or arterial surgery to the symptomatic leg, myocardial infarction
within past 6 months, patients taking oral anticoagulants, duration of symptoms less than 1 month,
inability to manage the treadmill examination, any psychiatric illness or other reason making follow up
difficult.
Interventions
Treatment (n=30): Balloon angioplasty plus aspirin/smoking/exercise advice.

Control (n=32): Daily low dose aspirin and advice on smoking and exercise.
Outcomes
6 months and 2 year follow up: Reported walking distance, treadmill distances,
ABPI.
Duplex: patent %, velocity ratio, Nottingham Health Profile.
Notes
Compliance with aspirin/smoking/

exercise advice was not assessed.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate

Oxford
Methods
Study design: RCT.

Method of randomisation: Random allocation using sealed envelopes.
Blinding: Unblinded, not intention to treat.
Exclusions post-randomisation: 2.
Losses to follow up: 19.
Participants
Country: United Kingdom.

Setting: Hospital.
No. of participants: 36.
Age (mean): 62.9 years.
Gender: 27 males, 9 females.
Inclusion criteria: Stable, unilateral claudication with failure of conservative treatment for at least 3
months, walking distance less than 375 m, angiographically significant lesions suitable for treatment with
angioplasty, as agreed by both surgeon and radiologist, informed consent.
Exclusion criteria: None stated.
Interventions
Treatment (n=20): Balloon angioplasty plus continued aspirin of varying dose if taken pre-angioplasty.
Control (n=16) : Standard exercise therapy comprising 30 minutes twice weekly sessions in physiotherapy
dept. for 6 months. (No mention of aspirin therapy).
Outcomes
15 months follow up: ABPI, treadmill distances.

6 years follow up: ABPI,
treadmill distances.
Notes
In report of 6 years follow up, sample size on entry had increased to n = 56 of whom 30 had been
randomised to angioplasty and 26 to exercise therapy. 37 were re-evaluated after 6 years. Level of aspirin
consumption was not assessed in either arm of trial.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
ABPI - ankle brachial pressure index

RCT - randomised controlled trial
Characteristics of excluded studies [ordered by study ID]
Study
Reason for exclusion
Chetter 1997
The participants in this trial were not randomised.

Characteristics of ongoing studies [ordered by study ID]

Dunedin
Trial name or title
Dunedin percutaneous angioplasty study
Methods
Participants
100 total.
Interventions
PTA versus no treatment.
Outcomes
Radiologically confirmed determioration, ABPI, run off, type of lesion < 10 cm, presence of diabetes.
Starting date
1991
Contact information
A. M. van Rij
Notes
Correspondence with the principal investigator indicated that a full publication is planned.
ABPI - Ankle brachial pressure index

PTA - percutaneous transluminal angioplasty

DATA AND ANALYSES
Comparison 1. Any angioplasty versus any non surgical management at 6 months
No. of
studies
Outcome or subgroup title

1 Treadmill claudication distance
2 Treadmill walking distance
3 Ankle brachial pressure index
4 Duplex patent artery
1
1
2
1
No. of
participants
95
Statistical method
Effect size
Mean Difference (IV, Fixed, 95% CI)

Peto Odds Ratio (Peto, Fixed, 95% CI)
Totals not selected

Totals not selected
0.17 [0.11, 0.24]
Totals not selected
Comparison 2. Any angioplasty versus any non surgical management at 24 months and over
Outcome or subgroup title
No. of
studies
No. of
participants
0
0
1
1
0
0
55
53
1 Treadmill claudication distance

2 Treadmill walking distance
3 Ankle brachial pressure index
4 Duplex patent artery
Statistical method
Effect size

Peto Odds Ratio (Peto, Fixed, 95% CI)
Not estimable
Not estimable
0.06 [-0.04, 0.16]
5.51 [1.79, 17.01]
Analysis 1.1. Comparison 1 Any angioplasty versus any non surgical management at 6 months, Outcome 1
Treadmill claudication distance.
Review:
Angioplasty (versus non surgical management) for intermittent claudication
Comparison: 1 Any angioplasty versus any non surgical management at 6 months

Outcome: 1 Treadmill claudication distance
Study or subgroup
Oxford
Favours Control
Favours Angioplasty
Mean Difference
Mean(SD)
Mean(SD)
20
150 (157)
16
200 (140)
IV,Fixed,95% CI
-50.00 [ -147.16, 47.16 ]
-1000
-500
Favours Control

Mean Difference
IV,Fixed,95% CI
500
1000
Favours Angioplasty
10
Treadmill walking distance.
Review:

Outcome: 2 Treadmill walking distance
Study or subgroup
Oxford
Favours Control
Favours Angioplasty
Mean Difference
Mean(SD)
Mean(SD)
20
240 (223)
16
370 (200)
Mean Difference
IV,Fixed,95% CI
IV,Fixed,95% CI
-130.00 [ -268.40, 8.40 ]
-1000
-500
Favours Control
500
1000
Favours Angioplasty
Ankle brachial pressure index.
Review:

Outcome: 3 Ankle brachial pressure index
Study or subgroup
Favours Control
Favours Angioplasty
Mean Difference
Weight
Mean(SD)
Mean(SD)
Edinburgh
29
0.88 (0.16)
30
0.74 (0.16)
65.0 %
0.14 [ 0.06, 0.22 ]
Oxford
20
0.85 (0.18)
16
0.62 (0.16)
35.0 %
0.23 [ 0.12, 0.34 ]
Total (95% CI)
49
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
46
100.0 % 0.17 [ 0.11, 0.24 ]
Heterogeneity: Chi2 = 1.63, df = 1 (P = 0.20); I2 =39%

Test for overall effect: Z = 5.11 (P < 0.00001)
-1
-0.5
Favours Control

0.5
Favours Angioplasty
11
Duplex patent artery.
Review:

Outcome: 4 Duplex patent artery
Study or subgroup
Favours Control
Favours Angioplasty
n/N
n/N
27/28
12/29
Edinburgh
Peto Odds Ratio
Peto Odds Ratio
Peto,Fixed,95% CI
Peto,Fixed,95% CI
12.22 [ 4.04, 36.98 ]
0.01
0.1
Favours Control
10
100
Favours Angioplasty
Analysis 2.3. Comparison 2 Any angioplasty versus any non surgical management at 24 months and over,
Outcome 3 Ankle brachial pressure index.
Review:
Comparison: 2 Any angioplasty versus any non surgical management at 24 months and over
Outcome: 3 Ankle brachial pressure index
Study or subgroup
Favours Control
Edinburgh
Total (95% CI)
Favours Angioplasty
Mean Difference
Mean(SD)
Mean(SD)
27
0.81 (0.16)
28
0.75 (0.21)
27
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
100.0 %
0.06 [ -0.04, 0.16 ]
100.0 % 0.06 [ -0.04, 0.16 ]
28
Heterogeneity: not applicable

Test for overall effect: Z = 1.19 (P = 0.23)
-1
-0.5
Favours Control

0.5
Favours Angioplasty
12
Analysis 2.4. Comparison 2 Any angioplasty versus any non surgical management at 24 months and over,
Outcome 4 Duplex patent artery.
Review:
Comparison: 2 Any angioplasty versus any non surgical management at 24 months and over
Outcome: 4 Duplex patent artery
Study or subgroup
Favours Control
Favours Angioplasty
n/N
n/N
23/27
12/26
100.0 %
5.51 [ 1.79, 17.01 ]
27
26
100.0 %
5.51 [ 1.79, 17.01 ]
Edinburgh
Total (95% CI)
Peto Odds Ratio
Weight
Peto,Fixed,95% CI
Peto Odds Ratio

Peto,Fixed,95% CI
Total events: 23 (Favours Control), 12 (Favours Angioplasty)

Heterogeneity: not applicable
Test for overall effect: Z = 2.97 (P = 0.0030)
0.01
0.1
Favours Control
10
100
Favours Angioplasty
APPENDICES
Appendix 1. CENTRAL search strategy
#1 MeSH descriptor Arterial Occlusive Diseases explode all trees
#2 arter* near occlus*
#3 periph* near arter*
#4 occlus* near arter*
#5 obstruc* near arter*
#6 PAOD
#7 PAD
#8 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7)
#9 MeSH descriptor Intermittent Claudication explode all trees
#10 intermitt* near claudic*
#11 claudic*
#12 (#9 OR #10 OR #11)
#13 (#8 OR #12)
#14 angioplast*
#15 PTA
#16 (#14 OR #15)
#17 (#13 AND #16)

13
FEEDBACK
Angioplasty for intermittent claudication
Summary
1. Under Characteristics of included trials it is noted that the
method of randomisation in the Oxford trial is not stated. Were the
authors asked about this? (If not, they should be asked.) The
notes do not make it clear whether the additional 20 patients
recruited later were randomised as well, and how this fitted into the
study design. Did the controls in the Oxford study receive aspirin?
2. What dosage of aspirin was used in the trials and for how long?
3. It is puzzling that the Dunedin study (van Rij et al) is not in the
CCTR, and that publication is still awaited. Have the authors been
asked for details, or at least to inform the reviewers as soon as
their paper has been accepted for publication?
4. The results state that no mention is made of side effects in the
[Edinburgh] paper. Were all the angioplasties in the Edinburgh
study successful? Since the reviewer was an author of the
Edinburgh paper he presumably knows.
5. What were the differences in the exercise taken by the patients
in the two trials? How far did the patients follow the smoking
/exercise advice in the Edinburgh trial?
6. The influence of exercise in the trials deserves a comment in
the discussion.
7. The Implications for Research mention cost-effectiveness, but
neither trial says anything on costs. What does angioplasty cost,
very approximately?
8. The conclusion that Further trials are required seems
debatable, since angioplasty is only marginally effective and for a
short time, and the Dunedin trial results should be out soon. It
furthermore seems possible that local treatment methods other
than balloon angioplasty may offer better prospects of improving
claudication.
9. Under potential conflicts of interest it should be noted that one of
the reviewers was also an author of one of the two trials.
10. The asterisks identifying the main publication for each trial
should be inserted (though it is actually obvious which they are).
Reply
Amendments have been made to the updated review to take account of the criticisms. Another abstract reference to the Dunedin trial
which has not been published in full yet, has been included.
Contributors
Andrew Herxheimer

14
WHATS NEW
Last assessed as up-to-date: 22 August 2006.
Date
Event
Description
30 May 2008
Amended
Converted to new review format.
HISTORY
Protocol first published: Issue 1, 1996
Review first published: Issue 3, 1996
Date
Event
Description
4 November 1999
Feedback has been incorporated
Feedback received and added to the review. In response to the feedback, the
review authors contacted the authors of the Oxford trial for the method of
randomisation. The randomisationmethod of the Oxford trial was added to
the Characteristics of included studies table (3 January 2000).
CONTRIBUTIONS OF AUTHORS
FGRF selected trials for inclusion in the review. ING confirmed studies for inclusion. Both review authors assessed trial quality
independently. FGRF extracted data which was cross-checked by ING.
DECLARATIONS OF INTEREST
FGR Fowkes and IN Gillespie are authors of the Edinburgh trial.
SOURCES OF SUPPORT
Internal sources
University of Edinburgh, UK.

15
External sources
Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.
INDEX TERMS
Medical Subject Headings (MeSH)
Angioplasty,
Balloon; Intermittent Claudication [ therapy]
MeSH check words

Humans

16

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Angioplasty (versus non surgical management) for

intermittent claudication (Review)

Angioplasty (versus non surgical management) for intermittent claudication (Review)

Angioplasty (versus non surgical management) for intermittent claudication (Review)

Angioplasty (versus non surgical management) for

New Royal Infirmary of Edinburgh, EDINBURGH, UK

PLAIN LANGUAGE SUMMARY

angioplasty (PTA). Those with milder disease are advised to stop

Angioplasty (versus non surgical management) for intermittent claudication (Review)

angioplasty depends on the site of the lesion as well as the severity.

Clinical experience and case series indicate that angioplasty may

Angioplasty of any type (e.g. balloon, laser) applied to lesions in

Types of outcome measures

1. Maximum walking distance on treadmill exercise to onset

The specific hypotheses are:

(2) angioplasty is more effective than conservative therapy such as

1. Complications of angioplasty including local haematoma

Usual treatments such as aspirin and antismoking advice may or

Criteria for considering studies for this review

Search methods for identification of studies

Angioplasty (versus non surgical management) for intermittent claudication (Review)

Searching other resources

The review authors identified additional articles by reviewing the

Data collection and analysis

See: Characteristics of included studies; Characteristics of excluded

Risk of bias in included studies

The contact author (FGRF) collected data on each trial including

Two trials met our inclusion criteria. In the Edinburgh trial

The data synthesis comprised a comparison of group results where

Angioplasty (versus non surgical management) for intermittent claudication (Review)

ABPI six months following angioplasty. Treadmill distances were

Implications for research

Angioplasty (versus non surgical management) for intermittent claudication (Review)

References to studies included in this review

Whyman MR, Fowkes FGR, Kerracher EMG, Gillespie IN, Lee

Perkins JMT, Collin J, Creasy TS, Fletcher EWL, Morris PJ.

References to studies excluded from this review

References to ongoing studies

diseases in the limbs. Mechanisms and principals of treatment. Mosby

Indicates the major publication for the study

Angioplasty (versus non surgical management) for intermittent claudication (Review)

Characteristics of included studies [ordered by study ID]

Study design: RCT.

Country: United Kingdom.

Treatment (n=30): Balloon angioplasty plus aspirin/smoking/exercise advice.

Compliance with aspirin/smoking/

Angioplasty (versus non surgical management) for intermittent claudication (Review)

Study design: RCT.

Country: United Kingdom.

15 months follow up: ABPI, treadmill distances.

ABPI - ankle brachial pressure index

Characteristics of excluded studies [ordered by study ID]

Reason for exclusion

The participants in this trial were not randomised.

Angioplasty (versus non surgical management) for intermittent claudication (Review)

Characteristics of ongoing studies [ordered by study ID]

Dunedin percutaneous angioplasty study

PTA versus no treatment.

ABPI - Ankle brachial pressure index

Angioplasty (versus non surgical management) for intermittent claudication (Review)

DATA AND ANALYSES

Comparison 1. Any angioplasty versus any non surgical management at 6 months

Outcome or subgroup title

Mean Difference (IV, Fixed, 95% CI)