Cochrane: Library

Cochrane
Library
Cochrane Database of Systematic Reviews
Angioplasty versus stenting for subclavian artery stenosis (Review)
Iared W, Mourão JE, Puchnick A, Soma F, Shigueoka DC
Iared W, Mourão JEduardo, Puchnick A, Soma F, Shigueoka DCarlos.

Angioplasty versus stenting for subclavian artery stenosis.
Cochrane Database of Systematic Reviews 2022, Issue 2. Art. No.: CD008461.
DOI: 10.1002/14651858.CD008461.pub4.
www.cochranelibrary.com
Angioplasty versus stenting for subclavian artery stenosis (Review)

Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
BACKGROUND.............................................................................................................................................................................................. 3
OBJECTIVES.................................................................................................................................................................................................. 3
METHODS..................................................................................................................................................................................................... 3
RESULTS........................................................................................................................................................................................................ 5
Figure 1.................................................................................................................................................................................................. 6
DISCUSSION.................................................................................................................................................................................................. 7
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 7
ACKNOWLEDGEMENTS................................................................................................................................................................................ 7
REFERENCES................................................................................................................................................................................................ 8
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 9
APPENDICES................................................................................................................................................................................................. 10
WHAT'S NEW................................................................................................................................................................................................. 15
HISTORY........................................................................................................................................................................................................ 15
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 15
DECLARATIONS OF INTEREST..................................................................................................................................................................... 16
SOURCES OF SUPPORT............................................................................................................................................................................... 16
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 16
INDEX TERMS............................................................................................................................................................................................... 16
Angioplasty versus stenting for subclavian artery stenosis (Review) i

Informed decisions.
[Intervention Review]
Angioplasty versus stenting for subclavian artery stenosis
Wagner Iared1, José Eduardo Mourão2, Andrea Puchnick2, Fernando Soma2, David Carlos Shigueoka2
1Department of Internal Medicine, Universidade Federal de São Paulo, Brazilian Cochrane Centre, São Paulo, Brazil. 2Department of
Diagnostic Imaging, Universidade Federal de São Paulo, São Paulo, Brazil
Contact: Andrea Puchnick, [email protected].
Editorial group: Cochrane Vascular Group.

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 2, 2022.
Citation: Iared W, Mourão JEduardo, Puchnick A, Soma F, Shigueoka DCarlos.Angioplasty versus stenting for subclavian artery stenosis.
Cochrane Database of Systematic Reviews 2022, Issue 2. Art. No.: CD008461. DOI: 10.1002/14651858.CD008461.pub4.
ABSTRACT
Background
The subclavian arteries are two major arteries of the upper chest, below the collar bone, which come from the arch of the aorta.
Endovascular treatment for stenosis of the subclavian arteries includes angioplasty alone, and with stenting. There is insufficient evidence
to guide the use of stents following angioplasty for subclavian artery stenosis. This is the second update of a review first published in 2011.
Objectives
The aim of this review was to determine whether stenting was more effective than angioplasty alone for stenosis of the subclavian artery.
Search methods
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE,
Embase, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and
ClinicalTrials.gov trials registers to 2 February 2021.
Selection criteria
We searched for randomised controlled trials of endovascular treatment of subclavian artery lesions that compared angioplasty alone and
stent implantation.
Data collection and analysis

Two review authors independently evaluated studies to assess eligibility. Discrepancies were resolved by discussion. If there was no
agreement, we asked a third review author to assess the study for inclusion. We planned to undertake data collection and analysis in
accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions, and assess the certainty
of the evidence using a GRADE approach.
Main results
To date, we have not identified any completed or ongoing randomised controlled trials that compare percutaneous transluminal
angioplasty and stenting for subclavian artery stenosis.
Authors' conclusions
There is currently insufficient evidence to determine whether stenting is more effective than angioplasty alone for stenosis of the subclavian
artery.
Angioplasty versus stenting for subclavian artery stenosis (Review) 1

Informed decisions.
PLAIN LANGUAGE SUMMARY
Angioplasty alone or with stenting for subclavian artery stenosis
Key message
We could not find any randomised controlled trials in the medical literature that compared the effectiveness and safety of implanting a
stent (a small tube that acts like a scaffold to help keep a blood vessel open) with angioplasty (surgical procedure to unblock a blood vessel)
alone for the treatment of subclavian artery stenosis (narrowing or blockage of a blood vessel). There is currently insufficient evidence to
determine whether stenting is more effective than angioplasty alone.
Why is this question important?
The subclavian arteries are two major blood vessels in the upper chest, below the collar bone, which come from the arch of the aorta.
The left subclavian artery supplies blood to the left arm, and the right subclavian artery supplies blood to the right arm; some branches
supply blood to the head and chest. A history of smoking, high blood pressure, lower levels of 'good' (high-density lipoprotein) cholesterol,
and peripheral arterial disease are associated with an increased risk of subclavian artery stenosis. Subclavian artery stenosis often occurs
without symptoms. When they occur, symptoms include short-lasting vertigo (commonly described as the environment spinning) due
to decreased blood flow in the back part of the brain, and blood circulation problems in the hands and arms. Endovascular (minimally
invasive) treatment for stenosis of the subclavian arteries includes angioplasty alone or with stenting. It is not clear if angioplasty alone or
with stenting offers the most benefit for people with subclavian artery blockages.
What did we do?
We searched the medical literature for randomised controlled studies of endovascular treatment of subclavian artery stenosis that
compared angioplasty alone, or with a stent implanted. In randomised controlled studies, the treatments or tests people receive are
decided at random. These usually give the most reliable evidence about treatment effects.
What did we find?
We did not find any randomised controlled studies to help answer our question. There is a lack of evidence to help healthcare professionals
and people with subclavian artery stenosis decide if stenting is more effective than angioplasty alone to treat subclavian artery stenosis.
How up to date is this systematic review?
This Cochrane Review updates our previous review. The evidence is current to February 2021.

Informed decisions.
BACKGROUND data on file for review and analysis. In addition, we considered

randomised trials conducted by the stent device manufacturers
Description of the condition that were on file, but not published. There was no restriction on
language.
Arterial reconstruction is less frequently performed in the upper
limbs than in the lower limbs, probably because of the lower Types of participants
muscular mass, rich collateral circulation, and the lesser burden
of the weight carried by the upper limbs compared with the We planned for the studies selected for review to include:
lower limbs. The prevalence of subclavian artery stenosis in the
• men and women with an indication for revascularisation of the
general population is estimated at approximately 2%. In a clinical
subclavian artery (stenosis > 70%);
population (that is, people recruited from vascular laboratories or
medical institutions), the prevalence is about 7% (Shadman 2004). • people with symptomatic subclavian artery or brachiocephalic
trunk disease; claudication of the upper limb or vertebrobasilar
Subclavian artery stenosis may be asymptomatic. When symptoms insufficiency, or both;
occur, they are mainly due to vertebrobasilar insufficiency (that • people with symptomatic coronary-subclavian steal syndrome;
is, decreased blood flow in the posterior circulation of the brain), • people with documented occlusions or stenoses of the
upper limb ischaemia, or both. subclavian artery or brachiocephalic trunk (diagnosed by duplex
ultrasound scan or angiogram);
A history of smoking, higher levels of systolic blood pressure, lower
levels of high-density lipoprotein cholesterol, and the presence of • people with lesions who were allocated to treatment with
peripheral arterial diseases are associated with an increased risk of balloon angioplasty or stenting;
subclavian artery stenosis (Shadman 2004). • people receiving medical therapy for associated pre-
morbid conditions, e.g. diabetes mellitus, hyperlipidaemia,
Description of the intervention or hypertension, pre- or post-intervention (e.g. antiplatelets,
antihypertensive drugs, lipid-lowering drugs);
Bachman and colleagues reported the first case of successful
subclavian angioplasty (Bachman 1980). Lyon and colleagues • people receiving anticoagulation pre- or post-intervention (e.g.
suggested that the placement of metallic stents in supra-aortic heparin or warfarin);
arteries represented an effective adjunct to percutaneous balloon • people not receiving any medical or anticoagulation therapy.
angioplasty of atherosclerotic stenosis in these vessels, and that
primary stent placement may be an effective treatment for selected Types of interventions
lesions (Lyon 1996). The primary interventions of interest were angioplasty with or
without a stent after restoration of patency in occlusions or
How the intervention might work stenoses of the subclavian artery or brachiocephalic trunk; that is,
Elastic recoil of the vessel wall is a common cause of failure of primary stenting.
percutaneous transluminal angioplasty. Expandable metal stents
We planned to also include interventional studies fulfilling the
are used to oppose such recoil (Palmaz 1987).
following criteria:
Why it is important to do this review
• studies in which stenting was done for secondary purposes, i.e.
There is insufficient evidence to guide stent usage following to treat post-angioplasty vessel wall dissections;
angioplasty in subclavian artery stenosis. This review investigated • studies using balloon angioplasty techniques to restore patency
the effectiveness and safety issues that could help with establishing (transluminal or subintimal);
practice guidelines. • studies including various types of stent and configuration, e.g.
uncovered or covered, steel or reinforced nitinol, drug eluting or
OBJECTIVES simple stents.
The aim of this review was to determine whether stenting was Types of outcome measures
more effective than angioplasty alone for stenosis of the subclavian
artery. Primary outcomes
• vessel patency rate – i.e. restenosis or re-occlusion rates, both
METHODS
primary and secondary, including time to restenosis or re-
Criteria for considering studies for this review occlusion as defined by an imaging modality. We planned to
assess the vessel patency, restenosis or re-occlusion rates by any
Types of studies major imaging modality, such as duplex ultrasound, magnetic
resonance angiography, or computed tomography angiography.
We planned to include randomised controlled trials (RCTs) with a
parallel (e.g. cluster or individual) design comparing stenting and Secondary outcomes
angioplasty for stenosis of the subclavian artery. Because of the
nature of the procedures involved, we did not expect to identify • improvement of symptoms – i.e. disappearance of the
cross-over trials. We considered trials that were published in full, symptoms of upper limb claudication or vertebrobasilar
or had results presented in abstract form. We planned to include insufficiency, or both
abstracts only if there were sufficient data for analysis, there were • follow-up of restenosis (1, 6, 12 months or longer)
plans for full publication, or the authors had available unpublished
Informed decisions.
• decrease in the difference of blood pressure between the upper Data collection and analysis
limbs post-treatment
Selection of studies
• morbidity rates:
◦ stent-related – stent failure or fracture, stent migration, stent Two review authors (AP and JEM) independently evaluated studies
infection, stent occlusion to assess eligibility. Discrepancies were resolved by discussion. If
◦ procedural related – groin or brachial haematoma, wound there was no agreement, we asked a third review author (WI) to
infection, wound bleeding, vessel rupture or perforation, assess the study for inclusion.
vessel wall dissection, distal emboli
Data extraction and management
◦ general morbidity – development of acute myocardial
infarction, acute renal failure, chronic renal failure, or We intended that three review authors would extract data from
cerebrovascular events published reports using a data collection form. We intended to
• mortality at 30 days, one year, and two years resolve disagreements by consensus.
• measures of efficacy – such as quality of life scores at 30 days, We intended to extract the following data.
one year, and two years
• the method of randomisation, and whether the person
Search methods for identification of studies undertaking the randomisation was blinded to the allocated
Electronic searches treatment
• the number of participants originally allocated to each
The Cochrane Vascular Information Specialist conducted treatment group, to allow an intention-to-treat analysis
systematic searches of the following databases for randomised
• the method of measuring outcomes, and whether outcome
controlled trials and controlled clinical trials without language,
assessment was independent or blinded, or both
publication year, or publication status restrictions. Here are the
updated search dates for this version. • the number of exclusions and losses to follow-up
• intervention characteristics
• Cochrane Vascular Specialised Register via the Cochrane • outcome measures, as defined above
Register of Studies (CRS-Web; 25 February 2014 to 2 February
• details of study funding and study author declarations of interest
2021)
• Cochrane Central Register of Controlled Trials (CENTRAL) in Assessment of risk of bias in included studies
Cochrane Register of Studies Online (searched February 2021)
We planned to assess the risk of bias of the included studies,
• MEDLINE Ovid; MEDLINE Epub Ahead of Print, In-Process & Other
using the Cochrane risk of bias (RoB 1) tool to assess sequence
Non-Indexed Citations, Ovid MEDLINE Daily and Ovid MEDLINE
generation; allocation concealment; blinding of participants,
(25 February 2014 to 2 February 2021)
providers, and outcome assessors; completeness of outcome data;
• Embase Ovid (25 February 2014 to 2 February 2021) selective outcome reporting; and other potential sources of bias
• CINAHL EBSCO (25 February 2014 to 2 February 2021) (Higgins 2011). Three review authors planned to assess these
• LILACS (Latin American and Caribbean Health Science domains and assign a judgement of either low, high, or unclear
Information database; 25 February 2014 to 2 February 2021) risk of bias according to Higgins 2011. We planned to resolve
disagreements by consensus.
The Information Specialist modelled search strategies for other
databases on the search strategy designed for CENTRAL. Where Measures of treatment effect
appropriate, the Information Specialist combined them with We intended to use the following measures to calculate the effect
adaptations of the highly sensitive search strategy designed of treatment.
by Cochrane for identifying randomised controlled trials and
controlled clinical trials (Lefebvre 2011). Search strategies for major • For time-to-event data, we would use hazard ratio, if possible.
databases are provided in Appendix 1. • For dichotomous outcomes, we would use odds ratio (OR).
The Information Specialist also searched the following trials • For continuous outcomes, we would use mean difference (MD)
registries on 2 February 2021. between treatment arms.
• US National Institutes of Health Ongoing Trials Register We intended to report the results as OR with 95% confidence
ClinicalTrials.gov (clinicaltrials.gov) intervals (CI). In view of expected heterogeneity between trials, we
• World Health Organization International Clinical Trials Registry planned to calculate the OR using the random-effects model with
Platform (apps.who.int/trialsearch) inverse variance weighting (DerSimonian 1986).
Searching other resources Unit of analysis issues
For this update, we planned to check the reference lists of any We planned to consider each participant as the unit of analysis.
relevant studies identified by the searches. We planned to individually assess each cluster-randomised trial
before deciding whether or not to include it in the review. Because
of the nature of the procedures involved, it was not expected
that there would be any cross-over trials. In studies with multiple
treatment groups, we planned to assess the possibility of including
the subgroups with the interventions of interest.
Informed decisions.
Dealing with missing data If possible, we would synthesise the studies making different
comparisons using the methods of Bucher 1997.
We did not plan to impute missing outcome data for the primary
outcome. If, in future updates of this review, data are missing, or Subgroup analysis and investigation of heterogeneity
only imputed data are reported, we will contact the trial authors to
request data on the outcomes only for those participants who were We intended to undertake subgroup analyses, grouping the trials
assessed. by:
Assessment of heterogeneity • symptomatic and asymptomatic participants in each treatment

group;
We planned to assess heterogeneity between studies by visually
• degree of baseline stenosis in each treatment group;
inspecting forest plots; estimating the percentage of heterogeneity
between trials that could not be ascribed to sampling variation • stent types: drug-eluting versus non-drug eluting, steel versus
(Higgins 2003); undertaking a formal statistical test of the reinforced (nitinol), covered (PTFE) versus uncovered;
significance of the heterogeneity using a standard Chi2 test with • stent location: brachiocephalic trunk versus subclavian artery
P = 0.1 as the level of significance (Deeks 2001); and if possible, stenting.
by subgroup analyses (see below). When there was evidence of
heterogeneity (Chi2 test with P < 0.1), we planned to investigate We planned to consider factors, such as age, clinical stage, type of
and report the possible reasons. In view of expected heterogeneity intervention, length of follow-up, adjusted or unadjusted analysis,
between trials, we planned to calculate the OR using the random- in the interpretation of any heterogeneity.
effects model with inverse variance weighting (DerSimonian 1986). Sensitivity analysis
Assessment of reporting biases We planned to undertake sensitivity analyses by excluding studies
We planned to examine funnel plots corresponding to the meta- at high risk of bias (studies that did not report adequate
analysis of the primary outcome, to assess the potential for small concealment of allocation or blinding of the outcome assessor).
study effects, such as publication bias (Higgins 2011). Summary of findings and assessment of the certainty of the
Data synthesis evidence
If sufficient clinically similar studies were available, we planned to We planned to prepare a summary of findings table for 'Angioplasty
pool their results in a meta-analysis. versus stenting for subclavian artery stenosis', according to the
Cochrane Handbook for Systematic Reviews of Interventions (Higgins
• for time-to-event data, we would pool hazard ratios using the 2011). We intended to use GRADEpro GDT software to create
generic inverse variance facility of Review Manager 5 (Review the table (GRADEpro GDT). We planned to include all primary
Manager 2020) and secondary outcomes, as described in the Types of outcome
• for any dichotomous outcomes, we would calculate the OR for measures section. Using the GRADE approach, we planned to
each study, and then pool them. assess the certainty of the body of evidence for the primary and
secondary outcomes as high, moderate, low, or very low, based on
• for continuous outcomes, we would calculate the MD between
the criteria of risk of bias, inconsistency, indirectness, imprecision,
the treatment arms at the end of follow-up, and pool them if all
and publication bias (GRADE Working Group).
trials measured the outcome on the same scale, otherwise we
would calculate and pool standardised mean differences (SMD) RESULTS
If any trials had multiple treatment groups, we planned to divide
Description of studies
the 'shared' comparison group into the number of treatment
groups and comparisons between each treatment group, and treat Results of the search
the split comparison group as an independent comparison.
See Figure 1.
We planned to use random-effects models with inverse variance
weighting for all meta-analyses (DerSimonian 1986).

Informed decisions.
Figure 1. PRISMA flow diagram

Informed decisions.
Included studies inclusion criteria. The best evidence about whether stenting is
more effective than angioplasty alone for stenosis of the subclavian
We did not find any randomised controlled trials (RCTs), therefore,
artery stems from retrospective observational studies. This type of
we did not include any studies in the review.
study presents biases inherent to non-randomised studies.
Excluded studies
Potential biases in the review process
For this update, we excluded four additional studies
(Mohammadian 2013; Tian 2020; Tokatli 2015; Yamao 2020). Although we conducted extensive literature searches, we only
identified observational studies.
In total, we excluded 12 studies (Angle 2003; De Vries 2005;
Henry 1999; Mathias 1993; Mohammadian 2013; Motarjeme 1996; Agreements and disagreements with other studies or
Schillinger 2001; Sixt 2009; Tian 2020; Tokatli 2015; Westerband reviews
2003; Yamao 2020). All were observational studies. Eight of them We did not find any randomised controlled trials, but there have
compared results of percutaneous transluminal angioplasty and been some observational studies that compared angioplasty and
stenting for subclavian artery stenosis (Angle 2003; De Vries 2005; stenting for subclavian artery lesions (Angle 2003; De Vries 2005;
Henry 1999; Mathias 1993; Motarjeme 1996; Schillinger 2001; Henry 1999; Mathias 1993; Motarjeme 1996; Schillinger 2001; Sixt
Sixt 2009; Westerband 2003); two evaluated the wrong vessels 2009; Westerband 2003). Most of these were summarised and
(vertebral and extracranial arteries (Mohammadian 2013; Yamao meta-analysed in a systematic review that also failed to find any
2020)); one was not a comparative study (Tokatli 2015); and one did RCTs (Chatterjee 2013). The observational studies identified in our
not assess the intervention of interest (Tian 2020). Cochrane Review all suggested that stenting after percutaneous
transluminal angioplasty was superior to angioplasty alone for
Risk of bias in included studies
the treatment of subclavian artery stenosis. During the 10 years
It was not possible to assess the risks of bias because there were no since the first publication of this Cochrane Review, there have been
included studies. no randomised clinical trials conducted to answer the research
question (Burihan 2011).
Effects of interventions
AUTHORS' CONCLUSIONS
Results based on RCTs are not available, as we did not identify any
RCTs. Implications for practice
Information about whether stenting is more effective than There is currently insufficient evidence from randomised controlled
angioplasty alone for stenosis of the subclavian artery is currently studies to determine whether stenting is more effective than
based on observational studies only. angioplasty alone for stenosis of the subclavian artery. The best
current evidence about whether stenting is more effective than
DISCUSSION angioplasty alone for stenosis of the subclavian artery stems from
retrospective observational studies.
Summary of main results
There are no randomised controlled trials (RCTs) to determine
Implications for research
whether stenting is more effective than angioplasty alone for Given the lack of high certainty evidence, randomised controlled
subclavian artery stenosis. trials comparing angioplasty versus stenting for subclavian artery
stenosis would be desirable. These studies should focus on
There is currently insufficient evidence to determine whether the main clinical endpoints of improvement of the symptoms
stenting is more effective than angioplasty alone for stenosis of the of upper limb ischaemia, vertebrobasilar insufficiency, and the
subclavian artery. subclavian steal phenomenon. Complications should include distal
embolisation, stroke, and transient ischaemic attack; technical
The best evidence about whether stenting is more effective than
endpoints should be assessed by primary and secondary patency,
angioplasty alone for stenosis of the subclavian artery stems from
and restenosis or re-occlusion rates in short-, mid- and long-
retrospective observational studies.
term follow-up. However, given the results from non-randomised
Overall completeness and applicability of evidence studies, it is unlikely any randomised studies will be carried out in
the future, due to ethical reasons.
We did not identify any RCTs that assessed the participants,
interventions, or outcomes of interest. Therefore, there is a lack of ACKNOWLEDGEMENTS
evidence for completeness or applicability.
We would like to thank Prof Dr Álvaro Nagib Atallah and Dr
Quality of the evidence Edina Mariko Koga da Silva for their guidance. We are very
grateful to Cochrane Vascular for their support and guidance in the
It was not possible to review methodological quality or the preparation of this review.
certainty of the evidence in the absence of studies meeting the

Informed decisions.
REFERENCES
References to studies excluded from this review atherosclerotic subclavian artery obstruction. Catheterization
and Cardiovascular Interventions 2009;73(3):395–403.
Angle 2003 {published data only}
Angle FJ, Matsumoto AH, McGraw JK, Spinosa DJ, Hagspiel KD, Tian 2020 {published data only}
Leung DA, et al.Percutaneous angioplasty and stenting of Tian X, Liu JL, Jia W, Jiang P, Cheng ZY, Zhang YX, et
left subclavian artery stenosis in patients with left internal al.Comparison of traditional vascular reconstruction with
mammary-coronary bypass grafts: clinical experience and covered stent in the treatment of subclavian artery injury.
long-term follow-up. Vascular and Endovascular Surgery Chinese Journal of Traumatology 2020;23(1):25-8.
2003;37:89-97.
Tokatli 2015 {published data only}
De Vries 2005 {published data only}
Tokatli A, Cakar MA, Tatli E, Vatan MB, Aksoy M, Atac MT, et
De Vries JP, Jager LC, Van den Berg JC, Overtoom TT, al.Percutaneous endovascular therapy for symptomatic chronic
Ackerstaff RG, Van de Pavoordt ED, et al.Durability of total occlusion of the left subclavian artery: initial and mid-term
percutaneous transluminal angioplasty for obstructive lesions results of 16 patients. Anadolu Kardiyoloji Dergisi 2015;15:29.
of proximal subclavian artery: long-term results. Journal of
Vascular Surgery 2005;41(1):19-23. Westerband 2003 {published data only}
Westerband A, Rodriguez JA, Ramaiah VG,
Henry 1999 {published data only}
Diethrich EB.Endovascular therapy in prevention and
Henry IP, Benjelloun A, Henry MC.Percutaneous transluminal management of coronary-subclavian steal. Journal of Vascular
angioplasty of the subclavian arteries. Long-term follow up. Surgery 2003;38(4):699-703.
Journal of the American College of Cardiology 2013;62(18 Suppl
1):B156. Yamao 2020 {published data only}
Yamao Y, Ishii A, Satow T, Iihara K, Sakai N, Japanese Registry
* Henry M, Armor M, Henry I, Ethevenot G, Tzvetanov K,
of Neuroendovascular Therapy investigators.The current status
Chati Z.Percutaneous transluminal angioplasty of the
of endovascular treatment for extracranial steno-occlusive
subclavian arteries. Journal of Endovascular Surgery
diseases in Japan: analysis using the Japanese Registry of
1999;6:33-41.
Neuroendovascular Therapy 3 (JR-NET3). Neurologia Medico-
Henry M, Hugel M, Henry I, Polydorou A.Percutaneous Chirurgica 2020;60(1):1-9.
transluminal angioplasty of the subclavian arteries. Long-
term follow up. Journal of the American College of Cardiology
2010;56(13):B95.
Additional references
Bachman 1980
Mathias 1993 {published data only}
Bachman DM, Kim RM.Transluminal dilatation for subclavian
Mathias KD, Lüth I, Haarmann P.Percutaneous transluminal steal syndrome. American Journal of Roentgenology
angioplasty of proximal subclavian artery occlusions. 1980;135(5):995-6.
Cardiovascular and Interventional Radiology 1993;16:214-8.
Bucher 1997
Mohammadian 2013 {published data only}
Bucher HC, Guyatt GH, Griffith LE, Walter SD.The results of
Mohammadian R, Sharifipour E, Mansourizadeh R, Sohrabi B, direct and indirect treatment comparisons in meta-analysis of
Nayebi AR, Haririan S, et al.Angioplasty and stenting randomized controlled trials. Journal of Clinical Epidemiology
of symptomatic vertebral artery stenosis. Clinical and 1997;50(6):683-91.
angiographic follow-up of 206 cases from Northwest Iran.
Neuroradiology Journal 2013 Aug;26(4):454-63. Chatterjee 2013
Chatterjee S, Nerella N, Chakravarty S, Shani J.Angioplasty
Motarjeme 1996 {published data only}
alone versus angioplasty and stenting for subclavian artery
Motarjeme A.Percutaneous transluminal angioplasty of stenosis - a systematic review and meta-analysis. American
supra-aortic vessels. Journal of Endovascular Surgery Journal of Therapeutics 2013;20(5):520-3.
1996;3(2):171-81.
Deeks 2001
Schillinger 2001 {published data only}
Deeks JJ, Altman DG, Bradburn MJ.Statistical methods for
Schillinger M, Haumer M, Schillinger S, Ahmadi R, Minar E.Risk examining heterogeneity and combining results from several
stratification for subclavian artery angioplasty: is there an studies in meta-analysis. In: EggerM, SmithGD, AltmanDG,
increased rate of restenosis after stent implantation? Journal of editors(s). Systematic reviews in health care: meta-analysis in
Endovascular Therapy 2001;8(6):550–7. context. 2nd edition. London, UK: BMJ Publication Group, 2001.
[DOI: 10.1002/9780470693926.ch15]
Sixt 2009 {published data only}
Sixt S, Rastan A, Schwarzwalder U, Burgelin K, Noory E,
Schwarz T, et al.Results after balloon angioplasty or stenting of

Informed decisions.
DerSimonian 1986 Palmaz 1987

DerSimonian R, Laird N.Meta-analysis in clinical trials. Palmaz JC, Kopp DT, Hayashi H, Schatz RA, Hunter G, Tio FO,
Controlled Clinical Trials 1986;7(3):177-88. et al.Normal and stenotic renal arteries: experimental balloon-
expandable intraluminal stenting. Radiology 1987;164(3):705-8.
GRADEpro GDT [Computer program]
McMaster University (developed by Evidence Prime) GRADEpro Review Manager 2020 [Computer program]
GDT.Version (Accessed 24 November 2021). Hamilton (ON): Review Manager 5 (RevMan 5).Version 5.4.1. Cochrane, 2020.
McMaster University (developed by Evidence Prime). Available
from gradepro.org. Shadman 2004
Shadman R, Criqui MH, Bundens WP, Fronek A, Denenberg JO,
GRADE Working Group Gamst AC, et al.Subclavian artery stenosis: prevalence, risk
GRADE Working Group.Grading quality of evidence and strength factors, and association with cardiovascular diseases. Journal of
of recommendations. BMJ 2004;328(7454):1490-4. the American College of Cardiology 2004;44(3):618-23.
Higgins 2003
Higgins JP, Thompson SG, Deeks JJ, Altman DG.Measuring References to other published versions of this review
inconsistency in meta-analyses. BMJ 2003;327(7414):557-60. Burihan 2010
Higgins 2011 Burihan E, Soma F, Iared W.Angioplasty versus stenting
for subclavian artery stenosis. Cochrane Database of
Higgins JP, Green S, editor(s).Cochrane Handbook
Systematic Reviews 2010, Issue 4. Art. No: CD008461. [DOI:
for Systematic Reviews of Interventions Version 5.1.0
10.1002/14651858.CD008461]
(updated March 2011). The Cochrane Collaboration, 2011.
training.cochrane.org/handbook/archive/v5.1/. Burihan 2011
Lefebvre 2011 Burihan E, Soma F, Iared W.Angioplasty versus stenting
for subclavian artery stenosis. Cochrane Database of
Lefebvre C, Manheimer E, Glanville J.Chapter 6: Searching for
Systematic Reviews 2011, Issue 10. Art. No: CD008461. [DOI:
studies. In: Higgins JP, Green S, editor(s). Cochrane Handbook
10.1002/14651858.CD008461.pub2]
for Systematic Reviews of Interventions Version 5.1.0 (updated
March 2011). The Cochrane Collaboration 2011. Available from Iared 2014
training.cochrane.org/handbook/archive/v5.1/.
Iared W, Mourão JE, Puchnick A, Soma F,
Lyon 1996 Shigueoka DC.Angioplasty versus stenting for subclavian artery
stenosis. Cochrane Database of Systematic Reviews 2014, Issue
Lyon RD, Shonnard KM, McCarter DL, Hammond SL, Ferguson D,
5. Art. No: CD008461. [DOI: 10.1002/14651858.CD008461.pub3]
Rholl KS.Supra-aortic arterial stenoses: management with
Palmaz balloon-expandable intraluminal stents. Journal of
Vascular and Interventional Radiology 1996;7(6):825-35. * Indicates the major publication for the study
CHARACTERISTICS OF STUDIES
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Angle 2003 Not a randomised controlled trial
De Vries 2005 Not a randomised controlled trial
Henry 1999 Not a randomised controlled trial
Mathias 1993 Not a randomised controlled trial
Mohammadian 2013 Not a randomised controlled trial
Motarjeme 1996 Not a randomised controlled trial
Schillinger 2001 Not a randomised controlled trial
Sixt 2009 Not a randomised controlled trial

Informed decisions.
Study Reason for exclusion
Tian 2020 Not a randomised controlled trial
Tokatli 2015 Not a randomised controlled trial
Westerband 2003 Not a randomised controlled trial
Yamao 2020 Not a randomised controlled trial
APPENDICES
Appendix 1. Databases searched and strategies used
Source Search strategy Hits retrieved
CENTRAL (the Cochrane #1 MESH DESCRIPTOR Subclavian Artery EXPLODE ALL AND Feb 2021: 160
Library) CRS WEB 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CENTRAL:TARGET
#2 MESH DESCRIPTOR Brachiocephalic Trunk EXPLODE ALL AND

01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CENTRAL:TARGET
#3 MESH DESCRIPTOR Brachiocephalic Veins EXPLODE ALL AND

#4 MESH DESCRIPTOR Vertebrobasilar Insufficiency EXPLODE ALL AND

#5 subclav* or sub-clav* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND

CENTRAL:TARGET
#6 brachioceph* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CEN-

TRAL:TARGET
#7 vertebro* adj3 insuff* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND

CENTRAL:TARGET
#8 steal AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CENTRAL:TAR-

GET
#9 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8
#10 MESH DESCRIPTOR Angioplasty EXPLODE ALL AND INREGISTER
#11 MESH DESCRIPTOR Endovascular Procedures EXPLODE ALL AND IN-

REGISTER
#12 angioplas* or percutan* or PTA AND 01/01/2014_TO_02/02/2021:CRSIN-

CENTRAL AND CENTRAL:TARGET
#13 recanali* or revascular* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL

AND CENTRAL:TARGET
#14 dilat* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CEN-

TRAL:TARGET
#15 balloon or baloon AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND

CENTRAL:TARGET
Informed decisions.
(Continued)
#16 endovascular AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CEN-
TRAL:TARGET
#17 MESH DESCRIPTOR Blood Vessel Prosthesis EXPLODE ALL AND

#18 MESH DESCRIPTOR Blood Vessel Prosthesis Implantation EXPLODE ALL

AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CENTRAL:TARGET
#19 MESH DESCRIPTOR Stents EXPLODE ALL AND

#20 stent* or graft* or endograft* or endoprosthe* AND

#21 powerlink or talent or excluder or aorfix or zenith or endologix or anacon-

da or Triascular or Cordis or Endurant or Quantum or Aneurx or Ancure or Ad-
vanta or Intracoil or Zilver or Luminex AND 01/01/2014_TO_02/02/2021:CRSIN-
CENTRAL AND CENTRAL:TARGET
#22 #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR
#20 OR #21
#23 #22 AND #9
MEDLINE In-process 1 exp Subclavian Artery/ Feb 2021: 449

and other non-indexed
citations and MEDLINE 2 exp Brachiocephalic Trunk/
Ovid
3 exp Brachiocephalic Veins/
1950 to present
4 exp Vertebrobasilar Insufficiency/
5 (subclav* or sub-clav*).ti,ab.
6 brachioceph*.ti,ab.
7 (vertebro* adj3 insuff*).ti,ab.
8 steal.ti,ab.
9 or/1-8
10 exp Angioplasty/
11 exp Endovascular Procedures/
12 (angioplas* or percutan* or PTA).ti,ab.
13 (recanali* or revascular*).ti,ab.
14 dilat*.ti,ab.
15 (balloon or baloon).ti,ab.
16 endovascular.ti,ab.
17 exp Blood Vessel Prosthesis/
18 exp Blood Vessel Prosthesis Implantation/
19 exp Stents/
20 (stent* or graft* or endograft* or endoprosthe*).ti,ab.

Informed decisions.
(Continued)
21 (powerlink or talent or excluder or aorfix or zenith or endologix or anacon-
vanta or Intracoil or Zilver or Luminex).ti,ab.
22 or/10-21
23 9 and 22
24 randomized controlled trial.pt.
25 controlled clinical trial.pt.
26 randomized.ab.
27 placebo.ab.
28 drug therapy.fs.
29 randomly.ab.
30 trial.ab.
31 groups.ab.
32 or/24-31
33 exp animals/ not humans.sh.
34 32 not 33
35 23 and 34
Embase 1 exp subclavian artery/ Feb 2021: 659
1974 to present 2 exp brachiocephalic trunk/
3 exp brachiocephalic vein/
4 exp vertebrobasilar insufficiency/
5 (subclav* or sub-clav*).ti,ab.
6 brachioceph*.ti,ab.
7 (vertebro* adj3 insuff*).ti,ab.
8 steal.ti,ab.
9 or/1-8
10 exp Angioplasty/
11 (angioplas* or percutan* or PTA).ti,ab.
12 (recanali* or revascular*).ti,ab.
13 dilat*.ti,ab.
14 (balloon or baloon).ti,ab.
15 endovascular.ti,ab.
16 exp blood vessel prosthesis/
17 exp stent/
18 (stent* or graft* or endograft* or endoprosthe*).ti,ab.

Informed decisions.
(Continued)
19 (powerlink or talent or excluder or aorfix or zenith or endologix or anacon-
vanta or Intracoil or Zilver or Luminex).ti,ab.
20 or/10-19
21 9 and 20
22 randomized controlled trial/
23 controlled clinical trial/
24 random$.ti,ab.
25 randomization/
26 intermethod comparison/
27 placebo.ti,ab.
28 (compare or compared or comparison).ti.
29 ((evaluated or evaluate or evaluating or assessed or assess) and (compare

or compared or comparing or comparison)).ab.
30 (open adj label).ti,ab.
31 ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab.
32 double blind procedure/
33 parallel group$1.ti,ab.
34 (crossover or cross over).ti,ab.
35 ((assign$ or match or matched or allocation) adj5 (alternate or group$1 or

intervention$1 or patient$1 or subject$1 or participant$1)).ti,ab.
36 (assigned or allocated).ti,ab.
37 (controlled adj7 (study or design or trial)).ti,ab.
38 (volunteer or volunteers).ti,ab.
39 trial.ti.
40 or/22-39
41 21 and 40
CINAHL EBSCOhost S37 S21 AND S36 Feb 2021: 30
S36 S22 OR S23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30 OR S31
OR S32 OR S33 OR S34 OR S35
S35 MH "Random Assignment"
S34 MH "Triple-Blind Studies"
S33 MH "Double-Blind Studies"
S32 MH "Single-Blind Studies"
S31 MH "Crossover Design"
S30 MH "Factorial Design"

Informed decisions.
(Continued)
S29 MH "Placebos"
S28 MH "Clinical Trials"
S27 TX "multi-centre study" OR "multi-center study" OR "multicentre study"

OR "multicenter study" OR "multi-site study"
S26 TX crossover OR "cross-over"
S25 AB placebo*
S24 TX random*
S23 TX trial*
S22 TX "latin square"
S21 S8 AND S20
S20 S9 OR S10 OR S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR
S19
S19 TX powerlink or talent or excluder or aorfix or zenith or endologix or ana-

conda or Triascular or Cordis or Endurant or Quantum or Aneurx or Ancure or
Advanta or Intracoil or Zilver or Luminex
S18 TX stent* or graft* or endograft* or endoprosthe*
S17 (MH "Stents+")
S16 (MH "Blood Vessel Prosthesis")
S15 TX endovascular
S14 TX balloon or baloon
S13 TX dilat*
S12 TX recanali* or revascular*
S11 TX angioplas* or percutan* or PTA
S10 (MH "Endovascular Procedures+")
S9 (MH "Angioplasty")
S8 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7
S7 TX steal
S6 TX vertebro* N3 insuff*
S5 TX brachioceph*.
S4 TX subclav* or sub-clav*
S3 (MH "Brachiocephalic Veins")
S2 (MH "Brachiocephalic Trunk")
S1 (MH "Subclavian Artery")
LILACS BIREME vascular surgical procedures OR blood vessel prosthesis implantation [Subject Feb 2021: 0
descriptor] and Balloon Dilatation OR Stents OR Stent OR angioplasty OR PTA
OR revascularization OR dilatation OR endovascular [Words] and Subclavian

Informed decisions.
(Continued)
OR Brachiocephalic Trunk OR Brachiocephalic Veins OR Vertebrobasilar Insuf-
ficiency [Words]
ClinicalTrials.gov Subclavian OR sub-clavian or Brachiocephalic | vascular surgical procedures Feb 2021: 16

OR blood vessel prosthesis OR Stents OR Stent OR angioplasty OR endovascu-
(clinicaltrials.gov) lar OR dilatation
ICTRP Subclavian OR sub-clavian or Brachiocephalic | vascular surgical procedures Feb 2021: 0

OR blood vessel prosthesis OR Stents OR Stent OR angioplasty OR endovascu-
(apps.who.int/tri- lar OR dilatation
alsearch)
Cochrane Vascular Spe- #1 Subclavian Artery AND INREGISTER AND 01/01/2014_TO_02/02/2021:CRSIN- Feb 2021: 35
cialised Register (CRS CENTRAL
web)
#2 subclav* or sub-clav* AND INREGISTER AND
01/01/2014_TO_02/02/2021:CRSINCENTRAL
#3 #1 OR #2
WHAT'S NEW
Date Event Description
22 November 2021 New citation required but conclusions Search updated. No new included studies were identified. Four
have not changed new studies were excluded. New authors have joined the review
team. Minor changes were made to the text of the review as re-
quired by current Cochrane standards. Conclusions not changed.
22 November 2021 New search has been performed Search updated. No new included studies were identified. Four
new studies were excluded.
HISTORY
Protocol first published: Issue 4, 2010
Review first published: Issue 10, 2011
Date Event Description
25 February 2014 New search has been performed Searches rerun. No new included studies were identified, five ad-
ditional studies were excluded.
25 February 2014 New citation required but conclusions New authors have joined the review team. Searches rerun. No
have not changed new included studies were identified, five additional studies
were excluded. Minor changes to the text of the review. Conclu-
sions not changed.
CONTRIBUTIONS OF AUTHORS
WI: assessed methodological quality, extracted data and wrote the review
JEM: selected trials for inclusion, and updated the review
AP: selected trials for inclusion, and updated the review

Informed decisions.
FS: resolved any disagreements in trial selection, assessed methodological quality, and extracted data
DSC: assessed methodological quality
DECLARATIONS OF INTEREST
IW: none known
JEM: none known
AP: none known
FS: none known
DCS: none known
SOURCES OF SUPPORT
Internal sources
• No sources of support provided
External sources
• Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK
The Cochrane Vascular editorial base is supported by the Chief Scientist Office.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

2021
In the 2014 version, the review authors carried out additional searches in MEDLINE, Embase, and LILACS databases. We did not consider
them necessary for this update, due to the extensive searches run by the Cochrane Vascular Information Specialist.
INDEX TERMS
Medical Subject Headings (MeSH)

Angioplasty; Constriction, Pathologic [therapy]; Stents; *Subclavian Steal Syndrome [therapy]; Systematic Reviews as Topic
MeSH check words

Humans


Cochrane: Library

Uploaded by

Copyright:

Available Formats

Cochrane: Library

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Cochrane: Library

Uploaded by

Copyright:

Available Formats

Cochrane

Angioplasty versus stenting for subclavian artery stenosis (Review)

Iared W, Mourão JE, Puchnick A, Soma F, Shigueoka DC

Iared W, Mourão JEduardo, Puchnick A, Soma F, Shigueoka DCarlos.

Angioplasty versus stenting for subclavian artery stenosis (Review)

Angioplasty versus stenting for subclavian artery stenosis (Review) i

Angioplasty versus stenting for subclavian artery stenosis

Contact: Andrea Puchnick, [email protected].

Editorial group: Cochrane Vascular Group.

Data collection and analysis

Angioplasty versus stenting for subclavian artery stenosis (Review) 1

PLAIN LANGUAGE SUMMARY

Angioplasty alone or with stenting for subclavian artery stenosis

Why is this question important?

What did we do?

What did we find?

How up to date is this systematic review?

Angioplasty versus stenting for subclavian artery stenosis (Review) 2

BACKGROUND data on file for review and analysis. In addition, we considered

Searching other resources Unit of analysis issues

Assessment of heterogeneity • symptomatic and asymptomatic participants in each treatment

Angioplasty versus stenting for subclavian artery stenosis (Review) 5

Figure 1. PRISMA flow diagram

Angioplasty versus stenting for subclavian artery stenosis (Review) 6

Angioplasty versus stenting for subclavian artery stenosis (Review) 7

Angioplasty versus stenting for subclavian artery stenosis (Review) 8

DerSimonian 1986 Palmaz 1987

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Angle 2003 Not a randomised controlled trial

De Vries 2005 Not a randomised controlled trial

Henry 1999 Not a randomised controlled trial

Mathias 1993 Not a randomised controlled trial

Mohammadian 2013 Not a randomised controlled trial

Motarjeme 1996 Not a randomised controlled trial

Schillinger 2001 Not a randomised controlled trial

Sixt 2009 Not a randomised controlled trial

Angioplasty versus stenting for subclavian artery stenosis (Review) 9

Study Reason for exclusion

Tian 2020 Not a randomised controlled trial

Tokatli 2015 Not a randomised controlled trial

Westerband 2003 Not a randomised controlled trial

Yamao 2020 Not a randomised controlled trial

Appendix 1. Databases searched and strategies used

Source Search strategy Hits retrieved

#2 MESH DESCRIPTOR Brachiocephalic Trunk EXPLODE ALL AND

#3 MESH DESCRIPTOR Brachiocephalic Veins EXPLODE ALL AND

#4 MESH DESCRIPTOR Vertebrobasilar Insufficiency EXPLODE ALL AND

#5 subclav* or sub-clav* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND

#6 brachioceph* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CEN-

#7 vertebro* adj3 insuff* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND

#8 steal AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CENTRAL:TAR-

#10 MESH DESCRIPTOR Angioplasty EXPLODE ALL AND INREGISTER

#11 MESH DESCRIPTOR Endovascular Procedures EXPLODE ALL AND IN-

#12 angioplas* or percutan* or PTA AND 01/01/2014_TO_02/02/2021:CRSIN-

#13 recanali* or revascular* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL

#14 dilat* AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND CEN-

#15 balloon or baloon AND 01/01/2014_TO_02/02/2021:CRSINCENTRAL AND

#17 MESH DESCRIPTOR Blood Vessel Prosthesis EXPLODE ALL AND