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Health Policy Advisory Committee on
Technology
Technology Brief
Stenting versus medical therapy for atherosclerotic renal
artery stenosis
April 2016
© State of Queensland (Queensland Department of Health) 2016
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DISCLAIMER: This Brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This Brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
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This Brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
Advisory Committee on Technology (HealthPACT). The production of this Brief was overseen by
HealthPACT. HealthPACT comprises representatives from health departments in all States and
Territories, the Australian and New Zealand governments and MSAC. It is a sub-committee of the
Australian Health Ministers’ Advisory Council (AHMAC), reporting to AHMAC’s Hospitals Principal
Committee (HPC). AHMAC supports HealthPACT through funding.
This Brief was prepared by Jacqueline Parsons and Benjamin Ellery from Adelaide Health Technology
Assessment, University of Adelaide.
Summary of findings
Early observational studies on stenting for renal artery stenosis showed promising results in
terms of hypertension control and renal function, however the results have not been
replicated in clinical trials. Recent meta-analyses including around 1,000 patients in each
arm showed no benefit of angioplasty with stenting over medical therapy alone. These trials
have been criticised for including patients with only mild and moderate disease; subgroup
analyses on the groups with more severe disease has not been available to date. Despite a
lack of trial evidence, there is still considerable support for the use of renal artery stenting in
selected patient groups; namely those with flash pulmonary oedema, severe refractory
hypertension or progressive decline in renal function.
HealthPACT Advice
Despite a lack of robust clinical evidence to support its use, stenting for renal artery stenosis
was introduced into routine clinical practice to prevent the progression of chronic kidney
disease. It was thought that stenting would lower blood pressure, and as a consequence
prevent the development of adverse cardiovascular and renal events. The pivotal CORAL
study demonstrated that renal artery stenting proffers no clinical benefit for patients with
severe stenosis and that comprehensive, multifactorial medical therapy is the preferred
treatment option in these patients. It should be noted, however, that renal artery stenting
may be appropriate for use in patients with acute pulmonary oedema, severe refractory
hypertension or progressive decline in renal function.
The number of renal stenting procedures performed in Australia and New Zealand has
markedly reduced in recent years, however clinical practice guidelines still support its use.
HealthPACT does not support the use of renal artery stenosis for patients with severe
stenosis in clinical practice and recommends these patients are treated with multifactorial
medical therapy. However, renal artery stenting should remain a treatment option for
patients with acute pulmonary oedema, severe refractory hypertension or progressive
decline in renal function. HealthPACT recommends the relevant Australian and New Zealand
clinical practice guidelines be amended to reflect this change in clinical practice.
Stenting versus medical therapy for atherosclerotic renal artery stenosis: April 2016
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Technology, Company and Licensing
Register ID
WP207
Technology name
Stenting versus medical therapy for atherosclerotic renal
artery stenosis
Patient indication
Patients with secondary hypertension caused by hardening
and narrowing of the arteries supplying the kidneys
Description of the technology
Stenting for renal artery stenosis is an established technology. Where narrowed renal
arteries are unable to be satisfactorily opened with balloon angioplasty, a stent may be used
to maintain patency of the blood vessel. This is very similar to angioplasty and stent
insertion in the cardiac arteries.
Company or developer
Various companies make stents and the accompanying equipment for angioplasty and
stenting.
Reason for assessment
Recent research indicates that stenting for renal artery stenosis does not incur benefit,
however it may be beneficial in certain patient indications. A summary of evidence is
required for potential partial disinvestment from public health systems in Australia and New
Zealand.
Stage of development in Australia
Yet to emerge
Established
Experimental
Established but changed indication
or modification of technique
Should be taken out of use
Investigational
Nearly established
Licensing, reimbursement and other approval
Established technology.
Technology type
Procedure
Technology use
Therapeutic
Patient Indication and Setting
Disease description and associated mortality and morbidity
Atherosclerotic renal artery stenosis (ARAS) is characterised by narrowing and hardening of
the renal arteries, resulting in impaired blood flow to the kidneys. It is the most common
Stenting versus medical therapy for atherosclerotic renal artery stenosis: April 2016
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cause of secondary hypertension. The mechanism is well understood: reduced blood flow
results in activation of the renin-angiotensin-aldosterone axis, which results in
vasoconstriction, sodium and water retention, aldosterone secretion, sympathetic nervous
system activation, vascular remodelling and resultant hypertension.1 It is strongly associated
with atherosclerosis in other parts of the body, and increases the chances of cardiovascular
events, as well as contributing to decline in renal function and subsequent kidney failure.2
One study found the risk ratio for patients with more than 50 per cent stenosis, compared
to age-matched controls, to be 3.3 for overall mortality and 5.7 for cardiovascular mortality;
another study found the overall mortality rate to be three times higher in patients with
ARAS compared to patients without.3 Interestingly, patients with ARAS are six to 28 times
more likely to die of a cardiovascular event than to develop end-stage kidney disease
(ESKD), although it is estimated that between two and 20 per cent of ESKD is caused by
ARAS.3 Kidney Health Australia estimate that 1.7 million Australians have chronic kidney
disease, and 12 per cent of these cases are caused by hypertension.4 ARAS is more common
in older patients, and with the ageing of the population and widespread use of non-invasive
screening tests, the prevalence of ARAS is likely to increase over time. 5
Number of patients
Estimating the number of patients with ARAS and the number who undergo surgery for the
condition is difficult as the location of the artery is not specified in Australian procedure
data on angioplasty and stenting. The Australian Institute of Health and Welfare (AIHW)
reported that atherosclerosis of the renal artery was the principal diagnosis in 387 episodes
of hospital care in 2013-14.6 Patients also experienced episodes of care for hypertensive
kidney disease, hypertensive heart and kidney disease, and secondary hypertension, all of
which could be related to ARAS (however details are not available).
An American study found that the estimated prevalence of ARAS in the general population
aged older than 65 years was seven per cent, but higher in patients with comorbidities; the
estimated prevalence of ARAS was 20 per cent in patients with hypertension and diabetes,
25 per cent in patients with peripheral vascular disease and 54 per cent in patients with
congestive heart failure.3 Another study reported the prevalence of ARAS to be between
two per cent (in unselected hypertensive patients) and 40 per cent (in older patients with
atherosclerotic comorbidities).7 It is estimated that ARAS is responsible for one to five per
cent of all cases of hypertension.5 A recent review noted a prevalence of ARAS of 0.5 per
cent in the general population, seven per cent in the population over 65 years, up to 59 per
cent in patients with peripheral arterial disease and 50 percent in patients with refractory
congestive heart failure.8
Speciality
Cardiovascular disease and vascular surgery
Technology setting
General and specialist hospitals
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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Impact
Alternative and/or complementary technology
Renal artery stenting is used alongside balloon angioplasty and in conjunction with medical
therapy for the control of hypertension in patients with ARAS.
Diffusion of technology in Australia
Established technology.
International utilisation
Country
Level of Use
Trials underway or
completed
Limited use
World wide
Widely diffused

Cost infrastructure and economic consequences
It is difficult to estimate the cost of renal artery stenting with the data available in the AIHW
hospitals database, however percutaneous transluminal balloon angioplasty with insertion
of a single stent, in vascular sites other than the coronary or carotid arteries, was recorded
in 6,923 procedures in 2013-14, and insertion of multiple stents in 2,759 procedures. The
Medicare rebate for ‘transluminal balloon angioplasty of 1 peripheral artery or vein of 1
limb, percutaneous or by open exposure, excluding associated radiological services or
preparation, and excluding aftercare’ is $515.35. There is no mention of stenting for arteries
other than the coronary arteries in the item descriptors.
Ethical, cultural, access or religious considerations
As with any percutaneous transluminal balloon angioplasty procedure, it must be conducted
in a setting with appropriate infrastructure (including imaging) and skilled physicians to
minimise potential adverse events; these hospitals are likely to be in cities and larger
regional centres, with rural and remote patients being required to travel for the procedure.
Evidence and Policy
Safety and effectiveness
Revascularisation of the renal arteries accelerated in use in the 1990s, based on the positive
results of case series and increase in the general availability of endovascular procedures.
Other observational and experimental studies of revascularisation followed; however it was
not until 2009 that trials specifically investigating the performance of renal artery stenting
were reported. In 2014, the largest trial to date was published. Since then, many reviews
and opinion pieces have been published, and two systematic reviews (SRs) were identified.
These SRs (Level I Intervention evidence) are summarised below.
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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A Cochrane SR published in 2014 included only randomised controlled trials (RCTs) that
compared the effectiveness of balloon angioplasty, with and without stenting, to medical
therapy in patients with ARAS.5 The review included studies where the patients had
‘haemodynamically significant’ renal artery stenosis, defined as greater than 50 per cent
reduction in luminal diameter, and hypertension (diastolic blood pressure ≥95mmHg). The
outcomes of interest were blood pressure control, renal function, cardiovascular and renal
adverse events (including death), occurrence of restenosis, side effects of medical therapy
and use of antihypertensive drugs. The outcomes were reported after a minimum follow up
of six months. In the eight included trials, there was a considerable difference in the
proportion of patients who underwent stenting with their angioplasty; in the older trials
(1998, 2005) between zero and nine per cent received a stent, and in the more recent trials
(2009-2014) between 72 and 95 per cent of participants received a stent. The authors
reported results of the five studies that used stenting as a subgroup analysis, and the results
did not significantly change any of the results, apart from making the significant difference
in diastolic blood pressure, seen in the overall analysis, no longer significant. The results
from this subgroup are not reported; thus, the overall results are presented with the caveat
that not all the studies included in each meta-analysis used stenting, but that this made little
difference to the results. The authors reported that the overall quality of the evidence was
moderate but variable, and noted that two trials contributed the majority of patients to the
meta-analysis. Heterogeneity was low. The results of the meta-analyses are shown in Table
1.
The authors concluded that there was insufficient evidence to conclude if revascularisation
of the renal artery is superior to medical therapy in lowering blood pressure, nor in reducing
the incidence of cardiovascular or renal adverse events. However angioplasty does appear
to be safe. Importantly, they noted that none of the trials presented data separately
according to the severity of the stenosis, and analyses to try and identify particular groups
who may have benefit was not possible.5
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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Table 1
Results of meta-analysis of selected outcomes in revascularisation trials, as reported in Jenks et al
(2014)5
Number of
trials
Revascularisation
(n)
Medical Therapy (n)
Result (95% CI)
Change in systolic BP (mmHg) at 2 years
or end of follow-up
5
857
886
MD -1.07 (-3.45, 1.30)
Change in diastolic BP (mmHG) at 2
years or end of follow-up
4
397
412
MD -2.00 (-3.72, -.027)*
Number of antihypertensive drugs
3
847
870
MD -0.18 (-0.34, -0.03)*
Cardiovascular adverse events
7
1039
1071
OR 0.91 (0.75, 1.11)
Renal adverse events
7
1036
1068
OR 1.02 (0.75, 1.38)
Outcome (measure)
Table notes: BP = blood pressure; MD = mean difference; OR = Peto odds ratio; * = favours revascularisation; note that all trials, including those that did
not stent patients, were eligible for inclusion in the meta-analysis. Subgroup analysis (meta-analyses not reported) showed that the stenting trials made no
significant difference to the results, except for the diastolic BP outcome which was not statistically significant in the stenting trials alone.
A second SR also published in 2014 included seven RCTs, all of which were in the Cochrane
review.9 The trial not included was the trial prematurely terminated for which only
preliminary data were available. This review used appropriate methods and appraised the
risk of bias in the studies using the Cochrane tool. Not unexpectedly, the results were very
similar to the Cochrane review, although this review conducted a meta-analysis on more
specific outcome measures. Rather than cardiovascular adverse events as a whole, this
review separated several cardiovascular endpoints, i.e. non-fatal myocardial infarction,
congestive heart failure, and stroke, and considered all-cause mortality as a separate
outcome. This review also presented the results for the stenting trials separately to the
angioplasty-only trials. As with the Cochrane review, this review found stenting to be no
better than medical therapy with respect to all-cause mortality, non-fatal myocardial
infarction, stroke, systolic blood pressure, hospitalisation due to congestive heart failure or
renal events. There was a small, statistically significant decrease in the number of
antihypertensive medications in the stented group; the clinical significance of this reduction
is not discussed. Results are presented in Table 2.
The authors’ conclusions were similar to the Cochrane review, stating that revascularisation
with stenting is not superior to medical therapy for ARAS. They also noted that the
measurement of stenosis and heterogeneity in the degree of stenosis in patients in the trials
was a limiting factor.9
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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Table 2
Results of meta-analysis of selected outcomes in revascularisation trials that used stenting, as
reported in Riaz et al (2014)9
Outcome (measure)
Number of trials
Result (95% CI)
Non-fatal MI
4
OR 0.99 (0.69, 1.43)
Number of antihypertensive drugs1
5
MD -0.18 (-0.27, -0.09)*
All cause mortality
4
OR 0.91 (0.72, 1.15)
Stroke
4
OR 1.21 (0.72, 1.74)
Congestive heart failure
3
OR 1.15 (0.84, 1.57)
Renal events
4
OR 0.95 (0.76, 1.18)
Table notes: BP = blood pressure; MD = mean difference; OR = Peto odds ratio; * = favours revascularisation;
1 meta-analysis included all revascularisation trials, not only stenting
Thus, it is clear that in these meta-analyses, revascularisation with stenting is not superior to
medical therapy on any outcome except the number of antihypertensive drugs used, and
the clinical significance of that difference is questionable. However, the authors of both
reviews note that limited information about the severity of stenosis and other clinical
conditions affecting the patient was available, and investigation of particular subgroups has
not occurred to date. The inclusion criteria of a selection of trials, reported in the Cochrane
review, give some indication as to the heterogeneity of patient indications that participated
in the trials.5 The ASTRAL trial only included patients with ‘uncontrolled or refractory
hypertension, or unexplained renal dysfunction with evidence of substantial anatomical
atherosclerotic stenosis in at least one renal artery’ and in whom the value of stenting was
uncertain; thus, if the physician thought the patient would benefit from revascularisation,
they were excluded from the study. This is likely to have been the more severe cases of
stenosis. The CORAL trial included patients only with a stenosis of 80 to 90 per cent, or 60 to
70 per cent with a systolic pressure gradient of more than 20 mmHg, and elevated blood
pressure or chronic kidney disease or both. They excluded patients with stenosis or kidney
disease due to other causes and patients in whom they believed could not be treated with a
single stent. However, the original enrolment criteria were relaxed during the trial due to
slow recruitment, and patients without hypertension and chronic kidney disease were
recruited. The STAR trial included patients with impaired renal function with stenosis of >50
per cent, but excluded patients with creatinine clearance of less than 15 mL/min, small renal
diameter, small renal size, diabetes with proteinuria or malignant hypertension; again, likely
to exclude the more severe cases.
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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It is worth mentioning that many of the reviews and opinion pieces that have been
published on this topic believe that there is a place for stenting in ARAS with the correct
patient indication. A review of the history of treatment for ARAS stated that even without
definitive evidence, high-risk patients such as those with recurrent flash pulmonary oedema,
rapidly declining kidney function or refractory hypertension may benefit from
revascularisation.8 Chrysant (2013) agreed that these were indications for significant ARAS
and compelling reasons for intervention.10 Another review reported that, in their practice,
revascularisation is reserved for patients with severe and truly refractory hypertension that
is failing aggressive medical management, patients with severe hypertension and declining
renal function and patients with hypertensive emergency. This is despite recognising that
trial data could not support or refute the effectiveness of revascularisation in severe ARAS. 11
Jennings et al also noted that there is likely to be a place for revascularisation in clinical
care, but selecting the correct patients is difficult and there is currently no reliable method
for identifying them, especially given that the degree of stenosis correlates poorly with
outcomes. The authors conclude that revascularisation may be considered in patients who
fail to stabilise with medical management or who present with multiple high risk features
such as flash pulmonary oedema.12 Australian authors Mohan and Bourke state that ‘best
evidence still supports intervention’ for patients with severe ARAS but do not offer that
evidence; however they are strong in their assertion that the trials to date have only shown
that stenting is no better than medical therapy in patients with moderately severe ARAS. 13
Likewise, Mousa (2015) stated that patients with pulmonary oedema without valvular or
ischaemic substrate should be considered for stents, and patients with uncontrolled
hypertension, deteriorating renal function, abrupt congestive heart failure or a combination
of these should be referred for intervention; however noted that there is a lack of ‘”Level I”
data for any indication’.14
In summary, clinical trials have shown no added benefit of stenting over medical therapy in
the general population of patients with ARAS; however, many participants in these trials had
only moderate severity of disease and subgroup analyses of particular groups with more
severe disease have not occurred to date. There is still considerable interest in renal artery
stenting and its application in these groups. There does seem to be support for the use of
revascularisation in patients with flash pulmonary oedema, severe refractory hypertension
and progressive deterioration in renal function.
Guidelines from around the world were consulted to check on their recommendations for
the use of renal artery stenting. No relevant Australian guidelines were identified. Overall,
the level of evidence supporting the guidelines for specific groups was low, as these groups
have not been investigated in trials.
Canadian hypertension guidelines do not recommend renal artery angioplasty and stenting,
given that it offers no benefit over medical management.15 However, the guidelines group
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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also noted that the trials are likely to have included patients with less severe stenosis, and
given that the point estimates in the meta-analyses favoured angioplasty, it is possible that
it could be useful in patients with severe or refractory hypertension. They recommended
that it could be considered in ’patients with uncontrolled hypertension resistant to
maximally tolerated pharmacotherapy, progressive renal function loss, and acute pulmonary
edema’.15
The Society for Cardiovascular Angiography and Interventions Consensus Statement for
Renal Artery Stenting Appropriate Use published in 2014 recommended that renal artery
stenting represents appropriate care in patients with flash pulmonary oedema, severe
bilateral ARAS or stenosis to a solitary functioning kidney, accelerated or resistant
hypertension, progressive deterioration in renal function and global renal ischaemia. 1 The
procedure rarely represents appropriate care in patients with haemodynamically mild to
moderate stenosis. Although these recommendations mentioned ‘multisocietal guidelines’
with evidence levels, these levels are not explained, so it is difficult to ascertain what they
pertain to and whether the evidence for these recommendations is robust.
European Cardiac Society guidelines, last published in 2011, also recommend angioplasty
with stenting in some patients with more severe ARAS.16 Their recommendations were
based on three levels of evidence: Level A, supported by multiple RCTs or meta-analyses;
Level B, supported by data derived from a single RCT or large non-randomised studies; and,
Level C, consensus of opinion of experts and/or small studies, retrospective studies or
registries. These were combined with ‘class’ of recommendation; ranging from Class I,
recommended or indicated; Class IIa and IIb, should be and may be considered; and, Class
III, not recommended. Stenting is recommended in patients with ostial stenosis (Level B),
and may be considered in patients with symptomatic ARAS with stenosis of more than60 per
cent (Level A), patients with impaired renal function (Level B) and patients with ARAS and
unexplained recurrent congestive heart failure or sudden pulmonary oedema and preserved
left systolic ventricular function (Level C).16 It should be noted that these guidelines were
published before the release of the results from the CORAL trial.
The American College of Cardiology Foundation and American Heart Association Task Force
on Practice Guidelines (2013) used the same Level and Class rating system as described
above.17 These guidelines state that indications for revascularisation are: asymptomatic
bilateral or solitary viable kidney with haemodynamically significant ARAS (Level C, Class IIb);
haemodynamically significant ARAS and accelerated, resistant or malignant hypertension
(Level B, Class IIa); bilateral ARAS or ARAS in a solitary functioning kidney and progressive
chronic kidney disease (Level B, Class IIa); patients with chronic renal insufficiency with
unilateral ARAS (Level C, Class IIa); patients with haemodynamically significant ARAS and
recurrent, unexplained congestive heart failure or sudden pulmonary oedema (Level B, Class
I); and, patients with haemodynamically significant ARAS and unstable angina (Level B, Class
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
8
IIa). Stent insertion is indicated for ostial ARAS lesions that meet the clinical criteria for
intervention (Level B, Class I).17 Again, these guidelines have not been informed by the most
recent trial data.
Economic evaluation
No recent economic evaluations of renal artery stenting were identified; however it should
be noted that this Brief is not a systematic review and therefore information about this
aspect of the procedure could have been missed. Even older economic evaluations were
limited and tended to focus on diagnosis of ARAS rather than treatment, and so have not
been considered here. As yet, the procedure has not appeared on the ‘Choosing Wisely’ list
in the United States nor on the UK’s National Institute of Health and Care Excellence (NICE)
‘do not do’ list.
Ongoing research
A search of ClinicalTrials.gov for RCTs comparing stenting with medical therapy revealed an
RCT of similar design to the previous trials (NCT01208714); eligible patients have ‘clinical or
radiological evidence of unilateral or bilateral renal atherosclerotic stenosis, defined by
stenosis of the proximal portions of the renal artery and its main bifurcations at angioCT
(angio-computed tomography)’. This trial is being conducted in Italy, however its status is
recorded as not yet open for recruitment, despite it being due for completion in 2016. A
second RCT in France (NCT02539810) is currently recruiting participants with officemeasured blood pressure of at least 140 mmHg systolic and/or 90 mmHg diastolic despite a
stable medication regime including full tolerated doses of three or more anti-hypertensive
treatments of different classes, and unilateral or bilateral ARAS of at least60 per cent. Two
other trials of stenting versus medical therapy have unknown status as they have not been
recently updated: NCT00711984 and NCT01173666. No relevant trials were identified on
the Australian and New Zealand Clinical Trial Registry (ANZCTR).
Other issues
None identified.
Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according
to the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the HealthPACT web site.
Total number of studies: 2
Total number of Level I studies: 2
Stenting versus medical therapy for atherosclerotic renal stenosis: April 2016
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Search criteria to be used (MeSH terms)
Renal artery stenosis (text)
MeSH: renal artery obstruction
References
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what to stent?'. Curr Atheroscler Rep, 16 (6), 416.
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Tendera, M., Aboyans, V. et al (2011). 'ESC Guidelines on the diagnosis and
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