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hypertension. However, balloon angioplasty resulted in a small improvement in diastolic blood pressure and a small reduction in antihypertensive drug requirements.
Balloon angioplasty appeared safe and resulted in similar numbers of cardiovascular and renal adverse events to medical therapy.
A systematic review by Piaggio etal. [6] replicated the same research methods
and meta-analysis as described by Jenks etal. while expanding it to include papers
between 2014 and 2018. One of the trials included in the previous review published
results in the interim. Additionally, 2 ongoing trials identied in the 2014 review are
yet to publish any result. Meta-analysis of the reports showed no heterogeneity
between trials and no signicant improvement shown by balloon angioplasty, with
or without stenting, versus medical therapy.
Mohan and Bourke [7] assessed the literature on intervention for RAS, with special emphasis on the last two and largest randomized trials, the ASTRAL and
CORAL trials. According to this systematic review, best evidence still supports
intervention for patients with
• RAS of >80% with a signicant translesional pressure gradient;
• difcult to control blood pressure with more than three antihypertensives, espe-
cially in younger patients;
• those with truncal rather than ostial stenosis;
• patients with a rapid deterioration of renal function;
• ash pulmonary oedema;
• and post-transplant RAS.
The Agency for Healthcare Research and Quality (AHRQ) has published a systematic review with a comparative analysis of the effectiveness and safety of percutaneous transluminal renal angioplasty with stent placement (PTRAS) versus medical
therapy, and also versus surgical revascularization, to treat RAS [8]. They included
9 randomized controlled trials (RCTs), 11 nonrandomized comparative studies, 67
cohorts (in 63 studies) of PTRAS; 20 cohorts (in 17 studies) of medical therapy
alone; and 4 cohorts of surgery. There was a low strength of evidence of no statistically signicant or minimal clinically important differences in important clinical
outcomes (death, cardiovascular events, renal replacement therapy) or blood pressure control between PTRAS and medical therapy alone, and that kidney function
may improve with PTRAS.Clinically important adverse events related to PTRAS
are rare; however, studies generally did not report medication-related adverse
events. Based on the evidence, subsets of patients benet from revascularization,
but the evidence does not clearly dene who these patients are, except that case
reports demonstrate that some patients with acute decompensation benet from
revascularization. The RCTs had limited applicability to many patients for whom
PTRAS is recommended, particularly those who present with pulmonary edema or
rapidly declining kidney function. As summarized in Table6.1, for all outcomes, the
strength of evidence is low regarding the relative benet of PTRAS versus medical
therapy alone for patients with RAS, across both comparative and noncomparative
studies.
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Table 6.1 Angioplasty with stent versus medical therapy alone for the treatment of RAS: Strength
of evidence. (According to Balk etal. [8])
Strength of
Outcome
Death Low RCT:4
RRT/ESRD Low RCT:4
Cardiovascular
event
Kidney function Low RCT: 6
Blood pressure
control
Adverse events Low RCT: 4
RRT renal replacement therapy, ESRD end-stage renal disease, RCT randomised controlled trials,
NRCS nonrandomised comparative studies, PTRAS percutaneous transluminal renal angioplasty
with stent placement
evidence
Low RCT: 5
Low RCT: 6
Design
No of studies Finding
Comparative studies: No evidence of a
NRCS: 5
NRCS: 5
Case reports 18
NRCS: 3
Case reports:18
NRCS: 7
Case reports:18
NRCS: 6
Case reports: 18
NRCS:4
Cohort
PTRAS: 34
Cohort medical
therapy alone: 0
difference
Comparative: No evidence of a difference
Case reports: RRT averted with
revascularisation
Comparative: No evidence of a difference
Case reports: Cardiovascular symptoms
resolved immediately with revascularisation
RCT: No evidence of a difference
NRCS: Heterogeneous effect on kidney
function after PTRAS, favouring PTRA
Case reports: Improvement with
revascularisation
Comparative: Inconsistent
Case reports: Improvement with
revascularisation
Severe adverse events rare, but reported only
in PTRAS studies
6 Renal Artery Stenosis
6.2.1.2 Randomised Trials
The Cardiovascular Outcomes in Renal Athero-sclerotic Lesions (CORAL) study
was a multi-center, open-label, randomized, controlled trial that compared medical
therapy alone (480 patients) with medical therapy plus renal-artery stenting (467
patients) in patients with atherosclerotic renal-artery stenosis and elevated blood
pressure, chronic kidney disease, or both [9]. The primary end point was the occurrence of a major cardiovascular or renal event—a composite of death from cardiovascular or renal causes, stroke, myocardial infarction, hospitalization for congestive
heart failure, progressive renal insufciency, or the need for permanent renalreplacement therapy. Over a median follow-up period of 43months, the rate of the
primary composite end point did not differ signicantly between participants who
underwent stenting in addition to receiving medical therapy and those who received
medical therapy alone (35.1% and 35.8%, respectively). Renal-artery stenting did
not confer a signicant benet with respect to the prevention of clinical events when
added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. Key ndings
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from this largest randomised trial of renal-artery stenting in patients with renal
artery stenosis are given in Table6.2.
Under the assumption that the outcomes in randomized trials were due to overly
liberal inclusion criteria, e.g. inclusion of hemodynamically insignicant lesions
with a stenosis diameter< 70%, the RADAR study aimed to evaluate the clinical
impact of percutaneous renal artery stenting on renal function measured by estimated glomerular ltration rate (eGFR) in patients with hemodynamically signicant atherosclerotic RAS, based on duplex ultrasonographic patient screening [10].
In RADAR, outcomes of renal artery stenting were similar to BMT.These results
have to be interpreted with the caveat that the study did not reach its statistically
based sample size. Due to slow enrollment, RADAR was terminated early after
inclusion of 86 of the scheduled 300 patients (28.7%). Change in eGFR between
baseline and 12 months was 4.3 ± 15.4 ml/min/1.73 m2 (stent group) and
3.0±14.9ml/min/1.73m2 (BMT group), p>0.999.
6.2.1.3 Uncontrolled Trials
While the randomised trials demonstrated no benet of PTRAS versus medical
therapy in patients with renal artery stenosis, the uncontrolled trials showed more
positive results. The Safety and Effectiveness Study of the Herculink Elite Renal
Stent to Treat Renal Artery Stenosis (HERCULES) trial is a prospective,
Table 6.2 Stenting and medical therapy for atherosclerotic renal artery stenosis. Outcomes of the
randomised CORAL trial/median follow-up period 43months. (According to Cooper etal. [9])
Stenting + Medical Therapy
(n=459)
End Point
Primary end pointa, rst event 161 (35.1) 169 (35.8)
Components of primary end point
– Death from cardiovascular or
renal causes
– Stroke 12 (2.6) 16 (3.4)
– Myocardial infarction 30 (6.5) 27 (5.7)
– Hospitalisation for congestive
heart failure
– Progressive renal insufciency 68 (14.8) 77 (16.3)
– Permanent renal replacement
therapy
Secondary clinical end points
– Death from any cause 63 (13.7) 76 (16.1)
– Death from cardiovascular causes 41 (8.9) 45 (9.5)
– Death from renal causes 2 (0.4) 1 (0.2)
a
Primary end point: Death from cardiovascular or renal causes, myocardial infarction, stroke,
hospitalisation for congestive heart failure, progressive renal insufciency, or permanent renalreplacement therapy
n (%)
20 (4.4) 20 (4.2)
27 (5.9) 26 (5.5)
4 (0.9) 3 (0.6)
Medical Therapy only
(n=472)
n (%)
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6 Renal Artery Stenosis
multicenter trial evaluating the safety, effectiveness, and durability of the RX
Herculink Elite renal stent system in select patients with atherosclerotic renal artery
stenosis and uncontrolled hypertension [11]. A total of 202 patients were enrolled
between August 2007 and October 2009. The primary endpoint, 9-month binary
restenosis, was 10.5%. At 36months, freedom from death, nephrectomy, and target
lesion revascularisation were 90.1%, 100%, and 91.8%, respectively. The mean
baseline systolic blood pressure of 162± 18mmHg signicantly decreased post
procedure and through 36 months (mean systolic blood pressure 141 mmHg
(P<.0001) and 146mmHg (P<.0001), respectively). The trial demonstrated sustained clinically and statistically signicant reduction in systolic blood pressure in
patients with uncontrolled hypertension.
In another observational study, 54 patients with resistant hypertension and angiographically conrmed renal artery stenosis >70% were followed for 4years after
renal stenting [12]. Blood pressure decreased rapidly after renal stenting and was
normalized in 67% of patients at 6 months, with signicant reduction in the number
of antihypertensive drugs. Creatinine clearance increased in 39% of patients,
decreased in 52% and remained stable in 9%. Urinary albumin excretion did not
change throughout the study. After 4years, left ventricular wall thickness and concentric geometry decreased signicantly and variables of left ventricular diastolic
function improved. The authors concluded that timely identication and correction
of RAS in patients with resistant hypertension could modify the natural history of
the disease with signicant benets for both renal and cardiovascular outcomes.
Atherosclerotic renal artery stenosis (RAS) is associated with high mortality
rates, but large randomized trials have not shown improvement in survival with
renal artery stenting. These results suggest that factors other than ongoing renal
hypoperfusion are important in determining survival in patients with RAS.Using
logistic regression models, Meredith et al. [13] performed a single-center, casecontrol study that included 188 patients with ≥70% RAS; 118 patients (63%)
underwent renal artery stenting. A total of 89 patients (47%) died during an average
follow-up of 5.1years. The risk associated with left ventricular ejection fraction
(LVEF) ≤35% and previous myocardial infarction were additive with mortality of
40%, 54%, and 85%, respectively, with 0, 1, or both these factors. Renal artery
stenting was associated with a 43% reduction in mortality in patients with 0 or 1
mortality risk factors (dened as LVEF ≤35%, previous MI, and glomerular ltration rate≤45ml/min/1.73m2) but had no effect on mortality in patients with 2 or 3
mortality risk factors. This retrospective analysis suggests that clinical, in addition
to anatomic and physiological, factors should be considered in future studies examining effects of renal artery stenting on survival.
Bradaric etal. [14] assessed the impact of drug-eluting stents (DES) compared to
bare metal stents (BMS) for the endovascular treatment of atherosclerotic renal
artery stenosis (RAS). Overall, 338 renal arteries were treated in 298 patients. BMS
were implanted in 163 (48%), and DES in 175 lesions (52%). Of the 175 lesions
treated with DES, 55 (31%) were treated with a BMS-in-DES hybrid technique.
After 12months, the rate of in-stent restenosis >50% was 18.6% in the BMS group
and 7.2% in the DES group (p=0.031). None of the BMS-in-DES-treated (hybrid)
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lesions developed in-stent restenosis. Systolic BP and number of antihypertensive
drugs remained unchanged in the BMS group but declined in the DES group
(p=0.02). Renal function signicantly deteriorated in the BMS group (p=0.03) but
did not change signicantly in the DES group (p=0.188). Overall, the BMS-inDES-technique (hybrid) achieved the lowest risk for in-stent restenosis.
6.2.1.4 Endovascular Treatment ofTransplant Renal Artery Stenosis
Transplant renal artery stenosis (TRAS) following kidney transplantation is a possible cause of graft failure. A review summarized the evidence about physiopathology, diagnosis and early and late effectiveness of endovascular treatment, including
angioplasty and stenting procedures [15]. Fifty-six studies with 1442 patients were
included. TRAS incidence ranged from 1% up to 12% in transplanted kidneys and
was usually observed in the rst year after transplantation. Treatment indications
were non-adjustable hypertension or/and deterioration of graft function. The most
frequent localization of stenosis was para-anastomotic (ranging from 25% to 78%).
In 9 studies, all patients were treated by percutaneous transluminal angioplasty
(PTA), in 16 studies all patients received percutaneous transluminal stenting (PTS)
and in 21 series patients received either PTA or PTS.The 12 months patency rates
after endovascular treatment ranged from 72% to 94%. The complication rates of
the procedures varied between 0 and 25%, the reintervention rates between 0% and
53%. Pseudoaneurysms and hematomas were the most frequent complications.
TRAS can be successfully and safely treated through an endovascular approach.
Stent delivery seems to guarantee a higher patency rate compared to simple angioplasty, however further studies are needed to conrm these results.
Patel etal. [16] compared long-term graft and patient survival after PTA or stent
placement for TRAS with a control cohort without TRAS in a retrospective matched
cohort study of 41 patients. Twenty-four patients underwent PTA and 17 received
stent placements. Ten-year graft survival was 92.1% versus 81.4% (P=.56), and
10-year patient survival was 89.9% vs. 84.7% (P=.49), for the study and control
groups, respectively. Five patients (12%) resumed dialysis in each group and a total
of 17 patients died (eight in the study group and nine in the control group). Most
patients died with a functioning graft (seven of eight in the study group and seven
of nine in the control group). In conclusion, long-term graft and patient survival
after endovascular correction of transplant renal artery stenosis (TRAS) was similar
to that without TRAS and most patients avoided returning to dialysis.
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6.2.2 Registry Data
The Nationwide Inpatient Sample, 1988–2009, was used by Liang et al. [17] to
identify patients with a diagnosis of renal artery atherosclerosis undergoing open
surgical repair (bypass or endarterectomy) or percutaneous transluminal
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angioplasty with or without stenting (PTRA/S). 308,549 PTRA/S and 33,147 open
surgical repairs were identied. PTRA/S increased from 1.9/100K adults in 1988 to
13.7in 2006 followed by a decrease to 6.7in 2009. Open surgical repair steadily
decreased from 1.3/100K adults in 1988 to 0.3in 2009. In 2009, PTRA/S procedures (6.4/100K adults) greatly outnumbered procedures done by open repair alone
(0.1/100 K), combined open renal and aortic repair (0.2/100 K), and combined
PTRA/S and endovascular aneurysm repair (0.3/100 K). The total number of
PTRA/S performed in the outpatient setting remained stable from 2005 (3.8/100K)
to 2009 (3.7/100K), whereas the total number of inpatient procedures mirrored the
national trend, declining from 2006 (7.9/100K) to 2009 (4.2/100K). PTRA/S had
lower in-hospital mortality (0.9% vs. 4.1%; P<.001) compared with open repair.
Mortality was higher after combined open renal and open aortic surgery compared
to open repair alone (6.5% vs. 4.1%; P<.001). Mortality was similar for combined
PTRA/S and endovascular aneurysm repair compared with PTRA/S alone (1.2% vs.
0.9%; P= .04). The performance of PTRA/S procedures for the management of
RAS has decreased signicantly after 2006. An increasing proportion of these procedures are performed in the outpatient setting. PTRA/S remains the dominant
revascularization procedure for RAS with lower in-hospital mortality and morbidity
than surgery.
6 Renal Artery Stenosis
6.2.3 Fibromuscular Dysplasia (FMD)
A meta-analysis by Tian etal. [18] is available on the outcomes following endovascular treatment of renal artery stenosis caused by FMD. 36 relevant studies of 1916
total repairs conducted in 1191 patients were identied. The overall technical success rate across these studies was 94.3%. Rates of total, major, and minor complications in these pooled studies were 12.9%, 4.6%, and 7.4%, respectively. Pooled
rates of cured hypertension and improved hypertension following angioplasty,
dened according to study-specic criteria, were 37.0% and 80.0%, respectively,
although these rates varied highly among studies. Cure rates in studies using current
denitions of cured hypertension (blood pressure< 140/90 mmHg without treatment) were just 18.1% following angioplasty. Cure rates fell markedly with increasing mean patient age (OR associated with an increase in mean age of 10 years:
−0.24 [95% CI: −0.44 to −0.04, P = 0.019] and with mean known duration of
hypertension (OR associated with an increase in mean hypertension duration of
5years: −0.09 [95% CI: −0.12 to −0.05, P=0.001]). These ndings suggest that
endovascular treatment yielded moderate benets to renal artery FMD patients,
with substantial variation across studies. The blood pressure outcome was strongly
inuenced by patient age.
In the prospective ARCADIA registry (Assessment of Renal and Cervical Artery
Dysplasia), symptomatic patients with renal artery (RA) FMD underwent tomographic- or magnetic resonance-angiography from the aortic arch to the intracranial
arteries and those with cervical FMD from the diaphragm to the pelvis [19]. Of 469
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patients (84.0% women), 225 (48.0%) had multisite FMD.The mean age at diagnosis of FMD was 53±13.4years. The clinical presentation of FMD was renal in 304
(64.8%) patients, including 268 with hypertension and 11 with acute renal infarction. It was cerebrovascular in 165 (35.2%) patients, including 100 with acute cerebrovascular events. Among the 165 patients with a cerebrovascular presentation, the
prevalence of RA FMD was 63 of 95 (66.3%) if they had a history of hypertension
and 29 of 70 (41.4%) in the absence of such history (OR, 3.4; 95% CI, 1.99–6.15).
Most patients with multisite FMD had bilateral RA (59.7%) or extracranial carotid
and vertebral (72.5%) FMD lesions. These ndings have implications for the guidelines concerning vascular screening of patients with FMD. Patients with FMD
should be informed of the possibility of lesions affecting asymptomatic vascular
beds, particularly older patients and those with a cerebrovascular presentation
because age and cerebrovascular symptoms are independently associated with multisite FMD.Among patients with a cerebrovascular presentation, those with hypertension are 3× more likely to have RA FMD than those without hypertension. Such
patients should be screened with RA imaging because hypertension could be amenable to RA angioplasty in selected cases.
Fibromuscular dysplasia is a non-atherosclerotic, noninammatory vascular disease that affects children from infancy throughout childhood. In children, it most
commonly affects the renal arteries, but also frequently involves the mesenteric
arteries and abdominal aorta. The most common signs and symptoms in children are
hypertension, headache, abdominal bruits, and dizziness. Green etal. [20] described
the demographics, presenting symptoms and signs, and diagnostic and treatment
modalities utilized in pediatric patients with FMD.As of October 2014, there were
1032 patients in the United States Registry for FMD.Of those patients, 33 were
classied as pediatric (less than 18years of age at the time of diagnosis). Mean age
at diagnosis was 8.4±4.8years. Compared with adults, pediatric FMD occurred in
more males (42.4 vs. 6%, p<0.001). Hypertension (100%), headache (55%), and
abdominal bruits (10.7%) were the most common presenting signs and symptoms.
FMD affects renal vasculature in almost all children (97 vs. 69.7%, p= 0.003),
whereas the extra-cranial carotid vessels are less commonly involved in children
(23.1 vs. 73.3%, p<0.001). At the time of enrollment, 87.9% of pediatric patients
were medically managed with antihypertensive agents, and 54% had undergone
therapeutic procedures related to their FMD diagnosis. Of the pediatric patients
who required intervention, 78.9% underwent balloon angioplasty alone. 15.8% of
children who underwent therapeutic procedures had stent placement, in addition to
their balloon angioplasty. Stent placement should be avoided whenever possible as
the initial management of FMD in children, as they have a high incidence of signicant morbidity in this scenario. Stent placement, however, may be required to manage dissection or other complications.
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6 Renal Artery Stenosis
6.3 Conclusions forClinical Practice
1. Medical therapy is recommended for treatment of hypertension associated with
unilateral renal artery stenosis (RAS). Routine revascularization is not recommended in RAS secondary to atherosclerosis.
2. Balloon angioplasty, with or without stenting, may be considered in selected
patients with RAS and unexplained recurrent congestive heart failure or sudden
pulmonary oedema.
3. PTA +/− stenting have largely replaced the indication for open surgery, as can be
seen from the lack of current publications in this eld.
4. Surgical revascularization should be considered for patients with complex anat-
omy of the renal arteries, after a failed endovascular procedure or during open
aortic surgery.
5. Randomized, controlled trials of revascularization versus medical therapy in
patients with renal artery FMD have not been performed. The negative trials on
stent implantation for atherosclerotic renal artery disease do not apply to patients
with FMD given the differing pathophysiology and natural history of these two
vascular disorders.
6. The European Renal Association (ERA)/European Society of Hypertension
(ESH) summarized the indications of percutaneous transluminal renal artery
angioplasty with or without stenting in patients with atherosclerotic renovascular disease [21]. The indications are shown in Table6.3.
Table 6.3 Indications of percutaneous transluminal renal artery angioplasty with or without
stenting in patients with atherosclerotic renovascular disease (according to Saradis etal. [21])
Strong indications
• High-grade (>70%) RAS in association with one of the following criteria:
– Resistant hypertension
– New-onset or recently uncontrolled hypertension
– Acute pulmonary oedema or acute decompensated heart failure
– Rapid decline of eGFR (bilateral stenosis or solitary kidney)
– ACEI or ARB intolerance (≥30% eGFR reduction)
– Renal replacement treatment (with possibly viable renal parenchyma) if stenosis detected
<3months after renal replacement treatment or if uncontrolled hypertension with multiple (ve
or more) antihypertensive agents
– AKI due to acute renal artery occlusion or high-grade stenosis
– Kidney transplant with RAS
Moderately strong indications
• High-grade (>70%) RAS in association with one of the following criteria:
– Chronic heart failure
– Asymptomatic but either bilateral or supplying a solitary kidney with viable renal
parenchyma (non-atrophic kidney, distinct renal cortex)
References
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