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Abstract

In recent years, endovascular treatments have become more common in patients with renal artery stenosis and aneurysm. Although the treatment algorithms are not universally accepted, endovascular therapy can be readily utilized for the appropriate indications in the context of surgical treatment for renovascular diseases. The most important factor to consider is that the correct indication is applied for such treatment. Although the applied procedures are believed to have minimal risk, any complications that occur may result in major problems. Moreover, the pathology that is being treated (e.g., hypertension, high serum creatinine concentration, or low glomerular filtration rate) must be well defined. As stent and balloon technologies continue to be developed, more positive results are expected in the coming years. In the present study, we reviewed the endovascular treatment algorithms for atherosclerotic renovascular disease and performed a narrative review of the current literature.

Keywords

Renal artery renovascular disease renal stenosis fibromuscular dysplasia renal artery angiography atherosclerotic renal artery endovascular treatment renal artery stenting

Introduction

Renovascular diseases (RVDs) have been an area of research in vascular surgery since 1954.¹ Although RVDs have been studied for many years, a definite consensus regarding medical and surgical treatment options has not been reached. The role of endovascular therapy in the treatment of RVDs is controversial; however, such therapy remains a good alternative in select patients with a high risk of mortality and morbidity.²

RVDs have many causes. The most common cause of symptomatic manifestations is atherosclerotic renal artery stenosis. Although its incidence in the general population is 5%, this incidence rises to 40% among individuals aged >75 years.³ The present narrative review of the current literature focuses on the endovascular treatments of atherosclerotic RVD.

Definition

RVD is defined as ≥60% stenosis of the renal artery as shown by angiographic imaging. If the stenosis is <60%, a pressure gradient of ≥15 mmHg is also defined as RVD.⁴

Clinical presentation

RVD may present as hypertension developing before the age of 30 years, abdominal bruit with hypertension, resistant hypertension, hypertensive crisis, deterioration of renal function or development of azotemia after use of renin–angiotensin–aldosterone system blockers, unexplained kidney atrophy, sudden pulmonary edema, or newly developing hypertension in patients aged >55 years with coronary artery disease³ (Table 1). Fibromuscular dysplasia is an RVD that affects <1% of the general population and occurs in disproportionately more women than men (9:1).⁴

Table 1.

Clinical presentations.

Hypertension diagnosed before 30 years of age

Severe hypertension associated with CKD or heart failure diagnosed after 55 years of age

Hypertension with abdominal bruit

Sudden worsening of controlled hypertension

Resistant hypertension (despite treatment with four drug classes, including a diuretic and a mineralocorticoid receptor antagonist at appropriate doses)

Hypertensive crisis (acute renal failure, acute heart failure, hypertensive encephalopathy, or grade 3–4 retinopathy)

Azotemia or worsening renal function observed after treatment with RAAS blockers

Kidney atrophy (unknown cause), kidney size mismatch, or kidney failure (unknown cause)

Sudden pulmonary edema

CKD, chronic kidney disease; RAAS, renin–angiotensin–aldosterone system.

Indications for treatment

The natural history of RVD is characterized by an increase in anatomical stenosis and a decrease in kidney size and function. Progression of anatomical stenosis is thought to be rare if hypertension is not present. At the 8-year follow-up in one study, the severity of stenosis had increased at an annual rate of 0.5% in the elderly population.⁵ In addition, RVD has been associated more with kidney size than function.⁶

Although several randomized trials focused on revascularization, none of them showed any advantage of renal artery stenting over optimal medical therapy alone.^7–9 Therefore, the indications for endovascular treatment remain controversial. The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial,¹⁰ Atherosclerotic Ostial Stenosis of the Renal Artery (STAR) trial,¹¹ and North American Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial¹² showed no conclusive evidence for renal stenting in the treatment of ischemic nephropathy and renovascular hypertension.

The ASTRAL and STAR trials had some methodological problems. In the CORAL trial, there was no significant difference in clinical benefits for patients with renal artery stenosis with or without severe hypertension. In addition, although the degrees and gradients of stenosis were measured, a precise definition of stenosis was not given. Moreover, some patient groups with RVD were excluded from the study. Therefore, the study is being replanned in the form of the CORAL-2 trial. Although the results of large studies have been negative, many authorities on RVD advocate the use of renal revascularization only for patients with truly resistant hypertension and hypertension complicated by defined end-organ damage.^13–15

Unfortunately, with no clear data, a definitive relationship between stenosis and the dynamic functions of the kidney has not been established. However, the improvement in renal function over time after revascularization suggests the importance of revascularization.¹⁶

Although its indications have not been firmly established, renal revascularization is recommended in patients with severe renal artery stenosis resulting in cardiac syndromes due to hypertension that is difficult or impossible to control.^3,4,7–9 Additionally, RVD should be considered in patients with pulmonary edema that develops suddenly with an abrupt increase in blood pressure, hypertensive crisis causing organ damage, hypertensive encephalopathy, myocardial infarction, or acute renal failure.

Revascularization is not routinely recommended in patients with renal artery stenosis secondary to atherosclerosis according to the joint guideline of the European Society for Vascular Surgery and the European Society of Cardiology. In the presence of hypertension associated with renal arterial fibromuscular dysplasia either with or without symptoms of renal failure, balloon angioplasty (stenting if unsuccessful) should be considered (IIa). Balloon angioplasty with or without a stent may be considered in select patients with renal artery stenosis and unexplained recurrent congestive heart failure or sudden pulmonary edema (IIb).³

Contraindications

Contraindications for endovascular treatment of RVD can be grouped under three main categories: anatomical factors, stenosis that would be optimally treated by revascularization via open surgery, and prophylactic treatment in the absence of symptoms. Endovascular treatment should be avoided in patients with RVD extending to the terminal portion of a main renal artery or patients with a very short main renal artery because of the high probability of technical problems.

Anatomical contraindications include renal arteries that cannot be easily treated with existing endovascular devices as well as arteries that would not have a positive outcome even if revascularized. Additionally, patients with RVD in branches distal to the main bifurcation, patients with lesions in multiple small renal arteries, and children (most commonly those with hypoplastic lesions) are poor candidates for endovascular therapy because of concerns about long-term outcomes. Unless there is a high risk associated with open surgery, surgical revascularization is probably the best option for these patients.

In patients with an indication for open aortic surgery for other reasons, surgical revascularization should be considered if there is also an indication for renal revascularization. Prophylactic intervention for RVD is aggressively applied because of its absence of procedural complications and high technical success. However, there is no evidence to support prophylactic application when kidney function is normal and hypertension can be controlled with medical treatment.¹³ The natural history of atherosclerotic renal artery stenosis is characterized by an increased severity of stenosis in 30% of patients and total occlusion in 7%.¹⁷ Progression of the disease does not appear to be closely related to increases in blood pressure or the serum creatinine concentration.¹⁸

In conclusion, endovascular treatment should not be applied in patients with chronic total occlusion or mild to moderate renal artery stenosis.

Endovascular access preference

Common femoral artery access is the safest and most preferred site of access for endovascular therapy. When selective renal artery cannulation is planned, choosing the femoral artery contralateral to the targeted renal artery may facilitate ostial cannulation as the catheter moves along the contralateral aortic wall of the access site. The brachial artery can be used in patients with aortoiliac lesions, patients in whom the angulation of the renal artery is downward-oriented, and patients in whom cannulation of the femoral artery is unsuccessful. The disadvantages of access in the brachial region are the use of a sheath with a smaller diameter than the femoral artery and the higher rate of access-related complications.

Angioplasty and/or stent application

Existing accessory arteries may not be visualized by Doppler ultrasonography before the procedure. Therefore, these arteries should be observed in detail during the procedure. The renal arteries arise obliquely from the abdominal aorta. Standard anteroposterior aortography may be insufficient to visualize osteal lesions because overlapping will occur during imaging of the aorta and proximal renal artery. Therefore, an oblique view is more useful.⁹

After the initial aortography, systemic heparinization is performed to reach the target renal artery. Access can be achieved using a guiding or diagnostic catheter. The tip of the appropriate catheter is inserted into the orifice of the target renal artery, and a guide wire is then passed through the stenotic lesion. The smaller wire is thought to minimize renal artery trauma and provide a technical advantage in passing critical lesions. A 0.14-inch guide wire with a radiopaque tip is preferred for the renal artery. After accessing the wire, the guide catheter should be withdrawn to avoid renal artery injury.

When employing protection against embolization in the distal renal artery, a wire system containing a distal renal artery occlusion balloon or filter is used to cross the lesion and position the balloon or filter in the distal portion of the artery. If an occlusion balloon device is used, complete renal artery occlusion is confirmed by manual injection of contrast agent.

After stenting, the distal part of the lesion is aspirated. After washing with heparinized saline, the aspiration process is repeated. The distal occlusion balloon is then deflated, and control angiography is performed. Filter devices allow distal renal artery blood flow from the site of insertion and have a porous membrane to capture embolic material. After angioplasty and stenting, the embolic material is trapped inside the device by closing the filter before the device is withdrawn.⁹

In patients with critical lesions, predilatation may be needed before stenting. The angioplasty balloon diameter should be selected based on quantitative angiography measurements. The normal arterial diameter without stenosis can be used as a reference for the balloon diameter when performing primary stenting. If predilatation is required, smaller balloons should be chosen (usually 2–4 mm × 20 mm low-profile balloons). For predilatation, the balloon should be inflated at nominal pressure for 15 to 30 s. Patients may feel pain during angioplasty, but symptoms that persist after deflation suggest renal artery injury (renal artery rupture is the worst complication). The shortest stent that completely covers the lesion should be used. Positioning can be accomplished by frequent injection of small volumes of contrast material through the guide catheter or sheath. The guide wire should be protected during balloon deflation and removal. Although balloon-expandable stents provide more flexibility, they are not usually the preferred choice. Therefore, dilatation with a balloon can be applied to stents that did not expand adequately. However, dense calcifications can sometimes prevent the stent from fully deploying, and excessively vigorous attempts to expand the vessel may increase the risk of vessel rupture.⁹

When applying the procedure to the renal arteries, the normal renal artery diameter should be used as the reference. In these patients, it may be misleading to measure the renal artery diameter immediately after the stenotic segment because of the post-stenotic dilatation that occurs in this region. Balloon angioplasty suitable for the normal renal artery diameter should be performed, or a stent should be selected.

Technical success

Anatomically, technical success can be defined as angiographic disappearance of the stenosis and placement of a stent that covers the entire stenotic segment.¹⁹ Post-intervention residual stenosis of <30% is the reported threshold for technical success versus failure.²⁰ When contrast angiography demonstrates anatomically successful treatment of the stenotic lesion, these findings should be further confirmed by measurement of the transducer pressure immediately proximal and distal to the treated lesion. A pressure difference of ≥10 mmHg also suggests inadequate treatment, and complementary angioplasty can be performed even if residual stenosis is not observed.²¹

In terms of functionality, technical success is determined by evaluating the improvement in the patient’s clinic status. If the patient underwent an intervention for hypertension, a decrease in the systolic and diastolic pressures or a decrease in the dose of the antihypertensive medication should be considered technical success. In addition, the serum creatinine concentration, cystatin C concentration, estimated glomerular filtration rate (eGFR), and kidney length/volume can be used to evaluate the response to the intervention in terms of renal function. An eGFR increase of ≥20% is defined as technical success. None of these values alone can prove the success of the intervention, however.^11,22 When evaluated in light of real-life data, technical success is also indicated by the time the patient spends off dialysis and the absence of renal infarction and cardiovascular morbidity.

Contrast nephropathy

Angiographic visualization of the arterial anatomy is an essential element of both the diagnosis and endovascular management of atherosclerotic RVD. In addition to associated renal dysfunction and hypertension, common conditions that may predispose to contrast-induced renal dysfunction in patients with RVD include diabetes mellitus, congestive heart failure, anemia, and heavy diuretic drug use.^2,9

The volume and density of the contrast agent used during the procedure are also important factors. Prophylactic strategies to prevent contrast-induced nephropathy include maximizing renal perfusion, reducing oxidative stress, and preventing vasoconstriction. Hydration is a generally accepted prophylactic method. However, the evidence supporting the routine use of N-acetylcysteine, sodium bicarbonate, and ascorbic acid is inconsistent.^2,9

Many clinics routinely apply iso-osmolar saline hydration and N-acetylcysteine to all patients prior to the procedure, although this strategy is not based on definitive data. Additionally, sodium bicarbonate is administered in patients with renal dysfunction.²³ In patients with severe renal dysfunction (eGFR of <30 mL/minute/1.73 m²), carbon dioxide can be used as the primary contrast agent or as an adjunct material during the first aortography to reduce the volume of iodinated contrast material administered.^2,9

Primary balloon angioplasty and stent placement

Primary angioplasty is currently considered the most appropriate endovascular therapy for patients with renal artery fibromuscular dysplasia. However, primary stenting for the treatment of ostial atherosclerotic RVD is considered superior to angioplasty alone because of its high technical success rate and low incidence of recurrent stenosis.³ Primary angioplasty can be used for the treatment of recurrent disease. Non-ostial atherosclerotic lesions may also respond well to angioplasty alone. However, if primary angioplasty fails, stenting should be considered in subsequent attempts.

Postoperative management

Postoperatively, the patient should be closely followed overnight for access site complications (e.g., bleeding or hematoma formation) and hemodynamic instability. The serum creatinine concentration should be checked in all patients the day after the procedure (before discharge). Clopidogrel is maintained for at least 30 days after the intervention. It can be extended up to 1 year depending on the stent material. Aspirin and statin therapy are continued indefinitely. Clinical follow-up with renal duplex ultrasonography is performed at 6-month intervals for 2 years, with the first control examination performed in the first month after the intervention, and annually thereafter.^3,4,24 The frequency of clinical follow-up and imaging is increased for patients who develop anatomical recurrence when the blood pressure is maintained or renal function responds to intervention. However, intervention is not planned unless clinical signs appear. When repeated intervention is required for recurrent disease, an endovascular approach is often preferred. Early disease recurrence should be suspected in patients who develop intra-stent stenosis due to intimal hyperplasia.²⁵

Restenosis after endovascular intervention

Restenosis can be diagnosed by angiography or Doppler ultrasonography. The literature demonstrates remarkable differences in restenosis rates among studies, ranging from 5% to 66%. These significant differences are thought to be due to the different follow-up periods of the patients in the studies and the frequency of imaging controls.^24–26 Restenosis can be encountered during routine follow-ups. Additionally, in patients with clinical improvement, relapse of the clinical symptoms should prompt clinicians to consider restenosis.

Restenosis is more common in women and in patients with metabolic syndrome. It is less common in patients receiving adequate statin therapy. Risk factors for restenosis include stent misplacement (often due to an inability to place the stent at the proximal end of osteal lesions), compression of the stent due to severe calcification, and stent breakage.²⁷

Complications

Major reported complications include bleeding, access site pseudoaneurysm, bowel or limb ischemia, myocardial infarction, renal artery thrombosis, and acute renal failure.^3,4,24

Hemodynamic instability after endovascular renal intervention should be considered a hemorrhagic complication until proven otherwise. Computed tomography is vital when hemodynamic instability has occurred. Bleeding is most commonly associated with the arterial entry site, but it may also occur with renal artery rupture secondary to the angioplasty balloon or with mortal hemorrhage causing perinephric hematoma due to guidewire perforation of the kidney parenchyma.^3,4,24 Bleeding due to renal artery perforation can usually be managed with endovascular techniques, although surgical exploration may be required in rare cases.⁹ Perinephric hematoma due to guidewire perforation is an emergency and should be treated as soon as possible with endovascular embolization or open surgery. When the renal artery is thrombosed as a result of the procedure, patency can be achieved by thrombolysis.²⁸

Current literature review on renal artery stenosis

With the increase in the frequency of endovascular interventions, endovascular approaches have begun to be added to treatment algorithms for many vascular diseases. In recent years, endovascular treatments have become more common for renal artery stenosis and aneurysm. Although the ASTRAL and STAR studies failed to show significant benefits of endovascular treatments, different studies involving different patient groups are still ongoing. We searched Google Scholar and PubMed using the keywords “renal artery stenosis,” “stenting,” and “angioplasty,” and studies involving patients with aneurysm were excluded. Studies that performed comparisons of stenting versus angioplasty, comparison with best medical treatment, or single-arm follow-up were included (Table 2).

Table 2.

Current studies on atherosclerotic renal artery disease.

Reference	Aim	Groups	Sample size	Intervention	Primary results	Other results	Comments
Corriere et al.²⁹ (2008)	Early GFR results of patients with angioplasty and stent implantation	Single	108 patients	Stents (n = 108)	Technical success rate: RA-PTAS: 94.5%GFR: 27.7% improved, 62.3% did not improve	5.5% developed periprocedural complicationsNo mortalityHypertension response to RA-PTAS: 1.1% were cured, 20.5% improved, 78.4% remained unchanged	Positive effects on blood pressure were observed.
Touma et al.³⁰ (2014)	Assessment of safety and efficiency of TRAS endovascular therapy	Single	24 patients (TRAS)	Angioplasty (n = 5)Stents (n = 12)	Stenosis-free primary patency: 76.5%Freedom from reintervention: 88.2%Serum creatinine concentration decreased (P = 0.0036)GFR increased (P = 0.004)	SBP decreased (P = 0.11)Diastolic BP decreased (P = 0.36)Number of preoperative antihypertensive medications remained unchanged (P = 0.33)	Renal function improved.
Louis et al.³¹ (2020)	Atherosclerotic RAS patency rate	BMT vs. stenting	10,318 patients	Stents (n = 5,159)MT (n = 5,159)	Acute kidney injury:RAS: 30%Nonelective 30-day readmission:- RAS: 18.2%- MT: 18.7% (P = 0.49)	RAS was associated with higher index rates of: - Acute kidney injury - Major bleeding - Transfusion - Vascular complications	When a stent was placed, the results were not different from those of MT alone.In fact, the rate of readmission and the total cost were higher in patients who underwent stenting.
Cooper et al.³² (CORAL Trial) (2014)	Mortality and patency rate in atherosclerotic RAS	BMT alone vs. BMT with stenting	931 patients	Stents (n = 459)MT (n = 472)	No difference in mortality of any causeNo difference in renal complications	Hypertension decreased more rapidly in the stent group	Considering the long-term outcome, stenting does not have an advantage in patients undergoing BMT
Zeller et al.³³ (RADAR Trial) (2017)	Effect of atherosclerotic RAS on mortality and GFR	BMT alone vs. BMT with stenting	86 patients	Stents (n = 45)BMT (n = 41)	No difference in GFR or mortalityNeed for target vessel revascularization (3 years):- RAS: 3.0%- BMT: 29.4%	Clinical event rates (cardiac death, stroke, myocardial infarction, and hospitalization for congestive heart failure)1 year:-RAS: 2.9% - BMT: 5.3% (P = 0.526)3 years: - RAS: 14.8% - BMT: 12.0% (P = 0.982)	No difference was found between the two groups. This may have been due to the insufficient number of patients.
Jaff et al.⁷ (HERCULES Trial) (2012)	Effect on SBP and patency rate in patients with RAS with uncontrolled hypertension	Single	202 patients	Stents (n = 245)	Freedom from major adverse events (9 months): 94.8%Restenosis (9 months): 10%Mean SBP significantly decreased (P < 0.0001)	There was no correlation between SBP reduction and baseline BNP or BNP reduction.	Although there was a risk of restenosis due to stenting, SBP significantly decreased in patients using three or more antihypertensive drugs.
Kalra et al.⁸ (2010)	Effect of MT vs. interventional therapy on GFR in patients with CKD	BMT vs. BMT with renal intervention	908 patients	Conservative group (n = 347)Revascularized patients (n = 561)	Multivariate analysis showed that revascularization independently reduced the risk of death by 45% in all patients.Improvements in renal function were observed in twice as many patients who underwent revascularization as compared with MT, particularly in the latter CKD stages: 15.2% (German revascularization) vs. 0.0% in CKD 1–2; 12.2% (UK) and 32.8% (German) revascularization vs. 14.1% in CKD 3; and 53.1% and 53.8% vs. 28.3% in patients with CKD 4–5The improvements in eGFR were 10.2 (16) and 8.1 (12.5) mL/min/year in the German and UK revascularized groups, respectively, vs. −0.05 (6.8) mL/min/year in the medical cohort of CKD 4–5.	Improvements in blood pressure control were noted at 1 year overall and within each CKD category.	This study has important methodological limitations. However, it showed that percutaneous renal revascularization can improve kidney function in advanced CKD (stages 4–5).The prospective analysis showed that percutaneous renal revascularization may provide a survival advantage.

RAS: renal artery stenosis, BMT: best medical treatment, MT: medical treatment, CKD: chronic kidney disease, eGFR: estimated glomerular filtration rate, BP: blood pressure, SBP: systolic blood pressure, TRAS: transplant renal artery stenosis, BNP: B-type natriuretic peptide, RA-PTAS: renal artery percutaneous angioplasty and stenting.

We identified many studies comparing the results of using balloons or stents in endovascular treatments within this patient group (Table 2). In most of the studies, the success of the procedure was higher in the stented group, and stenting had a positive effect on blood pressure in the early period. Positive effects on the GFR and serum creatinine concentration were also observed (Table 2). However, higher rates of restenosis were reported compared with balloon angioplasty.

Another patient group, which has grown in recent years, is patients with renal transplants. Considering these patients’ clinical situation, endovascular therapy has become the first-line treatment of renal artery stenosis developing in the transplanted kidney. The effects of endovascular treatment, especially on the GFR, serum creatinine concentration, and blood pressure control, are the important benefits in this population (Table 2).

With the continued development of stent and balloon technologies, these treatments will play an increasingly important role for patients with renal artery stenosis. In addition, patency rates are expected to increase while the risk of restenosis is expected to decrease with these technological developments. Successful results have been seen in the treatment of renal artery stenosis using sirolimus and paclitaxel and the development of coating technologies; thus, studies are expected to continue to explore the benefits of these therapies, and their indications will be further expanded.

Conclusion

No studies to date have definitively proven the superiority of renal artery angioplasty over optimal medical therapy. Nevertheless, many authors recommend interventions in patients with resistant hypertension and in patients who develop end-organ failure as a result of stenosis.

Balloon angioplasty should be considered for patients with renal arterial fibromuscular dysplasia (IIa). In patients with known renal artery stenosis, balloon angioplasty with or without a stent may be considered if sudden pulmonary edema or recurrent congestive heart failure develops (IIb). All these interventions should be performed under consideration of their contraindications and should not be applied if the patient has chronic total occlusion or mild to moderate arterial stenosis. Stent application has been found to be more successful in ostial lesions and should be considered in recurrent diseases. However, if the clinician decides to perform an intervention in other patients, balloon angioplasty should be prioritized despite its higher risk of recurrence.

Importantly, the success of the procedure depends on appropriate patient selection, detailed imaging and pre-procedure planning, an experienced team, proper drug use, and close patient follow-up after the intervention.

Footnotes

Author contributions

All authors read and approved the final version of the manuscript.

All authors contributed equally.

Declaration of conflicting interests

The authors declare that there is no conflict of interest.

Ethics statement

Ethics approval was not required for this review article. Informed consent was obtained from all participants.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

ORCID iD

Ahmet Ozan Koyuncu

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Endovascular treatments of atherosclerotic renovascular disease: a narrative review and literature search

Abstract

Keywords

Introduction

Definition

Clinical presentation

Indications for treatment

Contraindications

Endovascular access preference

Angioplasty and/or stent application

Technical success

Contrast nephropathy

Primary balloon angioplasty and stent placement

Postoperative management

Restenosis after endovascular intervention

Complications

Current literature review on renal artery stenosis

Conclusion

Footnotes

Author contributions

Declaration of conflicting interests

Ethics statement

Funding

ORCID iD

References