ASTRAL Trial Research Articles

Long-Term Outcomes After Renal Revascularization for Atherosclerotic Renovascular Disease in the ASTRAL Trial

Long-Term Outcomes After Renal Revascularization for Atherosclerotic Renovascular Disease in the ASTRAL Trial

Medium-term Results of Renal Artery Revascularization in the Post-astral Era

Introduction: Renal artery stenosis (RAS) can cause severe hypertension and renal impairment. Pharmacological treatment has improved, and the additional benefit of invasive treatment with percutaneous transluminal renal angioplasty (PTRA) has been questioned since the publication of the ASTRAL trial in 2009 (1). The aim of this study was to investigate contemporary results of PTRA. Methods: Consecutive patients treated with PTRA for primary symptomatic RAS between 2010 and 2013 at four tertiary referral centres were retrospectively reviewed. Information on indications, co-morbidities, procedural details, and treatment results were retrieved from medical records of hospitals, interventional units, and primary care. Measures of outcomes were systolic and diastolic blood pressures, anti-hypertensive medication evaluated by number of drugs and by a calculated anti-hypertensive treatment index, and renal function evaluated by the estimated glomerular filtration rate (eGFR). The number of PTRA procedures done at the participating centres during the preceding four years (2006‒2009) were recorded for comparison, to evaluate change in PTRA frequency Results: The number of PTRA procedures decreased by approximately 50% from 2006 to 2013. Patients treated in the post-ASTRAL period, 2010‒2013, had a significant reduction in mean systolic blood pressure (from 168 to 146 mmHg, p<0.01), mean diastolic blood pressure (84 to 76 mmHg, p<0.01), mean number of anti-hypertensive drugs (3.54 to 3.05, p<0.01), and mean anti-hypertensive treatment index (21.75 to 16.92, p<0.01) compared to before PTRA. These improvements were maintained at one year and at the last clinical evaluation after a mean follow-up of 4.31 years. In contrast, renal function (eGFR) increased only transiently following the PTRA procedure, without sustained improvement during later follow-up. There was no significant difference in outcomes between subgroups differentiated by different indications for PTRA. Conclusion: The frequency of PTRA has decreased, indicating a higher threshold for invasive treatment of RAS in recent years compared to before the publication of the ASTRAL trial. The reduction in systolic and diastolic blood pressures, and the reduced need for anti-hypertensive medication, suggest a clinical benefit for patients who are now being treated with PTRA.

Spleno-renal anastomotic bypass revascularization for worsening renal failure and uncontrolled hypertension in bilateral calcific atherosclerotic renal artery stenosis

Following the recent publications of the STAR-study, the ASTRAL trial, the HERCULES trial and the CORAL trial on renal revascularization versus medical therapy in the management of atherosclerotic renovascular disease, there has been a near paradigm shift implying the nonutility of revascularization as a useful and necessary therapeutic option. Our recent experience with a patient who underwent an anastomotic bypass revascularization for worsening renal failure and uncontrolled hypertension in bilateral calcific atherosclerotic renal artery stenosis in Burlington, VT rekindled this debate. We posit that in appropriately selected patients, patients with acutely worsening renal failure, uncontrolled hypertension and/or symptomatic pulmonary edema, there is indeed a place for revascularization therapy, especially in the light of improved and safer surgical and anesthesiology techniques. It must be correctly acknowledged that the above well popularized randomized trials recruited mostly patients with otherwise stable chronic kidney disease at the time of enrollment. Similarly, only 12% of the patients in both arms of the ASTRAL trial demonstrated rapidly worsening renal failure prior to enrollment

Cardiac structure and function after revascularization versus medical therapy for renal artery stenosis: the ASTRAL heart echocardiographic sub-study

BackgroundThe ASTRAL trial showed no difference in clinical outcomes between medical therapy and revascularization for atherosclerotic renal vascular disease (ARVD). Here we report a sub-study using echocardiography to assess differences in cardiac structure and function at 12 months.MethodsASTRAL patients from 7 participating centres underwent echocardiography at baseline and 12 months after randomisation. Changes in left ventricular ejection fraction (LVEF), left ventricular mass (LVM), left atrial diameter (LAD), aortic root diameter (AoRD), E:A, and E deceleration time (EDT) were compared between study arms. Analyses were performed using t-tests and multivariate linear regression.ResultsNinety two patients were included (50 medical versus 42 revascularization). There was no difference between arms in any baseline echocardiographic parameter. Comparisons of longitudinal changes in echocardiographic measurements were: δLVEF medical 0.8 ± 8.7% versus revascularization − 2.8 ± 6.8% (p = 0.05), δLVM − 2.9 ± 33 versus − 1.7 ± 39 g (p = 0.9), δLAD 0.1 ± 0.4 versus 0.01 ± 0.5 cm (p = 0.3), δAoRD 0.002 ± 0.3 versus 0.06 ± 0.3 cm (p = 0.4), δE:A − 0.0005 ± 0.6 versus 0.03 ± 0.7 (p = 0.8), δEDT − 1.1 ± 55.5 versus − 9.0 ± 70.2 ms (p = 0.6). In multivariate models, there were no differences between treatment groups for any parameter at 12 months. Likewise, change in blood pressure did not differ between arms (mean δsystolic blood pressure medical 0 mmHg [range − 56 to + 54], revascularization − 3 mmHg [− 61 to + 59], p = 0.60).ConclusionsThis sub-study did not show any significant differences in cardiac structure and function accompanying renal revascularization in ASTRAL. Limitations include the small sample size, the relative insensitivity of echocardiography, and the fact that a large proportion of ASTRAL patient population had only modest renal artery stenosis as described in the main study.

IN1 - Impact of Sofosbuvir-Based Regimens for Chronic Hepatitis C Infection: A Work Productivity Model from Mainland China

Chronic Hepatitis C (CHC) imposes a considerable disease burden in China. There are approximately 10 million Chinese CHC patients, the majority of which are genotype 1 (GT1). Untreated infections are associated with a poor clinical prognosis and impairment in work productivity (WP), which has not been comprehensively evaluated in mainland China. This study models the impact of CHC infection on WP in China and estimates potential WP gains associated with ledipasvir/sofosbuvir (LDV/SOF) and sofosbuvir/velpatasvir (SOF/VEL) treatments, which are currently under review by China FDA. An economic model was developed to assess the impact of treatment with LDV/SOF on WP over a one-year period, with patients entering the model post-treatment, having achieved sustained virological response at 12 weeks (SVR12), or not. Absenteeism (absence from work) and presenteeism (reduced productivity at work) rates were extracted from the Phase III ION and ASTRAL trials as measured by the Work Productivity and Activity Index-Specific Health Problem questionnaire (WPAI-SHP); rates were assumed to be unchanged from baseline for patients not achieving SVR12. These rates were converted into hours of lost productivity, multiplied by the average working wage, total employment rate, and adult GT1 population in mainland China. We assumed universal treatment with either LDV/SOF or SOF/VEL in the model and contrasted the results relative to no treatment. Total annual work productivity loss due to not treating GT1 CHC patients was estimated to be around ¥18.11 billion. Treatment with sofobusvir-based regimens resulted in estimated productivity gains of ¥6.85 billion, primarily due to reduced presenteeism. Productivity losses due to untreated HCV infection represent a substantial indirect economic burden in China. Treatment with sofobusvir-based regimens is likely to result in substantial economic savings for society versus no treatment, which should be considered when assessing the value of CHC treatment.

24. Pan-genotypic response to velpatasvir and sofosbuvirin chronic hepatitis C in Kashmiri population

Background and Aims: Efficacy and safety of Velpatasvir and Sofosbuvir combination has been shown in ASTRAL trial 1–5 in Chronic hepatitis C. We aim to evaluate the efficacy (RVR and SVR) and safety of Velpatasvir and Sofosbuvirin Chronic hepatitis C regardless of genotype in Kashmiri population. Methods: It was a prospective, open label, hospital based observational study. All patients of chronic hepatitis C regardless of type of genotype were randomized into two groups: Non-cirrhotic and Cirrhotic. Both groups weredivided further into two groups: Treatment Naive and Treatment Experienced. Non-cirrhotic patients received Velpatasvir/Sofosbuvir (100/400 mg) for 12 weeks, however treatment was extended to 24 weeks or Ribavirin was added to 12-week combination in cirrhotics. Results: Till now we have enrolled 45 patients of chronic hepatitis Csince August 2016, this is an interim data of 25 patients and the study is still going on. Females constituted 14 (56%) and males were 11 (44%). Average age was 44 years (rage 20–70 years). Out of 25 patients, 16 (64%) were non-cirrhotic and 9 (36%) were cirrhotic. 24 (96%) were treatment naïve and 1 (4%) was treatment experienced. All patients 25 (100%) achieved SVR12 both in non-cirrhotic and cirrhotics. All patients tolerated the combination well, however some patients experienced nausea (26%), headache (25%) and fatigue (21%). No patient had to discontinue therapy due to adverse drug reactions. Conclusions: Single daily dose of tablet Velpatasvir and Sofosbuvir combination is safe and effective in all types of chronic hepatitis C regardless of genotype. The authors have none to declare.

Sofosbuvir/Velpatasvir: A Review in Chronic Hepatitis C.

A once-daily, single-tablet, pangenotypic regimen comprising the hepatitis C virus (HCV) NS5B polymerase inhibitor sofosbuvir and the HCV NS5A inhibitor velpatasvir (sofosbuvir/velpatasvir; Epclusa®) was recently approved for the treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection in the USA, EU and Canada. In the phase III ASTRAL trials, once-daily oral sofosbuvir/velpatasvir for 12weeks provided very high rates of sustained virological response at 12weeks post treatment (SVR12) in treatment-naive and -experienced patients with chronic HCV genotype 1-6 infection, including those with compensated cirrhosis or HIV-1 co-infection. High SVR12 rates were also observed with sofosbuvir/velpatasvir plus ribavirin for 12weeks in patients with chronic HCV genotype 1-6 infection and decompensated cirrhosis. Sofosbuvir/velpatasvir was generally well tolerated, with low rates of adverse events. Thus, sofosbuvir/velpatasvir represents a valuable treatment option in adults with chronic HCV genotype 1-6 infection, including those with compensated or decompensated cirrhosis, previous treatment experience or HIV-1 co-infection.

Where now in the management of renal artery stenosis? Implications of the ASTRAL and CORAL trials.

The neutral findings of Angioplasty and Stenting for Renal Artery Lesions and Cardiovascular Outcomes in Renal Artery Lesions trials have shown that unselected revascularization does not improve outcomes in atherosclerotic renovascular disease (ARVD). This review highlights recent translational, clinical and epidemiological studies and suggests directions for future research. Imaging studies show that the degree of renal artery stenosis is not the most important determinant of outcome and response to therapies in ARVD. Porcine models have established a better understanding of the microvascular and inflammatory changes that occur in ARVD. Biomarkers of inflammation and cardiovascular dysfunction may be informative but do not yet help assess prognosis or response to treatment. Stem cell therapies show promise in animal models but have yet to translate into clinical practice. Analysis of patient subgroups with high-risk presentations of ARVD has provided new insights into treatment response and may guide future studies. It is time to reframe thinking and research in ARVD. We need better ways to identify patients likely to benefit from revascularization and to improve response to treatment in these individuals. Many preclinical studies show promise, but these are often small scale and difficult to replicate. Future work should focus on establishing an international disease registry as a foundation for collaborative research.

Renal artery stenosis: Up-date on diagnosis and treatment

Significant renal artery stenosis (RAS) can cause or result in deterioration of arterial hypertension and may promote the development of renal insufficiency. The activation of the renin-angiotensin-aldosterone system results in structural heart disease and may impact patient survival. Technical improvements of diagnostic and interventional endovascular tools have led to a more widespread use of endoluminal renal artery revascularization and extension of the indications for this type of therapy during the past two decades. Whereas balloon angioplasty is still the method of choice for the treatment of fibromuscular dysplasia, stent implantation is indicated in ostial atherosclerotic RAS. However, none of the so far published or presented randomized controlled trials could prove a beneficial outcome of RAS revascularization compared to medical management. As a result of these negative trials including the largest published trial to date, the ASTRAL trial, referrals to endovascular renal artery revascularization have declined and, moreover, reimbursement of these procedures has become a matter of debate. Crucial for a clinical benefit following revascularization of RAS is proper patient selection, revascularization being only indicated after proof of hemodynamic relevance of RAS. This article summarizes the appropriate diagnostic work-up of patients with suspected RAS, discusses the limitations of the results published so far and their impact on the indication for RAS revascularization.

Revaskularisation der Nierenarterienstenose: State of the Art

Atherosclerotic renal artery stenoses (aRAS) are often associated with an aorto-iliac type of peripheral occlusive artery disease and may result in deterioration of blood pressure control, chronic kidney disease and myocardial dysfunction. Stenting of aRAS has almost replaced surgical revascularisation. However, the benefit of endovascular treatment of aRAS was challenged by the results of the STAR and ASTRAL trials demonstrating similar outcomes for revascularisation and conservative treatment. Due to severe limitations in trial design, the study results can only be applied to a small proportion of the affected patient population. A clinical benefit of renal stenting can only be expected if the indication for endovascular procedure was correct, in particular if the hemodynamic relevance of the lesion was verified by non-invasive (duplex) or invasive (pressure gradient) methods. The known predictors (pulse pressure > 50 ± 10 mmHg, high diastolic blood pressure, elevated BNP levels, renal insufficiency) for clinical success are often not sufficiently implemented in the decision-making process. Unquestioned by international guidelines is the indication for revascularisation of aRAS of a single functioning kidneys, severe bilateral lesions, resistant hypertension, worsening of renal function, and in each kind of severe RAS of non-atherosclerotic nature.

“Re: Renal Artery Stenting is no Longer Indicated After ASTRAL: Pros and Cons”

The authors of the ASTRAL trial [1] were interested to read the debate about the trial in CVIR [2]. They have listened with some bemusement to the criticisms that have been levelled at the study in this debate and other publications [3]. Although constructive criticism and intelligent debate is healthy, it appears that many are confused about the methodology and results of the ASTRAL Trial. It is important to be clear that after years of small case series, cohorts, and randomized, controlled trials, ASTRAL succeeded in randomizing a significant number of patients with chronic renal impairment to renal stenting and best medical therapy against best medical therapy alone. It is more than 7.5-times larger than the previous largest reported study [4]. This was quite an achievement. Some critics of ASTRAL did not enter any patients into the trial, either because they were never ‘‘uncertain’’ how to treat their patients (lucky them) or they misunderstood the ‘‘uncertainty principle.’’ Patient eligibility based on the ‘‘uncertainty principle’’ has been widely used in a number of trials [5] and is scientifically and ethically acceptable in those situations where a clinician is uncertain how to treat a patient. This principle resulted in a heterogeneous patient population being entered into the trial, as different clinicians had different areas of uncertainty regarding the use of renal stenting. One of the criticisms levelled at ASTRAL is that many patients (and especially patients considered likely to benefit from renal stenting) were not entered into the trial. However, randomization is only ethically justified if one is unsure of the benefits of intervention to the individual patient. In the event, the patients recruited to ASTRAL did not have trivial disease. The majority had severe renal artery stenosis and/or impaired renal function. Randomization was stratified according to disease severity and the number in each prespecified subgroup was substantial (often larger in patient numbers than the previous trials). We found no evidence of benefit for renal stenting in any of the subgroup analyses or in the post-hoc analysis of the most severe patients. Those who criticize the ASTRAL trial on the basis that it excluded those patients who were likely to benefit from intervention have misunderstood the uncertainty principle. It is impossible to know why individual patients were excluded, but it is likely that many patients with accepted indications for intervention, such as acute anuric renal failure, very rapid decline in renal function, malignant hypertension, and flash pulmonary edema, were not randomized. Fibromuscular disease was a specific exclusion criterion. Critics should recognize that ASTRAL is not at a variance with all the previous small studies mentioned above. In fact many of these results are supported by the ASTRAL analyses. The difference between ASTRAL and these other studies is that nearly all of the patients in ASTRAL were taking best medical therapy. Quite simply, the benefits attributed to angioplasty or stenting in previous studies could be achieved by best medical therapy alone. It is important to recognize that no other study on renal artery N. Chalmers (&) Department of Radiology, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, UK e-mail: Nicholas.chalmers@cmft.nhs.uk

Erratum Regarding Renal Artery Stenting

In the October publication (vol 33, no 5, p 884), Heiko Alfke mentions the ‘‘Study of Tamoxifen and Raloxifene’’ [1]. I am sure that this should have read, ‘‘Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial’’ [2]—both of course with the acronym STAR. In the United Kingdom, the latter (and the ASTRAL trial) seem to have had a huge impact on clinical practice. I find it curious that other trials, such as the EVAR and the Vertebroplasty trials, have had so little impact. Surely, all are imperfect. Do we interpret trials to suit our prejudices? Conflict of interest None.

Revascularization versus medical therapy for renal-artery stenosis. The ASTRAL Investigators. The New England Journal of Medicine 2009; 361: 1953—1962

Study objective: The objective of ASTRAL was to determine whether percutaneous revascularization combined with medical therapy compared to medical therapy alone improves renal function and other outcomes, such as blood pressure, time to first renal event, time to first major cardiovascular event, and mortality. Study population: ASTRAL enrolled 806 patients with atherosclerotic renovascular disease from 57 centers. Patients were screened if treating clinicians felt they had clinical features suggestive of underlying atherosclerotic renovascular disease (i.e. hypertension refractory to medical therapy, or renal impairment as suggested by laboratory measurements). All patients had to have an imaging modality (i.e. computed tomographic angiography (CTA), magnetic resonance angiography (MRA) or renal artery ultrasound). This imaging had to convey that the patient had ‘substantial’ anatomical atherosclerotic stenosis in at least one renal artery that was suitable for endovascular therapy. Also, the treating clinician had to be ‘uncertain’ that the patient would benefit from revascularization. Fifty-nine percent of patients were reported to have renal artery stenosis of &gt; 70%, and 60% had a serum creatinine of ≥ 150 mmol per liter. Design and methods: ASTRAL was a randomized, unblinded study of patients with atherosclerotic renal artery disease who were assigned to percutaneous revascularization plus best medical therapy or best medical therapy alone. The primary outcome of the ASTRAL trial was the change of renal function over time, as determined by the mean slope of the reciprocal of serum creatinine. Secondary outcomes included blood pressure, time to first renal event (defined as: new onset of kidney injury, dialysis, renal transplantation, nephrectomy, or death from renal failure), time to first major cardiovascular event (defined as: myocardial infarction, stroke, death from cardiovascular cause, hospitalization for angina, fluid overload or congestive heart failure, coronary artery revascularization, or another peripheral arterial procedure), and all-cause mortality. Randomization was 1:1 via computer algorithm and was stratified by serum creatinine, glomerular filtration rate (GFR), severity of renal artery stenosis, kidney length on ultrasound, and rate of progression of renal impairment. Patients who were assigned to the revascularization plus medical therapy arm underwent percutaneous revascularization within 4 weeks. The procedure type (angioplasty alone or with stenting), was left to the discretion of the local operator. Distal protection devices were not used. Medical therapy in both arms consisted of antihypertensive drugs, statins, and antiplatelet agents. The trial was powered to detect a 20% reduction in the mean slope of the reciprocal of serum creatinine. Based on low crossover rates, it was determined that at least 750 patients would have to be enrolled. Analysis was by intention to treat. Continuous variables were subject to repeated measures analysis. Time-to-event data were expressed via Kaplan Meier curves and compared via log-rank testing. Prespecified subgroup analyses included baseline serum creatinine, GFR, severity of renal artery stenosis, kidney length, and progression of renal disease. Results: Of the 806 patients included, 403 were randomized to the revascularization arm and 403 to medical therapy only. The median follow-up was 34 months. Only 337 (83%) patients randomized to revascularization underwent the procedure, whereas 24 patients (6%) randomized to the medical therapy arm underwent revascularization. The number of antihypertensive medications used was greater in the medical therapy group than in the revascularization group at the 12-month follow-up: 2.97 versus 2.77 ( p = 0.03). The mean slope of the reciprocal of the serum creatinine concentration was —0.07 × 10— 3 liters per micromole per year in the revascularization group versus —0.13 × 10—3 liters per micromole per year in the medical-therapy group (difference of 0.06 × 10 —3 liters per micromole per year) (95% confidence interval [CI], —0.002 to 0.13, p = 0.06) with a trend favoring revascularization. After 5 years of follow-up, there was a trend toward lower mean systolic blood pressure (1.6 mmHg lower, p = 0.06) in the revascularization group. However, the mean diastolic blood pressure was significantly lower in the medical therapy group at long-term follow-up (divergence of slope of mean diastolic blood pressure: 0.61 mmHg per year, p = 0.03). There was no significant difference between renal events, time to first renal event, acute kidney injury, or development of end-stage renal disease in either group. Further, there was no difference in major cardiovascular events or overall survival in either group. The periprocedural complication rate within the revascularization group was 9% (31/359 patients). Fifty-five out of 280 patients (20%) had an adverse event by 1 month post procedure. Overall, there were 31 serious complications of revascularization in 23 patients. Per protocol analysis of patients suggested that there was no significant difference in outcomes between patients who received revascularization versus medical therapy. No differences between treatment groups were identified in any of the pre-specified subgroup analyses. Conclusions: Renal artery stenting combined with medical therapy did not improve renal function compared to medical therapy alone in patients with atherosclerotic renal artery disease.

Percutaneous revascularization of the renal arteries offers no evidence of clinical benefit in patients with atherosclerotic renal artery stenosis—the astral trial

Percutaneous revascularization of the renal arteries offers no evidence of clinical benefit in patients with atherosclerotic renal artery stenosis—the astral trial

Critical review of indications for renal artery stenting: Do randomized trials give the answer?

Significant renal artery stenosis (RAS) is a well accepted cause of deterioration of arterial hypertension and of renal insufficiency. Just recently, more interest has been focused on the impact of RAS on structural heart disease and patient survival. Technical improvements of diagnostic and interventional endovascular tools have lead to a more widespread use of endoluminal renal artery revascularization and extension of the indications for this type of therapy during the past 2 decades. Since the first renal artery angioplasties performed by Felix Mahler and Andreas Grüntzig, numerous single centre studies have reported the beneficial effect of percutaneous transluminal renal angioplasty, and since the early 1990's stenting of renal artery stenosis caused either by atherosclerosis or fibromuscular dysplasia. However, none of the so far published or presented randomized controlled trials (RCT) could prove a beneficial outcome of RAS revascularization compared with medical management. As a result of these negative trials including the recently presented ASTRAL trial, referrals to endovascular renal artery revascularization went down and moreover, reimbursement of these procedures became a matter of debate. This article summarizes the background and the limitations of the so far published and still ongoing controlled trials. Moreover, we discuss why well-designed registries might give important insight on the impact of endovascular revascularization of hemodynamically relevant atherosclerotic RAS.

Gadolinium‐enhanced magnetic resonance imaging for renovascular disease and nephrogenic systemic fibrosis: Critical review of the literature and UK experience

To examine the positive reporting bias regarding the link with gadolinium (Gd) exposure and nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This link has impacted strongly the international radiology safety guidelines. We believe that positive reporting bias has prevailed in the literature and that very few patients with a glomerular filtration rate (GFR) 15-29 mL/min (stage 4 chronic kidney disease [CKD]) should be regarded as high risk. To examine this, we conducted the following steps: 1. A critical literature search on NSF. 2. An analysis of our centers magnetic resonance angiography (MRA) experience since 1999. 3. A survey of participating centers of the multicenter ASTRAL trial to assess whether any patients screened or enrolled into ASTRAL had developed NSF. The vast majority (90%) of NSF cases reported in the literature have occurred in patients with endstage renal disease treated with dialysis; very have had stable stage 4 or 5 (nondialysis) CKD. In all, 562 patients were followed up at our center: 30.4% were CKD4, 14.4% CKD5, 5.3% on dialysis, and 0.2% had renal transplants when imaged. No patients developed any symptoms or signs of NSF. In all, 347 patients were enrolled into ASTRAL on the basis of MRA (32% CKD4/5). One patient out of 45 centers (CKD5, received two Gd scans) developed NSF. Approximately 5 times as many patients were screened as were entered into ASTRAL. No cases of NSF were observed at our center. By extrapolation, 1/1735 patients screened for the ASTRAL trial developed NSF, giving a crude incidence rate of 0.06%. We would argue that patients with CKD4 can safely undergo Gd-MRA, albeit using a minimal dose of a macrocyclic agent and avoiding repeat doses.

Renal Artery Stenting – Developments in Practice

Significant renal artery stenosis (RAS) is a well-accepted cause of arterial hypertension and renal insufficiency. Technical improvements of diagnostic and interventional endovascular tools have led to more widespread use of endoluminal renal artery revascularisation and the extension of the indications for this type of therapy during the past two decades. Since the first renal artery angioplasties were performed by Felix Mahler and Andreas Grüntzig, numerous single-centre studies have reported the beneficial effect of percutaneous transluminal renal angioplasty, and since the early 1990s stenting of RAS caused by either atherosclerosis or fibromuscular dysplasia. However, none of the published or presented randomised controlled trials (RCTs) prove a beneficial outcome of RAS revascularisation compared with medical management. As a result of these negative trials, including the recently published or presented STAR and ASTRAL trials, referrals to endovascular renal artery revascularisation have decreased and, moreover, reimbursement of these procedures has become a matter of debate. This article provides an overview of the state-of-the-art endovascular technique of renal artery stenting and discusses the limitations of the published trials, highlighting the crucial aspect of proper patient selection.