Cardiac structure and function after revascularization. Results of the major randomized clinical trials of renal. Various study results suggest that patients with baseline or more severe renal. Influence and critique of the astral and coral trials. The astral trial was a multicenter, randomized, unblinded clinical trial including a total of 806 patients 1. Effect of renal artery stenting on left ventricular mass. Angioplasty and stent for renal artery lesions astral trial. The two study groups had similar rates of renal events hazard ratio in the revascularization group, 0. We believe that the unconventional study design and significant methodologic flaws of this trial led to inaccurate. Approval has been gained for long term astral followup. The astral trial results revisitedto stent or not to stent in renal artery stenosis. The astral trial in the angioplasty and stenting for renal artery lesions astral trial,8 the primary outcome measure was the change in renal function over time as assessed by the mean slope of the reciprocal of the serum creatinine. Although revascularization does not benefit most pa. The clinical data have resulted in less widespread acceptance of the benefits of renal artery stenting.
The coral trial demonstrated that subjects with ras had similar outcomes whether randomized to optimal medical therapy alone or. Whether renal revascularization reduces left ventricular hypertrophy in patients with coronary artery disease is uncertain. Mistry s, ives n, harding j, et al angioplasty and stent for renal artery lesions astral trial. From the 1990s to coral cardiovascular outcomes in renal. The angioplasty and stent for renal artery lesions astral trial comparing renal function in arvd patients randomized to either revascularization or medical management alone was designed to. The angioplasty and stenting for renal artery lesions astral trial was designed to determine reliably whether revascularization together with medical therapy improves renal function and other.
It has been hypothesized that ras is a potentially reversible cause of hypertension and these other sequelae, and the. The astral trial is designed to address the issue of whether renal arterial revascularisation with balloon angioplasty andor endovascular stenting can safely prevent progressive renal failure among a wide range of patients with arvd. Investigators in the angioplasty and stenting for renal artery lesions astral trial are listed in the supplementary appendix, available with the full text of this article at. Astral does not plug gap in renal stenting evidence. The future of renal artery stenting for atherosclerotic renal artery stenosis recently, the coral trial was published 1. The uncertain value of renal artery interventions core. The astral trial, which was performed with the goal of determining whether stenting of the renal artery renal artery percutaneous angioplasty and stenting raptas combined with best medical therapy improved renal function and other outcomes when compared with best medical therapy alone. The enrollment criteria addressed some of the weaknesses faced in star and astral. The astral trial also was published in 2009 but was a larger study, including 806 patients with atherosclerotic renal artery stenosis randomly assigned to percutaneous transluminal renal artery angioplasty with or without stent placement plus medical treatment or to medical treatment alone, with 403 patients in each arm. Angioplasty and stent for renal artery lesions astral. Now an nhlbisponsored trial makes it clear, there are no advantages to the intervention. The landmark astral trial, published in the nejm this week, failed to demonstrate benefit from renal artery stenting in most patients with atherosclerotic renal artery stenosis. Revascularization versus medical therapy for renalartery.
Coral cardiovascular outcomes in renal atherosclerotic lesions 35 is the largest ongoing trial on renal artery stenting, with 1,080 patients randomly allocated to stenting with medical therapy versus medical therapy alone. Lookat star,astral primaryendpoint renal functionyet manyhadunilateral. Methods using data from 947 patients with a history of hypertension or chronic kidney disease from the largest randomized trial of renal artery stent placement, the coral cardiovascular outcomes in renal atherosclerotic lesions study, we performed exploratory analyses to determine if subsets of patients experienced better outcomes after stent placement than the overall cohort. Revascularization for atherosclerotic renal artery. Do patients undergoing renal revascularization outside of. The future of renal artery stenting open access journal. The overall finding of the coral trial was that stenting of atherosclerotic renal artery ste noses did not reduce the composite end point. Endovascular treatment for atherosclerotic renal artery stenosis aras was. There still are indications for renal artery stenting. In this trial, 806 patients with atherosclerotic renal artery stenosis were randomized to either. The angioplasty and stenting for renal artery lesions astral trial 20 was designed to address several questions, but most importantly to determine reliably whether revascularization together with best medical therapy improves renal function and other outcomes as compared with medical therapy alone in patients with.
The angioplasty and stenting for renal artery lesions astral trial is the largest trial to date into treatment for the kidney condition, it considered whether there is any real benefit to a combined approach of revascularisation treatment and medical therapy, compared with just medical therapy alone. The astral study was widely criticized on several grounds, 1, 2, 3 which led to questioning its main conclusion that percutaneous transluminal. Cardiovascular outcomes in renal atherosclerotic lesions. The angioplasty and stenting for renal artery lesions astral investigators found substantial. Does stenting of severe renal artery stenosis improve. Randomized clinical trial testing the effect of renal artery stenting versus medical therapy on left ventricular hypertrophy progression in patients affected by ischemic heart disease and renal artery. Patients were screened for enrollment in the study. Landmark trials in renal artery stenosis renal fellow. Older renal artery trials, for example star stent placement in patients with. Astral trial results revisitedto stent or not to stent in. The angioplasty and stenting for renal artery lesions astral investigators found substantial risks without evidence of a worthwhile clinical benefit from revascularization in patients with. The star trial investigated renal artery stenting in 140 patients with impaired renal function creatinine clearance arteries. To determine the efficacy and safety of stent placement in patients with aras and impaired renal function. Update on intervention versus medical therapy for atherosclerotic.
Stents no benefit in renalartery stenosis medscape. Does renal artery stenting prevent clinical events. Atherosclerotic renal artery stenosis and renal artery. Disease study equation also are nearly ubiquitous in this population. Clinical and kidney morphologic predictors of outcome for. There still are indications for renal artery stenting after coral. Despite these technical improvements, the indications for renal artery stenting are still a matter of debate due to the unproven benefit of renal revascularisation compared with best medical therapy, 3,22,23 including the recently presented results of the astral trial angioplasty and stent for renal artery lesion 24 and the star trial. Renal artery stenosis can lead to several different clinical syndromes ranging from difficult to control hypertension to recurrent pulmonary edema shortness of breath due to the lungs filling with fluid to ischemic nephropathy kidney dysfunction due to compromised arterial blood flow and frank renal failure. Pdf atherosclerotic renovascular disease arvd is a relatively common condition which may lead to progressive renal dysfunction, and. Systematic study of the effects of renal intervention upon the heart has never previously been undertaken, so assessment of whether or not renal. The primary outcome measure of the astral angioplasty and stenting for renal artery lesions trial was longitudinal change in renal function, while that of the coral cardiovascular outcomes in renal atherosclerotic lesions trial was a composite of death or major morbidity from cardiovascular or renal causes 5, 6. Astral trial reported higher creatinine values at 5 years for both the stenting.
Astral started recruiting in november 2000 and, as of the end of 2006, 731 patients have been randomized into the trial 19 patients. Stenting for atherosclerotic renal artery stenosis. White, md the subject of renal artery stenting has received considerable attention with the release of the results of the coral trial. A few small randomized trials began in the late 1990s to determine a competitive advantage of angioplasty for ras. Stents no help in renal artery stenosis medpage today. Both trials showed no evidence of benefit in renal function or blood pressure reduction. Pdf the astral trial results revisitedto stent or not. The coral trial compared the incidence of cardiovascular and renal adverse events for medical therapy alone with medical therapy plus renalartery stenting in patients with atherosclerotic renalartery stenosis and elevated blood pressure, chronic kidney disease, or both. The angioplasty and stent for renal artery lesions astral trial comparing renal function in arvd patients randomized to either revascularization or. Astral angioplasty and stent for renal artery lesions possibly the most debated trial thats not yet published. Data from the angioplasty and stenting for renal atherosclerotic lesions trial conducted over nearly the same time interval indicate that mortality was in excess of 25% in the cohort compared with 4. The investigators of the recently published astral angioplasty and stenting for renal artery lesions trial concluded that there was substantial risk without worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease.
Initial results from the astral angioplasty and stenting for renal artery lesions trial. The results of the angioplasty and stenting for renal artery lesions astral trial were released in 2009. Primary stenting for atherosclerotic renal artery stenosis. Renal artery stenting is no longer indicated after. Pdf angioplasty and stent for renal artery lesions astral trial. In 2014, the society for cardiovascular angiography and interventions scai released a new expert consensus statement for the appropriate use of renal artery stenting. Astral trial results revisitedto stent or not to stent in renal artery. Revascularization versus medical therapy for renalartery stenosis. Renal artery stenting, as compared to medical therapy, does not reduce the incidence of cardiovascular or renal events among patients with atherosclerotic renal artery stenosis, according to results of the coral trial presented nov. One seriously flawed study of renal stenting after another. The angioplasty and stenting for renal artery lesions astral study 10 was a similar comparison with similar results, showing no benefit from stenting with respect to renal function, systolic blood pressure control, cardiovascular events, or death. Stenting for renal artery atherosclerosis has soared in popularity since the 1990s. Angioplasty and stent for renal artery lesions trial astral.
In the astral study, data were presented for the more affected kidney for which. Renal artery stenosis ras occurs in up to 5% of people with hypertension and is associated with ischemic nephropathy and other complications. The angioplasty and stent for renal artery lesions astral trial comparing renal function in arvd patients randomized to either revascularization or medical management alone was designed to provide this evidence. Below we will describe the landmark trials that have guided us to our current belief in optimal treatment for our patients with ras. Strengths and limitations of renal artery stenting trials and a look at whats next in this arena.
Clinical outcome of renal artery stenting for hypertension. Stent placement in patients with atherosclerotic renal. The conclusion of the astral trial should be that if you, as a wise doctor, think or feel that a patient needs to be treated with a stent, you should do so, but if you are uncertain, which seems to be rare looking at the astral inclusion data, the patient should get best medical treatment. The angioplasty and stenting for renal artery lesions astral investigators found substantial risks without evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. Likewise, two randomized studies published in 2009 the astral trial and the star trial failed to show a clear benefit for renal artery stenting with respect to kidney function the newly. Astral angioplasty and stenting for renal artery lesions trial was longitudinal change in renal function, while that of the coral cardiovascular outcomes in renal atherosclerotic lesions trial was a composite of death or major morbidity from cardiovascular or renal causes 5, 6. Effect of renal artery stenting on renal function and size in.
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