Atherosclerotic Renovascular Hypertension : Lessons from Recent Clinical Studies
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1 Review ISSN (Print) ISSN (Online) Electrolyte Blood Press 8:87-91, 2010 doi: /EBP Atherosclerotic Renovascular Hypertension : Lessons from Recent Clinical Studies Wookyung Chung, M.D. Sejoong Kim, M.D. Department of Internal Medicine, Gachon University of Medicine and Science, Incheon, Korea Received: October 27, 2010 Accepted: December 7, 2010 Corresponding author: Sejoong Kim, M.D. Department of Internal Medicine, Gachon University Gil Hospital, 1198 Guwol-dong Namdong-gu, Incheon, , Korea Tel: , Fax: imsejoong@hanmail.net Atherosclerotic renovascular hypertension is a form of secondary hypertension due to renal artery stenosis. After the introduction of medical therapy such as with statins and angiotensin blocking agents, it has been considered a very slowly progressive disease. In the 1990s, surgical methods were compared to radiological intervention and showed no additional benefits. Recent clinical data also demonstrate that in cases of relatively stable atherosclerotic renovascular disease, medical therapy is as effective as other interventions with regard to patient outcomes. In this paper the recent clinical outcomes are reviewed. Key Words: atherosclerosis; renal artery obstruction; hypertension This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Introduction Atherosclerotic renal artery hypertension is reported in almost 7% of adults older than 65 years 1) and is associated with cardiovascular events, and may double risk of mortality 2). In the 1990s, radiological angioplasty began to replace surgical revascularization. Galaria et al. showed that percutaneous and open renal revascularization had equivalent long-term functional outcomes 3). Over time, the less-invasive procedure became more accessible. Most cases of atherosclerotic renovascular disease (ARVD) are located in the ostium, and are extensions of calcified aortic plaques 4). These lesions tend to return to their original shape with balloon angioplasty alone. Stent placement might also provide additional force to increase the rates of technical success 5) and to reduce the rate of restenosis at 6 months after the initial procedure 6). Intervention with stents has become a standard procedure; in patients with stenosis of the renal artery, placement of a stent is likely to be the initial form of treatment. However, there is limited evidence to support revascularization over medical therapy for patients with atherosclerotic renal artery stenosis 7, 8). Natural history Retrospective studies previously reported that renal artery lesions might progress to severe stenosis and ultimately to renal artery occlusion 9). Michael et al. performed a prospective study that reported that the progression of renal artery disease was a frequent occurrence with an annual rate of progression of renal artery lesions reported to be 7% 10). However, at the time of these studies, statins were being used in fewer patients. A retrospective study of the effects of statins on the progression of ARVD has shown that the use of statins reduces the risk of progression and the development of ARVD 11). Another prospective population-based study reported that the progression to significant ARVD was observed in only 4.0% during 8 years of follow-up (annualized rate, 0.5% per year),
2 88 W Chung et al. Atherosclerotic Renovascular Hypertension and no case of ARVD progressed to occlusion 12). Dissociation between arterial patency and function Hypertension and renal artery stenosis are not necessarily renovascular hypertension. Essential hypertension and clinically silent renal artery stenosis often coexist, and essential hypertension also coexists with renovascular hypertension 13). This is why blood pressure control does not always improve after stenting. Renal injury distal to an atherosclerotic renovascular obstruction is due to multiple intrinsic factors producing parenchymal tissue injury (Fig. 1) 14). Non-traditional mediators of ARVD such as inflammatory pathways, reactive oxygen species production, ischemia/reperfusion damage and modulation of matrix turnover have been proposed as causes of the renal failure related to ARVD 15). This complexity of the pathophysiology might explain why the severity of the stenosis is not correlated with renal dysfunction. Clinical data support dissociation of improved renal artery patency from clinical outcome in patients with atherosclerotic renal artery stenosis; this may illustrate the effects of irreversible injury on the post stenotic kidney. A prospective clinical study reported by Wright et al. showed absence of a correlation between renal artery anatomy and baseline renal function or functional Reactive oxygen species /oxidative stress Vasoconstriction Immune responses Endothelial & tubular dysfunction and injury Atherosclerosis Inflammation Ox LDL Angiotension II Tubulointerstitial injury /glomerulosclerosis Fibrosis Renal scarring Fig. 1. Mechanisms of Renal Damage Associated with Atherosclerotic Renal Artery Stenosis. These mechanisms include an interaction among increased oxidative stress, immune responses, inflammation, immune responses, and angiotensin II/endothelin, which impair renal function, induce endothelial and epithelial dysfunction and injury, and may lead to irreversible scarring. Ox LDL, oxidized low-density lipoprotein cholesterol. *Modified from the study of Chade AR et al. Ref. 14. outcome, and a good correlation between renal functional outcome and proteinuria; these findings suggest that renal parenchymal damage is a major determinant of renal dysfunction and outcome rather than the severity of the renal artery stenosis in ARVD 16). Radermacher et al. reported that the mean arterial pressure did not decrease by 10 mmhg or more after revascularization and renal function declined in most patients with ARVD that had high resistance-index values before revascularization 17). Chrysochou et al. showed a correlation between baseline proteinuria and decline in estimated glomerular filtration rate (GFR) with time after revascularization 18). Therefore, post stenotic renal injury can lead to renal parenchymal injury reflected by high intrarenal resistance and/or the presence of proteinuria. Proteinuria and other factors involved in intrarenal resistance are predictors of a poor outcome after renal revascularization in ARVD. When patients with chronic kidney disease undergo renal angioplasty with/without stent placement, the response with regard to renal function can be negative as well as positive. Positive responses include improvement of renal function, and stabilization or attenuation of declining renal function, as expected. However, sometimes declining renal function is accelerated after revascularization. Possible causes of these adverse outcomes include contrast induced nephropathy, atheroembolism, and restenosis or stent thrombosis 19). The administration of contrast might increase the risk of acute renal dysfunction, especially in patients that have preexisting renal impairment. An ex vivo study reported that each manipulation of atheroma specimens, from simply advancing the guidewire through the atherosclerotic lesion to positioning and deploying the Wallstent, releases thousands of fragments, and that these atherosclerotic fragments are of sufficient size to create vascular occlusion and initiate significant renal parenchymal damage 20). Currently, there is no way to predict positive or negative responses after revascularization. Factors favoring medical therapy ARVD is a cardiovascular condition that is associated with renal artery stenosis. The nature of this disorder suggests that a systemic approach is necessary to provide cardiovascular protection. Previously, statin therapy was discussed as a method of altering
3 Electrolyte Blood Press 8:87-91, 2010 doi: /EBP the natural history of ARVD 11). Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers effectively reduce blood pressure in patients with renovascular disease. In addition, a population-based cohort study of over 3,500 patients with ARVD in Canada found that angiotensin inhibitors could cause acute renal toxicity in a small subset of vulnerable patients; however, they still improved the cardiovascular and renal outcomes in patients with ARVD, but at the expense of acute renal toxicity 21). Recently three randomized controlled trials have been performed: the Stent Placement and Blood Pressure and Lipidlowering for the Prevention of Progression of Renal Dysfunction Caused by Atherosclerotic Ostial Stenosis of the Renal Artery (STAR) trial, the Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial, and the Cardiovascular Outcomes in Renal Artherosclerotic Lesions (CORAL) trial (Table 1). Two large randomized trials of intervention vs. medical therapy showed negative results for the intervention. The last trial is under way. The STAR trial was a European multicenter trial that enrolled 140 patients with ostial renal artery stenosis greater than 50%, blood pressure controlled to less than 140/90 mmhg, and creatinine clearance 15 to 80 ml/min 7). All patients received angiotensin blocking agents and a statin, regardless of their lipid levels. After a 2-year interventional period, no difference was observed in the decline of renal function, the degree of blood pressure control, and the rates of cardiovascular morbidity and death. Investigators in the ASTRAL trial enrolled 806 patients with at least one stenotic renal artery considered suitable for balloon angioplasty, stenting, or both in their international, multicenter trial 8). The mean estimated GFR was 40 ml/min, and most of the patients were on statin and angiotensin blocking therapy. At a mean follow-up of 33.6 months, no difference was noted between the treatment groups in the decline of renal function or blood pressure control, and the renal function worsened slightly in both groups. Most of the enrolled patients in the two clinical trials had relatively asymptomatic atherosclerotic renal artery stenosis. Therefore, the practice of indiscriminately performing revascularization, without strong evidence, is no longer acceptable. The CORAL trial is an ongoing multicenter randomized controlled trial in the United States 22). It is still enrolling patients that have drug-resistant hypertension or a GFR < 60 ml/min. It is using a standardized medical protocol to control blood pressure, and embolic protection devices during procedures are encouraged. Thus far, intervention has not been recommended if renal function has remained stable over the past 6 to 12 months and if hypertension can be controlled medically. According to a clinical classification of atherosclerotic renal artery stenosis with guidelines for vascular intervention of surveillance published in 2008 by the Atherosclerotic Peripheral Vascular Symposium 23), additional recommendations favoring medical therapy were as follows: very advanced age and/or limited life expectancy, extensive co-morbidities that make revascularization too risky, high risk for or previous experience with atheroembolic disease, and other concomitant renal parenchymal diseases that cause progressive renal dysfunction (e.g., interstitial nephritis, diabetic nephropathy) 23). Table 1. Recent Three Randomized Controlled Trials in Patients with Atherosclerotic Renal Artery Stenosis Trial Main selection criteria STAR 7) ASTRAL 8) CORAL 22) Stenosis 50% GFR ml/min Stable BP Stenosis with no clear indication of revascularization Stenosis 60% Systolic BP 155 mmhg on 2 antihypertension drugs Treatment group (n) PTA plus stent (64) PTA with or without stent (403) PTA plus stent Control group (n) Medication (76) Medication (403) Medication Primary outcome Decrease in GFR 20% Reciprocal creatinine level over time Doubling of serum creatinine Need for renal replacement therapy Results No significant difference in primary outcome or BP No significant difference in primary outcome, BPand cardiovascular events On-going Intervention-related complications (%) Death (3.2) Hematomas (17) Acute kidney injury (8) Death (0.7) Hospitalization for hematomas (1.4) Acute kidney injury (2.1) STAR, Stenosis of the Renal Rrtery; ASTRAL, Angioplasty and Stenting for Renal Artery Lesions; CORAL, Cardiovascular Outcomes in Renal Artherosclerotic Lesions; GFR, glomerular filtration rate; BP, blood pressure; PTA, percutaneous transluminal angioplasty.
4 90 W Chung et al. Atherosclerotic Renovascular Hypertension They also recommended factors favoring medical therapy and intervention as follows: progressive decline in GFR during treatment of systemic hypertension, failure to achieve adequate blood pressure control with optimal medical therapy (medical failure), rapid or recurrent decline in the GFR in association with a reduction in systemic pressure, decline in the GFR during therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and recurrent congestive heart failure in a patient in whom the adequacy of left ventricular function does not provide an explanation 23). The best evidence supporting intervention is for bilateral stenosis with flash pulmonary edema, but the evidence is from retrospective studies 24-26). Conclusion The aim of treatment for ARVD should include the prevention of cardiovascular and/or renal events. Treatment of patients with ARVD should include consideration of the following factors: age, co-morbidity, blood pressure, renal function, and kidney size. The results of two recent studies suggest that patients with ARVD and stable renal function can be controlled medically. Intervention should be considered only in patients with ARVD and rapidly progressive cardiac or renal dysfunction. However, these conditions also increase the risk of complications related to revascularization procedures. Both the risks and potential long-term benefits of intervention should be considered. The results of the CORAL and the post hoc analysis of ASTRAL might provide additional evidence for revascularization. References 1) Hansen KJ, Edwards MS, Craven TE, et al.: Prevalence of renovascular disease in the elderly: a population-based study. J Vasc Surg 36: , ) Conlon PJ, Little MA, Pieper K, Mark DB: Severity of renal vascular disease predicts mortality in patients undergoing coronary angiography. Kidney Int 60: , ) Galaria, II, Surowiec SM, Rhodes JM, et al.: Percutaneous and open renal revascularizations have equivalent long-term functional outcomes. Ann Vasc Surg 19: , ) Kennedy DJ, Colyer WR, Brewster PS, et al.: Renal insufficiency as a predictor of adverse events and mortality after renal artery stent placement. Am J Kidney Dis 42: , ) Beutler JJ, Van Ampting JM, Van De Ven PJ, et al.: Long-term effects of arterial stenting on kidney function for patients with ostial atherosclerotic renal artery stenosis and renal insufficiency. J Am Soc Nephrol 12: , ) van de Ven PJ, Kaatee R, Beutler JJ, et al.: Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial. Lancet 353: , ) Bax L, Woittiez AJ, Kouwenberg HJ, et al.: Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial. Ann Intern Med 150: , ) Wheatley K, Ives N, Gray R, et al.: Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med 361: , ) Axelrod DA, Fendrick AM, Carlos RC, et al.: Percutaneous stenting of incidental unilateral renal artery stenosis: decision analysis of costs and benefits. J Endovasc Ther 10: , ) Caps MT, Perissinotto C, Zierler RE, et al.: Prospective study of atherosclerotic disease progression in the renal artery. Circulation 98: , ) Cheung CM, Patel A, Shaheen N, et al.: The effects of statins on the progression of atherosclerotic renovascular disease. Nephron Clin Pract 107:C35-42, ) Pearce JD, Craven BL, Craven TE, et al.: Progression of atherosclerotic renovascular disease: A prospective population-based study. J Vasc Surg 44: ; discussion , ) Textor SC: Atherosclerotic renal artery stenosis: how big is the problem, and what happens if nothing is done? J Hypertens 23 (Suppl 3):S5-13, ) Chade AR, Lerman A, Lerman LO: Kidney in early atherosclerosis. Hypertension 45: , ) Meier P, Rossert J, Plouin PF, Burnier M: Atherosclerotic renovascular disease: beyond the renal artery stenosis. Nephrol Dial Transplant 22: , ) Wright JR, Shurrab AE, Cheung C, et al.: A prospective study of the determinants of renal functional outcome and mortality in atherosclerotic renovascular disease. Am J Kidney Dis 39: , ) Radermacher J, Chavan A, Bleck J, et al.: Use of Doppler ultrasonography to predict the outcome of therapy for renal-artery stenosis. N Engl J Med 344: , ) Chrysochou C, Cheung CM, Durow M, et al.: Proteinuria as a predictor of renal functional outcome after revascularization in atherosclerotic renovascular disease (ARVD). QJM 102: , ) Simon JF: Stenting atherosclerotic renal arteries: time to be less
5 Electrolyte Blood Press 8:87-91, 2010 doi: /EBP aggressive. Cleve Clin J Med 77: , ) Hiramoto J, Hansen KJ, Pan XM, Edwards MS, Sawhney R, Rapp JH: Atheroemboli during renal artery angioplasty: an ex vivo study. J Vasc Surg 41: , ) Hackam DG, Duong-Hua ML, Mamdani M, et al.: Angiotensin inhibition in renovascular disease: a population-based cohort study. Am Heart J 156: , ) Cooper CJ, Murphy TP, Matsumoto A, et al.: Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: rationale and design of the CORAL trial. Am Heart J 152:59-66, ) Rocha-Singh KJ, Eisenhauer AC, Textor SC, et al.: Atherosclerotic Peripheral Vascular Disease Symposium II: intervention for renal artery disease. Circulation 118: , 2008
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